CN102641497B - Medicinal composition for treating gastrointestinal diseases - Google Patents
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- CN102641497B CN102641497B CN201210154337.9A CN201210154337A CN102641497B CN 102641497 B CN102641497 B CN 102641497B CN 201210154337 A CN201210154337 A CN 201210154337A CN 102641497 B CN102641497 B CN 102641497B
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- Micro-Organisms Or Cultivation Processes Thereof (AREA)
- Medicines Containing Plant Substances (AREA)
Abstract
The invention relates to a medicinal composition for treating gastrointestinal diseases, which contains the activity of cellulase. The composition adopts a secondary hedgehogt fungus culture prepared by a new process, namely the secondary hedgehogt fungus culture obtained by adopting aseptic culture, secondary culture, low-temperature drying and low-temperature sterilization, and then the secondary hedgehogt fungus culture is further combined with five traditional Chinese medicines for preparation. As the composition adopts the hedgehogt fungus culture prepared by the new process, the activity of the cellulase is retained, and the medicinal effects are improved.
Description
Technical field
The present invention relates to a kind of gastroenteropathy drug composition.
Background technology
HOUTOU JIANWEI LING is state-promulgated pharmacopoeia kind, and its function cures mainly and is: soothing liver-QI stomach function regulating, regulating QI to relieve pain.For incoordination between the liver and stomach, gastral cavilty distending pain over the hypochondrium, vomiting acid regurgitation; Chronic gastritis, gastric and duodenal ulcers belong to above-mentioned patient; It is a kind of specific drug for the treatment of gastropathy.Particularly have stronger inhibitory or killing effect to helicobacter pylori, long-term taking has certain preventive effect to digestive tract canceration, and can alleviate its symptom, has no side effect, and is the special medicine for the treatment of gastropathy in the market.
HOUTOU JIANWEI JIAONANG quality standard is recorded into " Chinese Pharmacopoeia " version in 2010, the HOUTOU JIANWEI JIAONANG prescription that pharmacopeia specifies is: Hericium erinaceus culture 160g, Endoconcha Sepiae 80g, vinegar Rhizoma Corydalis 40g, Radix Paeoniae Alba 40g, Rhizoma Cyperi (processed with vinegar) 40g, Radix Glycyrrhizae 40g, and production technology is: above Six-element, gets Hericium erinaceus culture 80g, decoct with water secondary, each 2 hours, filter, merging filtrate was evaporated in right amount, add remaining Hericium erinaceus culture, mixing, dry, pulverize into fine powder; The ground spices such as all the other Endoconcha Sepiaes are broken into fine powder, sieve, mix with upper fine powder and appropriate starch, sterilizing, incapsulate and make 1000, to obtain final product.
HOUTOU JIANWEI LING good effect, popularity are high, reputation good, market potential is large, and being a very distinctive product, is the product of biotechnology medicine and traditional medicine perfect adaptation, and primary raw material Hericium erinaceus culture has played important drug activity.
Hericium erinaceus culture is put down, sweet in the mouth, the sharp the five internal organs of energy are aid digestion, there is the curative effects such as antiulcer, anti-inflammatory, antitumor, defying age, hepatoprotective, blood sugar lowering, blood fat reducing and blood pressure lowering, and there is the effects such as suppressing and killing helicobacter pylori, staphylococcus aureus, escherichia coli, medical value is high, and market uses potentiality large.
Hericium erinaceus culture rich cellulose enzyme, and cellulase acts on digestive tract, play biocatalysis when decomposition of cellulose, can digestive tract environment be improved, increase acidity, activate pepsin, increase gastrointestinal enzyme secretory volume and activity, reduce alimentary canal content viscosity, be conducive to gastrointestinal tract digesting and assimilating food, can be used for the symptoms such as abdominal distention, indigestion, inappetence by other Chinese medicine of compatibility, the power of its vigor is directly connected to the curative effect of product.As a kind of compound protein, the performance of its stability and activity is subject to the impact of several factors, how to keep active constant before and after sterilizing, becomes critical core technology.
But HOUTOU JIANWEI LING is according to existing production technology, its curative effect does not reach best, the cellulase that the bioactive substance of Hericium erinaceus culture is particularly protein-based, through moist heat sterilization, high-temperature heating and being inactivated, thus also need to further improve, to reach optimum efficiency.By detecting, in Hericium erinaceus culture, carboxymethylcelluloenzyme enzyme activity is 133U/g, and in secondary Hericium erinaceus culture, carboxymethylcelluloenzyme enzyme activity is 183U/g, and HOUTOU JIANWEI LING is produced rear cellulase activity by original production process and is almost 0.
