CN105663650A - Probiotic fermentation traditional Chinese medicine composition for treating lung cancer and preparing method thereof - Google Patents

Probiotic fermentation traditional Chinese medicine composition for treating lung cancer and preparing method thereof Download PDF

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CN105663650A
CN105663650A CN201610092979.9A CN201610092979A CN105663650A CN 105663650 A CN105663650 A CN 105663650A CN 201610092979 A CN201610092979 A CN 201610092979A CN 105663650 A CN105663650 A CN 105663650A
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chinese medicine
lactobacillus
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medicine composition
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吴炳新
褚新红
牛纪江
甄宗武
孙筱林
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SANZHU fur PHARMACEUTICAL Co Ltd
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SANZHU fur PHARMACEUTICAL Co Ltd
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    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/88Liliopsida (monocotyledons)
    • A61K36/896Liliaceae (Lily family), e.g. daylily, plantain lily, Hyacinth or narcissus
    • A61K36/8968Ophiopogon (Lilyturf)
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    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/25Araliaceae (Ginseng family), e.g. ivy, aralia, schefflera or tetrapanax
    • A61K36/258Panax (ginseng)
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    • A61K36/42Cucurbitaceae (Cucumber family)
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    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/48Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
    • A61K36/481Astragalus (milkvetch)
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    • A61K36/48Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
    • A61K36/484Glycyrrhiza (licorice)
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    • A61K36/73Rosaceae (Rose family), e.g. strawberry, chokeberry, blackberry, pear or firethorn
    • A61K36/736Prunus, e.g. plum, cherry, peach, apricot or almond
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    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/78Saururaceae (Lizard's-tail family)
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    • A61K36/81Solanaceae (Potato family), e.g. tobacco, nightshade, tomato, belladonna, capsicum or jimsonweed
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    • A61K36/88Liliopsida (monocotyledons)
    • A61K36/896Liliaceae (Lily family), e.g. daylily, plantain lily, Hyacinth or narcissus
    • A61K36/8967Lilium, e.g. tiger lily or Easter lily
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    • A61K2236/10Preparation or pretreatment of starting material
    • A61K2236/19Preparation or pretreatment of starting material involving fermentation using yeast, bacteria or both; enzymatic treatment
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    • A61K2236/33Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
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    • A61K2236/50Methods involving additional extraction steps
    • A61K2236/51Concentration or drying of the extract, e.g. Lyophilisation, freeze-drying or spray-drying

Abstract

The invention discloses a probiotic fermentation traditional Chinese medicine composition for treating lung cancer and a preparing method thereof. The traditional Chinese medicine composition is prepared from radix ophiopogonis, American ginseng, lily, radix astragali, roasted carapax trionycis, bryozoatum, bittersweet herb, rhizoma bolbostemmae, heartleaf houttuymia herb, pericarpium citri reticulatae, honey-fried radix asteris, honey-fried flos farfarae, semen armeniacae amarae and licorice root. The Chinese herbal compounds are decocted and concentrated in water, glucose, yeast powder, yeast cream and peptone are added or not added, inorganic salt is added, saccharose and sucralose are added or not added, and then probiotic fermentation is conducted to obtain the traditional Chinese medicine composition. Bacteria good for people are utilized, in vitro fermentation of traditional Chinese medicine aqueous extract is conducted, all ingredients in the traditional Chinese medicine aqueous extract are reserved, the property of traditional Chinese medicine decoction is maintained, certain macromolecule substances are transformed in vitro through probiotic fermentation so as to be absorbed by the human body easily, and then treatment effect is improved. Clinical verifications prove that the composition is remarkable in clinical treatment effect, good in taste and free of toxic or side effect and can be accepted by patients easily.

Description

A kind of probiotics fermention Chinese medicine composition treating pulmonary carcinoma and preparation method thereof
Technical field
The present invention relates to a kind of probiotics fermention Chinese medicine composition treating pulmonary carcinoma and preparation method thereof, belong to pharmaceutical technology field.
Background technology
Pulmonary carcinoma is one of malignant tumor of serious harm human health, and in recent decades, its sickness rate and mortality rate are always in rising trend, is the cancer that current whole world M & M is the highest. TCM Therapy is the characteristic of China's treatment pulmonary carcinoma, in recent years application differentiation of tcm treatment pulmonary carcinoma, stable focus, extend life span, improve life quality etc. in there is advantage. How to improve the clinical efficacy of Chinese medicine on this basis further, also have the problem of many worth researchs.
