CN111184839A - Application of traditional Chinese medicine composition in preparation of medicine for treating intestinal dysbacteriosis - Google Patents
Application of traditional Chinese medicine composition in preparation of medicine for treating intestinal dysbacteriosis Download PDFInfo
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- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
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- A61K35/56—Materials from animals other than mammals
- A61K35/57—Birds; Materials from birds, e.g. eggs, feathers, egg white, egg yolk or endothelium corneum gigeriae galli
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- A61K36/06—Fungi, e.g. yeasts
- A61K36/07—Basidiomycota, e.g. Cryptococcus
- A61K36/074—Ganoderma
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- A61K36/28—Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
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- A61K2236/30—Extraction of the material
- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
- A61K2236/331—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation, decoction
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- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
- A61K2236/333—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using mixed solvents, e.g. 70% EtOH
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Abstract
The invention relates to the field of traditional Chinese medicines, and the traditional Chinese medicine composition for treating fatigue syndrome is prepared from the following raw materials, by weight, 120-360% of astragalus mongholicus, 100-300% of glossy privet fruit, 30-95% of ginseng, 30-95% of lucid ganoderma, 65-195% of curcuma zedoary, 30-90% of bighead atractylodes rhizome, 65-195% of barbed skullcap herb, 120-360% of gynostemma pentaphylla, 30-95% of poria cocos, 15-45% of endothelium corneum gigeriae galli, 65-195% of Indian mockstrawberry herb, 65-195% of solanum lyratum thunb, 65-195% of oriental wormwood, 65-195% of paniculate swallowwort root. The medicine can effectively treat the intestinal dysbacteriosis, and the test proves that the medicine has definite curative effect and better market prospect.
Description
Technical Field
The invention relates to a new application of a traditional Chinese medicine composition, in particular to an application of the traditional Chinese medicine composition in preparing a medicine for treating intestinal dysbacteriosis.
Background
The gastrointestinal tract of a healthy person is populated by a wide variety of microorganisms, which are referred to as intestinal flora. The intestinal flora is combined according to a certain proportion, the bacteria are restricted and dependent with each other, an ecological balance is formed on the quality and quantity, once the internal and external environments of the organism change, especially when the broad-spectrum antibiotics are applied for a long time, the sensitive intestinal flora is inhibited, and the bacteria which are not inhibited multiply by the organism, so that the flora imbalance is caused, the normal physiological combination of the sensitive intestinal flora is destroyed, the pathological combination is generated, and the clinical symptoms are called as the intestinal flora imbalance. The etiology of the symptoms is complex, and the symptoms mainly include: 1. dietary factors: the diet can cause the fecal flora to be obviously changed. Fiber-free foods promote bacterial translocation. The fiber can maintain normal metabolism and cell dynamics of intestinal mucosa cells. Dietary fiber reduces bacterial translocation but does not restore barrier function to normal. 2. Variable factors of flora: the flora composition may vary from individual to individual, but is quite stable for the same person over a significant period of time. The ecological status of each species is determined by the physiological state of the host, the interactions between bacteria and the environmental impact. 3. Metabolic factors of the drug: intestinal flora plays an important role in the metabolism of many drugs, including lactulose, azosulfapyridine salicylate, levodopa, etc. Any antibiotic can cause changes in intestinal flora depending on the antibiogram of the drug and its concentration in the intestinal lumen. Clindamycin and ampicillin are easy to cause dysbacteriosis, so that the drug-resistant clostridium difficile is propagated in large quantities to cause diseases, and antibiotic-associated diarrhea (pseudomembranous enteritis) is caused. The application of H2-receptor antagonists such as cimetidine can result in drug-induced gastric hyperacidity and proliferation of gastric bacteria. 4. Age factors: with the increase of age, the balance of intestinal flora can be changed, bifidobacteria are reduced, and the number of the clostridium perfringens is increased, wherein the former can weaken the stimulation of immune function, and the latter can cause the increase of toxin to inhibit the immunity. The elderly may have the ability to maintain intestinal flora balance in young people and improve immunity. 5. Gastrointestinal immune dysfunction: the normal immune function of the gastrointestinal tract is derived from plasma cells of the lamina propria of the mucosa, which produce large amounts of immunoglobulins, secretory IgA, the main substance of the gastrointestinal tract that prevents bacterial invasion. Once dysfunction of the synthetic monomeric or dimeric IgA or the synthetic secretory component of the gastrointestinal mucosa occurs, such that the secretory IgA of the gastrointestinal tract is deficient, the excessive reproduction of aerobic bacteria and anaerobic bacteria in the small intestine can be caused, thereby causing flora imbalance and chronic diarrhea. The intestinal flora may also multiply excessively in asymptomatic IgA-deficient patients. The incidence of dysbacteriosis is high in the neonatal period, and may be related to immature or incomplete development of the immune system.
