TWI243210B - A quality control method for assessing herbal compositions - Google Patents

Abstract

The present invention provides the tools and methodologies necessary to guide the standardization of herbal compositions, to determine which specific components of an herbal composition are responsible for any particular biological activity, to predict the biological activities of a particular herbal composition, and for the development of improved herbal therapeutics. This invention provides the tools and methodologies for creating, maintaining, improving and utilizing Herbal BioResponse Arrays (HBR Arrays), wherein the HBR Arrays constitute data sets associated with particular herbal compositions. The HBR Arrays of the present invention may include information on the plant-related parameters of the herbal constituents, marker information collected following the exposure of a biosystem to the herbal composition, and biological response information collected following the exposure of a biosystem to the herbal composition.

Description

1243210 A7 V. Description of the invention (Theories printed by the Consumer Cooperatives of the Intellectual Property Bureau of the Ministry of Economic Affairs. The western medicine generally uses purified compounds (whether natural or oral). However, the composition used in traditional Chinese medicine is usually composed of herbal medicines and compounds based on the independent and holistic view of body I. Traditional Chinese medicine is processed by different combinations and formulations. The original natural products treat different symptoms with fewer side effects. The powerful potential of traditional Chinese medicine has yet to be understood by most people in the world. The herbal medicine department in the typical traditional Chinese medicine prescription is entrusted with the main medicine, Secondary medicines (including ministerial medicines, adjuvant medicines, and medicines). The main medicine is the medicine that produces the main therapeutic effect in the treatment of the cause or main disease of a disease. The medicine helps to strengthen the role of the main medicine and treat the comorbidities It plays the main therapeutic role. There are three kinds of adjuvants. 1) Strengthen the therapeutic effect of the main medicine and the minister medicine or treat the third comorbidity; 2) Reduce or exclude the main medicine and the minister The toxicity or other side effects are; 3) Effect of the action of the non-complementary to the target meeting organizer main drug. Make the drug system direct other medicines to the disease center and / or synergize and reconcile the role of other medicines in the prescription or formula: in contrast to most grasses or additives that are composed of one or more parts of a single plant, The expected effect of traditional Chinese medicine is targeted at multiple organizations. m The famous Chinese medicine prescription, Mahuang Decoction for the treatment of asthma, is made up of ephedra, osmanthus, coix seed and licorice. Ephedra is the main medicine, and its function of dispersing cold, sweating, and promoting lung qi is to relieve asthma. Guizhiweiji's medicine helps ephedra sweat, and can warm the meridians to relieve yang and relieve body pain]. Bitter almond is an adjuvant, which helps to reduce lung qi and strengthen ephedra. This paper size applies Chinese national standard [NS) A4 (210 x 297 public love)

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1243210 V. Description of the Invention (6) The energy required for physiological functions comes from Qi, blood and body fluid, and the production and metabolism of Qi, blood and body fluid also depend on this. The traditional Chinese medicine takes into account the therapeutic effects of herbs on qi and blood. Traditional Chinese medicine advocates that the meridians, collaterals, and their subordinates are distributed throughout the body. It is through this that herbs work on pathological targets and achieve improvement in the condition. For example, ephedra acts on the meridians of the lungs and bladder to sweat and relieve cough and diuresis. As mentioned above, the clinical practice of acupuncture is also guided by meridian theory. In short, although in the traditional Chinese medicine, the nature and nature of any herb can be attributed to one of the yin or yang and the five elements. Such as viscera and pupae). The pathogenic factors can be disguised as vectors, and through the same meridians and collaterals, they negatively affect the functions of the five internal organs and the six organs and thus cause disease. From the above discussion, it is clear that traditional Chinese medicine terminology is as philosophical as anatomical. For example, the mind represents many tissues, organs, and systems in the human body that contribute to the functions described in traditional Chinese medicine. Therefore, the concept of mind requires a multifaceted combination of data to describe each concept of traditional Chinese medicine. Once this is done, a molecular holistic medicine may be developed. US Regulatory Procedures In the United States, dietary supplements (such as plant products, vitamins and minerals, menstrual acid, and tissue extracts) are regulated by the Dietary Supplement Health and Education Act of 1994 (DSHE Act). This bill separates the ingredients of dietary supplements from the control of food supplements under the Linked Foods, Drugs and Cosmetics Act. In addition, the DSHE Act requires the Food and Drug Administration) This paper size applies the Chinese National Standard (CNS) A4 specification (210 X 297 mm) -T--IJ ---- 3 ^^ 农 * --- L-- --Order ---- I --- I-(Please read the phonetic on the back? Matters before filling out this page) Printed by the Consumer Cooperatives of the Intellectual Property Bureau of the Ministry of Economic Affairs 9 1243210

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Γ Printed by the Consumer Cooperatives of the Intellectual Property Bureau of the Ministry of Economic Affairs, 2424l0A7 '---------—— —____ V. Description of the Invention (11) Using gas chromatography-mass spectrometry and atomic absorption spectrometry, California Health Science, Food and Drugs (Calif0rnia Department of Shantou

Sciences, Food and Drug Branch) recently tested contaminants in Asian medicines obtained from herb stores [Rj · Guo, 1998, New England Medicine = Various Issues No. 339, p. 847 (RJ · κ〇5 1998, N. Engl J Med Med 339.847)]. Of the 260 samples he tested, at least 83 (32%) contained unknown drugs or heavy metals, and 23 had at least one dopant. Using commercially available high-performance liquid chromatography, gas chromatography, and mass spectrometry, a commercially available composition of 8 herbs (pC-SpES) was found to contain estrogen-producing organic compounds [Dibaola et al., 1998 , New England Journal of Medicine (DiPaola et al., 1998, N. Engl. J. Med. 339: 785-791)]. Researchers have concluded that PC-SPES has potential estrogen-generating activity, and that patients with prostate cancer who take PC-SPES may confuse the results of standard treatments and may experience clinically significant negative effects. Different samples of traditional Chinese medicine "Wai Ling Xian," and gas phase layer data were also collected and the correlation of the anti-inflammatory activity of these samples was also explored. [Wei et al. Identification of chemical types was applied to traditional Chinese medicine "Wai Ling Xian Research on the Evaluation of Quality, Chinese Journal of Pharmacy 26 (10): 772-772 (1991)]. This study did not provide relevant herb bioresponse array data, such as time course, dose-dependent response, and control samples to verify the ability to distinguish between biomarkers. It also did not use a repetitive data creation process' to establish-for identification An easy-to-understand database of the effects of herbal compositions. Changes in protein concentration have also been used to identify the effect of herb composition or herb-specific knives. For example: from the surrounding blood mononuclear ball to particle ball paper rule (CNS) A4 specifications ^ 7297 mm) installed --------- order --------- ( (Please read the precautions on the back before filling this page) 14 A7 1243210 B7_ V. Description of the invention (12) The production of cell line stimulating factor (G-CSF) was found to be changed depending on which specific Chinese herb was added to the culture [ Yamashiki et al., 1992 Journal of Clinical Experimental Immunology 37 (2) 83-90 (Yamashiki et al., 1992, J. Chin. Lab. Immunol. 37 (2): 83-90)]. After artificially cultured human epithelial keratinocytes were treated with the most commonly used herbal herb Xiao Chai Hu Tang, the melanin-1 alpha receptor system was significantly positively regulated [Matsumoto et al., 1997, Japanese Pharmacology Zhu 73 (4): 333-336 (Matsumoto et al. 9 1997, Jph. J. Pharmacol. 73 (4): 333-336)] 〇 Fc gamma 11/111 receptors and complement receptors 3 of macrophage cells The performance was improved after being treated with Toki-shakuyakusan (TSS) (JC Cyong 1997, Nippon Yakurigaku Zasshillo (Suppl. 1): 87-92). Tetrandrine, an alkaloid isolated from a natural Chinese herb, inhibits message-induced NF-kappa B activation in mouse alveolar macrophages [Chen et al. 1997, Biochemical Research Letters 231 (1): 99 -102 (Chen et al., 1997, Biochem. Biophys. Res. Commun. 231 (1): 99-102)]. Herbs Sairie-to, alismatis rhizoma (Takusha) and 茯 茶 (Bukuryou) inhibit glomerular basement membrane nephritis and inhibit endothelin-1 synthesis in rats And performance (Hattori et al., 1997, Japanese Journal of Pharmacology, Vol. 39, No. 9, pp. 121-128). Increases or decreases in information RNA levels have also been used as indicators of the effects of different herbs and herb ingredients. Green ginseng (QYS) (a traditional Chinese medicine with anti-turning properties) and intraperitoneal injection of sodium diphenylhein reduce the alfa and beta of chronic eclampsia induced by kainic acid in rats Tubulin information ribonucleic acid and hippocampal c-fos information ribonucleic acid (Guo et al., This paper size applies Chinese National Standard (CNS) A4 specification (210 X 297 mm) (Please read the precautions on the back before filling in this page) Hold

*. ml · ϋ ϋ I Jr, ϋ ϋ ϋ ϋ II Printed by the Consumers ’Cooperative of the Intellectual Property Bureau of the Ministry of Economic Affairs 15 1243210 Printed by the Employees’ Cooperative of the Intellectual Property Bureau of the Ministry of Economic Affairs A7 B7 V. Invention Description (13) 1993, Traditional Chinese Medical Journal, Vol. 13, Vol. 4, pp. 281-286; Guo et al., 1995, Traditional Chinese Medical Journal, Vol. 15, Vol. 4, pp. 292_296; Guo et al., 1996, Traditional Chinese Medical Journal, No. 16 Volume 1 pp. 48-51). Treatment of cultured human umbilical vein endothelial cells (HUVECs) with baicalin (a component purified from baicalone) reduces cytoplasmin activation factor inhibitor-type (PAM) -specific information RNA performance And increase the specific RNA of tissue type cytoplasmin activation factor (t-PA) [Zhang et al., 1997, Journal of Vascular Research, Vol. 34, No. 4, pp. 273-280 (Zhang et al., 1997 J. Vase. Res. 34 (4): 273-280)]. A component isolated from the roots of human cormorants was found to be a potent inducer of interleukin-8 (IL_8) produced by human monocytes and produced by the human monocyte cell line THP-1. This induction was accompanied by Improved IL-8 information RNA performance (Sonoda et al., 1998, Immunopharmacology, 38, pp. 287-294) o Current advances in complementary DNA (cDNA) microarray technology have enabled gene performance Mass collection of information is possible in parallel. Such procedures have been used to study the cell cycle, biochemical pathways, genomic expression in yeast, cell growth, cell differentiation, cellular response to a single compound ', and genetic diseases (including the onset and progression of the disease) [M. Xu Na et al., 1998, Biotechnology Trends 16: 301 (M. Schena et al., 1998, TIBTECH 16: 301)]. No researcher has attempted to apply these new technologies to study the molecular effects of all-herb treatment and addition. Some researchers have attempted to characterize the effects of the main active ingredient isolated from the chosen herb. For example: since Panax n0toginseng, this paper size applies the Chinese National Standard (CNS) A4 specification (210 X 297 mm) 16 —I, —; — · I — ^ — II Order ——— (Please read the note on the back? Matters before filling out this page) A7 B7 1243210 V. Description of the invention (i) Purified notoginsenoside (NR1) produces tissue-type cytosolic element activating factor synthesis-dose-and time -Increased dependence [Zhang et al., 1994, Arteriosclerosis and Thrombosis 14 (7): 1040-1046 (Zhang et al., 1994, Arteriosclerosis and Thrombosis 14 (7): 1040-1046)]. Treatment with Panax notoginseng (NR1) did not change the synthesis of urokinase-type cytoplasmin-activating factor and cytoplasmin-activating factor-inhibitory factor-1 antigen, nor did it affect cytoplasmin-activating factor-inhibitory factor-1 in cells. Accumulation in the outer matrix. When human umbilical vein endothelial cells (HUVECs) were treated with NR1, tissue-type cytoplasmin activation factor message ribonucleic acid (mRNA) increased twice, while cytoplasmin activation factor inhibitor-1 specific message ribonucleic acid (MRNA) performance was not significantly affected by notoginsenoside (NR-1). Since most of the research on P. notoginseng involves mixtures with other herbs, researchers have noticed that when used therapeutically in humans, they want to assess how the results relate to conditions in the body. It's really difficult. (Id ·, at 1045, second volume, first paragraph). In addition, since the researcher only studies one of the main components of the herb, it is impossible to determine the molecular effect of the whole herb or the interaction between the components of the herb through this study.

Dobashi et. And chronic rheumatoid arthritis), which are two of the main ingredients. The dose of SS-d in a dose-dependent manner increases plasma adrenocorticotropic hormone (ACTH) levels, and the peptide family information ribose in the anterior gland Nucleic acid (mRNA) levels and information on adrenocorticotropic hormone release factor in mouse inferior colliculus. The paper size applies to Chinese National Standard (CNS) A4 (210 X 297 mm). (Fill in this page again)

Packing ----- r --- Order --------- I Printed by the Employees 'Cooperatives of the Intellectual Property Bureau of the Ministry of Economic Affairs Printed by the Employees' Cooperatives of the Intellectual Property Bureau of the Ministry of Economic Affairs 1243210 A7 -------- 2Z______ Fifth, invention description (17) biological response information. The present invention provides the necessary tools and methodologies for establishing a standardized herb bio-reaction array for a specific herb composition, wherein the standardized herb bio-reaction array is used as a reference mark to evaluate similar or different batches of Herbal composition. The invention further provides the tools and methodologies needed to update and maintain the herb bioreactor array. A special embodiment of the present invention relates to a iterative process in which additional batches of herbal composition information, additional plant-related information, additional identifier information, and / or additional biological response information are added periodically. To this standardized herb bioreaction array. Therefore, the present invention provides tools and methodologies for creation, maintenance, and renewal on a forward-looking basis. The present invention is directed to the standardization of the herbal composition, to determine which specific composition of the herbal composition corresponds to a particular biological activity, to predict the biological activity of the herbal composition, to develop, adjust or modify an improved herbal therapy. Herbal composition, identification of specific molecules in a batch of herbal composition that retains the required biological activity, determination of which herbal ingredient of a known herbal composition can be excluded from the known herbal composition and maintained Or to promote the required biological activity of the known herb composition, to identify new uses and previously unknown biological activities for the batch herb composition, and to use the predicted biological activity of the batch herb composition to assist in the inclusion of the herb component The design of therapies for synthetic and musical chemistry (including the design of therapies that use combinatorial chemistry) provides the tools and methodologies needed. More specifically, the present invention provides a method for establishing a standardized herb bio-response array (HBR array) for a herbal composition, wherein the method includes: The paper size is applicable to the Chinese National Standard (CNS) A4 specification (210 X 297 mm) 20 ---- * 5 ---- r ---- install ----- ^ ---- order --------- (Please read the notes on the back before filling this page) Economy Printed by the Consumer Cooperative of the Intellectual Property Bureau of the Ministry of Commerce 1224l10 ____ ^ __ 5. Description of the Invention (101) Select a herb composition based on at least one known biological response; 2) Expose a biological system to a batch Herb composition and collect data for 2 or more identifiers; 3) store the identifier information of step 2) as an HBR array; 4) use 2 or more of the same as those used in step 2) or Different markers repeat steps 2) and 3) for one or more additional batches of herb composition. 5) concatenating the HBR array obtained in steps 3) and 4); and 6) analyzing the concatenated HBr array in step 5) to produce a standardized HBR array for the herb composition, wherein the standardized HBR array has Information on at least one known biological response associated with the herb composition of two or more markers. The invention further provides further comprising exposing a biological system to one or more batches of the herb composition, collecting data for one or more biological responses, and adding the collected biological response data to the herb composition. Various methods in a standardized HBR array. The present invention provides methods for evaluating herb compositions, wherein the methods expose biological systems to a batch of herb compositions and collect data for two or more identifiers; and the collected identifier data and A standardized HBR array that is the same or substantially the same as the standardized HBR array of the herb composition is compared. The present invention provides a system for predicting the biological activity of a herb composition, which includes: 1) A standard containing Chinese Standards (CNS) containing one or more different types of cells, tissues, organs or raw paper A4 specification (21G χ 297mm) -------- ---- IJ—— 丨 —h 丨 丨 丨 Order ------- 1 (Please read the note on the back? Matters before filling out this page ) 1243210 A7 ____B7 V. Description of the invention (l9) Biological system of in vitro test substance; 2) — Batch herb composition; (Please read the notes on the back before filling this page) 3) Two or more molecular identifiers 4) a method for exposing the biological system to the batch of herb composition and measuring the differentiation response of the molecular marker; 5)-for analyzing and storing the differentiation response measurement data of the molecular marker, (2) A computer processor (including memory) of the Herbal Bioreactor Array (HBR Array) data set of the batch of herb composition; 6) — used to combine the HBR array of the batch of herb composition with one or more Comparison of many previously stored HBR arrays to predict the herb The biologically active substance into a computer processor (including memory), which is used to generate the one or more previously stored drug grass HBR arrays consisting of a biologically active homologue of those known. Illustrated Figure 1. Printed by the Consumer Cooperative of the Intellectual Property Bureau of the Ministry of Economic Affairs. Figure 1. Provides a flow chart of the basic method steps for establishing a standardized herbal bioreactor array (HBR array) for any selected herb composition. . This figure is shown in its most basic form for easy understanding. As discussed herein, any of the approaches in the flowchart can be repeated. In addition, any information contained in one box can be used to guide decisions about collecting information for any other box. In this way, a number of feedback loops are possible through the process. This paper size is applicable to China National Standard 4 (CNS) A4 (210 X 297 public) 22 1243210 Printed by the Consumers ’Cooperative of the Intellectual Property Bureau of the Ministry of Economic Affairs A7 B7 V. Description of the invention (20) Figure 2 Figure 2 A flow chart of the basic method steps for establishing a herb bioreactor array (HBR array) for any batch of herbal composition and comparing this batch of hbr array with a subgroup of information selected by a standardized HBR array. This figure is presented in its most basic form for easy understanding. As discussed here, either way of this process can be repeated. Furthermore, any information contained in one box can be used to guide decisions about collecting information for any other box. In this way, numerous feedback loops running through this process are also possible. Figure 3 Figure 3 provides a flow of basic method steps for creating and using a master data set. This figure is presented in its most basic form for easy understanding. As discussed here, any one of these processes can be repeated. Further, any information contained in the box can be used to guide decisions about collecting information for any other box. In this way, a number of feedback loops are possible through the process. Figure 4 Western transfers for different herb compositions. A. Herb-free composition B. Huang Zhi Tang A (HQTA) (0.2 mg / ml) C. Huang Zhi Tang A (4 mg / ml) D. Huang Zhi Tang B (0.2 mg / ml) Ε Huang Zhi Tang B ( 4 mg / ml) F · Scutellaria baicalensis (0.2 mg / ml) --- I L --- 丨 order ---------_ (Please read the note on the back? Matters before filling out this page)

