CN114081925A - Traditional Chinese medicine compound composition with immune regulation function and preparation method and application thereof - Google Patents

Traditional Chinese medicine compound composition with immune regulation function and preparation method and application thereof Download PDF

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CN114081925A
CN114081925A CN202111400905.4A CN202111400905A CN114081925A CN 114081925 A CN114081925 A CN 114081925A CN 202111400905 A CN202111400905 A CN 202111400905A CN 114081925 A CN114081925 A CN 114081925A
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traditional chinese
chinese medicine
vitamin
function
regulating
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周树远
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Beijing Yipinshuyuan Biotechnology Co ltd
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Beijing Yipinshuyuan Biotechnology Co ltd
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    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/81—Solanaceae (Potato family), e.g. tobacco, nightshade, tomato, belladonna, capsicum or jimsonweed
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Abstract

The invention discloses a traditional Chinese medicine compound composition with an immune regulation function, which comprises 8000 parts of medlar 6000-. The formula of the invention not only has medicinal and edible medicinal materials, but also has extracts, vitamins, nicotinic acid and the like, and has reasonable and unique formula. Has good function of regulating the immunologic function according to the traditional Chinese medicine theory. By optimizing the process and the taste of the auxiliary materials, the auxiliary materials are very suitable to be selected, and the taste is also very ideal.

Description

Traditional Chinese medicine compound composition with function of regulating immunity and preparation method and application thereof
Technical Field
The invention relates to the technical field of medicines, and in particular relates to a traditional Chinese medicine compound composition with an immune regulating function, and a preparation method and application thereof.
Background
Immunity is the body's own defense mechanism, and is the body's ability to recognize and destroy any foreign body (virus, bacteria, etc.) that invades from the outside, to treat aged, damaged, dead, denatured self cells, and to recognize and treat mutant cells and virus-infected cells in the body. Modern immunology considers that immunity is the physiological response of the human body to recognize and eliminate "isohexia". The immune system performs this function in the human body. With the accelerated pace of modern life, increased working pressure and the damage of industrial production to the environment, the functions of the human immune system are reduced, and the incidence of various diseases is on the rise.
The immune system of the body can be divided into immune organs, immune cells and immune molecules, which can recognize antigens together to carry out immune response, which is one of the indispensable systems for maintaining the stability of the internal environment of the body, and can react to various antigens invading the body to eliminate pathogens and cells which are mutated, aged and damaged. Two distinct but interrelated branches of the immune system, namely non-specific/innate and specific/adaptive immune responses, innate immunity represents the earliest protection against antigens, and adaptive immunity has two branches: humoral and cellular immunity, the former having an important role in recognizing imbalance of homeostasis caused by infectivity or non-infectivity, and the latter having a role in killing infected cells, neutralizing antigens, which do not act independently but act together with other systems to provide a guarantee for stabilization of the environment in the body. Diseases can be caused when the immunity of the organism is too strong or weak, hypersensitivity can be caused when the immunity of the organism is too strong, and self components can be attacked; when the immunity is weak, the body can not effectively respond to the invaded foreign matters, so that the body is more easily infected by bacteria, viruses, fungi and the like, so that the most direct expression of low immunity is that the body is easy to get ill, and the consumption of the body is aggravated due to frequent illness, so the body generally has the expressions of weak constitution, malnutrition, listlessness, fatigue, weakness, appetite reduction, sleep disorder and the like. The patient with illness, injection, medicine taking and defecation become a family and have a meal, the patient can recover from illness for a long time each time, and the attack is repeated frequently.
Therefore, it is necessary to develop a compound Chinese medicinal composition with the function of regulating the immunity of patients.
Disclosure of Invention
The invention aims to provide a traditional Chinese medicine compound composition with an immune regulation function, and a preparation method and application thereof. By optimizing and researching the extraction process of the traditional Chinese medicine compound for regulating immunity, the particle forming process and the preparation process of the product and the like, the optimal extraction process, the optimal auxiliary material formula and the preparation process are determined, so that the research work of the particle forming of the extract for regulating immunity is promoted. The invention mainly solves the technical problems through the following technical scheme.
The invention provides a traditional Chinese medicine compound composition with an immunity regulating function, which is prepared from the following raw materials in parts by weight: 6000-8000 portions of medlar, 8000-10000 portions of rhizoma polygonati, 8000-10000 portions of mulberry, 15000-20000 portions of astragalus root, 800-1200 portions of peanut extract, 10.1-0.5 portion of vitamin B, 20.1-0.5 portion of vitamin B, 0.8-1.5 portion of pantothenic acid, 60.1-0.5 portion of vitamin B, 0.07-0.12 portion of folic acid, 120.00075-0.0012 portion of vitamin B, 2-7 portions of nicotinic acid, 100-800 portions of calcium citrate and 100-700 portions of magnesium gluconate.
Preferably, the preparation method of the peanut extract comprises the steps of crushing peanuts, adding 8-30 times of 50-90% ethanol, adjusting to slightly boiling after the solution is boiled, extracting for 0.5-3h, sieving the liquid medicine with a No. 6 sieve, concentrating the extracting solution under reduced pressure to obtain thick paste, drying in vacuum and crushing into fine powder to obtain the peanut extract.
Preferably, the traditional Chinese medicine compound composition also contains auxiliary materials acceptable in the medicament, wherein the auxiliary materials comprise a filling agent and a flavoring agent, and the proportion of the filling agent to the flavoring agent in the traditional Chinese medicine compound composition is 20-70%: 35-75%: 0.1 to 5 percent.
Preferably, the filler is dextrin; the flavoring agent is aspartame.
Preferably, the preparation of the pharmaceutical composition is granules, capsules, tablets, powder or paste.