Current methods of modulating flora treatment are: (1) dietary modification of fermentative diarrhea should limit carbohydrates; septic diarrhea should limit protein intake. Enhancing the local defense barrier function of intestinal mucosa, preventing bacterial translocation, and adding fiber food. (2) The antibiotic drug stops the original antibiotic immediately, and the appropriate antibiotic and the bacteria inhibiting excessive reproduction are selected according to flora analysis and antibiotic drug sensitivity test, so as to indirectly support the bacteria with insufficient intestinal reproduction. In addition, the broad-spectrum antibacterial medicine can be adopted to eliminate most of intestinal bacteria, and then the bacteria liquid of normal intestinal flora is filled in to recover the intestinal bacteria. (3) Probiotic preparations currently used are lactobacillus acidophilus, lactobacillus bulgaricus, lactobacillus lactis, lactobacillus sporogenes, bifidobacterium, streptococcus faecalis, escherichia coli, bacillus faecalis, bacillus subtilis and the like. The compound viable bacteria preparation can also be prepared from normal human excrement suspension, and can be used for treating pseudomembranous enteritis caused by clostridium difficile, and a better effect is achieved. (4) The oral prebiotic preparation can also achieve the purpose of supporting normal flora. Such as lactobacillus to promote the growth of enterobacteria and folic acid to promote the growth of enterobacteria. The application of galactose-fruit acid, which is decomposed by bacteria to form lactic acid or acetic acid, lowers pH, inhibits other bacteria, and supports growth of Lactobacillus. (5) Drug-resistant enterococcus preparations, such as Nippon mu et al, adopt a thickening subculture method to obtain streptococcus BIO-4R strains of enterococcus which are resistant to streptomycin, erythromycin, tetracycline and ampicillin. Animal and human in vivo experiments show that the bacterium has multiple antibiotic resistance, so that abnormal reproduction of other flora can be prevented, flora imbalance can be overcome, abnormal stool characteristics can be improved, the curative effect is quicker than that of the conventional antibiotic treatment, and the drug resistance factor of the streptococcus faecalis BIO-4R strain can be prevented from transferring to the Escherichia coli K-12 strain. (6) The traditional Chinese medicine of the traditional Chinese medicine is considered as follows: the root of diarrhea is not due to the spleen and stomach. Acute diarrhea is mostly predominant and is responsible for the spleen and stomach; chronic diarrhea is usually due to deficiency, and usually involves the spleen and kidney. The former should clear heat and resolve dampness, while the latter should tonify spleen and kidney.
The medicine can effectively treat the intestinal dysbacteriosis, and the test proves that the medicine has definite curative effect and better market prospect.
Disclosure of Invention
The invention relates to a new application of a traditional Chinese medicine composition, in particular to an application of the traditional Chinese medicine composition in preparing a medicine for treating intestinal dysbacteriosis.
The medicine for treating the fatigue syndrome is prepared from the following raw materials, by weight, 120-360% of astragalus root, 100-300% of glossy privet fruit, 30-95% of ginseng, 30-95% of lucid ganoderma, 65-195% of zedoary, 30-90% of bighead atractylodes rhizome, 65-195% of barbed skullcap herb, 120-360% of gynostemma pentaphylla, 30-95% of poria cocos, 15-45% of chicken's gizzard-membrane, 65-195% of Indian mockstrawberry herb, 65-195% of bittersweet herb, 65-195% of oriental wormwood herb, 65-195% of paniculate swallowwort root, 10-30% of ground beeltle and 65-195%.
