CN103720718A - External biological bear gall powder and preparation method thereof - Google Patents
External biological bear gall powder and preparation method thereof Download PDFInfo
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- CN103720718A CN103720718A CN201210410213.2A CN201210410213A CN103720718A CN 103720718 A CN103720718 A CN 103720718A CN 201210410213 A CN201210410213 A CN 201210410213A CN 103720718 A CN103720718 A CN 103720718A
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Abstract
The invention provides an external biological bear gall powder and a preparation method thereof and belongs to the biological and biochemical field and the biomedical and biochemical field. The main effective ingredient of the external biological bear gall powder is 50-60% of sodium tauroursodeoxycholate, and the monomer content is not smaller than 97.0% and is more than 2 times the content of sodium tauroursodeoxycholate. The external biological bear gall powder can be also applied to the production and preparation of external biological bear gall powder for injection. According to the invention, the defects of poor content and appearance of bear gall powder artificially synthesized at present are overcome; the brutality of the drainage of bile powder from live bears and low and unbalanced content of the effective ingredient are avoided. The whole process is simple and safe in operation, low in cost and easy for industrial production; the external biological bear gall powder capable of equivalently replacing natural bear gall powder can be acquired.
Description
Technical field:
The present invention relates to a kind of external biological Fel Ursi powder and preparation method thereof, belong to biological biochemistry field and biology,drug and chemical industry field.
Background technology:
Fel Ursi and Fel Ursi powder are the dry gallbladder of ursidae animal black bear or brown bear.In China's clinical practice, have the history of more than 1000 year, the scope of application is very wide, relates to inside and outside, woman, youngster, oral cavity Deng Ge section, treatment 30 various diseases.There is the effects such as heat clearing away, suppressing the hyperactive liver, improving eyesight, analgesia, removing toxic substances, sterilization, nourishing the lung to arrest cough, hypolipemic stomach-fortifying.It is one of primary raw material in tens of kinds of Chinese medicine prescriptions.Ursus country second class protection animal, prohibits hunting and kills, and natural resources are in short supply.
As far back as 1902, people just started natural Fel Ursi to carry out intensive research, the Main Ingredients and Appearance of Fel Ursi, pharmacological action, clinical effect are also day by day accurate, and it is not identical to get the contained Main Ingredients and Appearance of different genera Fel Ursi clear yet, even significant difference, such as in black bear bile acid, contain ursodeoxycholic sodium up to 39%, the sloth bear bile acid in South Asia only contains sodium ursodexoxycholate 1%, equally, the glasses Bears in South America contains 6%, and sun bear contains 8%, polar bear contains 17%, and brown bear contains 19%.Certainly, also can slightly change different because of weather weather, environment diet, disease health, individual variation.This be also 1996.10.1 carry out < < drained bear bile powder > > (WS3-09 (B-09)-96 (Z) tauroursodeoxycholic acid content only has 23% reason place.Computational methods: on average to contain ursodesoxycholic acid 19% in brown bear bile acid as standard, 19% ÷ 392/499.7=19% ÷ 0.7845=24.22%, on average contains tauroursodeoxycholic acid 24.22% in bile acid.Slightly higher than standard, and standard is indicated as being ursidae animal black bear Selenaretos thibetanus Cuvier, is the bile drainage of brown bear Ursus arctosLasiotus (northeast brown bear) in fact.It,, mainly take ursodesoxycholic acid as main, take bile acids such as chenodeoxycholic acid, deoxycholic acid, cholic acid as auxiliary, and exists in conjunction with the form of salify with taurine, glycine.Contain in addition the compositions such as lipid, cholesterol, each seed amino acid, trace element, bile pigments.