Microecology is that postgraduate's object normal microflora and its host interdepend, mutually restrict the science of rule. Microecosystem is defined as by famous microecology expert professor Kang Bai of China: microecosystem refers in the space of a fixed structure, normal microflora is with the tissue of its host and cell and metabolite thereof for environment, and what formed in long-term evolutionary process can independently carry out the unified biosystem that material, energy and information exchange mutually. Intestinal microecology is the microecosystem that human body is maximum, it is believed that be human body one important " organ ", participates in the metabolism of human body, health plays vital effect. When intestinal microbial population is in health status, maintain human body various functions, its mechanism can be summarized as following some: nutrition facilitation, participate in the hypertrophy of intestinal mucosa, immunization etc. When intestinal flora imbalance, pathogenic bacterium will grow in a large number, causes that intestinal mucosa is coarse, blood circulation is not smooth, produces a large amount of harmful substance, gastrointestinal peristalsis exception and cause the intrusion of pathogen. Have been demonstrated that intestinal flora imbalance is relevant with multiple diseases such as cancers.
In a nearly century, the research of probiotic bacteria is got more and more by people, more and more deep, and research finds that probiotic bacteria is useful to health. Probiotic bacteria can produce beta galactosidase catalysing lactose decompose, alleviate lactose intolerance, moreover it is possible to promote the nutrient substance such as protein and calcium absorption, part probiotic bacteria can synthetic vitamin B and folic acid, play the effect of nutrition body.Probiotic bacteria produces substantial amounts of organic acid in reproductive process, stimulates intestinal wall to wriggle, increases gastric motility. Probiotic bacteria can produce bacteriocin and the increment of other metabolite suppression pathogenic bacterium, maintains the balance of intestinal microecology, keeps the physiological functions such as the normal nutrition of host, immunity, digestion.
Chinese medicine decoction is the organic conception using theory of Chinese medical science, determination for the treatment of based on pathogenesis obtained through differentiation of symptoms and signs, determined curative effect. But, the mouthfeel of Chinese medicine decoction is pained, and most people is difficult to accept, and particularly patient is because being more difficult to hypopharynx when loss of appetite after radiotherapy, chemotherapy. And patient exists the imbalance of intestinal microbial population more so that drug absorption weakens, even cannot absorb.
Summary of the invention
For overcoming the deficiencies in the prior art, the present invention, on the basis of Chinese medicine decoction, uses probiotics fermention technology, a kind of fermented type anti-lung-cancer medicament of preparation.
Herb fermenting technological development original new drug is utilized to become the study hotspot of the new trend of world today's medicament research and development, international medicine academia. Herb fermenting technology is to inherit on the basis of science of Chinese drug processing fermentation method, drawing Microecology achievement, the high-tech herbal pharmaceutical new technique formed in conjunction with Modern microbiological engineering.
It is an object of the present invention to provide a kind of probiotics fermention Chinese medicine composition treating pulmonary carcinoma. Technical scheme is as follows:
A kind of probiotics fermention Chinese medicine composition treating pulmonary carcinoma, the composition of described Chinese medicine compound and content is: in every 1000ml probiotics fermention Chinese medicine composition containing: Radix Ophiopogonis 16~60g, Radix Panacis Quinquefolii 4~36g, Bulbus Lilii 12~48g, the Radix Astragali 16~60g, Carapax Trionycis (processed) 12~48g, Pumex 36~72g, Herba Solani Lyrati 0~64g, Rhizoma Bolbostematis 16~60g, Herba Houttuyniae 24~72g, Pericarpium Citri Reticulatae 12~48g, honey Radix Asteris 12~48g, honey Flos Farfarae 12~48g, Semen Armeniacae Amarum 0~48g, Radix Glycyrrhizae 4~16g; After above-mentioned Chinese medicine compound boiling, concentration, add or without glucose, yeast powder, yeast extract and peptone, add inorganic salt, add or without sucrose and sucralose, prepare via probiotics fermention;
Described probiotic bacteria is bacillus bifidus and lactobacillus.