Preferably, the traditional Chinese medicine composition is prepared from the following raw material medicines in parts by weight:
120 parts of astragalus membranaceus, 300 parts of glossy privet fruit, 30 parts of ginseng, 95 parts of lucid ganoderma, 65 parts of curcuma zedoary, 90 parts of bighead atractylodes rhizome, 65 parts of barbed skullcap herb, 360 parts of gynostemma pentaphylla, 30 parts of poria cocos, 45 parts of chicken's gizzard-membrane, 65 parts of Indian mockstrawberry herb, 195 parts of solanum lyratum, 65 parts of oriental wormwood, 195 parts of paniculate swallowwort root.
Or
360 parts of astragalus mongholicus, 100 parts of glossy privet fruit, 95 parts of ginseng, 30 parts of lucid ganoderma, 195 parts of curcuma zedoary, 30 parts of bighead atractylodes rhizome, 195 parts of barbed skullcap herb, 120 parts of gynostemma pentaphylla, 95 parts of poria cocos, 15 parts of chicken's gizzard-membrane, 195 parts of Indian mockstrawberry herb, 65 parts of bittersweet herb, 195 parts of oriental wormwood, 65 parts of paniculate swallowwort root.
Or
250 parts of astragalus membranaceus, 200 parts of glossy privet fruit, 65 parts of ginseng, 65 parts of lucid ganoderma, 132 parts of curcuma zedoary, 64 parts of bighead atractylodes rhizome, 128 parts of barbed skullcap herb, 256 parts of gynostemma pentaphylla, 65 parts of poria cocos, 30 parts of chicken's gizzard-membrane, 128 parts of Indian mockstrawberry herb, 128 parts of solanum lyratum bunge, 128 parts of oriental wormwood, 128 parts of paniculate swallowwort.
Preferably, the rhizoma atractylodis macrocephalae in the raw materials of the traditional Chinese medicine composition is fried rhizoma atractylodis macrocephalae.
The invention also provides an active ingredient of the traditional Chinese medicine composition, which is prepared by the following steps:
(1) weighing the traditional Chinese medicinal materials according to the weight proportion of the raw materials, and cleaning and selecting;
(2) extracting fructus Ligustri Lucidi and radix Ginseng with 6-10 times of 50-90% ethanol for 1-3 times (each for 1-4 hr), mixing extractive solutions, filtering, recovering ethanol from filtrate until no alcohol smell exists, and collecting filtrate and residue;
(3) extracting volatile oil from Curcumae rhizoma, Atractylodis rhizoma and radix Cynanchi Paniculati with 4-8 times of water, collecting volatile oil, and collecting residue and water solution;
(4) pulverizing Eupolyphaga Seu Steleophaga, endothelium corneum Gigeriae Galli, and Poria into fine powder;
(5) mixing radix astragali, Ganoderma, herba Hedyotidis Diffusae, herba Scutellariae Barbatae, herba Gynostemmatis, herba Duchesneae Indicae, herba Solani Lyrati, and herba Artemisiae Scopariae with the residue obtained in step (2) after ethanol extraction, and the residue obtained in step (3) after oil extraction of rhizoma Curcumae, rhizoma Atractylodis Macrocephalae, and radix Cynanchi Paniculati, adding 7-10 times of water, decocting for 1-3 times, 1-3 hr each time, mixing decoctions, adding the filtrate of radix Ginseng and fructus Ligustri Lucidi obtained in step (2) and the aqueous solution obtained in step (3), concentrating until the relative density of the medicinal liquid is 1.15-1.30 at 65 deg.C, drying, and pulverizing;
the crushed powder obtained in the step (4), the volatile oil obtained in the step (3) and the dry paste powder obtained in the step (5) jointly form the active ingredients of the traditional Chinese medicine composition.
The traditional Chinese medicines can be processed according to the national Chinese medicine processing standard or the Chinese medicine dictionary.
The medicament of the invention is in the form of capsules, tablets, powders, oral liquids, soft capsules, pills, tinctures, syrups, suppositories, gels, sprays or injections.