The invention also provides a preparation method of the traditional Chinese medicine compound composition with the function of regulating immunity, which comprises the following steps:
(1) weighing fructus Lycii, rhizoma Polygonati, Mori fructus, and radix astragali according to formula ratio, decocting with 8-15 times of water for 0.5-3 hr, sieving the medicinal liquid, collecting for use, decocting the residue with 5-12 times of water for 0.5-3 hr, sieving the medicinal liquid, mixing with the first decoction, and concentrating; drying the concentrated solution under reduced pressure to obtain dry extract, pulverizing into powder, and sieving to obtain Chinese medicinal extract;
(2) weighing peanut extract, vitamin B1, vitamin B2, pantothenic acid, vitamin B6, folic acid 90, vitamin B12, nicotinic acid, calcium citrate and magnesium gluconate according to the formula proportion, uniformly mixing with the traditional Chinese medicine extract in the step (1), adding auxiliary materials, and uniformly mixing to prepare the preparation.
Preferably, in step (1), the sieve is a No. 6 sieve.
Preferably, in the step (2), the uniformly mixing is uniformly mixing and grinding by an equivalent incremental method.
The invention also provides application of the traditional Chinese medicine compound composition with the function of regulating immunity in preparing medicines, health-care products and foods which are beneficial to enhancing immunity.
The positive progress effects of the invention are as follows:
compared with the prior art, the formula of the traditional Chinese medicine composition with the function of regulating immunity has medicinal and edible medicinal materials, extracts, vitamins, nicotinic acid and the like, and is reasonable and unique. Has good function of regulating immunologic function according to the traditional Chinese medicine theory. In addition, the functional ingestible product has the mouthfeel which is also an important index, and the invention optimizes the process and the mouthfeel when selecting the auxiliary materials, so that the auxiliary materials are very suitable to be selected and the mouthfeel is also very ideal.
Drawings
FIG. 1 is a flow chart of the preparation process of the present invention.
FIG. 2 is a polysaccharide standard curve
Detailed Description
A traditional Chinese medicine compound composition with an immunity regulating function is composed of the following raw materials in parts by weight: 8000 portions of medlar 6000-.
The medicinal materials of Chinese wolfberry, rhizoma polygonati, mulberry and radix astragali used in the daming process research are purchased from Changda Chinese medicinal material decoction pieces Limited company in Annational city and all meet the relevant requirements of Chinese pharmacopoeia.
Record in pharmacopoeia
Chinese wolfberry
[ PROPERTIES, WESTERN AND CHANNEL tropism ] is sweet and neutral. It enters liver and kidney meridians.
[ FUNCTIONS AND INDICATIONS ] can nourish liver and kidney, replenish vital essence and improve eyesight. Can be used for treating consumptive disease and essence deficiency, soreness of waist and knees, giddiness and tinnitus, sexual impotence and nocturnal emission, internal heat and thirst, blood deficiency and sallow complexion, and blurred vision.
[ DOSAGE AND ADMINISTRATION ] 6-12 g.
Polygonatum sibiricum
[ PROPERTIES AND WESTERN GUIDANGSHEN ] is sweet, salty and neutral. It enters liver and kidney meridians.
[ FUNCTIONS AND INDICATIONS ] can secure essence, reduce urination, tonify kidney and strengthen yang. Can be used for treating spermatorrhea, enuresis, frequent micturition, and whitish and turbid urine.
[ DOSAGE AND ADMINISTRATION ] 5-10 g.
Mulberry
[ PROPERTIES, WESTERN AND CHANNELS GUIDING ] is sweet, sour and cold. It enters heart, liver and kidney meridians.
[ FUNCTIONS AND INDICATIONS ] can nourish yin, tonify blood, promote the production of body fluid and moisten dryness. Can be used for treating liver and kidney yin deficiency, giddiness tinnitus, cardiopalmus insomnia, early white beard and hair, body fluid consumption thirst, internal heat diabetes, and constipation due to intestinal dryness.
(usage and dosage) 9-15 g.
Astragalus membranaceus
[ PROPERTIES AND FLAVOUR AND GUIJING ] is sweet and slightly warm. It enters lung and spleen meridians.
[ FUNCTIONS AND INDICATIONS ] can invigorate qi, elevate yang, strengthen superficies, check sweating, induce diuresis to alleviate edema, promote salivation, nourish blood, remove stagnation, relieve arthralgia, expel toxin, expel pus, heal wound and promote granulation. Can be used for treating deficiency of vital energy, asthenia, anorexia, constipation peaceful, collapse of middle-jiao energy, chronic diarrhea, rectocele, hematochezia, spontaneous perspiration, qi deficiency, edema, internal heat, diabetes, blood deficiency, hemiplegia, arthralgia, numbness, carbuncle, cellulitis, and intractable ulcer.
[ DOSAGE AND ADMINISTRATION ] 9-30 g.
Wolfberry fruit (wolferry, goji berry) is a traditional and rare Chinese medicinal material, is loaded in Shen nong's herbal meridians and is listed as the superior product. The Chinese pharmacopoeia 2020 edition specifies that fructus Lycii is dried mature fruit of Lycium barbarum (Lycium barbarum) belonging to Solanaceae, and has effects of nourishing liver and kidney, replenishing vital essence and improving eyesight. At present, the medlar is widely used as a traditional Chinese medicine and a functional food all over the world. Modern researches show that the medlar is rich in various vitamins, amino acids, cellulose, trace elements, polysaccharide and bioactive substances, and the substances enable the medlar to have rich nutrition and various biological activities, such as resisting various diseases, including cancers, arteriosclerosis, tumors and the like, preventing chronic diseases, such as high cholesterol, diabetes, hepatitis, eye diseases, rash, allergy, insomnia, chronic liver diseases and kidney diseases, and simultaneously having health care effects of improving immunity, resisting oxidation, preventing aging and the like. In the invention, the addition amount of the medlar is 6000-8000 parts, preferably 6500-7500 parts, and more preferably 7000 parts by weight of the traditional Chinese medicine compound composition with the function of regulating immunity.