23 l2432l0 A7 V. Description of the invention (21) G. Scutellariae (4 mg / ml) Figure 5 High performance liquid chromatography chart of Paeonie lactiflora pallus printed by the Consumer Cooperative of the Intellectual Property Bureau of the Ministry of Economic Affairs. Figure 6. High-performance liquid chromatography of Ziziphi fructus. Detailed Description of the Invention Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by any person skilled in the art to which this invention belongs. Although any methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention, the preferred methods and materials are those described. Summary of the Invention As described above, the present invention is directed to tools and methods for predicting the biological response of a herb composition. More specifically, the present invention provides a method for establishing a herb bioresponse array (HBR array) database and a method for using these databases to enhance the design of an effective herb-based therapy. The purpose of the present invention is to The overall design, creation, improvement, and utilization of herbal bioreactor arrays for the preparation, testing, and administration of herbal compositions, as well as directing the development of new herb compositions and novel uses of existing herb compositions. Phytometry is based on the words used by the users here, depending on the context in which it is used. Phytometry refers to the use of bioinformatics and statistical methods to indicate the money and quantitative status of the components of the herb composition. Or is it to read > i on the back for the sake of clarity? Please fill in this page again for matters} Binding-binding --------- · This paper size is applicable to China National Standard (CNS) A4 (210 X 297 mm) 24 _ 1243210 A7 B7 Employees ’Intellectual Property Bureau, Ministry of Economic Affairs The cooperative prints V. Invention Description (22) An actual database developed to show these conditions. Herbal Bioreactor Array For the purposes herein, a Herbal Bioreactor Array contains a data set of two or more observations or measurements related to a herb composition. The herb bio-response array may contain qualitative and quantitative data (plant-related data) on the plant in the composition, and information about the identifier obtained after exposing a biological system to the herb composition (including a dose-dependent study) And biological response data obtained after exposing a biological system to the herb composition. The data in any particular herb bioreactor array can be analyzed statistically in 2 or 3 dimensions. Herb bioreactor arrays can be designed as batch herb bioreactor arrays and standardized bioreactor arrays. A batch herb bio-reaction array is an array of data related to a particular batch of a herb composition. Standardized Herbal Bioreactor Array is an array of information related to a standardized herbal composition. Master Data Set For the purposes of this user, the term master data set refers to the data set that serves as the baseline set of data, in order to compare or analyze other sets of data for the same or different herb composition. Generally, master data sets are established using biotechnological techniques to determine certain genetic or protein conditions of the herb composition. Therefore, master data sets are often, but not always, data sets of a genomic or proteomic group. For example ... DNA microarray results can be used to phase with other, secondary or secondary data sets. Secondary or subordinate data group ^ The paper size is applicable to China National Standard (CNS) A4 (210 X 297). Packing ----- ^-Order --------- (Please read the note on the back first Please fill out this page again for details) 25 1243210 A7 Printed by the Consumers' Club of Intellectual Property Bureau V. Invention Description (23) For the users here, "secondary data group, or" subordinate data group, "means one or More data sets are used for comparison with master data. Often, but not to say, this time the primary data set will contain data for a herb composition collected by more signalling methods. For example: secondary or subordinate data sets may contain-sets of plant-related data obtained by more traditional means. Examples of plant-related information include, but are not limited to, the genus / species name of the herb in the herb composition, the particular plant part of the herb in the composition, and the geographical location where the herb is distributed. Another example of a secondary data set may include the biological response of a group of cells, tissues, organs or organisms after treatment with one or more different amounts of the herbal composition. Examples of such biological responses or a complete organism may include, but are not limited to: cytotoxicity studies, enzyme treatment studies, growth rate, weight gain or loss, changes in motor skills, and changes in mental capacity. Herbs Technically, a herb is a small, non-lignified (ie, fleshy stalk), annual or perennial seed plant, and at the end of each growing season, all its parts die up. Herbs are prized for their medicinal, aromatic or aromatic qualities2. As this term is more commonly used, and because it is used here, a "herb" refers to any plant or plant part that has a food additive, medical, pharmaceutical, therapeutic or prolonged life use. Therefore, for the users here, a herb is not limited to the botanical definition of the herb, but refers to any plant product, plant or plant part used for these purposes, including the plant kingdom (including grass, shrubs) , Subshrubs and trees) = any plant species or any plant or plant part of the subspecies. This paper size applies to China National Standard (CNS) A4 specifications (210 X 297 mm 1243210, printed by the Consumer Cooperative of the Intellectual Property Bureau of the Ministry of Economic Affairs, A7) V. Description of the invention (24 Plant parts used in herbal compositions include, but are not limited to, seeds, leaves, stems, branches, trunks, buds, flowers, bulbs, tubers, rhizomes, vines, roots, fruits, Capsules, berries, forming layers and bark. Herbal composition, as used herein by the user, refers to a medicinal herb, herb, or herb Any composition of a plant part. Therefore, for the purposes of this application, a herb composition is any herb formulation that includes herb food supplements, herbs, herbs and medical foods. Examples of herb compositions include but Not limited to the following components: whole plants or plant parts of a single plant species, whole plants or plant parts of multiple plant species, multiple ingredients derived from a single plant species, multiple plants derived from multiple plant species Ingredients or any combination of these different ingredients. For a complete review of different herbal compositions, see, for example: Ke Zhang Huang, Chinese Herbal Pharmacology, CRC Press (1993) [Kee Chang Huang

The Pharmacology 〇f Chinese Herbs, CRC Press (1993)], here is a complete picture. Representative examples of various herbal compositions are provided in the following paragraphs. Herbal compositions containing willow bark have been used in the UK since the mid-18th century to treat fever. The active ingredient in willow bark is a bitter-flavored glycoside 'called salicin, which produces sugar and salicyl alcohol when hydrolyzed. Aspirin (acetylsalicylic acid) and aspirin-like drugs (such as ibuprofen) are often collectively referred to as non-steroidal anti-inflammatory drugs (NASAIDs) are often used to treat pain, fever and inflammation. Spiraea is another herb containing salicylic acid. The treatment of rheumatism and rheumatoid symptoms with willow bark or spiraea requires the elimination of this paper. The paper size applies the Chinese National Standard (CNS) A4 specification (210 X 297 mm). 27 Pack ---- l ·! (Please first Read the notes on the back and fill out this page) tr --------- ΜΨ, printed by the Consumer Cooperatives of the Intellectual Property Bureau of the Ministry of Economic Affairs 1243210 A7 _____B7 V. Description of the invention (25) Consumption made by these plants Made of herbal tea. The entire poplar species (ie poplars and shrubs) also contain precursors of salicylic acid and poplar buds have been used for anti-inflammatory, anti-pyretic and anesthetic purposes. U.S. patents have been issued to herbal compositions for the treatment of different diseases and other health-related problems that infringe upon humans and animals. For example, U.S. Patent No. 5,417,979 discloses a composition comprising a mixture of herbs (including species such as Stephania and Glycyrrhiza) and extracts thereof, which are used as an appetite stimulant and used For the treatment of pain. Herbal compositions containing Glycyrrhiza uralensis have been found to be useful for eczema, psoriasis, pruritus, and skin inflammation (U.S. Patent No. 5,466,452). U.S. Patent No. 5,595,743 discloses different herb compositions containing licorice (Glycyrrhiza), and weeds, locust flower, hydrangea, and dysentery for the treatment of different mammalian diseases, including inflammation and rheumatoid arthritis. Inflammation of the eyes can be treated with a pharmaceutical composition containing phytochloride and tetrandrine (U.S. Patent No. 5,627,195). U.S. Patent No. 5,683,697 discloses a pharmaceutical composition with anti-inflammatory, anti-pyretic, expectorant or antitussive effects, wherein the composition includes Meiia and Angelica Dendrobium: Impatiens, Citrus, Mulberry Parasitic, Barley , Cynanchum and coral plant species. An herbal composition containing ginger, coriander, green ox gall, quinoa, sleeping eggplant, and ginger roots, rhizomes, and / or plants has been found to reduce or alleviate rheumatoid arthritis, bones, joints, Active arthritis-related symptoms and for reducing pro-inflammatory cytokines (US Patent No. 5,683,698). Herbal composition is suitable for many forms, including capsules, tablets, or films. The paper size is applicable to China National Standard (CNS) A4 (21 × x 297). 28 --- τ ---- r --- -I --- ^-11 Order --------- (Please read the precautions on the back before filling out this page) 1243210 A7 Printed by the Consumer Cooperatives of the Intellectual Property Bureau of the Ministry of Economic Affairs 26 Coated tablets, pills, extracts or tinctures, powders, fresh or dried plants or plant parts, prepared decoctions, herbs, creams or ointments, essential oils, any combination of these forms. Herbs are made by Any one of different methods is administered, including: oral, rectal, parenteral, enteral, transdermal, intravenous, feeding tube, and topical administration. Herbs covered by the present invention The composition includes a herb composition that also contains a non-herb component. Such non-herb components include, but are not limited to: whole insects and insect parts, insects, animal or insect excreta, natural or crude oil, ammonia carbonic acid salts, tartaric acid Salt 'wine, water, glycerin, sterols, medicine Products, vitamins, nutrient extracts, serums, salts and gums. For oral administration, the disclosed herbal composition can take forms such as traditional methods, and generally acceptable excipients such as cumin. Mixtures (such as pre-gelatinized corn starch, polyethylene-based or fluorenylmethyl cellulose), fillers (such as lactose, microcrystalline cellulose, or calcium phosphate), lubricants (such as magnesium stearate, talc, or two Silicon oxide), disintegrating agents (such as potato starch or starch sodium glycolate) or wetting agents (such as sodium laurate sulfate), slip agents, artificial and natural flavors and sweeteners, artificial or natural pigments and dyes, and stability This herb composition can be further formulated to be released at a time well known in the art and as described in U.S. Pat. Nos. 4,69,825 and 5,055,300. It can be released into its active agent. It can be covered with a film by the method well known in this technique. Liquid preparations for oral administration can take forms such as solutions, syrups, suspensions or pastes (such as As described in Mulchandanietal et al., 1 992 U.S. Patent No. 5, i0,76 ^ Liquid M Zhang scale Gu + Kajia Xian (CNS) A4 specification (21〇x 297 mm) Pack ----- ^ ---- Order ---------. (Please read the notes on the back before filling this page) 29 Printed by the Consumer Cooperatives of the Intellectual Property Bureau of the Ministry of Economic Affairs 1243210 V. Description of the Invention (27) Body Nutrition Supplements), or it It is suitable for solvent-reduced drying of money before use. It is used to make money with water or its mineral liquid to form other vitamins Γ 液体 =. These liquid preparations can be added by traditional methods, Jiamei: Weixincheng "additives such as : Suspending agent (such as sorbitol syrup Laber: dual-purpose oil), emulsifier (such as: _ purpose or Gum Arabic) non-aqueous> cereal solvents (such as wood A, 1 ', almond oil, oily ester or Ethanol), preservatives (such as methyl or propyl para-one, TL formic acid or sorbic acid), and artificial or natural pigments and / or sweeteners are prepared. As for topical administration, in order to provide a composition that is most suitable for topical administration, such as-creams, gels, solids, pastes, ointments, powders, emulsions, liquids, spray treatments, etc., the herb composition can be combined with at least one species An acceptable carrier, diluent or other ingredients of the excipient are combined and combined. Sterile distilled water itself and simple creams, ointments and gel bases can be used as carriers for ingredients. Preservatives and buffers are also added. This formulation can be applied to hot-end tapes for local medicines, biodegradable 'absorbable patches or bandages, or to slow-release injection systems with a high-speed initial release decay to slow-release. For a more complete overview and discussion of one of the medicinal-based compositions, see... Yi Ermindale, Yier Mindale Herb Bible, Simon and Scaster Press, 1992 (Earl Mindel and Earl Mindell , S Herb Bible,

Simon & Schuster (1992)), the entire book of Schöpper's Herbs, w. Fulxian Co., Ltd. (originally published mid-16th century) (Culpeper, s Complete Herb, W. Foulsham & Co. Ltd.) and Luo Daier's illustration This paper size is applicable to China National Standard (CNS) A4 (210 X 297 mm) 30 ^ ----- r --- t --------- < Please read first Note on the back, please fill out this page again) 1243210 A7 B7 Printed by the Consumers' Cooperative of Intellectual Property Bureau of the Ministry of Economic Affairs V. Invention Description (28) It is Rodale's Illustrated Encyclopedia of Herbs, Rodale Press (1987)). In this regard, standardized herbal compositions are treated by users. "A standardized herbal composition refers to a batch of herbal compositions that are used to evaluate a batch of herbal compositions that have the same or different components from those of a standardized herbal composition." It is a special herb composition that is a standard herb composition. Sometimes it is also referred to as the "parent herb composition". It is shown that the quasi-Lezo composition is well-characterized and exhibited in a special biological system. A common herbal composition that requires a biological response. It is shown that quasi-standardized herbal compositions are usually standardized by chemical tests familiar to those skilled in the art and are well preserved for long-term use and control. This standardized herb The composition system is used to establish a standardized herb bioresponse array based on observations and measurements of plants (ie plant-related information), markers, and biological responses to characterize the herb composition. Batch Herb Compositions are used herein In the case of a "batch herb composition," it is meant to be used to establish an observation and measurement based on plants and markers. Any tested herb bioreactor array serve to characterize the pharmaceutical composition herb composition. Sometimes also referred to herein as a "tested," or "batch," herb composition. Inspection and measurement of biological responses may or may not be included. A herb composition used to establish a standardized herb composition may also be referred to as a "batch herb composition" before being referred to as a "standardized herb composition '". As far as the users are concerned, a "batch" refers to a special (please read the note on the back? Matters before filling out this page) .1 _1 I — ^ 1 ^ 1 ^ 1 > 1 I ϋ ϋ 1 I— I-31 1243210 可 物 A7 B7 V. Description of the invention (29) It was identified as a genus of familiarity, so that # and any other specific amount of the same herb, and the product area Knife-a specific amount of _ herb composition. For example ...-batch-herb, composition can be harvested at a time when one of the batches is different from the other batches or at a different geographical location. One batch of this same herb composition is distinguished. The differences between other batches that specifically distinguish may include, but are not limited to, the following ... 1) The specific plant parts used (eg, the root of a herb in a batch Is used 'while the same herb leaf is used in a different batch)', 2) post-harvest treatment of individual herbs or herb compositions (eg a batch is treated with steamed water, and a different The batch can be treated with nitrogen chloride to stimulate the acidity of the human stomach); and the phase of individual herbs in a herb composition (Eg one batch may have three different herbs with equal overlap or volume ratio, while another batch has one herb with a greater proportion than the other two herbs). System refers to any biological substance that is "observed or measured". Therefore, a biological system includes, but is not limited to, any cell, tissue, organ, whole organism or in vitro test-丨 丨 丨 · — — — — I 1111 — * (Please read the precautions on the back before filling this page) For the users here, the "biological response of a herb" refers to a specific biological system and a specific organism unique to a herb composition as a plant-related information. For the users here, "Plant-related information refers to the application of Chinese National Standard (CNS) A4 (210 X 297 mm) to the size of medicinal herbs paper." 32 1243210 Printed by the Consumer Cooperative of the Intellectual Property Bureau of the Ministry of Economic Affairs A7 Five 2. Description of the invention (30) The information collected by the composition includes, but is not limited to, information about the plant, the growth conditions and the treatment of this plant during and after harvesting. Plant-related information also includes the relative proportions of its components in a herb composition, which may be different plant parts, different plant species, other non-plant components (such as σ 卩, chemical drugs) or these variables Any combination. Information that can be collected for a herb composition, including but not limited to the following: 1) plant species (and, if available, specific plant varieties, cultivars, breeding plants, strains, etc.) and used in the composition The niche of the special plant, 2) the geographical origin of the herb, including longitude / latitude and the same altitude, 3) the growth conditions of the herb, including the type and quantity of fertilizer, the amount and time of the two drops and irrigation, and the daily Accepted micro-Einstein, use of pesticides (including herbicides, insecticides, acaricides and fungicides) and cultivation methods, 4) methods and conditions for treating herbs, including the age of the plants / Maturity, soaking time, drying time, extraction method and grinding method; and 5) storage methods and conditions of the herb ingredients and the final herb composition. In addition, privatized herb compositions can be chemically analyzed. Chemical properties can be created by any chemical analysis method widely known to those skilled in the art. Examples of applicable chemical analysis include, but are not limited to, high performance liquid chromatography (HPLC), thin layer chromatography (TLC), chemical fingerprints, mass spectrometer analysis, and vapor phase chromatography. Bioinformatics For the users here, ‘bioinformatics’ refers to the use and organization of biologically meaningful information. The meanings of bioinformatics are as follows: 丨) data acquisition and analysis; 2) database development; 3) integration and linking; and the paper size of the sentence applies the Chinese National Standard (CNS) A4 specification (210 X 297 mm) ^ i II l · I--Order--III I ---- (Please read the notes on the back before filling out this page) 33 Printed by the Consumer Cooperatives of the Intellectual Property Bureau of the Ministry of Economic Affairs 1243210 A7 --------- _B7__ 5. Explanation of the invention (Further analysis of the poor data base produced. Until the early 1990s, almost all bioinformatics resources were developed as free software in the public domain, and many were still available for free through the Internet. Some companies Owned database or analysis software has been developed. For the users here, "genomics," the term "genomics," refers to the study of genes and their functions. Genomics emphasizes comparison of genetic maps, molecular selection, Integration of large-scale restriction enzyme maps and DNA sequencing with DNA and basic and applied research in computerized analysis. Genetic information uses basic technologies (such as DNA sequencing, protein sequencing) It is extracted by chain reaction with polymerase pcR. Transport function is performed by 1) analyzing the health of DNA mutant cells, tissues, organs or organisms in a gene = different information in the DNA sequence, and 3) studying a gene by Or a system of related genes. Proteins Proteomics For the purposes of this document, the term "proteomics," also known as "proteomics," or "expressomics" means Under the defined conditions, a basal mouth, and the protein expression pattern. For the average user, proteomics refers to the method of using protein biochemical high unit time output and analysis. For many reasons, proteomics research is needed in addition to genomic research. First, the level of gene expression does not necessarily represent the amount of active protein in a cell. At the same time, the gene sequence has not been described as an egg paper size applicable to the Chinese National Cricket Standard (CNS) A4 specification (21 × X 297 public copy) 34 Μ ----- r --- t ------- -. (Please read the notes on the back before filling this page) Printed by the Consumer Cooperatives of the Intellectual Property Bureau of the Ministry of Economic Affairs 1243210 A7 ___B7 V. Description of the invention (32) Post-translational modification necessary for the function and activity of white matter. Furthermore, the genome itself does not describe dynamic cellular programs that alter the rise or fall of protein levels. Protein research seeks to characterize all proteins in a cell and to identify the amino acid sequence of at least a portion of an isolated protein. Generally, proteins are first separated using a two-dimensional 2D gel or high performance liquid chromatography (HPLC), and then peptides or proteins are sequenced using a high unit time output mass spectrometer. Using a computer, the output of the mass spectrometer can be analyzed to link a gene and the specific protein it encodes. This whole program is sometimes called "functional genomics". Some manufacturers currently provide proteomics services (eg: Pharmaceutical Proteomics ™; The Proteomics ™ System form Ciphergen Biosystem; PerSeptive Biosystems) o For general information about proteomics research, see, for example: JS Fullerton, 1999, Proteins, Enzymes Genes: the intersection of chemistry and biology, Yale University Publishing Department (JS Fruton, 1999, Proteins, Enzymes, Genes: The Interplay of Chemistry and Biology, Yale Univ. Pr.), Wilkinki et al., 1997, Protein Group research: New field of functional genomics (principle and operation), Wilkins et aL (1997, Proteome Research · New Frontier in Functional Genamics (Principles and Practice), Springer Verlag), AJ Link , 1999, 2D Proteome Analysis Process (Molecular Biology Method), 112, Renshi Press (AJ Link, 1999, 2-D Proteome Analysis Protocols (Methods in Molecular Biology), 112, Humana Pr.), Kan Pu et al., 1999, Proteomics and Protein Analysis, Springer Fletcher (Kamp et aL. 1 999, Proteome and Protein Analysis, this paper size is applicable to China National Standard (CNS) A4 (210 X 297 mm) 35 ---- I ---------------:- --Order ---- I --- (Please read the notes on the back before filling out this page) 1243210 A7 V. Description of the invention (33 Μ Property Bureau employee consumption