The preparation method of the capsule comprises the following steps:
(1) weighing the traditional Chinese medicinal materials according to the weight proportion of the raw materials, and cleaning and selecting;
(2) extracting Ginseng radix and fructus Ligustri Lucidi with 8 times of 70% ethanol under reflux for 2 times, 3 hr for the first time and 2 hr for the second time, mixing extractive solutions, recovering ethanol until no ethanol smell exists, and collecting filtrate and residues of Ginseng radix and fructus Ligustri Lucidi;
(3) mixing rhizoma Curcumae, rhizoma Atractylodis Macrocephalae, and radix Cynanchi Paniculati, extracting volatile oil for at least 8 hr, collecting volatile oil in another container, and collecting residue and water solution;
(4) washing two animal medicines including Eupolyphaga Seu Steleophaga and endothelium corneum Gigeriae Galli with water, oven drying at 60 deg.C, mixing with Poria, pulverizing into 100 mesh powder, and sterilizing;
(5) mixing radix astragali, Ganoderma, herba Hedyotidis Diffusae, herba Scutellariae Barbatae, herba Gynostemmatis, herba Duchesneae Indicae, herba Solani Lyrati, and herba Artemisiae Scopariae with the residue obtained in step (2) after ethanol extraction, and the residue obtained in step (3) after oil extraction of rhizoma Curcumae, rhizoma Atractylodis Macrocephalae, and radix Cynanchi Paniculati, adding 9 times of water, decocting for 2 times (2 hr for each time), mixing decoctions, adding the ethanol extractive solution of radix Ginseng and fructus Ligustri Lucidi obtained in step (2) and the aqueous solution obtained in step (3), concentrating into fluid extract with relative density of 1.20-1.25, drying, and pulverizing;
(6) adding a proper amount of filler into the dry paste powder obtained in the step (5), and granulating with 85% ethanol to obtain granules for later use;
(7) and (4) spraying the volatile oil obtained in the step (3) into the fine powder of the poria cocos, the ground beeltle and the endothelium corneum gigeriae galli obtained in the step (4), uniformly mixing the volatile oil with the particles obtained in the step (6), sealing for half an hour, and filling into capsules.
Other dosage forms of the medicament are prepared by a conventional preparation method after weighing raw material medicaments in proportion, for example, a preparation process recorded in Vanbitsin traditional Chinese medicine pharmacy (1 st 12 months in 1997 of Shanghai science publishers) to prepare pharmaceutically acceptable conventional dosage forms.
In order to make the above dosage forms possible, pharmaceutically acceptable excipients, such as: fillers, disintegrants, lubricants, suspending agents, binders, sweeteners, flavoring agents, preservatives, bases, and the like. The filler comprises: starch, pregelatinized starch, lactose, mannitol, chitin, microcrystalline cellulose, sucrose, etc.; the disintegrating agent comprises: starch, pregelatinized starch, microcrystalline cellulose, sodium carboxymethyl starch, crospolyvinylpyrrolidone, low-substituted hydroxypropylcellulose, croscarmellose sodium, etc.; the lubricant comprises: magnesium stearate, sodium lauryl sulfate, talc, silica, and the like; the suspending agent comprises: polyvinylpyrrolidone, microcrystalline cellulose, sucrose, agar, hydroxypropyl methylcellulose, and the like; the adhesive comprises starch slurry, polyvinylpyrrolidone, hydroxypropyl methylcellulose, etc.; the sweetener comprises: saccharin sodium, aspartame, sucrose, sodium cyclamate, glycyrrhetinic acid, and the like; the flavoring agent comprises: sweeteners and various essences; the preservative comprises: parabens, benzoic acid, sodium benzoate, sorbic acid and its salts, benzalkonium bromide, chloroacetidine acetate, eucalyptus oil, etc.; the matrix comprises: PEG6000, PEG4000, insect wax, etc. In order to realize the traditional Chinese medicine pharmacy, other pharmaceutically acceptable auxiliary materials (auxiliary materials recorded in each dosage form in the 12 th month and 1 st edition of Shanghai science Press 1997) are required to be added when preparing the dosage forms.
Preferably, the intestinal dysbacteriosis of the present invention is intestinal dysbacteriosis caused by a decrease in the number of bifidobacteria.
Preferably, the intestinal dysbacteriosis of the present invention is intestinal dysbacteriosis caused by reduction of the number of lactobacilli.
Preferably, the intestinal dysbacteriosis of the present invention is intestinal dysbacteriosis caused by an increase in the number of Escherichia coli and/or enterococcus.
The pharmaceutical composition has the effects of supplementing qi and nourishing yin, strengthening spleen and tonifying kidney, and eliminating stagnation and dredging collaterals, is clinically used for treating intestinal dysbacteriosis, and achieves good effects. The invention has reasonable compatibility, simple and easy operation, is a pure Chinese medicinal preparation, has small adverse reaction and can be used by patients for a long time.