A kind of preferred scheme, the composition of described Chinese medicine compound and content is: in every 1000ml probiotics fermentation-type anti-lung cancer mixture containing: Radix Ophiopogonis 36g, Radix Panacis Quinquefolii 8g, Bulbus Lilii 24g, Radix Astragali 36g, Carapax Trionycis (processed) 20g, Pumex 60g, Rhizoma Bolbostematis 36g, Herba Houttuyniae 40g, Pericarpium Citri Reticulatae 20g, honey Radix Asteris 24g, honey Flos Farfarae 24g, Radix Glycyrrhizae 4g.
The preparation method step of the probiotics fermention Chinese medicine composition of described treatment pulmonary carcinoma is as follows:
A. herbal mixture is taken, boiling secondary, 1.0~2.0 hours first times, second time 1.0~2.0 hours, collecting decoction, filter, filtrate reduced in volume is 1.01~1.10 to measuring relative density at 50 DEG C;
B. above-mentioned concentrated solution add percent by volume be 0~1.5% glucose, percent by volume be 0~0.2% yeast powder, percent by volume be 0~0.4% yeast extract, percent by volume be 0~0.5% peptone, inorganic salt (FeSO4·7H2O1.0mg/100ml、ZnSO4·7H2O4.4mg/100ml、MgSO4·7H2O70mg/100ml、KH2PO4100mg/100ml、K2HPO4·3H2O100mg/100ml), percent by volume be 0~10% sucrose, percent by volume be the sucralose of 0~0.03%, adjust pH7.0 ± 0.5, and at 110~121 DEG C sterilizing 30~60 minutes, when temperature is down to about 39 DEG C, inoculate the bacterium solution of a kind of of pre-incubated percent by volume each 0.2~1.0% or two kinds of bacillus bifiduss, cellar culture 2~6 hours, inoculate the bacterium solution of two kinds or three kinds lactobacilluss of pre-incubated percent by volume each 0.2~1.0%, then proceed to fermentation 12~42 hours, terminate fermentation when pH is down to below 4.2;
C. stabilizing treatment, aseptic subpackaged and get final product; Or be centrifuged or filter or Cryoprecipitation, add or without preservative, add purified water constant volume, subpackage, sterilizing, obtain the probiotics fermention Chinese medicine composition of described treatment pulmonary carcinoma;
The mode of the inoculation described in preparation method step b is alternatively the bacterium solution of two kinds or three kinds lactobacilluss of the bacterium solution simultaneously inoculating a kind of of pre-incubated percent by volume each 0.2~1.0% or two kinds of bacillus bifiduss and pre-incubated percent by volume each 0.2~1.0%; The time of described fermentation is normal fermentation 16~48 hours, terminates fermentation when pH is down to below 4.2.
Bacillus bifidus described in preparation method step b is selected from bifidobacterium bifidum, bifidobacterium breve, bifidobacterium longum, animal bifidobacteria, bifidobacterium adolescentis and bifidobacteria infantis; Described lactobacillus is selected from bacillus acidophilus, Deshi Lactobacillus, Lactobacillus plantarum, Lactobacillus crispatus, lactobacillus helveticus, Lactobacillus salivarius, form lactobacillus, Lactobacillus johnsonii, Lactobacillus paracasei, Lactobacillus fermenti, lactobacillus casei and lactobacillus rhamnosus.
Strain derives from China typical culture collection center (CCTCC) (China, Wuhan) or China General Microbiological culture presevation administrative center (CGMCC) (China, Beijing) or separate from the feces or intestinal submucosa tissue of normal person and obtain these bacterial isolateses.
In the present invention, this probiotics fermention Chinese medicine composition is commonly referred to as fermented type anti-lung cancer mixture, and this medication effect is notable, has no side effect, and mouthfeel is good.