Springer Verlag) 〇Signal transduction For the users here, "signal transduction, also known as cell Λ transduction" refers to the process by which cells receive external signals, transmit, amplify, and guide Λ The signal transmission pathway requires the step-by-step communication of the protein chain of protein L. Protein kinases often participate in the species reaction chain because many signal transductions involve receiving an extracellular chemistry that triggers phosphorylation of cytoplasmic proteins to amplify the signal. Signal. Post-translational modification For the users here, "post-translational modification" is a general term used to describe a change in a protein that occurs after it is synthesized into an initial polypeptide. Such post-translational modifications include, but are not limited to, saccharification, messy removal of N-terminal methionine (or nitrogen N-terminal methionine (or nitrogen N-formine methionine), signal victory Peptide removal, acetylation, f-acidification, amino acid decoration, internal cracking of peptide chains to release smaller proteins or peptides, phosphating and repair of methionine. Array or Microarray For the purposes of the user herein, an "array," or "microarray," refers to a standard grid system in which any-position or probe cell is occupied by-defined nuclei, fragments. Such arrays Also known as "wafer," "biochip," "DNA DNA wafer," or "gene wafer." High-density DNA DNA microarrays often have thousands / lattice patterns. Probe cells. ^ Once the array is assembled, the batch is added and the batch and the cover cover are modified in acid paper. The paper size applies to the Chinese National Standard (CNS) A4 size x 297 kg.

I 1243210 V. Description of the invention (34) A certain type of chemical interaction occurs between the columns and the array produces a certain type of identification for the array disk batch. Autoradiography of a radiolabeled batch is a traditional monitoring strategy, but other options are for the user's use including electronic signal transduction. For the purposes of this user, the term "identifier," means any biologically-based measurement or observation of a particular herb composition that is being exposed to a particular lot. The characteristics of a particular biological system of a herb composition. "Identifiers,-the term covers-measurement and observation of both qualitative and quantitative biological systems. The marker database contains a data set that characterizes the genes corresponding to the treatment of the herb, the current type, where the pattern shows that certain genes corresponding to the special herb composition are turned on, off, raised or lowered. Therefore, "identifier" refers to any biologically-based measurement and observation, which is used to characterize a biological system by increasing and decreasing the level of performance in a biological system or temporarily regulating or quantitatively or qualitatively changing. Differentiated biological response to a herb composition. One of the specific batches of the exposed biological system printed by the consumer cooperative of the Intellectual Property Bureau of the Ministry of Economic Affairs may be an unknown herb composition, a known herb composition Or a standardized herb group. There are examples of markers used to complete the present invention, including but not limited to: molecular markers, cytogenetic markers, biochemical markers, or molecular molecules. Macromolecular markers include, but are not limited to, enzymes, polypeptides, peptides, carbohydrates, antibodies, DNA DNA, RNA RNA negative (translated protein and post-translational protein), nucleic acids and polysaccharides . Any mark that satisfies the definition of "marker" here is suitable for leading the size of the paper + _fresh (CNS) A4 state-χ 29--37 1243210 A7 B7 V. Inventor (35) Inventor. ' 'Identifier,' the term includes related, different types of terms, such as: "biomarkers, or" genetic markers, or "gene markers." In order to improve the ability of a herb to respond to HBR arrays For the purpose, there may be one or more primary markers together with secondary markers or a series of markers. Therefore, the selected molecular marker may be different from other molecular, cytogenetic, biochemical or macromolecular markers. This combination makes it possible to make a more accurate and extended herbal bioreaction array. A marker contains one or more micromolecules from one or more sub-porous compounds, such as DNA, RNA, complementary DNA cDNA, nucleic acid fragments, proteins, protein fragments, fats, fatty acids, sugars and glycoproteins. Construction of available molecular markers, Generation and utilization are known to those skilled in the art. Examples of particularly useful technologies for the characterization of molecular markers include differentiation expression, reverse transcriptase polymerase chain reaction PCR, and expression sequence markers ESTs. Large-scale sequencing, sequence analysis of gene expression SAGE, Western immunotransfer or protein 2D (3D), 3D (3D) research and microarray technology. A person familiar with molecular marker technology is familiar with this technology Methods and uses [see eg Bernard R. Glick and Jack J. Pestnack, Molecular Biotechnology, Principles and Applications of Recombinant DNA, 2nd Edition ASM Press (1998) (Bernard R. Glick and Jack J. Pasternak, Molecnla Biotechnology, Principles and Application of Recombinant DNA, Second Edition, ASM Press (1998)), Matthew R. Walker and Lovrepuli, Maps of Genetic Technology 'Blakewell Scientific Publishing (1997) (Mathew R. Walker and this paper size applies to Chinese National Standard (CNS) A4 (210 X 297 mm) (Please read the note on the back? Matters before filling out this page) ----- r --- ^ 11 11111. Printed by the Consumer Cooperatives of the Intellectual Property Bureau of the Ministry of Economy 38 1243210 A7 B7 V. Description of Invention (36)

Ralph Rapley? Route Mapsin Geme Techhology, Blackwell Science (1997)), Roy et al., DNA Isolation and Sequencing, Roe et al, DNA Isolation and Sequencing, John Wiley & Sons (1996) James D. Watson et al., Recombinant DNA 2nd Edition 'Science American Series (l992) (James D. Watson et al., Recombinant DNA? Second Edition, Scientific American Books (1992)]. Deoxygenation Methods for isolating and sequencing RNA, RNA, and protein are known to those skilled in the art. Examples of these techniques are found in: Molecular Selection: Experimental Manual, 2nd Edition, Sambrook Et al., Molecular Cloning: A Laborator Manual 2nd Edition, Sambrook et al.? Cold Spring Harbor, NY (1989), Hans Peter Saruz and JP Zeist, Guidelines for Genomic Sequencing Laboratories : Direct Sequencing of Original Unselected DNA (Biological Methods Volume 1) Burkhorst (1998) (Hanspeter Saluz and JP Jost, A Laborator Guide to Genomic Sequencing ·· The Direct Sequencing of Native Uncloned DNA (Biomethods Vol, Birkhauster (1988) and B. Roy et al., DNA isolation and sequencing, Wiley (1996) (B. Roe et al. 9 DNA Isplation and Sequencing, Wiley (1996)). Examples of traditional molecular biology techniques include, but are not limited to, in vitro conjugation, restriction endonuclease digestion, polymerase chain reaction (PCR), cell transformation, hybridization, electrophoresis, DNA sequencing of DNA, cell culture, and the like. The specific kits and tools available on the market for the present invention include, but are not limited to: useful for RNA isolation and polymerase. This paper is sized to the Chinese National Standard (CNS) A4 (210 X 297 mm). _ 39 (Please read the precautions on the back before filling this page) ϋ ammmw I— 1 ammf I i_i I 1 I _ Printed by the Employees ’Cooperatives of the Intellectual Property Bureau of the Ministry of Economic Affairs 123210 Printed by the Employees’ Cooperatives of the Intellectual Property Bureau of the Ministry of Economic Affairs A7 B7 V. Description of the invention (37) Construction of a chain reaction PCR complementary DNA cDNA repository, antiviral performance repository, vector, gene expression analysis, protein and antibody purification, cytotoxicity test, protein Performance and purification and high unit time output plastid purification [see eg: Select Technology Product Catalog XIII (3), 1-32 (1988) (CLONTEniques product catalog, XIII (3), 1-32 (1998) or www. clontect.com. AtlasTM cDNA Expression Assay Product Catalog (1998) (AtlasTM cDNA Expression Assay product catalog (1998), SIGMA® Product Catalog (1997)). For discussions, methodologies and applications of oligonucleotide arrays, microarrays, DNA DNA wafers or biochips, see, for example, U.S. Patent Nos. 5,445,934, 5,605,662, 5,631,134, 5,735,257, No. 5,741,644, No. 5,744,305, No. 5,795,714; Sienna et al., Parallel Human Genome Analysis: Microarray-Based Performance Monitoring of 1000 Genes, National Research Institute Report No. 93, pp. 10614-10619 (1996) (Schera et al, Pareller Human Genome Analysis: Microarray-based expression monitoring of 1000 gehes, Proc Natl. Acad, Sci USA 93, 10614-10619 (1996)) • Direci et al., In a genome Exploring Metabolism and Genetic Control of Gene Performance on a Large Scale, Science No. 278, 680-686 (1997) (DeRisi et al., Exploring the Metabolic and Genetic Control of Gene Expression on a Genomic Scale, Science 278,680-686 ( (1997)) • In Dica et al., Genome-level performance monitoring of yeast (Saccharomyces cerevisiae), Natural Biotechnology Issue 15, Issue 1 Pp. 359-1367 (1997) (Wodicka et al., Genome-Wide Expression Monitoring in This paper size applies to China National Standard (CNS) A4 specification (210 X 297 mm) 40 --- J ------ ----- I l · I--Order ---- I ---- (Please read the notes on the back before filling this page) 1243210 A7 B7 V. Description of the invention (38)

Saccharomyces cerevisiae, Nature Biofechnology 15, 1359-1367 (1997)); Paddy, Genome-wide Performance Monitoring: Human, Natural Biotechnology, No. 15, pp. 1343-1344 (1997) (Pardee, Complete Genome Expression Monitoring: The Human Race, Nature Brotechnology 15, 1343-1344 (1997)); Schaeffer et al., DNA Variation and the Future of Human Genetics, Natural Biotechnology, No. 16, pp. 33-39 (1998) (Schafer et al. al., DNA Variation and the fature of human Gentics, Nature Biotechnology 16, 33-39 (1998)); Di Ruixi et al., The use of a cDNA microarray for the analysis of human cancer gene phenotypes, Natural Genetics, 14 Issue, pp. 457-460 (1996) (DeRisi et al, Use of a cDNA Microarray to Analyze Gene Expression Patterns in Human Cancer, Nature Genetic 14, 457-460 (1996)); Heller et al. Array invention and analysis of inflammatory disease-related genes, National Academy of Sciences Research Report, 94, 2150-2155 (1997) (Heller et al., Scorery and Analdysis of Infammatory Disea se-Related Genes Using cDNA Microarrays, Proc? Natl. Acad. Sci. USA 94: 2150-2155 (1997)); Matthew et al., DNA Chips: A Possibility Array | J, Natural Biotechnology No. 16 Issue, pp. 27-31 (1998) (Marshallet al., DNA Chips: An Array of Possibilites, Nature Biotechnology 16, 27-31 (1998)); Boehner et al., Microarrays: For Functional Genomics Discovery of Biotechnology, Biotechnology Trends No. 16 ', pp. 301-306 (1998) (Schena et al ·, Microarrays: Biotechnology ^ Discovery Platform for Function Genomics, This paper size applies to China National Standard (CNS) A4 specifications (210 X 297 mm) (Please read the notes on the back before filling out this page) ϋ Hi in i_i _1 11 ϋ 1 · 1 in I. Printed by the Intellectual Property Bureau Staff Consumer Cooperatives 41 1243210 A7 B7 V. Invention Instructions (39)

Tibtech 16, 301-306 (1998)); Lansay, DNA chips; Current status of science and technology 'Natural Biotechnology No. 16, pp. 40-44 (1998); Strange and others' approach genetic information with high-density DNA arrays , Science No. 274, p. 610 614 (1996); and Chen et al., Using a colorimeter to measure genes for phenotypic patterns and dissociative expression by the cdna U array system, genomics No. 50, p. Pp. 1-12 (1998); p. Andrew Audin et al., Characteristics of the stress-inducing effects of homocysteine, Journal of Biochemistry No. 332, pp. 213-221 (1988); and Jebert et al. Humans, will genetics revolutionize the process of new drug discovery, Curr, Opin Biotechn () 1 816), 699-674 (1997). Other more specific references that can be applied to the present invention include, but are not limited to, those who propose expression technology, such as ETS (see, for example, Michael I Feineng, Gene Expression in Rectification and Sickness _ Therapeutic Target's ^, Biotechnology Trends Issue M, page M298 (lean year ... general overview of protein generation (see, for example: Robinson et al.-Overview of Proteomic Kinases in Forefront Lung Cancer, National Academy of Sciences Research Report No. 93, Chau-Side Page (touching the year)), chemical and spectroscopic methods for the ingredients of the Zhongding herb composition (Kojima et al. From ⑹post Xiancai), Phytochemistry No. 48, Vol. 5, pp. 885-888 ( (Deleted years)), the determination of functional antigens (see, for example, Alix Rensidis, Functional Antigens' Natural Biotechnology No. 16, pages 305-307 (leap year), high performance liquid chromatography (see eg: Miller Twinn Sheen (editor), High Performance Liquid Chromatography of Proteins, Peptides, and Polynuclear Acids. · Contemporary Themes and Applications (Analytical Techniques and Laboratory Manuals for Clinical Chemistry, VCH Publishing, (1991), Electric ice (see, for example, · Hunston Mel et al., Electrophoresis Operation: This paper uses the national standard (CNS) A4 specification, Q χ No. 1243210 A7 B7 V. Description of the invention (40) The method of printing the second ship and protein separation by the staff of the Intellectual Property Bureau of the Ministry of Intellectual Property and Application refers to $, Yolanda Willie and Shangsi (1997)), and interactive reactive marker test (see eg: Ail '), Zhuoren Wood Chaco hepatitis virus · experimental infection and natural occurrence, Hepatology No. 4, Vol. 5, pp. 817-823 (1984)). Structural genomics is unraveling—the structure of all proteins encoded by the completed genome (its methodology includes direct output per unit time structure Judgment and computer algorithms) were discussed by Terry Jentland, Structural Genomics: The Road to Bioinformatics, Natural Biotechnology No. 16, pp. 625-627. About Bioinformatics · Genes and Proteins Analytical Guidelines for Operational Analysis = Hanley and Shangsi (1998) and Luke Alfie, DNA Sequencing • From Methodology to Bioinformatics (Introduction to Biotechnology Series) ). Cell biological parameters include, but are not limited to, karyotype analysis (such as relative staining elongation, position of centromere, presence or absence of secondary contraction), karyotype map (ie, a type of karyotype of the organism) (Shown), chromosomal behavior during mitosis and mitosis, chromosome staining and ribbon patterns, DNA-protein-parent interaction (also known as nuclease protection detection), neutron scattering research, rolling circles ) (AM Degerman and Red Coul, Nucleic Acid Research, Vol. 26, No. 13, pp. 3235_3241 (1998), Beckett et al., Molecular Cell Biology, No. 16, vol. 丨, p. 628, Hong 6294 (1996), Shi Ge Li et al., Journal of Virology No. 70, Vol. 2 1132 · 1136 (1996), A. Fayle and S. Su, National Scientific Research Report No. 92, No. 1 Volume 〇, pages 4641_4645 (1995), and after reacting with radiolabeled riboribonic acid, the automatic first house of the whole nucleic acid applies the Chinese National Standard (CNS) A4 ^ Grid G X 297 Love) " [243210 A7 B7 Explanation V. Invention Description (4 1) Radiography. Biochemical parameters include, but are not limited to, specific pathway studies, such as signal transduction, protein synthesis and delivery, ribonucleic acid transcription, cholesterol synthesis, and glycogen production and glycolysis. For the users here, the term "fixing pattern," as used herein, refers to the method of making the characteristic outline of a substance, especially a herb, for easy identification. As used herein, the term "fingerprint," Refers to the presentation of the results of a particular method used to fix patterns. Examples of a variety of different texturing methods include, but are not limited to: DNA texturing, protein texturing, chemical texturing, and footprint texturing. DNA patterning, or contouring, refers to a method of making a single pattern from DNA from a specific biological source (eg, a particular plant, plant species, plant genus, plant part, or plant tissue). This DNA fingerprint, or profile, can be used to distinguish that particular biological source from—different biological sources. The pattern obtained by analyzing a batch of specimens using a microarray, oligonucleotide array, DNA chip, or biochip is also referred to as "fingerprint." A protein is defined as a cell, tissue, organ, or organism. A body (such as a plant) coats as a protein, which immediately provides a fully characterized "fingerprint" of the cell, tissue, or one of the organisms. Chemical texturing refers to the analysis of low-molecular-weight chemicals in cells and mu cells , Tissue, organ, or organism (such as a plant), the most common, and its style. The analysis is usually done by gas chromatography (GC), high performance liquid chromatography (HPLC) or mass spectrometer. (Please read the back first Phonetic notation? Please fill in this page again for matters} ----- r --- ^ --------- A_vl. Printed by the Consumer Cooperatives of the Intellectual Property Bureau of the Ministry of Economic Affairs