Detailed Description
Example 1:
the formula of the raw material medicine is as follows: 250g of astragalus membranaceus, 200g of glossy privet fruit, 65g of ginseng, 65g of lucid ganoderma, 132g of curcuma zedoary, 64g of fried bighead atractylodes rhizome, 128g of barbed skullcap herb, 256g of gynostemma pentaphylla, 65g of poria cocos, 30g of chicken's gizzard-membrane, 128g of Indian mockstrawberry herb, 128g of solanum lyratum, 128g of oriental wormwood herb, 128g of paniculate swallowwort root, 20g of ground beetle and 128g of spreading hedyotis herb.
The preparation method comprises the following steps:
(1) weighing the traditional Chinese medicinal materials according to the weight proportion of the raw materials, and cleaning and selecting;
(2) extracting Ginseng radix and fructus Ligustri Lucidi with 8 times of 70% ethanol under reflux for 2 times, 3 hr for the first time and 2 hr for the second time, mixing extractive solutions, recovering ethanol until no ethanol smell exists, and collecting filtrate and residues of Ginseng radix and fructus Ligustri Lucidi;
(3) mixing rhizoma Curcumae, rhizoma Atractylodis Macrocephalae (parched) and radix Cynanchi Paniculati, extracting volatile oil for 8 hr, collecting volatile oil in another container, and collecting residue and water solution;
(4) washing Eupolyphaga Seu Steleophaga and endothelium corneum Gigeriae Galli with water, oven drying at 60 deg.C, mixing with Poria, pulverizing into 100 mesh powder, and sterilizing with 3KGY60CO-r radiation;
(5) mixing the astragalus membranaceus, lucid ganoderma, oldenlandia diffusa, barbat skullcap, gynostemma pentaphylla, Indian mockstrawberry herb, solanum lyratum thunb and virgate wormwood herb with the residues obtained in the step (2) after alcohol extraction of the ginseng and the glossy privet fruit and the residues obtained in the step (3) after oil extraction of the zedoary, the bighead atractylodes rhizome and the paniculate swallowwort root, adding 9 times of water, heating and decocting for 2 times for 2 hours each time, mixing decoction, adding the ethanol extract of the ginseng and the glossy privet fruit obtained in the step (2) and the aqueous solution obtained in the step (3), concentrating into clear paste with the relative density of 1.25, drying and crushing;
(6) adding 134 g of starch into the dry paste powder obtained in the step (5), and granulating with 85% ethanol;
(7) and (3) dissolving the volatile oil obtained in the step (3) by using 85% ethanol, spraying the dissolved volatile oil into the fine powder of the poria cocos, the ground beeltle and the endothelium corneum gigeriae galli obtained in the step (4), uniformly mixing the fine powder with the particles obtained in the step (6), sealing for half an hour, and filling the mixture into 1000 capsules to obtain the capsule.
Example 2:
the formula of the raw material medicine is as follows: 360g of astragalus, 100g of glossy privet fruit, 95g of ginseng, 30g of lucid ganoderma, 195g of curcuma zedoary, 30g of fried bighead atractylodes rhizome, 195g of barbed skullcap herb, 120g of gynostemma pentaphylla, 95g of poria cocos, 15g of chicken's gizzard-membrane, 195g of Indian mockstrawberry herb, 65g of solanum lyratum, 195g of oriental wormwood herb, 65g of paniculate swallowwort root, 30g of ground beetle and 65g of spreading hedyotis herb.