Huang Jing is recorded in Ming Yi Bie Lu (miscellaneous records of famous physicians), its taste is sweet, mild and non-toxic. Has the effects of invigorating spleen and replenishing qi, eliminating dampness, and calming five internal organs. Can be taken for a long time to lighten the body, prolong life, and avoid hunger. Therefore, polygonatum sibiricum is considered as a medicine for promoting longevity and prolonging life, and is a tonic product. Rhizoma polygonati contains compounds such as polysaccharide, alkaloid, saponin, flavone, anthraquinone compounds, volatile substances, phytosterol, lignan and various amino acids useful for human bodies, wherein the polysaccharide and the saponin are the most widely researched chemical components in rhizoma polygonati. Modern pharmacological research shows that rhizoma polygonati has the effects of resisting fatty liver, resisting diabetes, protecting kidney, resisting Alzheimer disease, protecting heart, resisting cancer, resisting oxidation, resisting aging and the like. In the invention, the addition amount of the sealwort is 8000-10000 parts, preferably 8500-9500 parts, and more preferably 9000 parts by weight of the traditional Chinese medicine compound composition with the function of regulating immunity.
Qi-tonifying Sheng Yao Huang is recorded in Shen nong Ben Cao Jing, with warm nature and sweet taste, and mainly for pus discharge and carbuncle. Then, with the application of Astragalus membranaceus by famous physicians in ancient times, the actions of Astragalus membranaceus are manifested as diabetes, deficiency of both qi and yin, exterior deficiency, etc. Until the recent times, the definition of the efficacy of astragalus is relatively full and complete. It has effects of invigorating qi, invigorating yang, reinforcing defensive system, expelling toxin, promoting muscle growth, inducing diuresis, and relieving edema, and can be used for treating deficiency of spleen-qi and stomach-qi, sinking of middle-warmer energy, unhealing ulcer, edema, and oliguria. Modern pharmacological research shows that astragalus has the functions of protecting heart and blood vessels, resisting tumors, regulating immunity, resisting inflammation, resisting oxidation, resisting aging, protecting nerves and the like. The immune function is closely related to various diseases of a human body, the astragalus polysaccharide regulates the cellular immunity, improves the thymus index and the spleen index of a model mouse by increasing the phagocytosis of splenic lymphocytes and peritoneal macrophages of the model mouse, recovers damaged thymus and spleen tissues, and prevents damaged organs from being damaged by anticancer drugs due to the action on immune organs. The research shows that the regulation effect of astragalus to macrophages is bidirectional, and the response of normal cultured macrophages RAW264.7 and LPS stimulated cultured macrophages to the effect of astragalus total flavonoids is opposite and dose-dependent. In the invention, the addition amount of the astragalus is 15000-20000 parts, preferably 16000-19000 parts, and more preferably 18000 parts by weight of the traditional Chinese medicine compound composition with the function of regulating immunity.
Mulberry fruit is indicated for its action in Tang Ben Cao (Tang materia Medica) in Tang dynasty. The traditional Chinese medicine believes that the mulberry is sweet in taste and cold in nature, enters heart, liver and kidney channels, has the effects of nourishing yin and supplementing blood, and can treat yin deficiency, little body fluid, insomnia and the like. In addition, many classical Chinese medicine documents record: benefiting five internal organs and joints, promoting blood circulation, tranquilizing, lowering blood pressure, quenching thirst, improving eyesight, whitening, and relieving alcoholism. Modern medical clinical evidence: the mulberry has good effects of nourishing heart, liver and kidney, nourishing blood and dispelling wind. Has obvious curative effects on reducing blood fat, relieving neurasthenia, arteriosclerosis, sexual function weakness, deafness and dim eyesight, early white beard and hair, internal heat diabetes, blood deficiency constipation and rheumatic arthralgia. Experiments of research groups led by John Pazuki in the United states show that the mulberry contains resveratrol which is an anti-tumor substance and has an anti-cancer effect. Pharmacological research shows that: the mulberry entering the stomach can supplement the lack of gastric juice, promote the digestion of gastric juice, enter the intestine and promote the secretion of intestinal juice and the gastrointestinal peristalsis, thereby having the effects of tonifying and strengthening. In the invention, the addition amount of the mulberry is 8000-10000 parts, preferably 8500-9500 parts, and more preferably 9000 parts by weight of the traditional Chinese medicine compound composition with the function of regulating immunity.
The peanut is a nut which is widely eaten in China, is also called a 'long-growing fruit', has high nutritive value, contains various vitamins, mineral substances and the like, and is one of plant species with higher coenzyme Q10 content; has the effects of resisting aging, reducing cholesterol, delaying aging, preventing tumor, etc. In the invention, the effective components in the peanuts are preferably separated and extracted by an alcohol extraction method, the peanuts are crushed, 8-30 times of 50-90% ethanol is added to the crushed peanuts, the solution is boiled and then is slightly boiled, the extraction is carried out for 0.5-3h, preferably 15 times of 75% ethanol is added to the solution, the solution is boiled and then is slightly boiled, the extraction is carried out for 1h, the liquid medicine is sieved by a No. 6 sieve, the extracting solution is decompressed and concentrated to obtain thick paste, and the thick paste is dried and crushed into fine powder in vacuum, so that the peanut extract is obtained. The source of the peanuts is not specially limited, and the peanuts are commercially available. In the invention, the addition amount of the peanut extract is 800-.