Summary of the invention
In order to overcome the problem of the cellulase inactivation existed in prior art, the invention provides a kind of new gastroenteropathy drug composition, the cellulase activity in medicine is preserved to greatest extent.Pharmaceutical composition of the present invention, carboxymethylcelluloenzyme enzyme activity is 20 ~ 40U/g, effectively improves the curative effect of medicine.
The present invention realizes according to following technical scheme:
A kind of gastroenteropathy drug composition, wherein the acid CMCase activity of every 1 gram of finished product is not less than 20U.
Above-mentioned gastroenteropathy drug composition, wherein comprises secondary Hericium erinaceus culture, Endoconcha Sepiae, Radix Paeoniae Alba, vinegar Rhizoma Corydalis, Rhizoma Cyperi (processed with vinegar), Radix Glycyrrhizae, and described secondary Hericium erinaceus culture is adopted and prepared with the following method:
(1) aseptic culture: Hericium erinaceus culture is by medium sterilization, and cultivate 40-50 days under inoculation, aseptic condition in 100,000 grades of clean areas, temperature is 20 DEG C-30 DEG C, preventing pollution;
(2) second incubation: once cultivate after drawing bottle and namely obtain Hericium erinaceus culture, then proceed at culturing room cultivation 5-10 days in plastic bag, cultivation temperature is 20-30 DEG C, takes out;
(3) cold drying: dry under the condition of temperature more than 60 DEG C;
(4) low temperature sterilization: sterilizing under the condition of temperature more than 60 DEG C.
Above-mentioned gastroenteropathy drug composition, is not less than 150U/g containing acid carboxymethyl cellulose enzymatic activity in wherein said secondary Hericium erinaceus culture.
Above-mentioned gastroenteropathy drug composition, the step (3) of wherein said secondary Hericium erinaceus culture preparation method adopts microwave drying technology or vacuum and low temperature continuous drying technology.
Above-mentioned gastroenteropathy drug composition, the step (4) of wherein said secondary Hericium erinaceus culture preparation method adopts the one in Co60 radiation sterilization, ultra-vioket radiation sterilizing.
Above-mentioned gastroenteropathy drug composition, wherein the mass ratio of secondary Hericium erinaceus culture, Endoconcha Sepiae, Radix Paeoniae Alba, vinegar Rhizoma Corydalis, Rhizoma Cyperi (processed with vinegar), Radix Glycyrrhizae is 4: 2: 1: 1: 1.
Above-mentioned gastroenteropathy drug composition, wherein Endoconcha Sepiae, Radix Paeoniae Alba, vinegar Rhizoma Corydalis, Rhizoma Cyperi (processed with vinegar), Radix Glycyrrhizae are all through sterilization treatment.
Adopt product of the present invention, remain cellulase activity, improve drug effect.Specific as follows:
1, Chinese medicine composition cellulase activity of the present invention is high, and be applicable to gastroenteropathy, digestion promoting is made good use of, and is obviously different from other Chinese patent medicine products.Cellulase acts on digestive tract, can improve digestive tract environment, increases acidity, activate pepsin, increase gastrointestinal enzyme secretory volume and activity, reduce alimentary canal content viscosity, be conducive to gastrointestinal tract digesting and assimilating food, the power of its vigor is directly connected to the curative effect of product.
2, adopt vacuum and low temperature continuous drying technology, preserve active component.Hericium erinaceus culture contains enzyme, the bioactive ingredients such as protein and multiple volatile ingredient, belong to heat sensitivity medical material, add thermal lability inactivation, and it is high through extracting concentrated obtained extractum viscosity, not easily dry, how to keep dry, active constant before and after sterilizing, become critical technical barrier, adopt fully automatic vacuum low temperature continuous drying technology, both effective active component can be retained substantially, play the curative effect that medical material is best, make again Hericium erinaceus culture and extractum thereof fully dry, appearance luster is good, fully enclosed automatic simultaneously, there is certain bactericidal action.