Chinese medicine compound of the present invention uses the organic conception of theory of Chinese medical science, determination for the treatment of based on pathogenesis obtained through differentiation of symptoms and signs, wherein holds concurrently clear asthenic fire with nourishing lung-YIN Radix Ophiopogonis, and Radix Panacis Quinquefolii boosting qi and nourishing yin, clearing away heat and promoting production of body fluid, be monarch drug altogether. It is aided with Bulbus Lilii clearing away lung-heat and moistening for dryness, cough-relieving, Radix Astragali QI invigorating invigorating middle warmer, detumescence poison holding, the salty-cold softening the hard mass of Pumex, the old expectorant of kindization, eliminating stagnation removing food stagnancy, Herba Solani Lyrati clearing away heat-damp and promoting diuresis, removing toxic substances and promoting subsidence of swelling, the salty-cold nourishing kidney of Carapax Trionycis, hard masses softening and resolving, Rhizoma Bolbostematis eliminating stagnation, detumescence, removing toxic substances, Herba Houttuyniae clearing heat, releasing toxin, removing swelling, is ministerial drug altogether. Assistant is with Pericarpium Citri Reticulatae, honey-fried RADIX ASTERIS, honey-fried FLOS FARFARAE, Semen Armeniacae Amarum activating QI to eliminate phlegm cough-relieving. Make with the raw gold of Radix Glycyrrhizae spleen invigorating, coordinating the actions of various ingredients in a prescription. Full side chemical combination is use, plays effect of moistening lung qi-benefitting yin nourishing, resolving phlegm and softening hard masses detumescence altogether.
The probiotic bacteria used in the present invention is bacillus bifidus and lactobacillus, and wherein bacillus bifidus is most important physiological antibacterial in people or mammal body, is distributed mainly on small intestinal bottom and colonic. Bacillus bifidus can directly or indirectly participate in the synthesis of vitamin B, nicotinic acid, folic acid and the water soluble vitamins except pantothenic acid, vitamin K in intestinal. Bacillus bifidus can substantially increase activity and the content of superoxide dismutase in blood (SOD), reduces the oxidation reaction that free radical participates in. Lactobacillus is the most commonly used probiotic bacteria of people's distribution in vivo, and in the gastrointestinal tract, this antibacterial is distributed mainly on widely different intestines. Tumor is had Immunotherapy by lactobacillus, its mechanism can be divided into following some: 1. lactobacillus can the balance of regulating intestinal canal flora, it is suppressed that the excessive multiplication of pathogenic bacterium, thus the carcinogenic precursor reducing its generation is converted into carcinogen and enters human body. 2. activating macrophage, NK cell, T cell, B cell etc. are thus improving body's immunity. 3. improve the secretion of splenocyte TNF B. 4. induce the generation of N0. 5. antimutagenic effect. 6. reverse regulation and control Bc-2, Bax gene expression.
The present invention selects the common probiotics strain such as bacillus bifidus, lactobacillus, is mainly based upon the overall popularity that they are distributed in human or animal's intestinal and the complementarity of they physiologically actives.
The present invention utilizes the antibacterial that human body is useful, fermented tcm water extract in vitro. On the one hand, in accordance with Chinese medical theory, remain the water extract whole part of Chinese medicine, maintain the characteristic of Chinese medicine decoction; On the other hand, Chinese medicine extract is through probiotics fermention, and some macromolecular substances are converted in vitro, it is easy to absorption of human body, heighten the effect of a treatment; And probiotic bacteria is during the fermentation, produces abundant flavor substance, improve the mouthfeel of Chinese medicine.
Generally, the qf oral administration dosage of the fermented type anti-lung cancer mixture of the present invention can according to disease to be treated or the character of pathological state, the order of severity, the age of patient, body weight, general health state, and patient is to factors such as the sensitivity of medicine used, toleration and administering modes, determines by clinician according to the principle of individuation.
According to clinical verification, the probiotics fermentation-type anti-lung cancer mixture clinical efficacy of the present invention is notable, and patient is prone to accept.
Detailed description of the invention
Embodiment 1: the preparation of probiotics fermentation-type anti-lung cancer mixture A
Press column weight amount and weigh each Chinese medicine ingredients: Radix Ophiopogonis 36g, Radix Panacis Quinquefolii 8g, Bulbus Lilii 24g, Radix Astragali 36g, Carapax Trionycis (processed) 20g, Pumex 60g, Rhizoma Bolbostematis 36g, Herba Houttuyniae 40g, Pericarpium Citri Reticulatae 20g, honey Radix Asteris 24g, honey Flos Farfarae 24g, Radix Glycyrrhizae 4g. Above Chinese medicine, boiling secondary, 1.5 hours first times, second time is 1.0 hours, collecting decoction, filtering, filtrate reduced in volume is 1.02~1.08 to measuring relative density at 50 DEG C, add glucose that percent by volume is 0.7%, percent by volume be 0.1% yeast powder, inorganic salt (FeSO4·7H2O1.0mg/100ml、ZnSO4·7H2O4.4mg/100ml、MgSO4·7H2O70mg/100ml、KH2PO4100mg/100ml、K2HPO4·3H2O100mg/100ml), percent by volume is the sucrose of 3.0%, percent by volume is the sucralose of 0.015%, adjust pH6.8, it is settled to 1000ml, and at 115 DEG C after sterilizing 40 minutes, when temperature is down to about 39 DEG C, inoculate bifidobacterium bifidum (normal human's separation of pre-incubated percent by volume each 0.5%, identify through Institute of Microorganism, Academia Sinica) and the bacterium solution of bifidobacterium breve (AS1.2213), cultivate after about 6 hours for 37 DEG C, inoculate the bacillus acidophilus (AS1.1854) of percent by volume each 0.5%, the bacterium solution of Lactobacillus plantarum (AS1.19) and Deshi Lactobacillus (AS1.1480), 16 hours detection pH value of 37 DEG C of fermentations, fermentation is terminated when pH value is down to below 4.2, stabilizing treatment, aseptic subpackaged, obtain.