Vitamin B1 is mainly derived from food, cannot be synthesized in the human body, and is in the form of thiamine pyrophosphate (TPP), which is involved in the catabolism of saccharides and also promotes gastrointestinal motility. In 2015, spines et al reported that TPP influences the expression of intercellular adhesion molecules (ICAM) in immune cells by modulating heme-dependent oxidase activity. In 2018, Moskowitz et al report that the inoxidizability of TPP can antagonize the immune oxidation of neutrophils, and reduce the level of cytokines released by macrophages through the inhibition of NF-kB channels, so that the TPP has an anti-inflammatory effect. The source of vitamin B1 in the present invention is not particularly limited, and a commercially available product may be used. In the invention, the addition amount of the vitamin B1 is 0.1-0.5 part, preferably 0.2-0.4 part, and more preferably 0.3 part by weight of the traditional Chinese medicine compound composition with the function of regulating immunity.
Vitamin B2 is also known as "riboflavin", and a deficiency in vitamin B2 inhibits the activity of acetyl-coa dehydrogenase during fatty acid oxidation, adversely affects the production of acetyl-coa, and thus affects fat metabolism and the tricarboxylic acid cycle (TCA). While the dependence of mature B, T cells on TCA and fat metabolism is obviously enhanced, the generation of acetyl coenzyme A is blocked, the maturation of immune cells and related immune response are influenced, and the direct relation of vitamin B2 to the immune response is suggested. The source of vitamin B2 in the present invention is not particularly limited, and a commercially available product may be used. In the invention, the addition amount of the vitamin B2 is 0.1-0.5 part, preferably 0.2-0.4 part, and more preferably 0.3 part by weight of the traditional Chinese medicine compound composition with the function of regulating immunity.
Vitamin B5, pantothenic acid, is not synthesized directly by the human body and is mainly derived from food intake. The active form of vitamin B5 in the body is involved in various energy metabolism processes of cells by converting into coenzyme A, regulates the synthesis of antibodies and has certain antioxidant function. The source of pantothenic acid in the present invention is not particularly limited, and commercially available products may be used. In the invention, the addition amount of pantothenic acid is 0.8-1.5 parts, preferably 1.0-1.4 parts, and more preferably 1.2 parts by weight of the traditional Chinese medicine compound composition with the function of regulating immunity.
Vitamin B6 includes three forms of pyridoxal, pyridoxine and pyridoxamine, and is not synthesized de novo in the human body and is mainly derived from food. In 2017, Ueland et al reported that vitamin B6 deficiency caused a decrease in the level of IL-2, an anti-inflammatory cytokine, and an increase in the level of an anti-inflammatory cytokine, such as IL-4, in serum. The source of vitamin B6 in the present invention is not particularly limited, and a commercially available product may be used. In the invention, the addition amount of the vitamin B6 is 0.1-0.5 part, preferably 0.2-0.4 part, and more preferably 0.3 part by weight of the traditional Chinese medicine compound composition with the function of regulating immunity.
Vitamin B9 is also known as folic acid, and a deficiency of folic acid leads to megaloblastic anemia and leukopenia. Vitamin B9 combines with folate receptor 4 on the surface of Treg cells to promote the differentiation and growth of Treg cells, which helps to maintain the homeostasis of the intestinal immune system. The source of folic acid is not particularly limited in the invention, and a commercially available product can be used. In the invention, the addition amount of folic acid is 0.07-0.12 part, preferably 0.08-0.11 part, and more preferably 0.09 part by weight of the traditional Chinese medicine compound composition with the function of regulating immunity.
Vitamin B12 promotes the development and maturation of red blood cells, and its deficiency results in severe anemia. In 2018, Pannierec et al reported that vitamin B12 deficiency could reduce intestinal uptake and renal reabsorption, thereby accelerating human aging. Vitamin B12 in the form of coenzyme increases the utilization rate of folic acid and promotes the metabolism of carbohydrate, fat and protein. In immunology, vitamin B12 and vitamin B9 act synergistically, and act as coenzymes of vitamin B9 to participate in the immunoregulation of vitamin B9 on the body. The source of the vitamin B12 is not particularly limited in the present invention, and a commercially available product can be used. In the invention, the addition amount of the vitamin B12 is 0.00075-0.0012 parts, preferably 0.0008-0.001 parts and more preferably 0.00095 parts by weight of the traditional Chinese medicine compound composition with the function of regulating immunity.
Nicotinic acid, also known as vitamin B3, is usually converted to its active form, nicotinamide, in humans after food intake, and the effect of vitamin B3 on immunity is mainly manifested by mediating the anti-inflammatory action of macrophages and indirectly affecting the immune response of T cells. In 2014, Singh et al reported that vitamin B3 content was low in a variety of autoimmune diseases with excessive macrophage activation. Its studies further indicate that vitamin B3 reduces the immune effect by affecting the phagocytic activity of a range of phagocytic cells that are macrophage-dominated; vitamin B3 inhibits the ROS signal path of macrophage, reduces the elimination function of the macrophage on pathogeny, and has antioxidation effect. The source of the nicotinic acid is not particularly limited, and a commercially available product is adopted. In the invention, the addition amount of the nicotinic acid is 2-7 parts, preferably 3-6 parts, and more preferably 4.75 parts by weight of the traditional Chinese medicine compound composition with the function of regulating immunity.
The traditional Chinese medicine compound composition is also added with calcium citrate and magnesium gluconate. The calcium citrate has the functions and effects of strengthening bones, diminishing inflammation, relieving pain, maintaining normal excitability of nerve and muscle, and treating skin rash caused by allergic diseases. The magnesium gluconate dissociates into magnesium ions and gluconic acid in vivo, participates in all energy metabolism in vivo, and activates or catalyzes more than 300 enzyme systems. The synthesis of DNA and RNA and the structure of cell membrane have less magnesium ion, can prevent platelet aggregation and coronary thrombosis caused by magnesium deficiency, and has calcium junction resistance and membrane stabilization effects. The sources of the calcium citrate and the magnesium gluconate are not specially limited, and the calcium citrate and the magnesium gluconate can be obtained by adopting a commercially available product. In the invention, the addition amount of the calcium citrate is 800 parts by weight, preferably 600 parts by weight, and more preferably 500 parts by weight of the traditional Chinese medicine compound composition with the function of regulating immunity. The addition amount of the magnesium gluconate is 100-700 parts, preferably 300-500 parts and more preferably 400 parts.