3, the present invention adopts secondary solid fermentation culture medium, is more conducive to mycelium and changes into effective ingredient, which produces the change of matter, and drug effect is better, and planning secondary Hericium erinaceus culture precise expression is Hericium erinaceus (Bull. Ex Fr.) Pers. mycoplasma.After one time solid fermentation is cultivated, because of ischaemia in bottle, particularly bottle bottom part, mycelia is failed thorough for culture medium decomposition and inversion, and color is comparatively dark, in order to make the thorough bioconversion medium of mycelium, carries out second incubation.Once cultivate after drawing bottle, then proceed at culturing room's cultivation certain hour in plastic bag, take out, oven dry, to obtain final product.Compare by carrying out detection to Hericium erinaceus culture and secondary Hericium erinaceus culture, result is as follows:
Hericium erinaceus culture compares with the carboxymethylcelluloenzyme enzyme activity of secondary Hericium erinaceus culture
4, the aseptic docking mixing of medicated powder improves carboxymethylcelluloenzyme enzyme activity, heightens the effect of a treatment.Mixed powder is adopted 121 DEG C of steam sterilization process 30 minutes by the former technique of HOUTOU JIANWEI LING before preparation final molding, state-promulgated pharmacopoeia regulation is reached to make microbial limit, but high temperature long-time operation, the multiple effective substances such as volatile ingredient, enzyme and the protein in this special biological medicament mycoplasma of monarch drug Hericium erinaceus culture are destroyed, especially acid carboxymethyl cellulose enzyme activity, the curative effect having had a strong impact on HOUTOU JIANWEI LING plays.For this reason, adopt and the Hericium erinaceus culture obtained with aseptic culture after other medicated powder sterilization treatment such as Endoconcha Sepiae, the Radix Paeoniae Alba is directly carried out aseptic docking mix.Measure through inspection, result show the aseptic docking HOUTOU JIANWEI LING of medicated powder not only microbial limit meet state-promulgated pharmacopoeia relevant regulations, and acid carboxymethyl cellulose enzyme activity improves greatly.
Former technique HOUTOU JIANWEI LING compares with aseptic docking HOUTOU JIANWEI LING acid carboxymethyl cellulose enzyme activity
Acid carboxymethyl cellulose enzyme activity detection method is as follows:
The preparation of reference substance solution: the anhydrous glucose reference substance that is dried to constant weight of learning from else's experience 105 DEG C is appropriate, accurately weighed, adds water and makes the solution of every 1ml containing 1mg, to obtain final product.
The preparation of standard curve: precision measures reference substance solution 2.0ml, 4.0ml, 6.0ml, 8.0ml, 10.0ml, puts respectively in 10ml volumetric flask, respectively adds water to scale, shake up.Precision measures above-mentioned solution 1.5ml respectively, put in 25ml tool plug scale test tube, each precision adds pH4.8 citrate buffer 0.5ml, mixing, precision adds DNS reagent 1.5ml immediately, shake up, put in boiling water bath and be incubated 15 minutes, take out, rapid tap water cools 10 minutes, add water to scale again, shake up, leave standstill 1.5 hours, with corresponding reagent for blank, according to ultraviolet visible spectrophotometry (" Chinese Pharmacopoeia " version in 2010 annex V A), absorbance is measured at 540nm wavelength place, take absorbance as vertical coordinate, glucose amount is abscissa, drawing standard curve.
The preparation of need testing solution: get Hericium erinaceus culture or secondary Hericium erinaceus culture fine powder (crossing No. two sieves) about 2.0g, accurately weighed, put in tool plug conical flask, precision adds water 200ml, close plug, weighed weight, jolting 3 hours, more weighed weight, supply the weight of less loss with water, shake up, to obtain final product.This liquid should face uses brand-new.
Algoscopy: precision measures 1% carboxymethylcellulose sodium solution 1.5ml and puts in 25ml tool plug scale test tube, precision adds need testing solution 0.5ml, mixing, put in 50 DEG C of water-baths and be incubated 30 minutes, take out, the method under the preparation of sighting target directrix curve, from " precision adds DNS reagent 1.5ml immediately ", measure absorbance in accordance with the law, read the weight (mg) of reducing sugar in need testing solution from standard curve.Blank tube adds 1% carboxymethylcellulose sodium solution 1.5ml, puts in 50 DEG C of water-baths and is incubated 30 minutes, and take out, precision adds need testing solution 0.5ml, and mixing, the method under the preparation of sighting target directrix curve, from " precision adds DNS reagent 1.5ml immediately ", carries out in accordance with the law.Be calculated as follows:
U=A×1/0.5×n×2
U in formula---every 1g contains acid carboxymethyl cellulose enzyme activity unit, U/g;
The reducing sugar weight that A---absorbance checks on standard curve, mg;
N---diluted sample multiple;
2---time scale factor.
1g solid enzyme 50 ± 1 DEG C, under pH4.8 condition, 1 hour hydrolysis 1% sodium carboxymethyl cellulose substrate, producing the reducing sugar amount being equivalent to 1mg glucose is an acid carboxymethyl cellulose enzyme activity unit, represents with U/g.
In secondary Hericium erinaceus culture, every 1g acid carboxymethyl cellulose enzymatic activity should be not less than 150U, and in HOUTOU JIANWEI LING, every 1g acid carboxymethyl cellulose enzymatic activity should be not less than 20U.