Embodiment 2: the preparation of probiotics fermentation-type anti-lung cancer mixture B
Press column weight amount and weigh each Chinese medicine ingredients: Radix Ophiopogonis 16g, Radix Panacis Quinquefolii 24g, Bulbus Lilii 12g, Radix Astragali 16g, Carapax Trionycis (processed) 36g, Pumex 36g, Herba Solani Lyrati 24g, Rhizoma Bolbostematis 16g, Herba Houttuyniae 24g, Pericarpium Citri Reticulatae 16g, honey Radix Asteris 36g, honey Flos Farfarae 36g, Radix Glycyrrhizae 8g. Above Chinese medicine, boiling secondary, 1.0 hours first times, second time is 1.0 hours, collecting decoction, filtering, filtrate reduced in volume is 1.01~1.06 to measuring relative density at 50 DEG C, add glucose that percent by volume is 1.0%, yeast extract that yeast powder that percent by volume is 0.2%, percent by volume are 0.2%, percent by volume be 0.5% peptone, inorganic salt (FeSO4·7H2O1.0mg/100ml、ZnSO4·7H2O4.4mg/100ml、MgSO4·7H2O70mg/100ml、KH2PO4100mg/100ml、K2HPO4·3H2O), percent by volume is the sucrose of 10%, adjust pH7.2, and at 121 DEG C after sterilizing 30 minutes, when temperature is down to about 39 DEG C, inoculate the bacterium solution of the bifidobacterium longum (CICC6212) that pre-incubated percent by volume is 1.0% and the bacterium solution of the lactobacillus helveticus (CICC22816) of percent by volume each about 0.3% and Lactobacillus paracasei (CICC6236) simultaneously, 24 hours detection pH value of 37 DEG C of fermentations, fermentation is terminated when pH value is down to below 4.2, stabilizing treatment, filtering, filtrate adds water and is settled to 1000 milliliters, subpackage, sterilizing, to obtain final product.
Embodiment 3: the preparation of probiotics fermentation-type anti-lung cancer mixture C
Press column weight amount and weigh each Chinese medicine ingredients: Radix Ophiopogonis 60g, Radix Panacis Quinquefolii 36g, Bulbus Lilii 48g, Radix Astragali 60g, Carapax Trionycis (processed) 48g, Pumex 36g, Rhizoma Bolbostematis 60g, Herba Houttuyniae 60g, Pericarpium Citri Reticulatae 48g, honey Radix Asteris 48g, honey Flos Farfarae 48g, Semen Armeniacae Amarum 24g, Radix Glycyrrhizae 16g.
Above Chinese medicine, boiling secondary, 2.0 hours first times, second time is 2.0 hours, collecting decoction, filters, and filtrate reduced in volume is 1.03~1.10 to measuring relative density at 50 DEG C, adds inorganic salt (FeSO4·7H2O1.0mg/100ml、ZnSO4·7H2O4.4mg/100ml、MgSO4·7H2O70mg/100ml、KH2PO4100mg/100ml、K2HPO4·3H2O), percent by volume is the sucralose of 0.03%, adjust pH7.5, and at 110 DEG C after sterilizing 60 minutes, when temperature is down to about 39 DEG C, inoculating pre-incubated percent by volume is respectively the animal bifidobacteria (CICC6165) of 1.0%, the bacterium solution of bifidobacterium adolescentis (CICC6176), cultivate after about 2 hours for 37 DEG C, inoculate the Lactobacillus salivarius (CICC23175) of percent by volume each about 0.5% and the bacterium solution of lactobacillus rhamnosus (CICC6163), 30 hours detection pH value of 37 DEG C of fermentations, fermentation is terminated when pH value is down to below 4.2, stabilizing treatment, centrifugal, supernatant adds 0.2% sodium benzoate, add water and be settled to 1000 milliliters, subpackage, sterilizing, obtain.