Along with 1981 Nian Yuan national corporation of medical herbs require the research of development of alternatives as early as possible, within 83 years, announce again animals and plants medical material quantity in short supply, once more require the research of developmental research succedaneum.Home and abroad some different succedaneum that all start, are two large classes: synthetic Fel Ursi powder and the drain of Fel Ursi live body like this.The former,, take Shenyang Pharmaceutical University (the former is as Shenyang Pharmacy College) Yang Zemin, Wang Yongjin, Zhou Jiewei representative, sees Chinese patent CN1513480A (application number: 03133771.6) chemical research > > (Shenyang Pharmacy College's journal) 8.4:286-289 of < < artificial Fel Ursi.Also has Chinese patent 02134299.7,01112258.7 etc.With bionical angle, manually prepare, synthetic Fel Ursi powder, the standard method of just selecting differs greatly, and outward appearance is also unsatisfactory.The latter is with the biological Pharmaceutical of the true hall of returning of Fujian, and the black precious Pharmaceutical in Heilungkiang is representative, says from North Korea and introduces the second filial generation without the drain of pain fistulation technique, and Bears is said: there is no pain, and also very comfortable.Just because long-term draining wound can not heal for a long time, festering suppurates needs a large amount of antibiotic of feed, and cause antibiotic remains, pathogenic bacteria is residual, also has long-term drain to cause liver and gall circulation imperfect, and imperfection is just excluded external, cause active ingredient unstable, proportional imbalance, though black bear bile contain active ingredient also between 16-46%, fluctuate larger.Also because long-term Fel Ursi drain causes liver and gall circulation imperfect, imperfection and start an inflammation of the liver, the complication of hepatocarcinoma is up to 46%, and dead drain Bears is up to more than 96%.Large-scale drain Bears rescue center is had in Animals Asia Foundation in Chengdu, and Chengdu Long Qiao Asian Black Bear protection base, address: Long Qiao town, Xindu District, phone 028.83079033
Guiding theory of the present invention: 1, at home and abroad on the basis of synthetic Fel Ursi, further improve perfect." external biological Fel Ursi powder " belongs to new drug Chinese medicine one class; 2, with bionics principle, there are science, the suitability, to be particular about " authentic medicinal herbs ", external biological Fel Ursi powder is with Modern Methods, has analyzed after high-quality natural Fel Ursi, in conjunction with documents and materials, selecting has take the black bear Fel Ursi of high-load as representative.Make the composition of external biological Fel Ursi and chemical constitution and natural Fel Ursi approximate.Guarantee the feature of " authentic medicinal herbs ", guaranteed the stability of content and structure composition, good to guarantee stability, the repeatability of clinical efficacy; 3, guarantee technical feasibility, be produced on a large scale.Guarantee that raw material is easy to get, technique is simple, with low cost, quality controllable, stable, without the three wastes, produces.External biological Fel Ursi is all similar to natural Fel Ursi at aspects such as active ingredient and content, physical behavior, physicochemical property, stability, pharmacology, pharmacodynamics, toxicology, clinical efficacy and safeties, is the equivalent equivalent substitution product of natural Fel Ursi; 4, due to the cough-relieving of Fel Ursi uniqueness, the effect of bringing down a fever, oral formulations, clinical efficacy are too slow, need to prepare ejection preparation, and other synthetic Fel Ursi powder and drainage bear bile powder have limited the application and development of ejection preparation.Thus, along with the development of clinical practice and social sciences is badly in need of releasing a kind of external biological Fel Ursi powder, meet the clinical needs of development and substitute the Bears drain of living and get gallbladder.
Summary of the invention:
The object of the invention is to be to provide a kind of external biological Fel Ursi powder and preparation method thereof, comprising: the scope of A, component and percentage by weight; The refinement of B, preparation method; The natural sex of C, outward appearance, character; D, can be applicable to injection, finally reach the standard-required of equivalent equivalent substitution natural Fel Ursi powder, guarantee effectiveness, stability and the repeatability of clinical effectiveness.