Printed by the Consumer Cooperatives of the Intellectual Property Bureau of the Ministry of Economic Affairs 1243210 A7 ----------- B7_______ V. Description of the Invention (42) Footprint marking refers to a method to find out how two molecules wither together. In the case of DNA, a protein is bound to a labeled job and the DNA is broken down by enzymes or chemical attack. Generated by the program-the "steps," which contain fragments of all sizes. The bound proteins are less likely to be broken down, so the "steps," appear fuzzy. Footprinting is a general technique for locating where proteins that regulate gene activity actually bind to DNA. The tools and methods used to accomplish any of these lines are detailed in the other paragraphs of this article. ^ Biological response As used herein, a "biological response" refers to any measurement or observation of a biological system after a biological system has been exposed to a herb composition. Sometimes it is also referred to as a "biological effect" A biological response is qualitative or quantitative data on the biological activity of a particular herb composition. Biological response data includes both dose and time information, where such information is familiar with measuring biological system responders to different treatments Known. Therefore, the biological response data contains information about a specific biological response of a specific biological system to a specific dose of a herbal composition that has been cast in a specific manner over a specific period of time. Biological responses include, but do not Limited to physiological responses, morphological responses, cognitive responses, motivational responses, autonomic responses, and post-translational modifications (such as message transduction measurements). Many herbal compositions exhibit more than one biological response (see, for example, Ji Zhanghuang, Chinese Medicine Herbal Physiology, CRC Press (1993)). Some specific biological reactions can be included in one The specified ethnic group or paper size applies the Chinese National Standard (CNS) A4 specification (210 X 297 mm) 45-IIIIIII »— — — — — — — (Please read the precautions on the back before filling this page)- * 1 ϋ «ϋ Β4.- 1243210

(Please read the precautions on the back before filling out this page) Install ----- = ---- Order ---------. 1243210 A7 ----------- B7______ Five State of the invention (44) (such as joint pain and inflammation), exercise, vision (such as: myopia, blindness), muscle tension (such as: wasting syndrome, muscle sprain), presence of pain, epidermis and dermis Health (such as skin irritation, itching, skin wounds), endocrine system function, heart function, neural coordination, head-related health (such as: headache, dizziness), age (such as life span, longevity), and breathing (Such as: obstruction, respiratory disease). A "morphological response" means any characteristic of a biological system after its exposure to a herb composition ' Morphological response 'Regardless of the type of biological system, including but not limited to: size, weight, height, width, color, degree of inflammation, general appearance (such as: opaque, transparent, pale), humidity or dryness, presence or absence of cancerous growth And the presence of parasites or pests (eg, mice, lice, fleas). Morphological responses based on a complete organism include, but are not limited to: the amount and location of hair growth (eg, hirsutism, baldness), the presence or absence of curl, the type and extent of nail and skin growth, the degree of blood clotting, ulceration or The presence of trauma and the presence of pruritus. One tolerance response refers to any characteristic of a biological system that is associated with a cognitive or psychological state following exposure to a herb composition. Cognitive responses include, but are not limited to: perception, recognition, understanding, judgment, recollection, inference, and thinking. A "motivational response" refers to any biological system that is associated with motivation or evoked actions following exposure to a herb composition. characteristic. Motivation reactions include, but are not limited to: emotions (such as joy), desires, driving forces for acquired learning, special psychological reasoning (such as appetite, sexual impulses), or the application of Chinese national standards on paper dimensions CNS) A4 size (210 X 297 mm) (Please read the precautions on the back before filling out this page) Binding · -------- Printed by the Consumer Cooperative of the Intellectual Property Bureau of the Ministry of Economic Affairs 47 1243210 A7 V. The invention (45) is similar to impulses (such as: energy, sexual impulses). An autonomous response ' ' refers to any characteristic of a biological system that is associated with an autonomous response following exposure to a herb composition. Autonomic responses are related to the autonomic nervous system of a biological system. Examples of spontaneous responses include, but are not limited to, autonomic functions (such as: tension, panic), or physiological needs (such as: breathing, heart rhythm, hormone release, immune response, insomnia, anesthesia). The biological response system of cells, cells, cells, and organisms treated with various herb compositions or herb ingredients is known in the art of herbs. For example, any of the herbal compositions Sairie-to (TJ-114), Zefu (head name "T- ,,"), and 茯 茶 (head name "Touchmachi ⑽,") were all found to inhibit mice Synthesis and expression of endothelin-1 (Hattoh et al., Sairai-to. Can inhibit the synthesis of endothelin · 丨 in glomerular silk. 12M_ 997))). Interleukin (IL) -1 A_genesis was significantly improved by the treatment of cultured human skin keratinocytes with the herb Xiaochaihu decoction (Matsumoto et al., Because of the human keratinocytes cultured by Xiaochaihu decoction Leukin- 丨 Improved the growth of spontaneous secretion induced by "Japanese Pharmacology Miscellaneous No. 37 Vol. 4, pp. 333_336 (DM year added Xiao Chai Hu Tang around healthy volunteers also single-nuclear agriculture, In the cultivation of field cells, it is dependent on the production of granulocyte cell line stimulating factor (G-CSF). (Yakizaki et al., Herbal "Xiao Chai Hu Tang," induces peripheral blood mononuclear cells Production of granulocyte cell line stimulating factors in vitro, Journal of Clinical Experimental Immunology, Vol. 37, Vol. 2, pp. 83-90 (Η% year) These 4 researchers who have been reduced to Xiaochaihu Decoction may be used for its efficacy Treatment of chronic liver disease, malignant disease and acute infectious disease. This paper is suitable for towels @ @ 家 标准 (CNS) A4 size ⑵G X 297. (Please read the note on the back? Matters before filling out this page)- --- r --- ^ ---------. Staff Consumption of Intellectual Property Bureau, Ministry of Economic Affairs Printed by Cooperatives 48 1243210

V. Invention Description (46) Printed by the Consumer Cooperative of Intellectual Property Bureau of the Ministry of Economic Affairs

After treatment of human umbilical vein endothelial cells (HUVECs) with purified baicalin IV (AS-W) from Chinese herbal medicine, cytoplasmin activation factor inhibitor type 1 (PAI-1) Decreased RNA performance and increased tissue-type plasminogen activating factor (t-PA) -specific message RNA. (Zhang et al. Regulation of solution fiber capacity of artificially cultured human umbilical vein endothelial cells: baicalin (IV) down-regulates cytosinogen activating factor inhibitor _ 丨 and up-regulates tissue-type cytosinogen activating factor Performance, Journal of Vascular Research, Volume M, Volume 4, 273_280 (1997)). One of the four components isolated from human roots was found to be a potent inducer for the production of human mononuclear globules and THP ·! Cells, and this induction was caused by an increased ratio of _8 message RNA Accompanied by performance (Sonoda et al., Stimulation of melanin-8-production with acidic polysaccharides from the roots of mandarin duck root, Immunopharmacology Vol. 3, Vol. 3, p. 287 294 (1998)). Through flow cytometric analysis, the expression of gamma 11/111 receptor and complement receptor 3 (CR3) on macrophages was improved after treatment with Chinese herbal medicine Toki 芍 Pharmacy (TSS) (Saion, from New BRM of Chinese herbal medicine, Japanese Journal of Pharmacology, Issue 110 (Appendix 丨), pages 87_92 (1997). Using computer image analysis, Chen et al. (For intercellular adhesion molecules in MRI / lpr mice-丨 performance Image analysis ·· The role of Chinese herbal medicine, Chinese Medical Journal Vol. 75, Volume 4, 2G4 German page (1995)) found that the intercellular adhesion molecule-IdCAM]), the distribution strength of immunoglobulin and C3 Chinese herb stragalin treatment was significantly improved in MRI / lpr mice. Western transfer shows that tetrandrine, isolated from a natural Chinese herb, inhibits signal-induced NF_carbaba activated towns in mouse alveolar macrophages. (Chen et al. 'Anticotanin inhibits ^ ----- r --- ^ ---------_ in alveolar giant cell of mouse (please read the note on the back first? Matters before filling in this Page) This paper rule (CNS) A4 specification (0x2m) 49 1243210 A7 B7 Printed by the Consumer Cooperatives of the Intellectual Property Bureau of the Ministry of Economic Affairs 5. Description of the invention (47) Signal-induced activation of NF-carbaba B Physiological Research Bulletin, No. 231, Vol. 1, pp. 99-102 (1997)). Algorithm For the users here, an "algorithm" refers to a step-by-step problem-solving program, especially a circular calculation program with a limited number of steps. It is used for plant-related, markers Suitable algorithms for biological response data sets two and three-dimensional analysis are well known to those skilled in algorithmic techniques. These algorithms are used to construct the herb biological response array of the present invention. For general information about the algorithms, see for example: Gerold H. Zaer, Biostatistical Analysis, Second Edition, Plenty Hall (1984), Rob A. Schwingert, Remote Sensing Image Processing and Classification, Academic Press (1983), Steve Golder, et al. Two-dimensional and three-dimensional point coordination algorithms: situation estimation and conformity, style identification No. 31, volume 8, page 1019_1031 (1998), Berklastian, nonlinear Programming and Multi-Objective Discriminant Algorithms, Wiley-Interdisciplinary Series (System and Optimization), John Wiley and Shang Si (1998), Jeffrey H. Kingston, Algorithms and Data Structure: Design, Correction, Minute Analysis, International Computer Science Series, Edison-Weasley Publishing Company (^^^^), Steven S. Steiner, Algorithm Design Manual, Springer Fletcher (1997), and Marshall! ^. Nutz, Probability of Algorithms: Problem Sets, Models and Models, Ipman, and Hall (1995). For more specific information on the application of algorithms to genetic-dominated data, see, for example, # 贾Fifield, Group, Tree, and Sequence Algorithms · Computer Science and Computer Biology, Cambridge University Press (1997), Maranne Mitchell, Introduction to Genetic Algorithms (Complex Adaptive Systems), MIT (1996), David E. Gaul (Please read the notes on the back before filling this page) Binding --------- A9 ·.

50 1243210 V. Description of the invention (48) = V :: two algorithms in search, optimization and machine learning, Edison algorithm + data: structure ~ 4 structure 1 program, Springer Fletcher (1996), An 7Witlinden and Jen nDNA Sorting: Genes =, Yales Howard Molecular Biology Series, Yelles Howard Co., Ltd. (4 years) and Pierbodie and Surem Brunk, Bioinformatics ★ • Machine ③ "Method (Adaptive Computing and Machines)", Publishing Department (1998). Combinatorial chemistry For the users here, "combinatorial chemistry" refers to technologies used to create hundreds or thousands of compounds, where any compound has one or more different characteristics, such as its shape and charge And / or anaerobic properties. Combinatorial chemistry can be used to produce compounds that are chemical variations of herbs or medicinal ingredients. These compounds can be evaluated using the method of the present invention. The concept of combinatorial chemistry is known to anyone skilled in chemical arts' and can also be found in Nicholas K. Trede, Combinatorial Chemistry (Oxford Chemistry 'Professionalism', Oxford University Publishing Department ⑽8 years), Anthony W. Zanick and Sheila Haberth DeWitt (editor), Guide to Combinatorial Chemistry Operations, American Chemical Society (leap year), Stephen R. Wilson (editor) and Anthony W. Zhanick (contributor) ' Combinatorial Chemistry: Synthesis and Applications, Yolanda Willy and Shangsi (1997), Eric M. Gordon and James F. Kevin (Editor), Combinatorial Chemistry and Molecular Density In the discovery of new drugs, Willie Lies (1998), Xu Mu Heng Billy (editor), Combined Peptide Depot Operation Method (Molecular Biology Method), Shumen Press (1997), 'John P. Di Flynn, High Unit Time Output Screening, MA

51 1243210

V. Description of the invention (49) Printed by Sodek (1998), Lai Rui Gaoerde and Joseph Alber, in the Consumer Cooperatives of the Intellectual Property Bureau of the Ministry of Economic Affairs, in parallel with combinatorial chemistry and genomics. 297 (1997); Aris Bosidis, Combinatorial Chemistry, Natural Biotechnology No. 16, 691-693 (1998). EXAMPLES Example 1: Establishing a standardized herb bio-reaction array for a selected herb composition The basic flow for establishing a standardized herb bio-reaction array is provided in FIG. 1. Definitions of any part of the process are provided above. With the selection of an interesting and interesting herb composition, information on different traits related to the herb composition is collected, which includes, but is not limited to, plant-related characteristics and identifiers and biological response information. Plant-related information includes, but is not limited to: plant species, specific plant parts, geographical origin of plants in herb compositions, plant growth conditions, processing methods used to prepare herb ingredients, storage methods and conditions, and the composition of the herb Different chemical analysis of things. The identifier information contains qualitative and quantitative information about the identifier that was collected after a biological system was exposed to the herb composition. Applicable markers include, but are not limited to: molecular markers, cytogenetic markers, biochemical markers, and macromolecular markers. Biological response information contains qualitative and quantitative data related to biological responses collected by a biological system after exposure to a herb composition. Any type of information (e.g., chemical substances, identifiers, biological reactions, can be tested using one or more of the same, similar, qualitatively similar, or similar batches of the herb composition of interest) Obtained. These paper sizes are applicable to the Chinese National Standard (CNS) A4 specification (21〇X 297 mm) ^ ------ ^ 一 ^ Packing ----- r --- Order ---- ----- (Please read the precautions on the back before filling out this page) 52 1243210 Printed by the Consumer Cooperative of the Intellectual Property Bureau of the Ministry of Economic Affairs A7 B7 V. Description of the invention (50) The same inspection can be performed at the same time or at different times Similarly, biological response data can be collected for the same or different biological responses at the same time or at different times. Therefore, the collection of biological response data for herbs is collected at one time, or on an ongoing basis. One of the biological systems is exposed to a herb composition to collect data, and information on the dose and processing time of the administered herb composition is collected. Biological response data may also include post-translational modifications, such as signal transduction Its measurement. Collection of two or more kinds of data (such as data about two or more markers and a biological response, data about plant-related traits, and a biological response data), which is analyzed using algorithms to establish 2 And / or% dimensional herb bioresponse array. Different statistical parameters for the herb bioresponse array can be calculated and can be part of the herb bioresponse data set. These statistical parameters can include, but are not limited to: average, standard deviation, Relevant or matching (or not matching), matrices, proportions, regression coefficients, and conversion values (such as the inverse sine percentage conversion of the original data). Therefore, the herb bioresponse array can contain the original data and some calculated values, distributions, and geographic representations And other data manipulation related to the original data. Specific examples of such information include, but are not limited to: digital images, scatter plots, group analysis, and marker data. Large-scale gene expression profiles. All accumulated data and final analysis Composition—The composition of a particular herb used to create a herb bioresponse array data set Standardized Herbal Biological Response Arrays. Due to the repeated nature of the procedures used to create and maintain the Herbal Biological Response Arrays of Herbal Compositions' These arrays can be regarded as applying the Chinese National Standard (CNS) A4 specification at this paper scale (210 X 297 mm)