Experimental example: clinical verification
1, trial drug: be respectively prepared probiotics fermentation-type anti-lung cancer mixture A, B, C that specification is 250ml/ bottle by embodiment 1, embodiment 2, embodiment 3, and press the above formula preparation Chinese medicine compound decoction without probiotics fermention, it is concentrated into same concentrations respectively, making specification is 250ml/ bottle, as control sample decoction a, b, the c of not fermenting.
2, instructions of taking: oral, every day 1 bottle, divides and takes for 2 times. Surrounding is a course for the treatment of, and two courses for the treatment of are a cycle observe indices.
3, case is included in: 120 example deficiency of both QI and YIN, expectorant heat stop up junction type patients with lung cancer. Case is grouped, and according to checking result, the similar person of the state of an illness is distributed evenly over same prescription fermented type mixture group and does not ferment in decoction group, makes case have comparability as far as possible. It is the patient of pulmonary carcinoma through x-ray or CT diagnosis and meets following condition person, all can include test case in.
1) cytopathology turns out to be primary lung cancer (scale cancer, adenocarcinoma, large cell carcinoma, small cell carcinoma);
2) tcm clinical practice syndrome standard person is met;
3) II phase Patients With Primary Lung Cancer of inoperable II~IV phase or refusal operation;
4) the middle and advanced stage patient that pulmonary carcinoma is postoperative or chemicotherapy is postoperative.
4, observation index: the indexs such as main detection body weight, health status, relevant immunity, tumor size, tcm syndrome (cough, expectorant blood, out of breath, chest pain, heating, spiritlessness and weakness, inappetence, spontaneous perspiration or night sweat etc.) change after treating.
5, experimental result:
1) body weight change
Body weight increases with the body weight before and after treating or minimizing compares, and reflects the quality of life of patient. All after terminating the course for the treatment of relatively before treatment body weight increase or reduce lkg as " increases " or " decline ", increase or minimizing are " stablizing " not less than lkg person, refer to table 1.
The change of body weight before and after table 1 treatment
From result shown in table 1 it can be seen that fermented type anti-lung cancer mixture provided by the invention can significantly improve patients ' life quality. Compare curative effect with unleavened identical prescription decoction to significantly improve, illustrate that preparation method of the present invention enhances the clinical efficacy of Chinese medicine compound in improving patients ' life quality.
2) Evaluation of Immunity
The change of immunologic function, to treat front and back index rising or to reduce by 10% for " rising " and " reduction ", " rising " and " reduction " are " stablizing " less than 10%.
In view of there is no clearer and more definite unified curative effect estimation standard both at home and abroad at present, we study regulation, compare with data before treatment with each patient data of immune detection result before and after treatment, as judging rising, the curative effect estimation standard declined.
Natural killer cell activity change (NK cell). Refer to table 2.
NK rising number of cases after table 2 treatment
The change of T lymphocyte and subgroup. In Table 3.
Before and after table 3 treatment, CD4/CD8 ratio raises number of cases
From result shown in table 2, table 3 it can be seen that fermented type anti-lung cancer mixture provided by the invention can significantly improve patient immune function. Compare curative effect with unleavened identical prescription decoction to significantly improve, illustrate that preparation method of the present invention enhances the clinical efficacy of described Chinese medicine compound in improving immunity.
3) the objective efficacy evaluation of tumor
According to Ministry of Public Health " China's common cancer diagnosis and treatment specification " the 6th fascicle primary bronchogenic carcinoma of lung chemotherapeutic efficacy evaluation criteria.
Remission rate: in CT sheet, longest diameter of tumor be multiplied by before vertical diameter is relatively treated to reduce more than 50% is effective, and less than 50% is invalid, can be divided into again according to degree of absorption: 1. CR: through X-ray film and fibre bronchus mirror, the whole absorber of focus; 2. PR: focus reduces >=50%; 3. stable (SD) focus reduces less than 25% or increases less than 25%. 4. PD:(progress) focus relatively treat before expand 25%. Therapeutic evaluation is done after two cycle therapy. Effective percentage=(CR+PR).