The present invention is directed to above-mentioned the deficiencies in the prior art; a kind of external biological Fel Ursi powder and preparation method thereof is provided; solved the defect of prior art; whole technological operation is easy, safe, with low cost; be easy to suitability for industrialized production; obtain the external biological Fel Ursi powder of equivalent equivalent substitution natural Fel Ursi powder; its content TUDCANa 50-60%, mixed gallbladder extract 10-50%, bilirubin 0.1-0.3%; aminoacid 3-7%; trace element 1-3%, cholesterol 0.2-0.5%, lecithin 0.5-2.0%; Animal fat 2-3%, vitamin E 0.1-0.5%.Can equivalent equivalent substitution in natural Fel Ursi powder; Be applied to injection stage, directly reduce some adjuvants, retain and mainly contain effective constituent TUDCANa, or row alkaline hydrolysis again, can suitability for industrialized production and reach the aseptic apyrogeneity requirement of injection stage.
Technical scheme of the present invention is as follows:
A, component and percentage by weight: TUDCANa 50-60%, mixed gallbladder extract 10-50%, bilirubin 0.1-0.3%, aminoacid 3-7%, trace element 1-3%, cholesterol 0.2-0.5%, lecithin 0.5-2.0%, Animal fat 2-3%, vitamin E 0.1-0.5%;
B, preparation method: by appropriate purified water stirring and dissolving for above-mentioned water solublity each component, 70-80 ℃ of heat filter, filtrate is stand-by, and oil-soluble each component adds appropriate medicinal alcohol to dissolve, and stirs, 70-80 ℃, make it fully emulsified, two large components are mixed 8 hours, and fully emulsified, homogenizing, heat filter, drying under reduced pressure, obtains described external biological Fel Ursi powder;
C, appearance character: be dark-brown or faint yellow irregular fragment, tool glassy lustre, semi-transparent phaneroplasm is crisp, the easily moisture absorption, the extremely bitter Hui Tian of taste, has refrigerant sense, the phenomenon of flying in circles in water, yellow line is vertically not loose, and in fire, calcination is bubbled without being charred smoke, is equal to " JINDAN " classification standard of Chinese Pharmacopoeia natural Fel Ursi;
D, be applied to injection: directly reduce some adjuvant components, only retain and mainly contain effective constituent, TUDCANa, or by main component alkaline hydrolysis, method for hydrolysis is sodium hydroxide 10-15%, 10 times of amounts of water, 105 ℃ of hydrolysis 24 hours.
TUDCANa content >=97% of the present invention; preparation method is shown in the preparation method > > and 200810176801.8 of inventor's series of patents < < tauroursodeoxycholic acid and its esters; 201010530337.5,201010604579.4.The content of TUDCANa is no less than 97%, is to guarantee not bring into other impurity, guarantees to be equal to the active ingredient of natural Fel Ursi, guarantees the clinical efficacy of external biological Fel Ursi powder.
TUDCANa constituent content 50-60% of the present invention; the more than 2 times of sodium taurochenodeoxycholate 5-23%; being the particularly Biological indicators of the normal liver and gall circulation of natural ursidae animal black bear Selenaretos thibetanus Cuvier of natural Fel Ursi, is not the Bears drain of living.The index of improper liver and gall circulation Fel Ursi powder.
Outward appearance of the present invention, character are for being dark-brown or faint yellow irregular fragment; tool glassy lustre, semi-transparent phaneroplasm is crisp, easily the moisture absorption; the extremely bitter Hui Tian of taste; there is refrigerant sense, the phenomenon of flying in circles in water, yellow line is vertically not loose; in fire, calcination is bubbled without being charred smoke; equivalent is equivalent to Chinese Pharmacopoeia natural Fel Ursi " JINDAN " index grade, is natural normal index, containing Main Ingredients and Appearance tauroursodeoxycholic acid 50-60%.