In the formula, 4 traditional Chinese medicines including medlar, rhizoma polygonati, mulberry and astragalus membranaceus are matched, and a peanut extract, vitamin B1, vitamin B2, pantothenic acid, vitamin B6, folic acid, vitamin B12, nicotinic acid, calcium citrate and magnesium gluconate are used as auxiliary materials, so that the effects of improving immunity are achieved together.
The pharmaceutical composition of the present invention can be prepared into granules, capsules, tablets, powders or pastes, and in the specific embodiment of the present invention, the pharmaceutical composition is preferably prepared into granules and wet granulation is adopted. The forming rate of the particles affects the production efficiency and cost, and the types and the proportion of auxiliary materials of the product need to be optimized. According to the invention, the types of the fillers, the flavoring agents and other auxiliary materials are inspected, the particle forming rate and the like are taken as inspection indexes, and finally, the fillers are preferably dextrin and the flavoring agents are preferably aspartame in the auxiliary materials. Through process optimization, the proportion of the traditional Chinese medicine compound composition, the filler and the flavoring agent is 20-70%: 35-75%: 0.1-5%, preferably 50% of Chinese medicinal compound composition powder, 49.5% of dextrin, and 0.5% of corrective.
The invention also provides a preparation method of the traditional Chinese medicine compound composition with the function of regulating immunity, which comprises the following steps:
(1) weighing the medlar, the sealwort, the mulberry and the astragalus root according to the proportion of the formula, adding 8-15 times of water for decocting for 0.5-3h, sieving and collecting liquid medicine for later use, adding 5-12 times of water for decocting for 0.5-3h into dregs of a decoction, preferably adding 12 times of water for decocting for 2h, sieving and collecting liquid medicine for later use, adding 10 times of water into dregs of a decoction for decocting for 2h, sieving the liquid medicine, merging and concentrating the liquid medicine with the first decoction; drying the concentrated solution under reduced pressure to obtain dry extract, pulverizing into powder, and sieving to obtain Chinese medicinal extract;
(2) weighing peanut extract, vitamin B1, vitamin B2, pantothenic acid, vitamin B6, folic acid 90, vitamin B12, nicotinic acid, calcium citrate and magnesium gluconate according to the formula proportion, uniformly mixing with the traditional Chinese medicine extract in the step (1), adding auxiliary materials, and uniformly mixing to prepare the preparation.
In the preparation process, in consideration of the difficulty and the feasibility of actual production and the category of the immunity-adjusting functional components in the medicinal materials, the scheme separates and extracts target effective components by using a water extraction method, and completes optimization and determination of other factors by constructing an orthogonal experimental design. In the present invention, the herb extract is preferably sieved with No. 6 sieve.
In the preparation process, when the preparation is granules, the components and auxiliary materials in the prescription are weighed according to the proportion of the prescription, the components and the auxiliary materials are mixed and ground uniformly by an equivalent incremental method, the mixture is poured into a tray, and a proper amount of 95% ethanol is preferably added to prepare a soft material until the soft material is in a state of being held, agglomerated and pressed to be dispersed, the soft material is taken and placed into a granulator for granulation, and the mixture is packaged: 15g of each portion.
The invention also provides application of the traditional Chinese medicine compound composition with the function of regulating immunity in preparing medicines, health-care products and foods which are beneficial to enhancing immunity.
The present invention is described in further detail below by way of specific examples, but the present invention is not limited thereby within the scope of the examples. The experimental methods without specifying specific conditions in the following examples were selected according to the conventional methods and conditions, or according to the commercial instructions.
The starting materials in the following examples were all commercially available unless otherwise specified.
Laboratory apparatus
An electronic balance: sartorius BSA3202S
A printer: XQ-Printer 132
Electric jacket: shanghai Lichen Bangxi Instrument science and technology Co Ltd
Oven: Shanghai-Heng scientific instruments Co., Ltd
A water bath kettle: changzhou Guohua electric appliances Co Ltd
And (3) vacuum drying oven: Shanghai-Heng scientific instruments Co., Ltd
Round bottom flask (3L): beijing Xin Weier glass Instrument Co Ltd
Screening: 14, 6, 1, 5 sieves
Experimental example 1 research on the process and quality control of the Chinese medicinal compound composition with immunoregulatory function
The medicinal materials of Chinese wolfberry, sealwort, mulberry and astragalus root used in the process research are purchased from Changda Chinese medicinal material decoction pieces Limited company in Annational city and all meet the relevant requirements of Chinese pharmacopoeia.
1. Process and quality control of Chinese medicinal extract
1.1 extraction of Chinese herbs
In consideration of the difficulty and the feasibility of actual production and the category of the immunity-regulating functional components in the medicinal materials, the scheme separates and extracts target effective components by using a water extraction method, and completes optimization and determination of other factors by constructing an orthogonal experimental design.
7g of medlar, 9g of rhizoma polygonati, 9g of mulberry and 18g of astragalus are weighed and subjected to nine experiments according to the method shown in an orthogonal experiment table (table 1).
Table 1 water extraction process orthogonal design table
Figure BDA0003364831040000091
1.2 extraction operations
Adding water with a corresponding volume according to experimental design, adjusting to slight boiling after the solution is boiled and starting timing, filtering the obtained decoction by using a No. 6 sieve, combining the solutions (after the last extraction, all the decoction in the residue needs to be extruded out), recording the volume of the obtained decoction, putting the obtained decoction on a constant-temperature water bath kettle at 80 ℃, concentrating the volume to be below 500mL, then adding deionized water to fix the volume of the concentrated solution to 500mL, and storing the obtained concentrated solution in a refrigerator at 4 ℃ for later use.