H ------— β --------- (Please read the notes on the back before filling out this page) 53 243210 A7 B7 Printed by the Consumer Cooperatives of the Intellectual Property Bureau of the Ministry of Economic Affairs 51) Any time point is static or dynamic over a period of time. The final analysis identifies subcombinations of standardized herb bioresponse arrays that are related (positive or negative) or related (ie show a common trend) to one or more specific biological activities of any particular herb composition. Example 2 • Establishing a Batch of Herbal Bioreaction Arrays for Batches of Herbal Compositions The basic flow for establishing a herb bioreaction array for a lot of herb compositions is provided in FIG. 2. The definition of any part of the process is provided above. The procedure used to create this array is the same as that previously proposed for standardizing herb bioreactor arrays. In general, the amount of data collected for a batch of herb biological responses will be less than that collected for the establishment of a standardized array. However, the data collected for a batch of herb composition can be added to an established herb bioreaction array S and used to create a new standardized herb bioreaction array. Through Φ, the only data collected for a batch of herbal bioreactor arrays are those found to be highly relevant or relevant to the biological activity required for the herb composition under test. For example, if it has been determined that a particular combination of plant-related and marker data is highly correlated with the biological activity required for a particular herb composition (based on standardized herb bioresponse array data and the analysis discussed earlier), In order to determine whether this batch has some biological activity, it is only necessary to test the properties of the combination of the batch composition. For this particular herb composition, by comparing the data obtained from the sub-combination traits of this batch (ie, its batch herb biological response array) with the standardized herb biological response array, those skilled in the art can determine that specific Does the batch have the required biological activity. --- J -------- 1 ----- r I--Order --------- AVWI (Please read the notes on the back before filling this page) 54 1243210 Ministry of Economic Affairs Printed by the Intellectual Property Bureau employee consumer cooperative A7 B7 V. Description of invention (52) Example 3: Basic process of establishing and using a master data set The master process of establishing and using a master data set is provided in Section 3. Illustration. Definitions of any part of the process are provided above. The first step is the creation of a master data set for a selected herb composition or batch of herb compositions. This is accomplished by exposing a biological system to the herb composition and collecting the generated identifier information that will form the master data set. In most, but not exclusively, the master data set consists of an array In the form of genomics and / or proteomics data, such as an array obtained using a DNA biochip. Second, this master data set was analyzed to investigate whether differentiated manifestations have been obtained from the tested herb composition. To produce meaningful algorithms in the next step, differentiated performance / results are needed. Examples of such differentiated manifestations / outcomes include, but are not limited to, those in which a certain gene is regulated up or down in response to exposure to the herb composition or that the concentration of certain proteins has been increased or decreased in response to this exposure Characterization. If no meaningful or useful differentiation manifestations / results are obtained, then this exposure and marker collection step must be performed. If it is considered that experimental errors lead to insufficient results for the first time, then this exposure / data collection step can use all the same variables as the first time (for example: the same biological system, the same set of markers, the same experimental operation steps Etc) was repeated. However, it may be necessary to change the sampling of the biological system (eg, the type of cell being used, the cell growth period), use a different set of markers, and / or change the experimental procedure ’to achieve differentiated performance / results. This paper size applies to China National Standard (CNS) A4 specifications (210 X 297 mm M, ----- r --- tr --------- · (Please read the precautions on the back before (Fill in this page) -Η- II 4 _ 55 1243210 Printed by the Consumers ’Cooperative of the Intellectual Property Bureau of the Ministry of Economic Affairs A7 B7 V. Description of Invention (53) Example 4 · Using Herbal Bioreactor Array Information Information can be used for many different purposes, including but not limited to the following: 1) Evaluating the composition of a herb composition, 2) Predicting the biological response of a herb composition, 3) Determining what kind of marker information is related to- A specific biological response of one of the herb components is most highly relevant, 4) The information of which data set (i.e. plant-related data, marker data and biological response data) is most relevant to a specific biological response of a herb component, 5 ) Determine what type of biological system is best for assessing the biological activity of a herb composition, 6) adjust or change the composition of a herb composition, so that the herb biological response array of the herb composition is the same or substantially the same Herb composition Corresponds to the standardized herb bio-response array, 7) adjusts or changes the composition of a herb composition so that the herb composition will have the required biological activity, 8) creates and updates a standardized herb bio-response array, 9) appraises Specific ingredients of biological activity required by a herb composition (such as plant parts, proteins, molecules), 10) determine which ingredients of a herb composition can be excreted, while maintaining or promoting the herb on the one hand The required biological activity of the composition, U) is the identification of one or more previously unknown biological activities of a herb composition, 2) the design of adjuvant therapy, which includes certain grass and non-some grass components, such as chemical synthesis Drugs or medicines and 13) combinatorial chemistry methods that complement the design of therapeutics using information from the biological response of the Chinese cornflower. Any of the embodiments of the present invention can be completed by those skilled in the art using the methods and tools provided herein. Example 5: Quality Control The herbal bioreactor array technology of the present invention is used to apply a substantially paper size to the Chinese National Standard (CNS) A4 specification (210 X 297 mm) ^ -------- --------- (Please read the notes on the back before filling out this page) 56 1243210 Printed by the Consumer Cooperatives of the Intellectual Property Bureau of the Ministry of Economic Affairs A7 B7 V. Invention Description (M) etc.-Specific batches One of the herb compositions (a unit drug or a wide range of herbs) is related or determined to be a standardized or master batch of the same or substantially similar herb composition. The herb bioresponse array used in this procedure contains an acceptable quantitative variation range for any biological effect (ie, biological response) and a total score that can include the weight value specified for any biological effect, which May contain multiple biochemical markers from the biological system. "Data mining refers to a process used to determine or select which combination of biological effects is the minimum number of biological effects required in any particular herb biological response array. Information used for data mining is derived from the Biological systems (such as a cell line) are exposed to a standardized herb composition in a dose-dependent manner to establish a standardized herb bioresponse array. This standardized herb bioresponse array can then be used differently from herbs established to test the herb composition Comparison of bioreactor arrays. These test herb compositions include 'but are not limited to: different batches made on different dates, different batches made from crude herbs collected at different times, and Different batches of crude herbs collected. Example 6: Modification of a herb composition or identification of a new application for a herb composition. The biological response of the herb is by exposing the biological system to the extraction of individual herbs from a formula Or extracts that are exposed to the entire formula and examine the biological effects of the extract. Observed biological effects can come from multiple biochemical pathways of a biological system and / or multiple tissues of an animal, in which different identifiers are for their corresponding qualitative and / or quantitative changes, and this paper standard applies Chinese national standards (CNS ) A4 size (210 X 297 mm) 57 _ Installed Printed by the Consumer Cooperatives of the Bureau A7 B7 V. Description of the invention (55) The bioreactor array of the herb produced by the evaluated juice can be used with the novel bioreactor array of the herb or from different herb compositions or herbs prepared by different procedures Comparison of similar biologic response arrays of herbs. This procedure is used to select the biological effect of a specified combination and predict the minimum number of markers required for a specified batch-human herb composition to have the biological effect of the specified combination. In order to construct the herb bio-response array, a person skilled in the art uses different data mining tools, including but not limited to: statistical analysis, human Intelligence and neural network database research. Alternative statistical methods include, but are not limited to: basic search-type data analysis (EDA), graphical search-type data analysis [such as bushing], and multivariate search techniques (such as: Group analysis, identity factor analysis, stepwise linear or non-linear regression, classification tree) (see for example: STATISTI CA ™, packaged software from StatSoft, Tuersha, OK74104; Tel. · 918-749-1119; Fax: 918 -749-2217: ^ OQV ^ StatSoft rnm) 〇 Data mining tools are used to search for a large number of herb biological response data 'to seek to establish a herb biological response array and various different herb biological response arrays inside, among or among each other Consistent pattern. This procedure involves searching, constructing, and validating a herb bioresponse array. This procedure is typically repeated again and again until a robust herbal bioreactor array or a standardized herbal bioreactor array is recognized. The above detailed description is only for clarity of understanding, so it must be understood that there are no unnecessary restrictions, because the way of change is obvious to those skilled in the art. This paper size applies to China National Standard (CNS) A4 specification (210 X 297 meals) --- J --------- III L ---- Order --------- (Please Read the notes on the back before filling out this page) 58 1243210 Printed by A7, Consumer Cooperatives of the Intellectual Property Bureau of the Ministry of Economic Affairs 5. Description of the Invention (56) Although the present invention has been described in conjunction with the specific embodiments here, it must be understood Yes, the present invention is a further change and the present invention is intended to cover generally following the principles of the present invention and including practices or customary practices, such as those in the art to which the present invention pertains, and may be applied to previously described herein The necessary features and areas of compliance with the scope of the patent application filed by the application are derived from new developments of the present invention. Example 7 • Establishing a standard herb bioreactor array for human pupae For the purpose of this example, the standard human pupae was selected as the human pupae growing in Northeast or South Korea (panax Ginseng C.A. Meyer G115). Raw

The long climate is between -10 and 10C, and the rainfall is 50-100 cm (see Huang Zhu TCM Pharmacology (1993) pp. 21-45, CRC Press, Paul Carreton, FL, with full authority). The mandarin duck batch will first be described by geographical origin, species, plant parts (eg rhizomes, roots, leaf bark, seeds, buds and flowers), growth conditions, processing methods and storage conditions before and after processing. The chemical content of these batches will be identified by using human saponins (such as: R0, Ral, Ra2, RM, Rb2, Rb3, Rc, Rgh Rg2, Rd, Re, Rf, Rhi, Rh2, NG-R2 And Z-R1), a qualitative high-performance liquid chromatography analysis was completed, which also included thin-layer chromatography on neolipidic components (see Ye Erjin et al., Chinese Journal of Pharmacology (1993), No. 14, Pp. 97-100 and Yoshikawa et al., Journal of Pharmacology (1993), p. 113, p. 46-467). The soap content of different herbs depends on the species (see Table 丨) and must be between 21 and 206% by weight. This data will then be stored, preferably in the memory of a computer processor, for further operation. This paper size applies to China National Standard (CNS) A4 (210 X 297 public love) «. ----- ^ ---- ^ --------- (Please read the precautions on the back before (Fill in this page) 59 1243210 A7 B7 V. Description of the invention (57) Printed by the Consumer Cooperatives of the Intellectual Property Bureau of the Ministry of Economic Affairs. Total saponins (% by weight) 2.1-4.4% 4.9% 13.6-20.6% 9.34%

The performance biomarkers of standard human 蔘 (ie G115) include the following: interleukin-8, interleukin_2, GM_CSF, NfkB, ICAm_1, interferon gamma, choline 醯 transferase, trk A, nerve growth Factors (Jin et al., Plant Medicine (1998) No. 64, page 11 (M15; Sonoda et al., Immunopharmacology (1998) No. 38 ru-gangue; Bao et al., European Applied Physiology Journal (1997) 76: 165-169; Iwangawa et al., Free Radical Biomedicine (1998) 24: 1256-1268; Ryder et al. 'European Journal of Applied Physiology (1996)' Issue 74, pages 348_36.) In addition, for larger batch sizes, Affmatrix's 400,000 oligonucleotide group / 1.6 cm2 wafer can be used (U.S. Patent No. 5,556,752). Performance markers will be prepared by using optical lithography, mechanical microspots, or inkjet applications (see Schiner et al., Bioscience Trends (1998) No. 16 pp. 301-306). Selecting a combination of cells Will be in contact with a standard person for a different period of time, under different conditions to produce multiple Array combination. This microarray combination will then be analyzed by hybridization-based monitoring of biochemical extracts of speculative steady-state information RNA (Mrna) concentrations from fluorescence intensity at any position on the microarray (Xi Na et al.'S paper size is applicable to Chinese National Standard (CNS) A4 (21〇χ 297 mm) --- J -------------- ^ ---- ^ --- ------ (Please read the notes on the back before filling this page) 60 1243210

Printed by the Consumer Cooperatives of the Intellectual Property Bureau of the Ministry of Economic Affairs, Science (1995) No. 270, pp. 467 to 470; Schenna et al., National Academy of Sciences (1996) No. 93, pp. 10614 to 10619; Rockha Special et al., Natural Biotechnology (1996) No. 14 pp. 1675-1680; Diriche et al., Natural Genetics (1996) No. 14 pp. 457-460; Holle et al., National Academy of Sciences Report (1997), Issue 94, pp. 215 to 2155). The array data set is then input to an algorithm to generate a statistical representation of a standard human biomarker. Biomarkers for standard human tadpoles include: Cyclohexamine susceptibility [3-]-leucine incorporation is proportional to an increase in protein synthesis and [氚] -thymidine corresponding to quantitative analysis of mitotic incorporation (see : Yamamoto et al., Arzneimittelforschung (1997), No. 27, pp. 1169 to 1173). As for biochemical biomarkers, under different conditions: the presence of [氚] -thymidine (for DNA synthesis) or the presence and absence of cyclohexamide and [氚] _leucine (for protein synthesis), bone marrow Cells will be in contact with standard human tadpoles for a different period of time to complete the quantitative analysis of biochemical biomarkers (ie, BBM testing). The biochemical biomarker is then input into an algorithm to generate a standard human biochemical biomarker value. The statistics will then be stored, preferably in the memory of a computer processor, for further manipulation. The biological response (ie, biological response) of a biological system will be measured using cells and the entire organism. Regarding cells, human cymbal batches will be exposed to specific cell types, including but not limited to: fibroblasts, macrophages, monocytes, polymorphic nucleated white blood cells, LAK cells, B16-F10 melanoma cells, THP-1 cells and hippocampal neurons (concentration increased from 0.5 mg / mL to 100 mg / mL). Regarding animal handling, the size of human paper of 0.5-100 mg / kg applies to Chinese National Standard (CNS) A4 (210 X 297 mm) 61 * ----- ^ ----- r --- ^- -------- (Please read the precautions on the back before filling out this page) 1243210 Printed by the Consumer Cooperatives of the Intellectual Property Bureau of the Ministry of Economic Affairs A7 B7 V. Invention Description (59) Peony herb extracts will be taken orally, It is administered intraperitoneally or subcutaneously. In order to determine a biological response of a biological system to a standard human tadpole, human indica cells will be implanted in nude mice, causing the formation of a touchable tumor. After tumorigenesis, the mice were co-administered with cis-diagas diamine platinum and standard human thallium. Mice will be examined for tumor growth inhibition, prolonged survival, and reduced side effects on blood specific volume value and weight (NaKada et al., Japanese Journal of Cancer Research (1998) 89: 733-740). The test will be repeated using standard human salamanders of different concentrations to produce measurements of intermediate propensity, dispersion, and variability of any variable. The generated data will then be imported into a multi-dimensional analysis to generate a multivariate normal distribution group as a method of determining the correlation between biological activity and a standard baseline between humans (see Zhal, jH. 2nd edition (1984), 328-360, Plenty Hall, Anglewood Cliffs, NJ). A second independent determination of the biological response of a biological system to one of the standard humans will be the effect of the standard humans on physical performance during exercise. Rats will be treated with standard human radon at different concentrations (between 0.5 and 100 g / kg / day) for 4 days and animals will be tested for elevated plasma free fatty acid concentrations and a maximum of about 70% Maintenance of blood glucose concentration during exercise under oxygen consumption (VO2max) (see Wang et al. 'Plant Medicine (1998) No. 64, pp. 13-30). The data generated will be collected and then imported into multidimensional analysis to generate a multivariate distribution of havoc distributions as a method of determining the baseline correlation between biological activity and standard human tadpoles (see Zhal, JH. 2nd edition (1984) 'pp. 328-360, Plenty Hall, Anglewood Cliff, Nj This paper is sized for the Chinese National Standard (CNS) A4 (210 X 297 mm) (please first Read the notes on the back and fill out this page) _Install L ---- Order ---------. 62 1243210 A7 V. Description of the invention (60) Here 70 Kings are for reference). The distribution composition of each biological response is then input to the calculation method to generate statistical values of standard humans. The statistics will then be stored, preferably in the memory of a computer processor, for further operation. Any of these steps (ie chemical analysis, generation of biomarkers, and determination of the response of a biological system) are repeated to generate a large database of statistical values. These values are compiled and entered into an algorithm to generate standard 2D and 3-dimensional herb biological response arrays (HBR arrays). Through iteration, the resulting array (ie, standardized array) shows the highest correlation between the standard human tadpole among the composition (including growth conditions), biomarker information, and biological response. Based on the performance of a test batch on a herb bioresponse array, by determining 2 or more known related variables of the composition and biomarker information values, the biological response variable values are compared by measuring 4 values and Standard human 蔘 standardized herb bioresponse array values can be predicted. The resulting predictions will be used to evaluate the quality of a given human / batch without using the observed biological response of a biological system (see Example 2). Example 8: Evaluation of a selected human peony herb composition using a set of variables related to a specific biological response In order to evaluate the quality of a test batch of herb composition, the selected herb The parameters of plant-related data (such as: plant species, plant parts, geographical origin, growth conditions, processing methods, and storage conditions) of the herbs in the composition are collected first. This selected herb composition is then subjected to a treatment such as chemical analysis that can be used to determine the chemical composition of the drug list (see ·· Yerkin et al., Chinese Journal of Pharmacology (1993) No. 14 Issue 97-100 This paper size applies to China National Standard (CNS) A4 (210 X 297 mm) (Please read the note on the back? Matters before filling out this page) Printed by the Consumer Cooperative of the Intellectual Property Bureau of the Ministry of Economic Affairs 63 l2432l〇

Printed by the Consumer Cooperatives of the Intellectual Property Bureau of the Ministry of Economic Affairs and Yoshikawa et al., Journal of Pharmacology (1993) No. 113 p. 46-467). Previously obtained ginseng data has shown a strong correlation between aerobic performance in aerobic performance and the presence of saponin components in the primary group, especially Rgl and Rg2 (Wang et al., Plant Medicine 998) 64th Issues 130-133). The test batch is then exposed to test cells including, but not limited to, fibroblasts, macrophages, monocytes, polymorphic nucleated white blood cells, LAK cells, B16-F10 melanoma cells, THpq cells, and hippocampal nerves Yuan (concentration of 0.5 mg / 亳 to 100 亳 L / ml) to determine the value of the object only when it is judged to be a manifesting organism. Information RNA was isolated from the exposed cells, which was subsequently used as a biochemical extract using a microarray containing melanin_8, melanin_2, and interferon gamma complementary DNA. The Matrix of Master's Performance Monitoring (Schenna et al., Science (1996) No. 27, pages 467-470; Schenna et al., National Academy of Sciences Report (1996), No.… pages 10614--10619 Diraci et al., Natural Genetics (^ Foreign Years) No. 14 pp. 457 to 460; Heller et al., National Academy of Sciences Report (1997) 94 pp. 2150-2155). Previously obtained ginseng data has shown a strong correlation between aerobic oxygen consumption and the induction of the biomarkers interleukin-8, interleukin_2, and interferon gamma in test cells (where Kaduramen et al., Sports Medicine Science (1997), 29th, pp. 333-334 and Wang et al., Plant Medicine (1998), 64th, pp. 13-30). 2. For biochemical biomarkers, rat bone marrow cells will then be exposed to test batches-humans and tested for [mitochondrial thymine incorporation as opposed to mitosis. The previously obtained human radon data has been shown in the rat bone Zhao Xi M and this paper size timely standard 0 CNS A4 specification (21Qx 297 public love) ------------- -Install ----- ： ---- Order --------- (Please read the notes on the back before filling this page) 64 1243210 A7 B7 V. Description of the invention (62)

Rgi shows a strong correlation with DNA (Yamamoto et al.