The preparation method of mixed gallbladder extract of the present invention is: by chicken or Fel Anseris domestica fragmentation, gauze leaches bile, washing, merge, 10 times of thin ups, adjust PH8.0-9.0, intensification 80-90 ℃, add 1+1 natural clarifying agent (production of Yao Sheng bio tech ltd, Chengdu) 1%, stir 2 hours, cooling, filter, adjust PH3.0, with after 95% dissolve with ethanol, add 2% 767# active carbon, adjust PH7.5, reflux 2 hours, cooling filter pressing, filtrate recycling ethanol, with dilute sodium hydroxide, adjust PH7.5, be evaporated to thick paste shape, now density is 1.4g/cm3.The Choline of processing like this can effectively retain conjugated bile acids composition, as the conjugated bile acids composition of chenodeoxycholic acid, cholic acid, deoxycholic acid and taurine, glycine.Also contain a small amount of bile pigments etc.
Bilirubin of the present invention is commercially available, content >=95%.
Aminoacid of the present invention refers to the mixture of taurine, aspartic acid, glutamic acid, alanine, serine, threonine and glycine.
Trace element of the present invention refers to calcium lactate, magnesium oxide, copper sulfate, zinc lactate, ferrous sulfate, manganese sulfate, the Rich chromium yeast powder of seven kinds of metallic elements such as containing calcium, magnesium, copper, ferrum, manganese, chromium.
Animal fat of the present invention, lecithin, vitamin E, can protect external biological Fel Ursi not oxidized in the course of processing, storage process, go rancid and become sour, thereby guarantee the stability of its active ingredient.Employing lecithin is emulsifying agent, has both added active ingredient phospholipid, has reduced again oil water interfacial tension, makes oil water mixture become stable emulsion, is convenient to processing.
Detailed process of the present invention is as follows:
1. the weighing of component and percentage by weight (calculating with 100kg finished product): the content of TUDCANa: 97.20%, 51kg, mixed gallbladder extract 39.8kg, bilirubin 0.2kg, aminoacid 3kg (comprises taurine 0.75kg, aspartic acid 0.6kg, glutamic acid 0.45kg, alanine 0.45kg, serine 0.3kg, threonine 0.3kg, glycine 0.15kg), trace element 2.8kg (comprises calcium lactate 0.5kg, magnesium oxide 0.2kg, copper sulfide 0.1kg, zinc lactate 0.5kg, ferrous sulfate 0.5kg, manganese sulfate 0.5kg, Rich chromium yeast powder 0.5kg), Animal fat 0.2kg, cholesterol 2.5kg, lecithin 0.5kg, bilirubin 0.2kg.
2. preparation method: by appropriate purified water stirring and dissolving for above-mentioned water solublity each component, 70-80 ℃ of heat filter, filtrate is stand-by, oil-soluble each component adds appropriate medicinal alcohol to dissolve, and stirs 70-80 ℃, make it fully emulsified, two large components are mixed 8 hours and fully emulsified, homogenizing, heat filter, drying under reduced pressure, obtains described external biological Fel Ursi powder;
3. the product obtaining is thus dark-brown or faint yellow irregular fragment, tool glassy lustre, semi-transparent phaneroplasm is crisp, the easily moisture absorption, the extremely bitter Hui Tian of taste, there is refrigerant sense, the phenomenon of flying in circles in water, yellow line is vertically loose, and in fire, calcination is bubbled without being charred smoke, be equal to " JINDAN " quality index of Chinese Pharmacopoeia natural Fel Ursi, can equivalent equivalent substitution in the clinical practice of natural Fel Ursi powder;
If be 4. applied to ejection preparation; only need add Main Ingredients and Appearance TUDCANa, content >=97.2%, 51kg; by 10 times of amounts of 95% medicinal alcohol; add 2%767# active carbon 1.0kg, reflux 2 hours, filter pressing de-carbon in GMP environmental requirement; remove pyrogen; decompression recycling ethanol, drying under reduced pressure obtains injection stage external biological Fel Ursi powder, aseptic apyrogeneity.Or Main Ingredients and Appearance TUDCANa is added to 10 times, water, and 12%, 105 ℃ of hydrolysis of sodium hydroxide 24 hours, finishes, and inclines and supernatant, and 20 times of lower floor's sodium ursodexoxycholate thin ups, adjust PH3.0, obtain sodium ursodexoxycholate.Use 10 times of 95% medicinal alcohols again, add 2%767# active carbon 1.0kg, reflux 2 hours, in GMP environmental requirement, filter pressing de-carbon, removes pyrogen, decompression recycling ethanol, and drying under reduced pressure obtains injection stage external biological Fel Ursi powder, aseptic apyrogeneity.