The preparation method comprises the following steps:
(1) weighing the traditional Chinese medicinal materials according to the weight proportion of the raw materials, and cleaning and selecting;
(2) extracting Ginseng radix and fructus Ligustri Lucidi with 6 times of 90% ethanol under reflux for 4 hr, recovering ethanol from the extractive solution until no alcohol smell exists, and mixing the filtrate with the residue of Ginseng radix and fructus Ligustri Lucidi;
(3) mixing Curcumae rhizoma, Atractylodis rhizoma (parched) and radix Cynanchi Paniculati, adding 4 times of water to extract volatile oil for 10 hr, collecting volatile oil in another container, and collecting residue and water solution;
(4) washing Eupolyphaga Seu Steleophaga and endothelium corneum Gigeriae Galli with water, oven drying at 60 deg.C, mixing with Poria, pulverizing into 100 mesh powder, and sterilizing with 3KGY60CO-r radiation;
(5) mixing radix astragali, Ganoderma, herba Hedyotidis Diffusae, herba Scutellariae Barbatae, herba Gynostemmatis, herba Duchesneae Indicae, herba Solani Lyrati, and herba Artemisiae Scopariae with the residue obtained in step (2) after ethanol extraction, and the residue obtained in step (3) after oil extraction of rhizoma Curcumae, rhizoma Atractylodis Macrocephalae, and radix Cynanchi Paniculati, adding 7 times of water, decocting for 3 times, 1 hr for the first time, 2 hr for the second time, and 3 hr for the third time, mixing decoctions, adding the ethanol extractive solution of radix Ginseng and fructus Ligustri Lucidi obtained in step (2) and the aqueous solution in step (3), concentrating into fluid extract with relative density of 1.15, drying, and pulverizing;
(6) adding 112 g of starch into the dry paste powder obtained in the step (5), and granulating with 78% ethanol;
(7) and (3) dissolving the volatile oil obtained in the step (3) by using 85% ethanol, spraying the volatile oil into the fine powder of the poria cocos, the ground beeltle and the endothelium corneum gigeriae galli obtained in the step (4), uniformly mixing the volatile oil with the granules obtained in the step (6), and preparing 1000 tablets according to a conventional preparation method.
Example 3:
the formula of the raw material medicine is as follows: 120g of astragalus, 300g of glossy privet fruit, 30g of ginseng, 95g of lucid ganoderma, 65g of curcuma zedoary, 90g of bighead atractylodes rhizome, 65g of barbed skullcap herb, 360g of gynostemma pentaphylla, 30g of poria cocos, 45g of chicken's gizzard-membrane, 65g of Indian mockstrawberry herb, 195g of solanum lyratum, 65g of oriental wormwood, 195g of paniculate swallowwort root, 10g of ground beetle and 195g of oldenlandia diffusa.
The preparation method comprises the following steps:
(1) weighing the traditional Chinese medicinal materials according to the weight proportion of the raw materials, and cleaning and selecting;
(2) reflux-extracting Ginseng radix and fructus Ligustri Lucidi with 10 times of 50% ethanol for 2 times, 3 hr for the first time and 2 hr for the second time, mixing extractive solutions, recovering ethanol until no ethanol smell exists, and collecting filtrate and residues of Ginseng radix and fructus Ligustri Lucidi;
(3) mixing Curcumae rhizoma, Atractylodis rhizoma and radix Cynanchi Paniculati, adding 10 times of water to extract volatile oil for 6 hr, collecting volatile oil in another container, and collecting residue and water solution;
(4) washing Eupolyphaga Seu Steleophaga and endothelium corneum Gigeriae Galli with water, oven drying at 60 deg.C, mixing with Poria, pulverizing into 100 mesh powder, and sterilizing with 3KGY60CO-r radiation;
(5) mixing the astragalus membranaceus, lucid ganoderma, oldenlandia diffusa, barbat skullcap, gynostemma pentaphylla, Indian mockstrawberry herb, solanum lyratum thunb and virgate wormwood herb with the residues obtained in the step (2) after alcohol extraction of the ginseng and the glossy privet fruit and the residues obtained in the step (3) after oil extraction of the zedoary, the bighead atractylodes rhizome and the paniculate swallowwort root, adding 10 times of water, heating and decocting for 3 hours, mixing decoction, adding the ethanol extract of the ginseng and the glossy privet fruit obtained in the step (2) and the aqueous solution obtained in the step (3), concentrating into clear paste with the relative density of 1.30, drying and crushing for;
(6) and (3) dissolving the volatile oil obtained in the step (3) with 80% ethanol, spraying into the fine powder of the poria cocos, the ground beeltle and the endothelium corneum gigeriae galli obtained in the step (4), uniformly mixing, mixing with the dry paste powder obtained in the step (5), and preparing into 1000 pills according to a conventional preparation method.