Comparing with rabat before and after patient treatment or CT, through 1. complete incidence graph (CR), 2. partial rcsponse (PR), 3. stably (SD), 4. progress (PD) carry out efficacy evaluation, in Table 4.
Cancer change after table 4 treatment
From result shown in table 4 it can be seen that fermented type anti-lung cancer mixture provided by the invention can significantly reduce patient's cancer. Compare curative effect with unleavened identical prescription decoction to significantly improve, illustrate that preparation method of the present invention enhances the clinical efficacy of described Chinese medicine compound.
4) tcm syndrome curative effect
The traditional Chinese medical science is with organic conception, determination for the treatment of based on pathogenesis obtained through differentiation of symptoms and signs for feature, and tcm syndrome improves the important evidence being to embody clinical efficacy. Curative effect determinate standard: formulate in conjunction with clinical practice with reference to according to " new Chinese medicine guideline of clinical investigations ". Therapeutic index (n)=(before treating integration after integration-treatment)/treat front integration × 100%. Evaluation methodology: according to symptom integral change before and after treatment, the curative effect of the symptom state of an illness is represented with score value × 100% before (after treatment score value before score value-treatment)/treatment, it is effective that score value declines be more than or equal to 70%, score value declines be more than or equal to 30%, being effectively less than 70%, score value is dropped by less than 30% for invalid.
Tcm syndrome change refers to table 5,6
Disease curative effect before and after the treatment of table 5 fermented type anti-lung cancer mixture
Table 6 does not ferment and compares disease curative effect before and after decoction treatment
From result shown in table 5,6 it can be seen that fermented type anti-lung cancer mixture provided by the invention can significantly improve patient's tcm syndrome. Compare curative effect with unleavened identical prescription decoction to significantly improve, illustrate that preparation method of the present invention enhances the clinical efficacy of described Chinese medicine compound.

Claims (10)

1. the probiotics fermention Chinese medicine composition treating pulmonary carcinoma, it is characterized in that, the composition of described Chinese medicine and content is: in every 1000ml probiotics fermention Chinese medicine composition containing: Radix Ophiopogonis 16~60g, Radix Panacis Quinquefolii 4~36g, Bulbus Lilii 12~48g, the Radix Astragali 16~60g, Carapax Trionycis (processed) 12~48g, Pumex 36~72g, Herba Solani Lyrati 0~64g, Rhizoma Bolbostematis 16~60g, Herba Houttuyniae 24~72g, Pericarpium Citri Reticulatae 12~48g, honey Radix Asteris 12~48g, honey Flos Farfarae 12~48g, Semen Armeniacae Amarum 0~48g, Radix Glycyrrhizae 4~16g;After above-mentioned Chinese medicine compound boiling, concentration, add or without glucose, yeast powder, yeast extract and peptone, add inorganic salt, add or without sucrose and sucralose, prepare via probiotics fermention;
Described probiotic bacteria is bacillus bifidus and lactobacillus.
2. the probiotics fermention Chinese medicine composition for the treatment of pulmonary carcinoma according to claim 1, it is characterized in that, the composition of described Chinese medicine compound and content is: in every 1000ml probiotics fermentation-type anti-lung cancer mixture containing: Radix Ophiopogonis 36g, Radix Panacis Quinquefolii 8g, Bulbus Lilii 24g, Radix Astragali 36g, Carapax Trionycis (processed) 20g, Pumex 60g, Rhizoma Bolbostematis 36g, Herba Houttuyniae 40g, Pericarpium Citri Reticulatae 20g, honey Radix Asteris 24g, honey Flos Farfarae 24g, Radix Glycyrrhizae 4g.
3. the probiotics fermention Chinese medicine composition for the treatment of pulmonary carcinoma according to claim 1, it is characterized in that, the addition of described glucose be percent by volume 0~1.5%, described yeast powder addition be percent by volume 0~0.2%, described yeast extract addition be percent by volume 0~0.4%, described peptone addition be percent by volume 0~0.5%.