Advantage of the present invention and effect:
Whole technological operation is easy, safe, with low cost; be easy to suitability for industrialized production, obtain the external biological Fel Ursi powder of equivalent equivalent substitution natural Fel Ursi powder, its content TUDCANa 50-60%; mixed gallbladder extract 10-50%; bilirubin 0.1-0.3%, aminoacid 3-7%, trace element 1-3%; cholesterol 0.2-0.5%; lecithin 0.5-2.0%, Animal fat 2-3%, vitamin E 0.1-0.5%.Can equivalent equivalent substitution in natural Fel Ursi powder; Be applied to injection stage, directly reduce some adjuvants, retain and mainly contain effective constituent TUDCANa, or row alkaline hydrolysis again, can suitability for industrialized production and reach the aseptic apyrogeneity requirement of injection stage.
The specific embodiment:
Below by embodiment, the present invention is further illustrated, and its object is to understand better content of the present invention, but not limits the scope of the invention.
Embodiment 1:
The preparation of mixed gallbladder extract: get frozen chicken gall bladder 140kg, broken skin, drain, washed several times with water is to clean, merge, 10 times of thin ups, adjust PH9.1, heat up 90 ℃, add 1+1 natural clarifying agent (production of Yao Sheng bio tech ltd, Chengdu) II-A1%, stir 2 hours, cooling, plate-and-frame filtration, adjust PH3.0, after dissolving with 95% ethanol 300kg, stir, add 2%0.2kg767# active carbon, adjust PH7.5, reflux 2 hours, cooling, filter pressing de-carbon, decompression recycling ethanol, is concentrated into thick paste shape, and density 1.40g/cm2 obtains 16kg mixed gallbladder extract.
Embodiment 2:
Take TUDCANa 52kg (content 97.21%, high performance liquid chromatography detects), mixed gallbladder extract 39.5kg, bilirubin 0.2kg, aminoacid 3kg (comprises taurine 0.75kg, aspartic acid 0.6kg, glutamic acid 0.45kg, alanine 0.45kg, serine 0.3kg, threonine 0.3kg, glycine 0.15kg), trace element 2.8kg (comprises calcium lactate 0.5kg, magnesium oxide 0.2kg, copper sulfate 0.1kg, zinc lactate 0.5kg, ferrous sulfate 0.5kg, manganese sulfate 0.5kg, Rich chromium yeast powder 0.5kg), Animal fat 0.2kg, cholesterol 2.5kg, lecithin 0.5kg.By appropriate purified water stirring and dissolving for above-mentioned water solublity each component, 70-80 ℃ of heat filter, filtrate is stand-by, oil-soluble each component adds appropriate medicinal alcohol to dissolve, and stirs 70-80 ℃, make it fully emulsified, two large components are mixed 8 hours and fully emulsified, homogenizing, heat filter, drying under reduced pressure, obtains described external biological Fel Ursi powder; The product obtaining is thus dark-brown or faint yellow irregular fragment; tool glassy lustre; semi-transparent phaneroplasm is crisp, the easily moisture absorption, the extremely bitter Hui Tian of taste; there is refrigerant sense; the phenomenon of flying in circles in water, yellow line is vertically loose, and in fire, calcination is bubbled without being charred smoke; equivalent is equivalent to Chinese Pharmacopoeia natural Fel Ursi " JINDAN " grade, containing mainly containing effective constituent TUDCANa 50%.
Embodiment 3:
The preparation of injection external biological Fel Ursi powder: add Main Ingredients and Appearance TUDCANa; content >=97.2%; 51kg, by 10 times of amounts of 95% medicinal alcohol, adds 2%767# active carbon 1.0kg; reflux 2 hours; in GMP environmental requirement, filter pressing de-carbon, removes pyrogen, decompression recycling ethanol; drying under reduced pressure obtains injection stage external biological Fel Ursi powder, aseptic apyrogeneity.