Arzneimitteelforschung (1978) No. 28, pages 2238 to 2241) After iterative analysis, data from any test will be entered into the chastity method 'to produce digitally-based plant-related data (including chemical analysis and biological analysis). Identifies the subgroup of the material) one of the selected herb components to test the herb bioresponse array. The quality of a test batch will be determined by comparing the test herb bioresponse array with the standard ginseng standardized herb bioresponse array by analyzing and observing the above-mentioned observations and subgroup variables. Among them, extracorporeal interleukin_2, interleukin_ 8 and interferon gamma-induced and [氚] • thymidine incorporation increase in rat bone marrow cells (including data collected for growth conditions, sources and identification of saponin Rgl and RM), etc. It can be predicted that the biological response effect of one equivalent of this test batch in terms of oxygen consumption is based on the sequence as if it was inhibited by standard humans. Based on this sequence, it can be determined whether the test batch is related to the specified biological response or the organism of interest. The response is similar or different from the standard quality. Example 9: Established for Coptis chinensis (HL)-Standardized Herbal Bioreactor Array Printed by the Consumer Cooperative of the Intellectual Property Bureau of the Ministry of Economic Affairs. Printed for the purpose of this example. The standard Coptis chinensis was selected to be harvested from CGptis Chinesis Franee. ), Where the growth conditions are known to those skilled in the art (see Huang Yu Chinese Medicine and Herbal Medicine Howling Pages and 287_288, CRC Press, Paul Carreton, called. The dried rhizomes will be borrowed Quantitative chemical analysis to determine Kun, Xiaomeng, Yuhua acid, tetrandrine, berberine, berberine cut, berberin _ !, lianhuangpu_2, page test, Kosinamine, table test , Ferulic acid, green paper This paper uses the Zhongguanjia Standard (CNS) A4 specification-χ Norwegian Gongfa _ prime 1243210 printed by the Consumer Cooperatives of the Intellectual Property Bureau of the Ministry of Economic Affairs A7 B7 V. Description of the invention (63) (greenlanchcme) , Iso-berberine, light hyaluronic acid, magnolitine, oxygen test, Tang ^ thalifendine, Mi Se, urbenine, methyl-page test, Bamatine, medicine root test and African tetamine is confirmed for its chemical content See also Chinese Traditional Medicine Bulletin (1984) No. 9 page）.) The content of micro-tests of different herbs should be between 7-9% (percent by weight). These data will be stored, preferably by computer processing In order to facilitate further operations, the bio-calibrators of the quasi-κ-connected cells include the following: Nfk B, bcl_2 analogs, A1, zinc finger protein, A2O, interleukin_2 receptors, cells Periodic needles, C-Ki-ras2, growth-regulatory factor probes, and probes for carbohydrate-dependent adrenocortin receptor-dependent autolysis (see Qi et al., Life Science (1994) No. 54, pp. 2009-2107; Yang et al., Pharmacology, Schmidberger Schiak, Liaoning (1996), No. 354, pp. 102-108); See Pu et al., Biochemical Pharmacology (1997), No. 53; Zhang KS, et al. , Journal of the Taiwan Medical Association (1991), 90th issue, pp. 10-14). In addition, for a larger batch size of 40,000 oligonucleotide groups / 1.6 cm2 wafers of Affimatrix (U.S. Patent No. 5,556,752) can be used. The performance biomarkers of the standard Coptis chinensis will be produced by microarrays as described in the Examples', including analysis and statistical data generation. Standard Coptis chinensis biochemical biomarkers include increased glucocorticoids in Hep G2 cells exposed to Coptis chinensis and inhibition of fetal protein secretion by Alfa (see: Qi et al. Life Science (1994) No. 54 No. 2099 to 2107). Biochemical biomarkers were generated and analyzed (as described in Example 1). The statistics will then be stored, preferably in a computer processor, for further manipulation. This paper size applies to China National Standard (CNS) A4 specifications (210 X 297 public love) 66 -------------- install -----: ---- order ---- --I--ASW1 (Please read the Zhuyin on the back? Matters before filling out this page) 1243210

V. Explanation of the Invention (64) The biological response of the biological system will be judged using cells and the entire animal. The batches of the selected herbal composition will be exposed to specific cell types, including but not limited to: human 11 邛 G2 liver tumor cells, human embryo tumor cells, and thymocytes (between 〇 · 丨 _ 1〇〇 Mg / ml). For animal treatment, 0.1 mg to 2 g / kg of Coptis chinensis composition (i.e. Coptis chinensis) will be administered orally, intraperitoneally or subcutaneously. In order to determine the biological response of a biological system to standardized Coptis chinensis, human embryo tumor lines (NT2 / D1) were exposed to different, standard concentrations of Coptis chinensis and cells would be examined for differentiation into cells with neuron-like cell types ( Zhang et al., Journal of the Taiwan Medical Association (1991) No. 90 p. HM4). This test will be repeated to produce measurements and the analysis of the person as described in the examples will be completed. A second and independent determination of the biological response of a biological system to standard Coptis chinensis will be the effect of Coptis chinensis on the infestation caused by enterotoxic E. coli (ETEL). Patients with diarrhea due to enterotoxic E. coli will be treated with different concentrations of Coptis chinensis (eg 2 g / kg) and stool volume will be judged (see eg Rabbani GH, Dan Med BuU (1996) 43: 173-185 ). This test will be repeated to produce measurements and the analysis as described for the human being in Example 1 will be performed. The distribution group of any biological system is then input into the algorithm to generate a statistical value for the standard Coptis chinensis. The statistics will then be stored, preferably in the memory of a computer's processor 'for further operations. Finally, as in Example 1, these steps were repeated to generate a standard herbal bioreaction array of Coptis chinensis, where the bioreactor array of the herb produced was then used to predict biological activity and evaluate batch quality. With this method, the paper size is applicable to the Chinese National Standard (CNS) A4 specification (210 X 297 cm) (Please read the notes on the back before filling this page)-· I 丨 丨 h I 丨 —Order ---- IIII. Printed by the Consumer Cooperatives of the Intellectual Property Bureau of the Ministry of Economic Affairs 67 1243210 A7 B7 V. Description of the Invention (65) A standardized herbal bioreactor array can be generated and regularly updated. Example 10: Evaluation of a selected herbal composition of Coptis chinensis using a subgroup related to a specific biological response. In order to evaluate the quality of a selected test batch of Coptis chinensis composition, plant-related Data (such as: plant species, plant parts, geographical origin, growth conditions, processing methods, and storage conditions) are first collected. The herb composition is then subjected to chemical analysis that can be used to determine the chemical content of the composition (see also: Zhu M. Chinese Medicine Bulletin (1984) No. 9 pp. 63_64). Previously obtained data have shown that the differentiation of human embryonic malignant tumor cell lines into neuronal lobe cells is strongly related to the presence of alkaloids (see Zhang KS, Journal of the Taiwan Medical Association (1991) No. 90 No. 1). _14). This test batch was then exposed to a test cell containing a human embryonic malignant tumor cell line, NT2 / IM, at a concentration starting from a non-toxic concentration, which is determined to be a known technique. Information RNA was isolated from the exposed cells, which was then used as a substrate for hybridization reactions based on the monitoring of the performance of biochemical extracts using a microarray containing melanin_2 receptor and Nfk B (see: Qi et al. Humans, Life Science (1994), 54 (2) 99-2021); Yang et al., Schmidberger Schiak Pharmacology (1996), 354 (102-108); Miura Et al., Biochemical Pharmacology (1997) Issue: Zhang KS, Journal of the Taiwan Medical Association (1991) No. 90, page 10; 4; US Patent No. 5,556,752), and can be used to determine Down regulation of c_ Ki-ras2 gene expression in this cell. The previously obtained data of Coptis chinensis has shown that the human embryonic malignant tumor cell line has become a differentiation line of neuron-like cells (please read the precautions on the back before filling this page)! Appropriate ruled paper rule A4 for employees 'cooperatives printed by the Intellectual Property Bureau of the Ministry of Economic Affairs N (c quasi-standard country and country) 97 68 Printed by employees' cooperatives of the Intellectual Property Bureau of the Ministry of Economic Affairs 1243210 A7 ------ -B7_ 5. Description of the invention (66) is strongly related to the induction of mitogen probes and the down-regulation of c-Ki-ras2 gene expression (see Qi et al., Life Science (1994) No. 54 No. 2099-2017 As for biochemical biomarkers, Hep G2 cells were exposed to this test composition and the cells were tested for increased glucocorticoid receptors and inhibition of fetal protein secretion by Alfa (see Qi et al., Life Science (1994) No. 54, pp. 2099-2107). The previously obtained data of Coptis chinensis has shown that the inhibition of autologous destruction induced by glucocorticoids is strongly related to the berberine-like biological system (see Mi ur a et al., Biochemical Pharmacology (1997), No. 53, pp. 13 15-1322). After repeated analysis, data from any test will be input into the algorithm to generate data-based observations , Chemical data, and one of the data related to the biomarker sub-group to test the herb bio-response array. The quality of a test batch will be compared by comparing the observations for the above-mentioned observations with the analysis of the sub-group to compare the test bio-response and standard Coptis chinensis. Herb bioresponse array variants, including the induction of melanin_2 receptor and NfkB, down regulation of c_ki_ras2 gene expression, related to the increase of glucocorticoid corticoid artefacts in HEP G2 cells and secretion of fetal fetal leukocytes in Alfa The presence of inhibition (including data collected on growth conditions, origin, and identification of small plant test) is expected to be the test batch for the differentiation and termination of human embryonic malignant tumor cell lines into neuron-like cells One of the equivalent biological response effects of semexone-induced autologous destruction is the same as those inhibited by standard Coptis chinensis. Based on this procedure, it can be determined that this test batch is It has similar or different qualities to those of the standard. This paper size applies to China National Standard (CNS) A4 (210 X 297 mm) t ---------- Order ------- -. (Please read the notes on the back before filling this page) 69 1243210

V. Description of the invention (67) (Chaihu, Pinellia ternata, Ginger, Scutellaria baicalensis, Jujube, Jujube: t 蔘, mandarin duck and licorice 'relative weight (see Table 2).

Implementation Example 11 · Evaluation of Xiao Chai Hu Tang using Lianghe biological test, in order to evaluate the quality of Xiao Chai Hu Tang from three sources, two biological tests were used: 1) cell growth inhibition and 2) hepatitis B virus Infected cells secrete. The composition of Xiao Chai Hu Tang is composed of a mixture of 6-7 herbs and plants. These three "magic formulas" are derived from Singapore, South Korea or Taiwan. The batches were evaluated by DNA quantification or detection of hepatitis 6 surface antigen (HbsAg) to assess toxicity and ability to inhibit hepatitis B virus (see Dong et al., National Academy of Sciences report ( (1991) 88 (8495-8499). Briefly, one gram of the preparation was added with 10 ml of water. The mixture was cooked for 30 minutes. The suspension was collected after centrifugation and filtered through 1022 micron filter paper. Two cell types are used: a) 2.2.15 cells that secrete hepatitis B virus (provided by Professor G. Ace; see Ace et al., National Academy of Sciences Report (1987) No. 84 (P. 105-10) and HepG2 cells (ATCC Cat # HB-8065). A 1:50 dilution is used for any inspection. The cytostatic assay was performed for 72 hours. All other paper sizes are in accordance with Chinese National Standard (CNS) A4 (210 X 297 mm) --------- ^ ---------. (Please read the note on the back first Please fill in this page again) Printed by the Consumer Cooperatives of the Intellectual Property Bureau of the Ministry of Economic Affairs 70 ο 2143 2 A7B7 Printed by the Consumer Cooperatives of the Intellectual Property Bureau of the Ministry of Economic Affairs 5. The description of the invention (68) The sequence is as described in Dong et al. Report of the Chinese Academy of Sciences (1991) No. 88 pages 8495-8499 were completed. The results of the tests using these three batches are presented in Table 3. Based on these data, Taiwanese sources will be selected as a standard herbal composition because of its low toxicity combined with its ability to reduce the secretion of hepatitis B virus surface antigen (proportionate to the virus release) by more than half. Table 3. Inhibition of cell growth source (%) of Xiao Chai Hu Tang by Hepatitis B virus (secreted) inhibition percentage Singapore HepG2 2.2.15 DNA HBsAG 73 100 65 38 Taiwan Taiwan ~ 13 60 20 「42 0 42 0 47 Table The data of the Taiwan herb composition presented in 2 and Table 3 constitute the starting data for the standardized herb bioreaction array of this herb composition. Therefore, this data set will initially include the source of the herb composition, the plant species, and any The relative amounts of the herb composition, and the two biological responses (ie, cell growth inhibition and hepatitis B virus secretion from infected cells). Use the flow chart in Figure 1 and those described in Examples 丨 and 3 Process, additional data on plant-related data, markers, and biological responses to standard herb compositions can be collected. This additional data is added to the initial standardized herb bioresponse array to generate an expanded standardized herb bioresponse array An appropriate analysis of the generated database can be performed as described in the detailed description and examples to facilitate determination of reaction with the organism of interest The second group of the most relevant or related variables. The batch of herbal bioreactor arrays uses the method described in Figure 2 and the procedures of Examples 2 and 4, and the paper dimensions apply Chinese national standards. (CNS) A4 specifications (210 X 297 male 1) t --------- tT --------- Avi. (Please read the precautions on the back before filling this page) 71 1243210 A7 B7_ Fifth, the description of the invention (69). The generated batch bio-response array of herbs can be compared with the standardized bio-response of the herb, so as to predict the biological response of the batch of herbal composition. Example 12: Formulation of Herbs and Pharmaceutical Extracts The standardized operation steps are as follows: The crude herb ingredients are placed in a jacketed reactor at an appropriate ratio, and they are mixed and extracted with water at a high constant temperature. The solids are extracted from a 120 mesh sieve Separated from liquid. The resulting filtrate is collected and then concentrated by evaporation of water under low pressure. The concentrate is spray-dried at high temperature to produce a granulated powder. This batch of material is then formulated into the required dosage form Example 13: Evaluation of Huang Zhi Tang (HQT) is an ancient Chinese herbal formula containing four different herbs: Scutellariae (Yellow Answer), Glycyrrhizae (Glycyrrhiza uralensis), Paeonielactiflora pallus (White Juice), and Fructus zizipho (Jujube) (Table 4). This formula In Asia, it has been used to treat different gastrointestinal diseases for a long time since 300 BC. (Please read the precautions on the back before filling out this page.)-装 ----- r Order · Ministry of Economic Affairs Intellectual Property Bureau Staff Consumer Cooperatives Printed table 4. Traditional Chinese medicine prescription of Huangpi decoction Herb name Scientific name Traditional name Scutellariae Radix Scutellaria skull root is used to reduce microvascular permeability; anti-inflammatory; treat enteritis and dysentery; increase the secretion of bile to treat yellow disease; relieve spasm Cough; deworming Glycyrrhizae Radix (Glycyrrhiza uralensis) Glycyrrhizae Radix (Glycyrrhiza uralensis) Glycyrrhiza root Radicals and cough; Antispasmodic and analgesic; reconciling various medicines; Fructus Ziziphi jujube with diuretic and strong functions of reducing fire and detoxifying Paeonie lactiflora pallus radix Paeoniae root for analgesic and emergency; This paper size applies to China National Standard (CNS) A4 specifications (210 X 297 mm) ^ _ Table 5. Batch properties (Huangyao soup) Properties Batch A Batch B Batch C Source Taiwan, Suncheon Taiwan, Suncheon Taiwan, Suncheon Preparation Method Standard Standard Boil 30 minutes Plant parts Roots 1243210 A7 _ B7 —----------- -5. Description of the invention (70) Biological and enzyme detection Jian Luzhi, 1 g of any batch of Huang Qin Tang (HQT) is added with 10 ml of water (1¾ g / ml). The mixture was treated as outlined in Table 5. The supernatant was collected after centrifugation and filtered through 1022 micron filter paper. Two cell types were used to determine the biological effects of Huangda Tang in any batch: a) Jurkat T cells (ATCC cat # TIB-152) and b) HepG2 cells (ATCC cat # HB_8065). A 1:50 dilution is used for any-test. Frozen cells (107 / ml) were quickly thawed in a 37 ° C water bath. Cells were then diluted in 10 ml of pre-warmed culture medium (see: Life Technologies, Catalog and Reference Guide, 1998-1999, Cell Culture Section), followed by centrifugation at 1500 rpm for 5 minutes. The suspension was subsequently discarded and the cells were cultured in 100 ml of culture medium at 37 ° C and 5% carbon dioxide. After two days, their cells were counted (approximately 8X105 / ml, 100ml total). Batches have also been evaluated for their ability to inhibit hepatitis B virus by DNA detection (see Dong et al., National Academy of Sciences Report U991, 88, 8495-8499). Briefly, 1 gram of the preparation was added with 10 ml of water. Its mixture was boiled for 30 minutes. The suspension was collected after centrifugation and filtered through a 0.22 micron filter paper. The size of this paper that secretes hepatitis B virus is applicable to the Chinese National Standard (CNS) A4 (210 X 297 mm) (Please read the precautions on the back before filling this page) ---------. Printed by the Consumer Cooperative of the Intellectual Property Bureau of the Ministry of Economic Affairs 73 l2432l0A7 B7 l, Description of Invention (71)