Experimental examples to confirm the efficacy of the drug of the present invention in the treatment of intestinal flora disorders, the following experimental studies were carried out using the capsules prepared in example 1:
with the development of micro-ecology and modern molecular biological detection technology, intestinal flora is becoming a focus of research of researchers in various subjects at home and abroad. The intestinal flora is not only various and large in quantity, but also strong in function, can affect the functions of metabolism, immunity, nutrition and the like of people, and many common diseases in clinic are related to intestinal flora imbalance, such as irritable bowel syndrome, obesity, diabetes and the like, so that for a human body, the intestinal flora is maintained in a balanced state, and the intestinal flora is an important link for ensuring the health of the human body. In addition, since the western medicines of liver injury and headache and foot pain are generally considered, the traditional Chinese medicine is mostly selected to regulate the intestinal tract, which promotes the exploration and development of the traditional Chinese medicine in the aspect of treating intestinal flora in recent years. In the process of years of clinical application, the medicine disclosed by the invention has the effects of enhancing the digestive metabolism, disease resistance, immunity and the like of a human body and is possibly related to the regulation of intestinal dysbacteriosis, so that relevant clinical researches are carried out, and the specific steps are as follows:
1. data and method
1.1 general data 70 patients with intestinal flora disturbance who were admitted to our hospital from 2017, month 1 to 2018, month 1 were selected as subjects. The subjects were randomly divided into the drug group of the present invention and the control group by the random number table method, and 35 cases were given to each group. The invention pharmaceutical group16 men and 19 women aged 18-65 years, with the average (36.5 + -8.6) years. The control group consisted of 18 men and 17 women aged 20-67 years, with the average (35.6. + -. 7.8) years. 2 general data comparison of subjects with no statistical significance (P>0.05), comparable. All the subjects were adult intestinal dysbacteriosis patients, and the primary patients with serious circulatory system, blood system, liver and kidney were excluded.
1.2 examination of intestinal flora and diagnosis of intestinal dysbacteriosis stool samples of 7-10 days after onset are collected by aseptic technique, inoculated to culture plates of Escherichia coli, enterococcus, lactobacillus and bifidobacterium, and cultured and counted respectively for aerobic bacteria and anaerobic bacteria. Diagnosis of gut flora disorders: sudden diarrhea or aggravation of the original diarrhea occurs, and staphylococcus, candida albicans, pseudomonas aeruginosa infection or other drug-resistant bacteria are cultured through excrement.
1.3 methods of treatment the pharmaceutical compositions of the present invention: the medicine of the invention (produced by Ling pharmaceutical products Co., Ltd.) is used for treatment, 4 pills per time and 3 times per day. Control group: the preparation is administered by using Bacillus subtilis dual viable bacteria enteric-coated capsule (produced by Beijing Korea medicine Co., Ltd.) 1 dose per time, 3 times per day. The treatment course is 1 week.
1.4 Observation index comparison of changes in Escherichia coli, enterococcus, Lactobacillus, and Bifidobacterium after 1 week of treatment in 2 groups of subjects.
2. Results after 1 week of treatment, the test subjects of the invention had significantly reduced amounts of E.coli and enterococcus, significantly increased amounts of Bifidobacterium and Lactobacillus, and statistical significance for the differences in the 2 groups (as compared to the control group) ((P<0.05), see table 1.
Claims (9)
1. The application of a traditional Chinese medicine composition in preparing a medicine for treating intestinal dysbacteriosis is characterized in that the medicine is prepared from the following raw materials in parts by weight: 120-360 parts of astragalus membranaceus, 100-300 parts of glossy privet fruit, 30-95 parts of ginseng, 30-95 parts of lucid ganoderma, 65-195 parts of curcuma zedoary, 30-90 parts of bighead atractylodes rhizome, 65-195 parts of barbed skullcap herb, 120-360 parts of gynostemma pentaphylla, 30-95 parts of poria cocos, 15-45 parts of chicken's gizzard-membrane, 65-195 parts of Indian mockstrawberry herb, 65-195 parts of solanum lyratum, 65-195 parts of oriental wormwood herb, 65-195 parts of paniculate swallowwort root, 10-30 parts of ground beetle.
2. The application of claim 1, wherein the medicament is prepared from the following raw material medicines, by weight, 120 parts of astragalus membranaceus, 300 parts of glossy privet fruit, 30 parts of ginseng, 95 parts of lucid ganoderma, 65 parts of curcuma zedoary, 90 parts of bighead atractylodes rhizome, 65 parts of barbed skullcap herb, 360 parts of gynostemma pentaphylla, 30 parts of poria cocos, 45 parts of chicken's gizzard-membrane, 65 parts of Indian mockstrawberry herb, 195 parts of solanum lyratum, 65 parts of oriental wormwood, 195 parts of paniculate swallowwort root, 10 parts.