1.3 measurement of polysaccharide content
(1) Preparation of control solutions: accurately weighing 1.2mg of anhydrous glucose reference substance, and adding 10mL of deionized water to obtain a solution containing 0.12mg per 1 mL.
(2) Preparation of a standard curve: precisely measuring control solution (glucose solution concentration: 0.12mg/mL)0.2, 0.4, 0.6, 0.8, 1.0, and 1.2mL, respectively placing in 10mL test tubes with plugs, adding water to 2.0mL each, rapidly and precisely adding sulfuric acid (specifically weighing anthraketone 0.1g, adding sulfuric acid 100mL to dissolve, shaking) 6mL, immediately shaking, standing for 15min, immediately cooling in 4 deg.C refrigerator for 15min, taking out, taking corresponding reagent as blank, irradiating with ultraviolet-visible spectrophotometry, measuring absorbance at 625nm wavelength, taking absorbance as ordinate, and taking concentration as cross-base to draw standard curve.
(3) Preparing a test solution: precisely weighing 25mg of the dry paste powder sample into a 25mL volumetric flask, and adding distilled water to reach a constant volume of 25 mL. If insoluble components exist in the supernatant, placing the supernatant into a centrifuge tube for centrifugation, and reserving the supernatant for later use.
(4) The determination method comprises the following steps: precisely measuring sample solution 2mL, placing in 10mL test tube with plug, performing the same method according to standard curve preparation method from "rapidly and precisely adding anthrapyridone sulfate solution 6 mL", measuring absorbance, reading anhydrous glucose content in sample solution from standard curve, and calculating.
1.4 calculate the cream yield
(1) Constant weight of an evaporating dish: the clean and dried evaporating dish is labeled, heating is stopped after 5h at 105 ℃, and the evaporating dish is placed in a dryer for cooling (about 40min) and weighing is carried out. The above procedure was repeated (with each subsequent heating being changed to 1 hour) until the difference between two adjacent weighing readings was less than 0.0003 g. And (4) placing the evaporation vessel with the good constant weight in a dryer for storage, and continuing to perform constant weight on the evaporation vessel with the good constant weight until the evaporation vessel with the good constant weight is used.
(2) Drying the liquid medicine: taking 50mL of the decoction with the constant volume of 500mL out, placing the decoction in an evaporation dish with constant weight, firstly concentrating the decoction in a water bath kettle at 80 ℃ until the decoction is nearly dry, then placing the decoction in a vacuum drying oven at 80 ℃ for drying until the weight is constant, recording, and calculating the cream yield.
1.5 orthogonal test results and analysis
(1) Results of polysaccharide content
The polysaccharide content of the samples was calculated from the polysaccharide standard curve (fig. 2), see table 2.
TABLE 2 polysaccharide content results for 9 samples of water extraction process
Figure BDA0003364831040000101
(2) Orthogonal analysis
The research takes polysaccharide content as a main investigation factor and carries out orthogonal experiment on the traditional Chinese medicine extractThe fruits are analyzed (Table 3), the importance of each factor on the influence of the water extraction process is sequentially C > B > A, namely the influence of the extraction time is the largest, and then the optimal process A is determined according to the material-liquid ratio and the extraction times3B3C3. Meanwhile, the research also considers the cream yield of the traditional Chinese medicine extract (table 4), and provides reference for the packaging specification and the daily dose of the product; as can be seen from Table 3, the importance of each factor on the water extraction process is sequentially C > B > A, i.e. the influence of the extraction time is the largest, and then the optimum process A is determined according to the material-liquid ratio and the extraction times3B3C3The method is the same as the optimal process obtained by taking polysaccharide as a research index. However, considering cost issues such as energy consumption, the present study is performed in a sub-optimal process A3B2C3For the final process, 12 times water, 2 times extraction, 2 hours each time.
TABLE 3 Water extraction Process orthogonal results analysis (polysaccharide content)
Figure BDA0003364831040000111
TABLE 4 Water extraction Process Quadrature results analysis (cream yield)
Figure BDA0003364831040000112
Figure BDA0003364831040000121
1.6 verification of extraction Process
The final water extraction scheme is adopted to carry out three times of parallel extraction, the experimental results are shown in tables 5 and 6, and the results show that the process is the optimal water extraction process and the extraction process is stable and feasible.
TABLE 5 Final Process verification results (cream yield)
Figure BDA0003364831040000122
TABLE 6 Final Process verification results (polysaccharide)
Figure BDA0003364831040000123
2. Peanut extract process and quality control
2.1 extraction of Chinese herbs (alcohol extraction)
In consideration of the difficulty, the feasibility and the like of actual production, the scheme utilizes an alcohol extraction method to separate and extract target effective components, and completes optimization and determination of other factors by constructing an orthogonal experimental design.
100g of peanuts were weighed and nine experiments were performed according to the method shown in the orthogonal experiment table (Table 7).
TABLE 7 orthogonal design chart of peanut alcohol extraction process
Figure BDA0003364831040000131
2.2 extraction operation and treatment
Weighing dried and crushed samples, adding ethanol with a corresponding volume according to experimental design, adjusting to slightly boil after the solution is boiled and timing, filtering the obtained decoction by using a No. 6 sieve, concentrating the obtained filtrate by using a rotary evaporator (the temperature of a water bath kettle is 40 ℃), drying the residual liquid in a freeze dryer after the ethanol is completely evaporated, and obtaining the extract. The extract weight was recorded and the cream yield was calculated.