HepG2.2.15 cells (provided by Professor Ace; see Ace et al., National Academy of Sciences Report (1987) No. 84, pages 105-109) were used in this test. A 1:50 dilution is used for any test. The cell growth inhibition test was performed for 72 hours. All other procedures were completed as described in Dong et al., National Academy of Sciences Report (1991), 88, 8495-8499. As Huanghuang Decoction is known for its anti-diarrheal drug properties, stone-gluconic acid was detected, and Huangzhi Decoction extract was added with a concentration of 0.1niM phenolphthalogluconate, 70mM trimethylolamine methane monohydrochloric acid (Tris_HCl) (pH 6.8) and 0.8 ng dialyzed / 5-glucuronidase (from E. coli, purchased from Sigma ™) in a 96-slot test dish with a triple volume to a final volume of 80 Slightly up. After 2 hours of incubation at 37 ° C, the reaction was terminated with 200 μl of a stop solution containing 0.2M glycine and 0.2M sodium chloride (pH 10.4) and its absorbance (OD) was determined by a dynamic microdisk The reader is monitored at a wavelength of 5401111. The test results using these three batches are presented in Table 6. Based on these data, compared with batch Huangpitang C, Huangpitang A and B have relatively low toxicity and higher inhibitory activity (ie, they are about 5 times more toxic to HepG2 cells than Huangpitang A or B and 0 -Glucuronidase has less than 3.3-fold inhibitory activity (see Table 6). This paper size applies to China National Standard (CNS) A4 (210 X 297 mm) (Please read the precautions on the back before filling this page) 丨 丨 h 丨 丨 Order ---------. Economy Printed by the Employees 'Cooperatives of the Ministry of Intellectual Property Bureau 74 Printed by the Consumers' Cooperatives of the Ministry of Economics and Intellectual Property Bureau 1243210 A7 _B7_ V. Description of the invention (72) Table 6. Biological detection of three Huanghuang Tang preparations * HepG2 Jurkat HBV; DNA Huang Da Tang A 0.6 1.50 0.76 without Huang Zhi Tang B 0.7 1.6 0.81 ND Huang Zhi Tang C 2.2 0.32 ND ND * represents IC5Q value ND, not determined: the percentage of control group Huang Zhi Tang on protein performance is evaluated in the drug Before addition, HepG2 cells X 106) were seeded in 3.0 ml of RPMI-1640 medium in a 25 cm 2 flask (see Life Technology Corporation, Catalog and Reference Guide, 1998-1999, Cell Culture Section) for 24 hours. The cells were treated with or without herbs, of which the former was added at a final concentration of 0.2 mg / ml or 4 mg / ml, respectively, and cultured for 24 hours at 37 ° C. Its culture medium was removed and its cells were washed twice with iced PBS. The cells were collected in 1 liter of PBS and centrifuged at 1,000 rpm for 2 minutes. The cells were placed on ice with 50 mM trimethylolaminomethane monochloride (pH 7.5), 0.2 mM PMSF and 10% glycerol. Buffer extraction followed by three freeze and thaw cycles. Before the centrifugation, potassium chloride was added to the cell lysate at a final concentration of 0.15M. Its protein concentration was determined and its cell extracts were electrophoresed according to the Laemmli method (Nature (1970), 227, pp. 680-685). Western transfer law systems are implemented using standard know-how, see, for example, Sambrook et al. (1989). The antibodies used were directed against the following proteins: Top 1; Stat (20707); Cyclin B1 (Cyclin Bl), MAPK (Antibody 2), and Nm 23 HI. This paper size applies to China National Standard (CNS) A4 specification (210 X 297 mm) 75 -------------- ^ Packing--l · ——Order -------- -ΜΨ (Please read the phonetic on the back? Matters before filling out this page) 1243210 Printed by the Consumer Cooperative of the Intellectual Property Bureau of the Ministry of Economic Affairs A7 B7 V. Description of the invention (73) Figure 4 reveals a higher concentration of Huang Zhi Tang A or Huang Zhi Tang b Differentially affects the performance of cyclin B1 (Cyclin B1) peptides. High Performance Liquid Chromatography (HPLC) analysis was performed on a Beckman ODS UltrasphereTM column (5 micron particles, 4.6 mm x 25 cm) by HPLC and analyzed by a UV spectrophotometer ( Platinum Elma) detection. The wavelengths used for UV light measurement are monitored at 280nm and 340nm. The mobile phase was pushed at 1 ml / min and contained a gradient of solvent A: water and solvent B: 20% methanol: 1) the first 5 minutes of the solvent was 100% solvent a; 2) the next 10 minutes Solvent was changed to 10% Solvent A / 90% Solvent B; 3) Secondly, the solvent was changed to 10% Solvent A / 90% Solvent B in 40 minutes. This was followed by the addition of 100% solvent A for 5 minutes. Its HPLC markers are baicalin and xanthophyll. Mass Spectrometer Analysis Herb extracts were analyzed by a Mariner ™ ESI-TOF mass spectrometer (MS) from a platinum Elma (PE) biological system. Control tracers were produced using baicalein and baicalin (both known active ingredients in baical decoction). Samples of Huangdatang in water and acid-treated batches were analyzed by HPLC and mass spectrometry. Although batches A and b of the water-treated Huangzhi soup had different HPLC and mass spectrometer traces, the acid-treated batches produced almost the same pattern (data not presented). The data collected by the algorithm form part of a multi-dimensional analysis used to generate a multivariate normal distribution group, as a determination of biological activity and standards (Li) ----------- install ----- ^ ---- order --------- Aww. (Please read the note on the back? Matters before filling out this page ) 76 1243210 A7 ----------- 2Z________ V. Description of the invention (74) Baseline correlation between substances (high performance liquid chromatography and mass spectrometer), and means of origin / growth characteristics. Example 14: Individual ingredients A. Licorice

Evaluation of Glycyirhizae Radix (Glycyrrhiza) Radix Glycyrrhizae is used to moisturize the lungs and cough, and to help relax spasms and pain. The properties of the licorice batches used in this example are presented in Table 7. Table 7 · Batch properties (Glycyrrhiza uralensis) properties Batch A Batch B Batch C ------ Batch • Times D Minutes of warm water, 30 minutes of plant parts and roots-Biological and enzyme testing To test the quality of herbal sources, any herb extract suspension was tested and its analysis was repeated three times. For a specific sample to be tested, 1 g of herbal powder was dissolved in a polypropylene tube and 10 ml of 80 ° C deionized water (neutral pH). This tube was then cultured as outlined in Table 7 and then centrifuged to obtain its suspension. Licorice was tested on HepG2 cells (ATCC Cat # HB-8065) or Jurkat T cells (ATCC cat # TIB-152) or both. Cell lines were cultured for 24 hours as described above. The batches also use DNA detection to estimate their ability to inhibit hepatitis B virus (see Dong et al., National Academy of Sciences report (1991). This paper applies Chinese National Standard (CNS) A4 specifications (210 X 297 mm) (Please read the notes on the back before filling this page)

Ding ϋ I ϋ · ϋ · ϋ ϋ 1 ϋ -1 I I Printed by the Consumer Cooperative of the Intellectual Property Bureau of the Ministry of Economic Affairs 77 1243210 A7 B7 V. Description of the Invention (75) 88th p. 8495-8499). Briefly, 1 gram of the preparation was added with 10 ml of water. Its mixture was boiled for 30 minutes. The suspension was collected after centrifugation and filtered through a 0.22 micron filter paper. HepG2.2.15 cells that secrete hepatitis B virus (provided by Professor Ace; see Ace et al., National Academy of Sciences Report (1987) No. 84, pages 1005 to 1009) were used in this test. A 1:50 dilution is used for any test. The cell growth inhibition test was performed for 72 hours. All other procedures were described as described in Dong et al., National Academy of Sciences Report (1991), 88, 8495-8499. Once again, / 3-glucosidase was detected. Different licorice extracts were added to a solution containing O.lmM phenolphthalein glucuronide and 70Mm tris-hydroxymethylaminomethane monohydrochloric acid (Tris-HCl) (pH 6.8). And 0.8 ng of dialyzed / 5-glucosidase (from E. coli, purchased from Sigma ™) in a 96-well test dish in a triple well to a final volume of 80 microliters. The results of the tests using these two batches are presented in Table 8. Based on these data, licorice batch A is more toxic (approximately 9 times) to Jurkat cells than licorice batch B and is a more effective inhibitor of-/ 3-glucosidase (see Table 8). ------------------ ； ---- Order --------- (Please read the notes on the back before filling this page) Intellectual Property of the Ministry of Economic Affairs Printed by the Consumer Cooperatives of the Bureau 8_Bioassay of four licorice preparations * β Escherichia coli-glucuronidase HepG2 Jurkat HBV; DNA Licorice A 1.3 1.07 0.41 Licorice-free B ND ND 3.6 ND Licorice C 2.1 ND ND ND Licorice D ND ND > 2.0 53.8 * Represents a value of 1,050 ND, not determined | Percentage of control group 78 This paper size is applicable to China National Standard (CNS) A4 (210 X 297 mm) 1243210 A7 B7 Employees ’Intellectual Property Bureau, Ministry of Economic Affairs Printed by the cooperative V. Description of the invention (76) Performance test In order to detect gene expression, Jurkat T cells were treated with herbal extracts as follows. Jurkat cells (107 / ml) were rapidly decomposed in a 37 ° C water bath; Dong. The cells were then diluted in 10 ml of pre-warmed culture medium (see Life Technology Corporation, Catalog and Reference Guide, 1998-1999, Cell Culture Section), followed by centrifugation at 1500 rpm for 5 minutes. The supernatant was subsequently decanted and the cells were cultured in 100 ml of culture medium at 37 ° C, 5% carbon dioxide. After two days, the cells were counted (8 × 105 / ml 'for a total of 1000 ml). The herb preparation is prepared as briefly described in the above (eg: 20 liters of sterile solution (0.05 g / ml) is obtained with 2 g of one herb powder. The cells are at a density of 2.5 x 10 ml, 100 ml / Each flask is divided into 3 flasks. The test is performed in the presence of a control group (without extracts) and 10 ml of extracts at a content of 10 g / ¾ liter and 1 g / liter. Again, the toxicity results were used to determine the concentration of a particular extract as "high, and" low. After the extract was added, the cell culture was cultured for 24 hours under the conditions as briefly described above. These cells were counted and then collected in a 100-liter centrifuge tube. The resulting cell mass was processed by a ribonucleic acid separation method to extract the ribonucleic acid (see, for example, Sambrook et al., 1989. Pages 7 · 3 and 7 · 9). Microarrays and microarray printing lines were implemented as follows: Genetic selection lines were obtained from IMA via Research Genetics (Hunts Ville, AL) Obtained from the Ge Group Library and contains genes from different organizations. Points special election (please read the back of the precautions to fill out this page)

a— · _1 I I ϋ I · 79 1243210 A7 V. Description of the invention (77) The strain has been partially sequenced and can be used as the expressed sequence tag by the dbEST database of GenBank. Selected strains containing pBluescript plastids were separately cultured and amplified using commercially available primers prior to application on Cicailong membranes (Chen et al., Genomics (1998) 51, pp. 313_324). Approximately 10ng of any enlarged target is controlled by a pC (Personal Computer) controlled whole column system and is coated on a positively charged Nylon film. Approximately 8,500 points can be placed on a piece of Nylon film with a size of 35 by 55 millimeters using a 24-pin full-row tool. Complementary DNA and membrane hybridization reaction. One microgram of any information nucleic acid sample (the ribonucleic acid is isolated as outlined in the former). Randomly initiated reverse transcription reaction is matched with biotin and / or isohydroxy digitalis Base calibration. The calibrated sample is treated with an alkali and the calibrated nucleic acid produced before being applied to the hybridization reaction is precipitated. Using the calibrated probe, membrane hybridization reactions and washing are performed, as disclosed in the report of Chen et al. (1998). In order to detect dots on the membrane in a dual tone (ie, biotin and isoxygenin), the / 3-galactosidase-conjugated streptavidin (Streptavidin) and alkali Phosphatase-conjugated isohydroxy foxglove poison ligand antibody (anti_Dig_Ap) was used. After color development, image digitization using an imaging tool is applied (such as a flatbed scanner or digital camera). Quantitative measurement is performed by measuring the integral density of the original color component at each point, performing a regression analysis of the integral density data, and setting the statistically explicit value as the gene with differential expression. (Please read the notes on the back before filling this page)

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1243210 A7 B7 V. Description of the invention (78) Gene expression data of samples 1, 2 and licorice (ST117) The cuts correspond to the extracts 1, 2 and 6 of Cordyceps sinensis H (STG27) and licorice extract. The method was tested: batches were evaluated for toxicity using JurkatT cells. The extract was prepared as described in Example 6 at a density of ^ 5xiG5 / ml and wml of rkat ,,, and cell # cells were divided into 2 continuous cell culture plates. The test was performed on a makeup set (without strokes, and 5 concentrations of extracts as described (see Table 9). The high and low concentrations of cell culture tests were between 亳 g / ml and 0 · 〇5 mg / 亳 liter (ie dry weight of milligrams per milliliter of grass extract), depending on the toxicity of the extractive polymer to the cell. For some samples, the toxicity of 10¾g / ¾liter For the so-called "high toxicity, and" low toxicity, "the concentration is adjusted downwards, but at least a one-digit step between the extremes is maintained. For example, for licorice (ST117), 0.5 mg / ml and its "low" was 0.05 mg / ml (see Table 9). After the extract was added, the cells were cultured for 24 hours under the conditions described in the examples. The cells were counted and The data generated are tabulated to show the toxicity of the extracts. The data generated are shown in Table 9. --------------- install -----: ---- order ---- ----- (Please read the note on the back? Matters before filling out this page) Printed by the Consumer Cooperatives of the Intellectual Property Bureau of the Ministry of Economic Affairs 81 This paper is applicable to China Standard (CNS) A4 size (210 x 297 mm) 1243210 A7 B7 Description of invention (79) Table 9 · Number of viable cells in different herb extract solutions

Note: After solitary hours of culture with = 1 as the operation steps: 1. Add 1 ml of 5 X 105 / ml Jurkat cells to a 24-well culture plate 2. Prepare 12 herb extract solutions and sterilize the lines ( (Please read the Zhuyin on the back? Matters before filling out this page)

Printed by the Consumer Cooperatives of the Intellectual Property Bureau of the Ministry of Economic Affairs in any analysis, 144 X96 genes (ie, 13,824 genes were analyzed (data not shown) and there were significant differences in about 100 genes compared to the control group. Some of these genes were up Regulation and others are down-regulated. The degree of difference from the control group varies depending on the relative amount of the herb composition to which the specific cells are exposed. Under C1 (control treatment) and η and L (herb) The number represents the intensity of the 4 RNAs after deducting the month hall and value (Table 10). The basin number is coded in the array AD, and it is traced back to a specific gene bank (GenBank) selection. Plants. The level of performance can be judged by dividing by c. Only a small portion of 13,824 genes in any herb-treated sample showed significant changes, that is, upward, downward, or unchanged ( (See Table 10). ^ ----- ^^ --------- 1 [Applicable to China National Standard (CNS) A4 specification (210 X 297 mm) 1243210 A7 B7 V. Description of the invention (80) < 80035> < 74,108 > < 74,012 > < 73,132 > < 72, 101〉 < 72o14 > < 7αο1 > < 69,107 > < 68,064〉 < 62,117 > < 62,084〉 < 62, § > Α1,11δ > < 59,142 > < 59,135 > < 58,087 > < 57,016 > < 56,088 > < 56,060 > < 55, harp < 54,134〉 < 53,04S > < 53,023> 织 woven KIAA— 4 ^ —emergency input Miao I fi.f .fs I 3- 露 -3--® ^^-粪 A ## 取 咖啡 13 屮 一 傻 i 曰 a 织 ^ Nt-tfIa 屮 3 ^ t ^ i ^ Μ, ^^ € β , ^ Awoven KIAA878_g13HV.l ^ «^» > 觫 鯓 la i ^ 00β ΚΓΜ, Ν, ΡΡ 薤 奇 身 麻 方 沐 # 1 '# 2. Ti will, 030 > tired 8 ^ 3 ^^ 今 素βθν $-is < 89,083> Ye Yi AJM does everything I do: HLA-ACHLA-A28, -B40, -CW3) < 87083> < 85,129 > ^ M ± MSE16 < 85_112 > < 84075> < 83,129 > A8.0SV < 82,027 > 01 Sg-Bk 55.29 89.55 80.68 85.33 99.48 90.64 3523 89.56 118.83 6023 65.11 9627 44.91 652 34.68 109.86 46.96 4.37 60.86 3792 224 106.71 U3 97.11 89.126.83 3.126. 0 0 025 6776 m Sg-Bk 00.55 9829 61.91 50.% 109.46 72.12 60.82 77.54 108 · 15 47.87 9001 99.% 4623 77.25 60s 10338 25.76 i P55 31.41 127 94.67 0 71.92 59 · 97 15.48 9023 46.86 16.47 5266 9128 43.58 0 0 R98 1LSI 7.15 7P26 46.13 37.75 105.62 92.75 48.87 77.9 — 34.96 66.74 1093 25.19 68s 57.73 82.35 1835 SI 5523.98. I 7633 44.61 59.53 92.08 3947 4300 0 4233 2h Sg-Bk 46.74 84003 59.86 b325 56.68 3797 44.04 66 · 1 75.84 37_41 66.3 81.88 7821 602 24.61 85.97 0.54 42.87 bi.39 82.82 021 8139 13.55 4201 66.86 27.71 53.167.69 9301 649.6 33.47 38.48 2L Sg-Bk 38.07 93003 29.64 25.54 67.54 7008 29.71 59.44 64s 9.84 64.44 8766 40.75 6621 48.93 625 17.87 22.76 40.65 28.64 2.5 61.45 0.58 78.94 43.05 27 · 86 38,17 22.52 66.89 16.89 70.21 46.42 64.2 28.6 0823 37_5 35.65 48.47 2825 43.37 55.8 4400 39.3 4832 37.48 51.52 4234 61.91 127 20.64 1636 36.95 42 77 32.81 83.94 65.65 2322 86.39 56.78 50.43 7287 7174 40: 32.61 0 2724 6L Sg-Bk 3P82 89OV3 32.35 49.82 49.72 78.82 79.72 78.78 70.19 65.02 3144 17.51 3S1 18.7 5 0 · 55 41.64 4100 17.71 96.87 34.92 1S8 312 63.4 35.52 6028 70.47 65.93 9.74 0.53 3724 0 0221074 0.154639 §7599 0.767353 0.597211 —22 P795675 172637 P865788 0.9S124 0.794787 138243 1.03833 192 l_il6 1.756632 0.941016 0 0460 602 0.548552 3.906 192 l_il6 L188Q28 1.482827 ai34 0229675 0.927603 1.135614

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530672 285979 31309 624595 42281 45327 567287 I (Please read the precautions on the back before filling out this page) mm— ϋ I one-on-one, II ... I ϋ ϋ I »This paper size applies to China National Standard (CNS) A4 (210 X 297 mm) 86 l2432l0A7 B7 V. Explanation of the invention (84) In this way, we can explore specific gene expression and a cell's air-to-air, low (L), or high-amount-herb composition Exposed relationship. Many of the genes identified in this way encode proteins that are important in known metabolic or biochemical pathways. Many of these proteins have direct or indirect effects on certain physiological and rationale items. Therefore, this method allows the association of a particular genetic fingerprint of a herb composition with the biological effects of its array. These associations can be used to analyze or characterize the herb composition for the purposes of σσ control and quality assurance, as well as evaluation of pharmacological or toxicological properties. The role of primary and secondary herbs in a herb formula can also be tested in this way. The HPLC analysis of the herb batch was performed on a Beckman ØDS UhrasphereTM column (5 micron particles, 4.6 mm x 25 cm) by HPLC and analyzed by a spectrophotometer. (Platinum Elma y detection. The wavelengths used for ultraviolet light detection are monitored at 280nm and 34nm. The mobile phase is driven at 1 ml / min and contains a solvent A with a gradient as follows: water And solvent B · 20% methanol: 1) the first 5 minutes of the solvent is 100% of the solvent a; 2) the next 10 minutes of the solvent is changed to 10% of the solvent A / 90% of the solvent B; 3) the next 40 minutes The solvent was changed to 10% solvent A / 90% solvent B. This was followed by the addition of 100% solvent A for 5 minutes. The HPLC identification system was glycyrrhizin. The data collected by the algorithm dimensionality forms part of the multi-analysis used to generate the multivariate normal distribution group, as a benchmark for determining biological activity and standard Huanghua Tanghua substances (high performance liquid chromatography and mass spectrometer) Linearity, and this paper size applies Chinese National Standard (CNS) A4 specifications (21〇7 ^ 97 issued) 87-1243210 A7