4. the probiotics fermention Chinese medicine composition for the treatment of pulmonary carcinoma according to claim 1, it is characterised in that described inorganic salt is FeSO4·7H2O1.0mg/100ml、ZnSO4·7H2O4.4mg/100ml、MgSO4·7H2O70mg/100ml、KH2PO4100mg/100ml、K2HPO4·3H2O100mg/100ml。
5. the probiotics fermention Chinese medicine composition for the treatment of pulmonary carcinoma according to claim 1, it is characterised in that the addition of described sucrose be percent by volume 0~10%, described sucralose addition be percent by volume 0~0.03%.
6. the probiotics fermention Chinese medicine composition of the treatment pulmonary carcinoma according to any one of claim 1-5, it is characterized in that, described bacillus bifidus is selected from bifidobacterium bifidum, bifidobacterium breve, bifidobacterium longum, animal bifidobacteria, bifidobacterium adolescentis and bifidobacteria infantis; Described lactobacillus is selected from bacillus acidophilus, Deshi Lactobacillus, Lactobacillus plantarum, Lactobacillus crispatus, lactobacillus helveticus, Lactobacillus salivarius, form lactobacillus, Lactobacillus johnsonii, Lactobacillus paracasei, Lactobacillus fermenti, lactobacillus casei and lactobacillus rhamnosus.
7. the preparation method of the probiotics fermention Chinese medicine composition of the treatment pulmonary carcinoma described in claim 1-6, it is characterised in that preparation method step is as follows:
A. herbal mixture is taken, boiling secondary, 1.0~2.0 hours first times, second time 1.0~2.0 hours, collecting decoction, filter, filtrate reduced in volume is 1.01~1.10 to measuring relative density at 50 DEG C, obtains concentrated solution;
B. sucrose, percent by volume that peptone that yeast extract that above-mentioned concentrated solution adds glucose that percent by volume is 0~1.5%, percent by volume is 0~0.2% yeast powder, percent by volume are 0~0.4%, percent by volume are 0~0.5%, inorganic salt, percent by volume are 0~10% are the sucralose of 0~0.03%, adjust pH7.0 ± 0.5, and at 110~121 DEG C sterilizing 30~60 minutes;
C. when temperature is down to 39 DEG C, inoculate the bacterium solution of a kind of of pre-incubated percent by volume each 0.2~1.0% or two kinds of bacillus bifiduss, cellar culture 2~6 hours, inoculate the bacterium solution of two kinds or three kinds lactobacilluss of pre-incubated percent by volume each 0.2~1.0%, then proceed to fermentation 12~42 hours, terminate fermentation when pH is down to below 4.2;
D. stabilizing treatment, aseptic subpackaged: centrifugal or filtration or Cryoprecipitation, add or without preservative, add purified water constant volume, subpackage, sterilizing, obtain the probiotics fermention Chinese medicine composition of described treatment pulmonary carcinoma.
8. the preparation method of the probiotics fermention Chinese medicine composition for the treatment of pulmonary carcinoma according to claim 7, it is characterised in that the inorganic salt described in step b is FeSO4·7H2O1.0mg/100ml、ZnSO4·7H2O4.4mg/100ml、MgSO4·7H2O70mg/100ml、KH2PO4100mg/100ml、K2HPO4·3H2O100mg/100ml。
9. the preparation method of the probiotics fermention Chinese medicine composition for the treatment of pulmonary carcinoma according to claim 7, it is characterized in that, the mode of the inoculation described in step c is the bacterium solution of two kinds or the three kinds lactobacilluss simultaneously inoculating the bacterium solution of a kind of of pre-incubated percent by volume each 0.2~1.0% or two kinds of bacillus bifiduss and pre-incubated percent by volume each 0.2~1.0%; The time of described fermentation is normal fermentation 16~48 hours, terminates fermentation when pH is down to below 4.2.
10. the preparation method of the probiotics fermention Chinese medicine composition of the treatment pulmonary carcinoma according to any one of claim 7-9, it is characterized in that, the bacillus bifidus described in step c is selected from bifidobacterium bifidum, bifidobacterium breve, bifidobacterium longum, animal bifidobacteria, bifidobacterium adolescentis and bifidobacteria infantis; Described lactobacillus is selected from bacillus acidophilus, Deshi Lactobacillus, Lactobacillus plantarum, Lactobacillus crispatus, lactobacillus helveticus, Lactobacillus salivarius, form lactobacillus, Lactobacillus johnsonii, Lactobacillus paracasei, Lactobacillus fermenti, lactobacillus casei and lactobacillus rhamnosus.
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