2.3 orthogonal test results and analysis
The research takes the cream yield as a main investigation factor, orthogonal experiment results of peanuts in the composition are analyzed (table 8), the influence of all factors on an alcohol extraction process is sequentially A & gtB & gtC, namely, the influence of ethanol concentration is the largest, and then the optimal process A is determined according to the material-liquid ratio and the extraction time3B2C1I.e. 90% of 15 times the volume, for 1 h. However, in the experimental process, the extract extracted by 90% ethanol contains more grease, which is not beneficial to the subsequent drying treatment, so that the extract is found to be beneficial to the subsequent drying treatment，A3B2C1And cannot be used as a final process. In addition, the present study is referred to as A in terms of convenience in terms of energy consumption, production cost, etc1B2C1The final process is 15 times of 70% ethanol, and the extraction is carried out for 1 hour and 1 time.
TABLE 8 analysis of the results of the alcohol extraction process
Figure BDA0003364831040000132
Figure BDA0003364831040000141
1.4 verification of extraction Process
The final alcohol extraction scheme is adopted to carry out three times of parallel extraction, the experimental results are shown in table 9, and the results show that the process is the optimal water extraction process, and the extraction process is stable and feasible.
Table 9 final process verification
Figure BDA0003364831040000142
Experimental example 2 formulation design and taste evaluation of the Compound Chinese medicinal composition having Immunity-regulating function
(1) Preparation method of granules
Pulverizing the extract, sieving with 20 mesh sieve, weighing the extract powder and adjuvants according to the prescription ratio, mixing and grinding uniformly by equivalent incremental method, pouring into a tray and adding appropriate amount of ethanol solution, and making into soft material until the soft material is in the state of holding, conglobating, and pressing to disperse.
(2) Experiment search of forming rate
The dosage form designed by the product is granules, and the forming rate of the granules influences the production efficiency and cost. According to the existing conditions in a laboratory, the granules are prepared by a wet granulation method, and the types and the proportion of auxiliary materials and the types and the proportion of flavoring agents of the products need to be optimized.
TABLE 10 product formulation Process study
Figure BDA0003364831040000151
From the above table (table 10), it can be seen that when dextrin is used as the main auxiliary material and the proportion of the formula powder is 40%, the product granule molding rate is higher, and the proportion of the formula powder is 50%. However, considering the problems of the dosage of the auxiliary materials, the daily dosage and the like, the process for forming the product particles is the best process when the prescription powder accounts for 50%, the dextrin accounts for 49.5% and the flavoring agent accounts for 0.5%.
(3) Taste assessment
In order to evaluate the influence of different contents of flavoring agents (the flavoring agents account for 0%, 0.5% and 1% of the formula granules) on the taste of the product, a taste evaluation experiment is carried out. The final choice of adding 0.5% aspartame is better in taste and can be generally accepted.
(4) Quality evaluation
Through the research, the product preparation forming process comprises the steps of 50% of formula powder, 49.5% of dextrin and 0.5% of aspartame, and a proper amount of 95% ethanol is added. The process was then verified and evaluated for quality:
appearance character
The product should be dry, uniform in appearance and uniform in color, and has no phenomena of moisture absorption, agglomeration, deliquescence and the like.
Solubility in water
The method is carried out according to 0104 'soluble particle inspection method' in general rules of Chinese pharmacopoeia (2020 edition). 10g of the granules were taken, 200mL of hot water was added, and stirred for 5 minutes, and immediately after observation, the soluble granules should be completely dissolved, allowing slight cloudiness.
Moisture content
Measured according to the moisture determination method of Chinese pharmacopoeia, the content of the water should not exceed 6 percent except for other regulations.
Determination of percent of pass of the granules
Percent of pass (%) < qualified granule mass/granule mass without sieving x 100%
Refer to the book 0982 "two methods double screening method" in general rules of Chinese pharmacopoeia (2020 edition). And weighing the dried particles, and sequentially sieving the dried particles through a No. 1 sieve and a No. 5 sieve, wherein the particles which can pass through the No. 1 sieve and do not pass through the No. 5 sieve are qualified particles. And weighing the qualified particles, and calculating the particle forming rate. If 15% of the particles fail, namely the particle forming rate is lower than 85%, the particle size fails.
Determination of the flowability of the granules
The method comprises fixing 3 funnels with an iron stand, placing the funnels in series to make the height from coordinate paper on a horizontal table top suitable, setting the height from the lower opening of the lowest funnel to the coordinate paper to be h, slowly pouring sample particles along the uppermost funnel wall until the sample on the coordinate paper is piled up and touches the lowest funnel opening, measuring the radius r of the bottom of the cone piled up on the coordinate paper, and calculating alpha as tan alpha h/r.
Difference in charge
Taking 10 bags of the granule test product subpackaged in single dose, respectively weighing the weight of the content in each bag, comparing the packaging amount in each bag with the marked weight, wherein the packaging amount exceeding the limit of the packaging amount is not more than 2 bags, and the packaging amount exceeding 1 bag is not 1 time (the marked packaging amount is 1.0g or less than 1.0g, more than 1.0g to 1.5g, more than 1.5g to 6g, and the difference limit of the packaging amount above 6g is respectively +/-10%, +/-8%, +/-7% and +/-5%).
(5) Quality evaluation results
As can be seen from Table 11, the preparation process of the product is stable and feasible, and the flow chart of the preparation process of the invention is shown in figure 1.
TABLE 11 evaluation results of product quality
Figure BDA0003364831040000161
Example 1 preparation of a Chinese medicinal Compound composition having an immune-modulating function according to the present invention into granules
The prescription is as follows: 7g of medlar, 9g of rhizoma polygonati, 9g of mulberry, 18g of astragalus, 1g of peanut extract, 10.3mg of vitamin B, 20.3mg of vitamin B, 1.2mg of pantothenic acid, 60.3mg of vitamin B, 90 mu g of folic acid, 120.95 mu g of vitamin B, 4.75mg of nicotinic acid, 0.5g of calcium citrate and 0.4g of magnesium gluconate.