Accompanying drawing explanation
1, Fig. 1 be in gastroenteropathy drug composition of the present invention enzymatic reaction temperature on the impact of enzyme activity determination.
Detailed description of the invention
Embodiment 1
1, aseptic culture: culture medium is by sterilizing, and cultivate 45 days under inoculation, aseptic condition in 100,000 grades of clean areas, temperature is 25 DEG C, preventing pollution;
2, second incubation: once cultivate after drawing bottle and namely obtain Hericium erinaceus culture, then proceed in plastic bag and cultivate 7 days in culturing room, cultivation temperature is 25 DEG C, takes out;
3, cold drying: be under the condition of 45 DEG C in temperature, adopts vacuum and low temperature continuous drying technology dry;
4, low temperature sterilization: be the mode sterilizing taking ultraviolet sterilization under the condition of 45 DEG C in temperature;
5, prepare clear paste: the secondary Hericium erinaceus culture 80 grams getting above-mentioned preparation, decocts with water, filter, filtrate reduced in volume becomes relative density to be 1.15(70 DEG C) clear paste;
6, powder is added: 80 grams, the clear paste of above-mentioned preparation and Endoconcha Sepiae powder, 40 grams, Radix Paeoniae Alba powder, vinegar Yanhusuo 40 grams, 40 grams, Rhizoma Cyperi (processed with vinegar) powder, 40 grams, Radix Glycyrrhizae powder are mixed homogeneously, dry, be ground into fine powder, sieve, sterilizing, add 80 grams, secondary Hericium erinaceus culture powder, mixing, incapsulates and makes 1000.
Claims (5)
1. a gastroenteropathy drug composition, is characterized in that comprising secondary Hericium erinaceus culture, Endoconcha Sepiae, Radix Paeoniae Alba, vinegar Rhizoma Corydalis, Rhizoma Cyperi (processed with vinegar), Radix Glycyrrhizae, and described secondary Hericium erinaceus culture is adopted and prepared with the following method:
(1) aseptic culture: Hericium erinaceus culture is by medium sterilization, and cultivate 40-50 days under inoculation, aseptic condition in 100,000 grades of clean areas, temperature is 20 DEG C-30 DEG C, preventing pollution;
(2) second incubation: once cultivate after drawing bottle and namely obtain Hericium erinaceus culture, then proceed at culturing room cultivation 5-10 days in plastic bag, cultivation temperature is 20-30 DEG C, takes out;
(3) cold drying: dry under the condition of temperature more than 60 DEG C;
(4) low temperature sterilization: sterilizing under the condition of temperature more than 60 DEG C;
20U is not less than containing acid carboxymethyl cellulose enzymatic activity in every 1 gram of finished product;
The mass ratio of secondary Hericium erinaceus culture, Endoconcha Sepiae, Radix Paeoniae Alba, vinegar Rhizoma Corydalis, Rhizoma Cyperi (processed with vinegar), Radix Glycyrrhizae is 4: 2: 1: 1: 1: 1.
2. gastroenteropathy drug composition as claimed in claim 1, is characterized in that being not less than 150U containing acid carboxymethyl cellulose enzymatic activity in described secondary Hericium erinaceus culture.
3. gastroenteropathy drug composition as claimed in claim 1, is characterized in that the step (3) of described secondary Hericium erinaceus culture preparation method adopts microwave drying technology or vacuum and low temperature continuous drying technology.
4. gastroenteropathy drug composition as claimed in claim 1, is characterized in that the step (4) of described secondary Hericium erinaceus culture preparation method adopts the one in Co60 radiation sterilization, ultra-vioket radiation sterilizing.
5. gastroenteropathy drug composition as claimed in claim 1, is characterized in that Endoconcha Sepiae, Radix Paeoniae Alba, vinegar Rhizoma Corydalis, Rhizoma Cyperi (processed with vinegar), Radix Glycyrrhizae are all through sterilization treatment.
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CN1736454A (en) * | 2004-08-19 | 2006-02-22 | 湖南新汇制药有限公司 | Process for preparing concentration type stomach-invigorating medicine of hericium erinaceus |
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CN1736454A (en) * | 2004-08-19 | 2006-02-22 | 湖南新汇制药有限公司 | Process for preparing concentration type stomach-invigorating medicine of hericium erinaceus |
CN1883634A (en) * | 2005-06-22 | 2006-12-27 | 湖南新汇制药有限公司 | Preparation process of stomach-caring Chinese medicine with monkey head mushroom |
CN101264202A (en) * | 2008-04-23 | 2008-09-17 | 湖南新汇制药有限公司 | Hericium erinaceus digestion-promoting Chinese medicinal composition and preparation thereof |
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