3. The application of claim 1, wherein the medicament is prepared from the following raw material medicines, by weight, 360 parts of astragalus membranaceus, 100 parts of glossy privet fruit, 95 parts of ginseng, 30 parts of lucid ganoderma, 195 parts of curcuma zedoary, 30 parts of bighead atractylodes rhizome, 195 parts of barbed skullcap herb, 120 parts of gynostemma pentaphylla, 95 parts of poria cocos, 15 parts of chicken's gizzard-membrane, 195 parts of Indian mockstrawberry herb, 65 parts of solanum lyratum thunb, 195 parts of oriental wormwood, 65 parts of paniculate swallowwort root.
4. The application of claim 1, wherein the medicament is prepared from the following raw material medicines, by weight, 250 parts of astragalus membranaceus, 200 parts of glossy privet fruit, 65 parts of ginseng, 65 parts of lucid ganoderma, 132 parts of curcuma zedoary, 64 parts of bighead atractylodes rhizome, 128 parts of barbed skullcap herb, 256 parts of gynostemma pentaphylla, 65 parts of poria cocos, 30 parts of chicken's gizzard-membrane, 128 parts of Indian mockstrawberry herb, 128 parts of solanum lyratum, 128 parts of oriental wormwood, 128 parts of paniculate swallowwort root, 20 parts of.
5. The use according to any one of claims 1 to 4, wherein the medicament is in the form of capsules, tablets, powders, oral liquids, pills, tinctures, syrups, suppositories, gels, sprays or injections.
6. The use according to claim 5, wherein the capsule is prepared by the steps of:
(1) weighing the traditional Chinese medicinal materials according to the weight proportion of the raw materials, and cleaning and selecting;
(2) extracting Ginseng radix and fructus Ligustri Lucidi with 8 times of 70% ethanol under reflux for 2 times, 3 hr for the first time and 2 hr for the second time, mixing extractive solutions, recovering ethanol until no ethanol smell exists, and collecting filtrate and residues of Ginseng radix and fructus Ligustri Lucidi;
(3) mixing rhizoma Curcumae, rhizoma Atractylodis Macrocephalae, and radix Cynanchi Paniculati, extracting volatile oil for 6-12 hr, collecting volatile oil in another container, and collecting residue and water solution;
(4) washing two animal medicines including Eupolyphaga Seu Steleophaga and endothelium corneum Gigeriae Galli with water, oven drying at 60 deg.C, mixing with Poria, pulverizing into 100 mesh powder, and sterilizing to obtain fine powder;
(5) mixing radix astragali, Ganoderma, herba Hedyotidis Diffusae, herba Scutellariae Barbatae, herba Gynostemmatis, herba Duchesneae Indicae, herba Solani Lyrati, and herba Artemisiae Scopariae with the residue obtained in step (2) after ethanol extraction, and the residue obtained in step (3) after oil extraction of rhizoma Curcumae, rhizoma Atractylodis Macrocephalae, and radix Cynanchi Paniculati, adding 9 times of water, decocting for 2 times (2 hr for each time), mixing decoctions, adding the ethanol extractive solution of radix Ginseng and fructus Ligustri Lucidi obtained in step (2) and the aqueous solution obtained in step (3), concentrating into fluid extract with relative density of 1.20-1.25, drying, and pulverizing to obtain dry extract powder;
(6) adding a proper amount of filler into the dry paste powder obtained in the step (5), and granulating with 85% ethanol to obtain granules for later use;
(7) and (4) spraying the volatile oil obtained in the step (3) into the crushed fine powder obtained in the step (4), uniformly mixing with the granules obtained in the step (6), sealing for half an hour, and encapsulating to obtain the capsule.
7. The use according to any one of claims 1 to 4, wherein the gut dysbiosis is caused by a decreased number of bifidobacteria.
8. The use according to any one of claims 1 to 4, wherein the gut dysbiosis is caused by a reduced number of lactobacilli.
9. Use according to any one of claims 1 to 4, wherein the gut flora disorder is caused by an increased number of Escherichia coli and/or enterococcus bacteria.
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