The preparation method comprises the following steps:
1) extracting and treating Chinese medicinal decoction pieces
(1) Decocting: weighing 7g of medlar, 9g of rhizoma polygonati, 9g of mulberry and 18g of astragalus, adding 12 times of water, and decocting for 2 h. The liquid medicine is screened and collected by a No. 6 sieve for standby, and the dregs of a decoction are added with 10 times of water and decocted for 2 hours. Sieving the medicinal liquid with No. 6 sieve, mixing with the first decoction, and concentrating;
(2) and (3) drying: drying the concentrated solution under reduced pressure to obtain dry extract, pulverizing into powder, and sieving with No. 6 sieve to obtain 15g of Chinese medicinal extract;
2) peanut extraction and processing
(1) Extraction: weighing 11g of peanuts, crushing, and adding 75% ethanol of which the amount is 15 times of the peanut weight for extraction for 1 hour. The liquid medicine is collected for standby after passing through a No. 6 sieve.
(2) And (3) drying: concentrating the extractive solution under reduced pressure to obtain soft extract, vacuum drying, and pulverizing into fine powder to obtain dry extract.
3) And (3) granulating: 15g of traditional Chinese medicine extract, 1g of peanut extract, 10.3mg of vitamin B, 20.3mg of vitamin B, 1.2mg of pantothenic acid, 60.3mg of vitamin B, 90 mu g of folic acid, 120.95 mu g of vitamin B, 4.75mg of nicotinic acid, 0.5g of calcium citrate, 0.4g of magnesium gluconate, 13.5g of dextrin and 0.5g of aspartame, uniformly mixing, adding a proper amount of 95% ethanol, and granulating.
4) And packaging: each bag is 15 g.
The formula has medicinal and edible medicinal materials, extracts, vitamins, nicotinic acid and the like, and is reasonable and unique. Has good function of regulating the immunologic function according to the traditional Chinese medicine theory. In addition, the taste of the functional orally-taken product is also an important index, and the experiment optimizes the process and the taste when auxiliary materials are selected, so that the auxiliary materials are very suitable to be selected, and the taste is also very ideal.
The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention, and various modifications and changes may be made by those skilled in the art. Any modification, equivalent replacement, or improvement made within the spirit and principle of the present invention should be included in the protection scope of the present invention.

Claims (9)

1. A traditional Chinese medicine compound composition with an immune regulation function is characterized by comprising the following raw materials in parts by weight: 6000-8000 portions of medlar, 8000-10000 portions of rhizoma polygonati, 8000-10000 portions of mulberry, 15000-20000 portions of astragalus root, 800-1200 portions of peanut extract, 10.1-0.5 portion of vitamin B, 20.1-0.5 portion of vitamin B, 0.8-1.5 portion of pantothenic acid, 60.1-0.5 portion of vitamin B, 0.07-0.12 portion of folic acid, 120.00075-0.0012 portion of vitamin B, 2-7 portions of nicotinic acid, 100-800 portions of calcium citrate and 100-700 portions of magnesium gluconate.
2. The compound traditional Chinese medicine composition with the function of regulating immunity according to claim 1, wherein the preparation method of the peanut extract comprises the steps of crushing peanuts, adding 50-90% ethanol in an amount which is 8-30 times that of the crushed peanuts, boiling the solution, then regulating the boiling temperature to be slightly boiling, extracting for 0.5-3h, sieving the liquid medicine with a No. 6 sieve, concentrating the extracting solution under reduced pressure to obtain thick paste, drying in vacuum and crushing into fine powder to obtain the peanut extract.
3. The compound traditional Chinese medicine composition with the function of regulating immunity according to claim 1, characterized in that the compound traditional Chinese medicine composition further contains auxiliary materials acceptable in the medicament, wherein the auxiliary materials comprise a filling agent and a flavoring agent, wherein the ratio of the filling agent to the flavoring agent in the compound traditional Chinese medicine composition is 20-70%: 35-75%: 0.1 to 5 percent.
4. The compound traditional Chinese medicine composition with the function of regulating immunity according to claim 3, wherein the filler is dextrin; the flavoring agent is aspartame.
5. The compound traditional Chinese medicine composition with the function of regulating immunity according to claim 1, wherein the preparation of the compound traditional Chinese medicine composition is granules, capsules, tablets, powder or paste.
6. A method for preparing the Chinese herbal compound composition with the function of regulating the immunity according to any one of claims 1 to 5, which is characterized by comprising the following steps:
(1) weighing fructus Lycii, rhizoma Polygonati, Mori fructus, and radix astragali according to formula ratio, decocting with 8-15 times of water for 0.5-3 hr, sieving the medicinal liquid, collecting for use, decocting the residue with 5-12 times of water for 0.5-3 hr, sieving the medicinal liquid, mixing with the first decoction, and concentrating; drying the concentrated solution under reduced pressure to obtain dry extract, pulverizing into powder, and sieving to obtain Chinese medicinal extract;
(2) weighing peanut extract, vitamin B1, vitamin B2, pantothenic acid, vitamin B6, folic acid 90, vitamin B12, nicotinic acid, calcium citrate and magnesium gluconate according to the formula proportion, uniformly mixing with the traditional Chinese medicine extract in the step (1), adding auxiliary materials, and uniformly mixing to prepare the preparation.
7. The method for preparing a Chinese medicinal compound composition with an immune function regulating function according to claim 6, wherein in the step (1), the sieving is No. 6 sieving.
8. The preparation method of the traditional Chinese medicine compound composition with the function of regulating immunity according to claim 6, wherein in the step (2), the uniformly mixing is uniformly mixing and grinding by an equivalent incremental method.
9. Use of a compound Chinese medicinal composition with immunity regulating effect of claims 1-5 in preparation of medicine, health product and food for improving immunity.
CN202111400905.4A 2021-11-19 2021-11-19 Traditional Chinese medicine compound composition with immune regulation function and preparation method and application thereof Pending CN114081925A (en)

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