V. Description of the invention (85) Means of origin / growth characteristics. B. Huang A. Huang's evaluation was used to reduce microvascular permeability and inflammation. It can also be used to treat enteritis and diseases, increase bile secretion, cure yellow colon, relieve muscle spasms, cramps / σ cure cough, and deworming. The characteristics of the yellow answer batches used in this example are shown in Table 丨 [. Table 11 · Batch characteristics (Scutellaria baicalensis) Characteristics Batch A Batch B Batch C Batch D Plant name Huangda Scutellaria baicalensis Scutellaria baicalensis Source Shanxi Province United States, Golden Gate Herb Center United States, Golden Gate Herb Center United States, Boston Preparation Method Standard H Cook Buddha boil for 30 minutes, boil for 30 minutes, 2 hours for plant parts— '--(Please read the note on the back? Matters before filling out this page) ▼ Install the printed biological and enzyme test briefs of the Employees ’Cooperatives of the Intellectual Property Bureau of the Ministry of Economic Affairs Lu Zhi '1 g of any formulated scutellaria baicalensis extract was added with 10 mg of water (1 g / ml). The mixture is processed as briefly listed in the table. The supernatant was collected after centrifugation and filtered through a 0.22 micron filter paper. Batches of Scutellaria baicalensis were tested against HepG2 cells (ATCC cat # HB_8065) or Jurkat cells (ATCC cat # I7B-152) or both. A 1:50 dilution is used for any test. Cells were cultured for 24 hours as described above. Batches have also been evaluated for their ability to inhibit hepatitis B virus by DNA detection (see Dong et al., National Academy of Sciences Report (1991) 88 (8495-8499). Briefly, 1 gram of the preparation was added with 10 ml of water. The mixture was boiled for 30 minutes. The suspension was collected after centrifugation. The paper size is in accordance with the Chinese National Standard (CNS) A4 (210 X 297 mm) 88 l · --- order ----- 1243210 A7 B7 V. Description of the invention (86) Collect and filter through a 0.22 micron filter paper. HepG2.2.15 cells that secrete hepatitis B virus (provided by Professor Ace; see Ace et al., National Academy of Sciences Report (1987) No. 84, pages 1005 to 1009) were used in this test. A 1:50 dilution is used for any test. The cell growth inhibition test was performed for 72 hours. All other procedures were described as described in Dong et al., National Academy of Sciences Report (1991), 88, 8495-8499. As for yS-glucuronidase, different extracts of Scutellaria baicalensis were added with a phenol glucuronide ester containing O.lmM, 70 mM Tris-HCl (pH 6.8) and 0.8 ng dialyzed / 3-glucosidase (from E. coli, purchased from Sigma ™) in a triple-well 96-well test dish with a final volume of 80 microliters. After 2 hours incubation at 37 ° C, the reaction was terminated with 200 μl of a stop solution containing 0.2M glycine and 0.2M sodium chloride (ρΗΙ10.4), and its absorbance (OD) was read on a dynamic microdisk The machine is monitored at a wavelength of 540nm. The results of the tests using these three batches are presented in Table 12. ---- Γ --- * ---- install ----- ^ ---- order --------- (Please read the precautions on the back before filling this page) Ministry of Economy Wisdom Printed by the Employees' Cooperatives of the Property Bureau 12. Bioassay of the four preparations of Scutellariae黄 芩 D ND 0.65 ND 27.5 * Represents the IC5Q value ND, the percentage of the control group is not determined 89 This paper size is applicable to the Chinese National Standard (CNS) A4 specification (210 X 297 mm) Printed by the Intellectual Property Bureau Staff Consumer Cooperatives of the Ministry of Economy 1243210 A7 ____B7___ V. Description of the invention (87) Evaluation of the effect of Scutellaria baicalensis on protein performance Prior to drug addition, HepG2 cells (1 X 106) were seeded into 3.0 ml of rpmI-1640 medium in a 25 cm 2 flask (see Life Science and Technology Corporation, Catalog and Reference Guide, 1998-1999, Cell Culture Festival) 24 hours. The cells were treated with or without herbs, of which the former was added at a final concentration of 0.2 mg / ml or 4 mg / ml, respectively, and cultured at 37 ° C for 24 hours. Its medium was removed and its cells were washed twice with iced pBS. The cells were collected in 1 ml of pBS and separated for 2 minutes and 4 minutes on ice. The cells were burned on ice with 50 mM tris (methyl) methylamine gas (ρΗ7.5), 〇_ 2mM PMSF and 10% glycerol buffer extraction followed by two freeze and thaw cycles. Before the centrifugation, potassium chloride was added to the cell lysate at a final concentration of 0.15M. Its protein concentration was determined and its cell extracts were electrophoresed according to the Laemmli method (Nature (1970), 227, pp. 680-685). Western transfer law systems are implemented using standard techniques, see, for example, Sambrok et al. (1989). The anti-system used was directed against the following proteins: TOP; Stat (2007); cyclin B1 (Cyclin Bl), MAPK (antibody 2), and Nm 23 H1. Figure 4 reveals that Scutellaria baicalensis B. and B. did not differentiately affect the performance of the multiple species that were dissolved on the western transfer film. The HPLC analysis of the herb batch was performed on a Beckman ODS Ultrasphere ™ column (5 micron particles, 4.6 mm x 25 cm) by HPLC and analyzed by a UV spectrophotometer ( Platinum Elma) detection. The wavelengths used for UV detection are monitored at 280nm and 34nm. Its dynamic phase is} ml / min (please read the precautions on the back before filling this page) f ----- ^ ---- Order ----

ο 2143 2 Α7Β7 V. Description of the invention (88) The clock is pushed and contains a solvent A with a gradient as follows: water and solvent B: 'Listen to methanol: 丨) The solvent is ⑽% solvent A in the first 5 minutes; 2) followed by 10 minutes dream solvent was changed to solvent A / 90% solvent B; 3) followed by 40 minutes solvent change: capacity agent A / 90% solvent B. This was followed by the addition of rigid% solvent A for 5 minutes. Its HPLC markers are baicalin and baicalein. Batch H of sample treated in water and I was analyzed by high performance liquid chromatography. Water and acid treated batches are essentially indistinguishable. The collected by the algorithm was used for multi-dimensional analysis of the variable m cloth group, which was used to determine the biological activity and standard Huang Da Tang chemicals (high performance liquid chromatography and mass spectrometer). Baseline correlation, and means of origin / growth characteristics. c. Evaluation of Baiji Baiji is used to suppress and relieve pain. It is also known for sparse tendons and blood. The properties of the Baigou batches used in this example are shown in Table ^ Table 13. Batch properties (Baiyu) Properties Batch A Batch B Plant name Baizhi Baizhi Source Boston, Anhui, USA Preparation method Standard boiling for 2 hours ~ Plant parts roots --- Λ In short '1g of any-white and extracts are added 10ml This paper is scaled to Chinese National Standard (CNS) A4 (21G X 297mm T (Please read the precautions on the back before filling out this page} ▼ Installation -------- r --- Order ---- Printed by the Employee Consumption Cooperative of the Intellectual Property Bureau of the Ministry of Economic Affairs 91 1243210 Preparation of A7 B7 V. Description of the invention (89) water (1 mg / ml). The mixture was treated as briefly described in Table 13. The supernatant was collected after centrifugation and passed through a 0.22 micron filter paper. Pass. The batches of White 3 are directed against HepG2 cells (ATCC cat # HB-8065) or

Jurkat cells (ATCC cat # IB-152) or both were tested. A 1:50 dilution is used for any test. Cells were cultured for 24 hours as previously described. The batches were also evaluated for their ability to inhibit hepatitis B virus by DNA detection (see Dong et al., National Academy of Sciences Report (1991) 88 (8495-8499). Briefly, 1 gram of the preparation was added with 10 ml of water. The mixture was boiled for 30 minutes. The suspension was collected after centrifugation and filtered through a 0.22 micron filter paper. HepG2.2 · 15 cells that secrete hepatitis B virus (provided by Professor Ace; see Ace et al., National Academy of Sciences Report (1987) No. 84, pages 1005 to 1009) were used for this test in. A 1:50 dilution is used for any test. The cell growth inhibition test was performed for 72 hours. All other procedures were completed as described in Dong et al., National Academy of Sciences Report (1991), 88, 8495-8499. Different Paeonia lactiflora extracts were added with a phenol glucuronide, 70 mM Tris_HCl (pH 6.8) and 0.8 ng dialyzed / 5-granulofuric acid Enzyme (from E. coli, purchased from Sigma ™) in a triple-well 96-well test dish to a final volume of 80 μl. After 2 hours incubation at 37 ° C, the reaction was terminated with 200 microliters of a stop solution containing 0.2M glycine and 0.2M sodium gasification (ρΗΙ 10.4), and its absorbance (OD) was read on a dynamic microdisk The machine is monitored at a wavelength of 540nm. The results are shown in Table 14. This paper size applies to China National Standard (CNS) A4 specification (210 X 297 mm) 92 -------- ^ ---- install ----- ^ ---- order ----- ---- (Please read the precautions on the back before filling out this page) 1243210 V. Description of the invention (9〇 Table 14. Biological detection of two kinds of Paeonia lactiflora preparations: 1ί ^ 〇2 Jurkat Xi-Gluconidase

HBV * stands for IC5Q value ND, without determining the percentage of the control group. High-performance liquid chromatographic analysis printed by the Consumer Cooperatives of the Intellectual Property Bureau of the Ministry of Economic Affairs. Cm) were analyzed by high performance liquid chromatography and detected by a UV spectrophotometer (Platinum Elma). The wavelengths used for UV detection are monitored at 280nm and 34nm. Its mobile phase is pushed at cc / min and contains a solvent A: water and solvent b: 20% methanol: 1) the first 5 minutes of the solvent is 100% of the solvent a; 2) the second minute Solvent was changed to 10% Solvent A / 90% Solvent B; 3) Secondly, the solvent was changed to 10% Solvent A / 90% Solvent B in 40 minutes. This was followed by the addition of 100% solvent A for 5 minutes. Its efficient chromatographic marker is paeoniflorin. The Bai Gou batch was analyzed by high performance liquid chromatography as shown in Figure 5. Herb batches were analyzed by two-effect liquid chromatography with a Beckman ODS Ultrasphere ™ column (5 microparticles, 4.6 cm X 2 5 cm) and analyzed by an external light spectrophotometer (turned gold Elma) Detect. The wavelengths used for UV detection are monitored at 280nm and 340nm. It ’s dynamic! Ml / minute is pushed and contains a solvent A with water and solvent B in a gradient as follows: 20% methanol: 1) the first 5 minutes of the solvent is 100% solvent A; 2) the second 10 dm is measured

* ^ ------------- (Please read the notes on the back before filling out this page) This paper size applies to China National Standard (CNS) A4 (210 X 297 mm) 93 1243210 A7

Printed by the Consumer Cooperatives of the Intellectual Property Bureau of the Ministry of Economic Affairs. 5. Description of the invention (91) Solvent was changed to 10% Solvent A / 90% Solvent B; 3) The next 40 minutes was changed to 10% Solvent A / 90% Solvent B. This was followed by the addition of 100% solvent A for 5 minutes. D. Jujube Jujube Jujube Jujube has been used for diuretic properties and strengthening effects. The characteristics of the jujube batches used in this example are shown in Table 15. Table 15 · Batch properties (Jujube) Nature Batch A Batch B Batch C Plant name Jujube Jujube Jujube Source Hebei Jinmen Herb Center United States, Jinmen Herb Center Preparation method ^ Standard boiling 30 minutes & Water, fruits of plant parts for 30 minutes-biological and enzyme test Briefly, 1 gram of any prepared jujube extract is added with 10 ml of water (1 mg / ml). The mixture is treated as briefly described in Table 5. The supernatant was collected after centrifugation and filtered through a 10.22 micron filter paper. Batches of jujube were tested against HepG2 cells (ATCC cat # HB-8065) or Jurkat cells (ATCC cat # IB-152) or both. A 1:50 dilution is used for any test. Cells were cultured for 24 hours as described above. The batches also used DNA detection to estimate their ability to inhibit hepatitis B virus (see Dong et al., National Academy of Sciences Report (丨 991), 88, pp. 8-8499). Briefly, 1 gram of the preparation was added with 10 liters of water. Its mixture was boiled for 30 minutes. The suspension was collected after centrifugation and filtered through a 0.22 micron filter paper. The size of this paper that secretes hepatitis B virus is applicable to the Chinese National Standard (CNS) A4 (21〇χ 297 mm) 94 illflIt — — — — ----- r --- ^ · 11111111 i (Please read the back first Please note this page and fill in this page again) 1243210 Printed by the Consumer Cooperative of the Intellectual Property Bureau of the Ministry of Economic Affairs A7 V. Description of Invention (92)

HepG2.2.15 cells (provided by Professor Ace; see Ace et al., National Academy of Sciences Report (1987) No. 84, pp. 005 to 109) were used in this test. A 1 to 50 dilution was used for either assay. The cell growth inhibition test was performed for 72 hours. All other procedures were described as described in Dong et al., National Academy of Sciences Report (1991), 88, 8495-8499. Different jujube extracts were added with 0.1 mM phenolphthalein glucuronide, 70 mM dimethylolaminopanehydrochloric acid (Tris_HC1) (pH 6 8) and 0.8 ng dialyzed cold-glucosaldehyde Acidase (from E.coli, purchased from Sigma ™) in a 96-well 96-well test dish with a triple well to a final volume of 80 microliters. After 2 hours incubation at 37 ° C, the reaction was terminated with 200 μl of a stop solution containing 0.2M glycine and 0.2M sodium gasification (pH 10.4), and its < absorbance (OD) was changed with a dynamic The microdisk reader is monitored at a wavelength of 54nm. The results are presented in Table 16. Table 16. Biological detection of three preparations of jujube * E. coli cold-glucuronidase HepG2 Jurkat HBV: DNA Jujube A 1.2 1.5 5.1 Jujube B ND > 2.0 ND 52.3 Jujube c 2.5 ND ND ND * Representative IC5. Value: Control group percentage ND. Undetermined LC LC batches were analyzed by high performance liquid chromatography on a Beckman ØDS Ultrasphere ™ column (5 micron particles, 4.6 mm x 25 cm). Applicable to Chinese paper standard (CNS) A4 (210 X 297 mm) at this paper size 95 -pack ----- ^-order ---------. (Please read the notes on the back first (Fill in this page again) 1243210

Printed by the Consumer Cooperatives of the Intellectual Property Bureau of the Ministry of Economic Affairs. 5. Description of the Invention (93) A UV spectrophotometer (Platinum Elma) detection. The wavelengths used for UV detection are monitored at 280mn and 34nm. The mobile phase is pushed at 1 ml / min and contains a solvent A: water and solvent B: 20% methanol with a gradient as follows: 1) the first 5 minutes of the solvent is 100% of the solvent a; 2) the second minute of the solvent change 10% solvent A / 90% solvent B; 3) followed by 40 minutes solvent changed to 10% solvent A / 90% solvent B. This was followed by the addition of 100% solvent A for 5 minutes. The HPLC markers of jujube are date acid and cyclic adenosine monophosphate. Jujube batches were analyzed by HPLC chromatography as disclosed in Figure 6. / 、 The data collected by the algorithm form part of a multidimensional analysis used to generate a multivariate normal distribution group, as a benchmark for determining biological activity and standard Huangqintang chemicals (high performance liquid chromatography and mass spectrometer) Line correlation, and means of origin / growth characteristics. The above detailed description is only for clarity of understanding and it must be understood that there are no unnecessary restrictions, because for those skilled in the art, the change will be obvious. Although the invention has been described in connection with specific embodiments thereof, it should be understood that it can be further modified and that the invention is intended to cover any variations, uses, or adaptations of the invention that generally follow the principles of the present invention and includes such Practices that fall on the knowledge or practice of the technology to which this invention pertains may be applied to the necessary features previously described herein and to follow new developments of the invention within the scope of the patent application. Dimensions of this paper ---- * 1;-^ -------- l · --- Order --------- & (Please read the notes on the back before filling in this (Page) 96

Claims (1)

Sixth, the scope of application for patent No. 089HM268 patent application Jing Xing is composed of bite j T Minglei application patent scope amendment I a type used to evaluate the composition of a yarrow grass; the same herb composition or real Iπ in May 1994 A quality control method for the equivalence of the same herb composition on the Hida Babe, wherein the herb group 3 has multiple chemical components derived from one or more whole plants or plant parts, the The quality control method includes: a batch; a. Selection-herb composition-preparation for use as the standard b. By yoke, J to characterize a biological response (HBR) to the standardized batch Array: Exposing the characterizing biological system to the standardized batch in vitro, comparing it with an untreated control group of the characterizing biological system to test a distinguishing gene expression profile, and obtaining-related to the standardized batch Array of gene expression change; and ϋ. Save the array of gene expression change obtained in step b⑴ into a standardized HBR array; c. Characterize a correlation by The Herbal Biological Response (HBR) array of the test batch: 1 • Expose the characteristic biological system used in step b⑴ to the test batch in vitro and compare it with one of the untreated control groups of the characteristic biological system to compare Test the distinguishing gene expression profile 'and obtain an array of gene expression 1243210 /, Shen Qing patent range change arrays related to the test batch; and Π. Change the gene table obtained in step C⑴ to see to test HBR Within the array; storing d. Evaluating the quantitative similarity value between the furnace standardization array and the test array by comparing the gene expression intensity and the gene expression pattern; and ^ estimating the similarity value obtained using the ㈣d towel The equivalence between the test batch and the standardized batch for quality control purposes. 2. The oldest method as claimed in the patent application, wherein the characteristic biological system is selected from the group consisting of: isolated cells, isolated tissues, isolated organs, and other forms of living organisms Outside analysis. 3. A method as described in the patent application, in which the gene expression occurs transcribed. 4. The method according to item 1 of the patent application range, wherein the quantized similarity value is estimated using the normalized values of the standardized HBR array and the test HBR array. -98-