Embodiment 4:
Take TUDCANa 60kg (content 97.60%, high performance liquid chromatography detects), mixed gallbladder extract 30.5kg, bilirubin 0.3kg, aminoacid 3kg (comprises taurine 0.75kg, aspartic acid 0.6kg, glutamic acid 0.45kg, alanine 0.45kg, serine 0.3kg, threonine 0.3kg, glycine 0.15kg), trace element 2.8kg (comprises calcium lactate 0.5kg, magnesium oxide 0.2kg, copper sulfate 0.1kg, zinc lactate 0.5kg, ferrous sulfate 0.5kg, manganese sulfate 0.5kg, Rich chromium yeast powder 0.5kg), Animal fat 0.2kg, cholesterol 2.5kg, lecithin 0.5kg.By appropriate purified water stirring and dissolving for above-mentioned water solublity each component, 70-80 ℃ of heat filter, filtrate is stand-by, oil-soluble each component adds appropriate medicinal alcohol to dissolve, and stirs 70-80 ℃, make it fully emulsified, two large components are mixed 8 hours and fully emulsified, homogenizing, heat filter, drying under reduced pressure, is about to described external biological Fel Ursi powder; The product obtaining is thus dark-brown or faint yellow irregular fragment, tool glassy lustre, semi-transparent phaneroplasm is crisp, the easily moisture absorption, the extremely bitter Hui Tian of taste, has refrigerant sense, the phenomenon of flying in circles in water, yellow line is vertically not loose, and in fire, calcination is bubbled without being charred smoke, is equal to " JINDAN " grade of Chinese Pharmacopoeia natural Fel Ursi.
Embodiment 5:
The another legal system of injection external biological Fel Ursi powder is standby, adds Main Ingredients and Appearance, TUDCANa 60kg; add 10 times of purified water, sodium hydroxide 12%, 72kg; 105 ℃, within 24 hours, stir, finish; by 10 times of amounts of 95% medicinal alcohol, add 2%767# active carbon 1.2kg, reflux 2 hours; in GMP environmental requirement, filter pressing de-carbon, removes pyrogen, decompression recycling ethanol; drying under reduced pressure obtains injection stage external biological Fel Ursi powder, aseptic apyrogeneity.
Claims (10)
1. an external biological Fel Ursi powder and preparation method, it is characterized in that: A, component and percentage by weight: TUDCANa 50-60%, mixed gallbladder extract 10-50%, bilirubin 0.1-0.3%, aminoacid 3-7%, trace element 1-3%, cholesterol 0.2-0.5%, lecithin 0.5-2.0%, Animal fat 2-3%, vitamin E 0.1-0.5%; B, preparation method: by appropriate purified water stirring and dissolving for above-mentioned water solublity each component, 70-80 ℃ of heat filter, filtrate is stand-by, and oil-soluble each component adds appropriate medicinal alcohol to dissolve, stir, 70-80 ℃, makes it fully emulsified, two large components is mixed 8 hours and fully emulsified, homogenizing, heat filter, drying under reduced pressure, obtains described external biological Fel Ursi powder; C, appearance character: be dark-brown or faint yellow irregular fragment, tool glassy lustre, semi-transparent phaneroplasm is crisp, the easily moisture absorption, the extremely bitter Hui Tian of taste, has refrigerant sense, the phenomenon of flying in circles in water, yellow line is vertically not loose, and in fire, calcination is bubbled without being charred smoke, and equivalent is equivalent to " JINDAN " standard-required of Chinese Pharmacopoeia natural Fel Ursi; D, be applied to injection, directly reduce some adjuvant components, only retain and mainly contain effective constituent.
2. external biological Fel Ursi powder according to claim 1 and preparation method; the composition and the percentage by weight that it is characterized in that external biological Fel Ursi powder are as follows: TUDCANa 50-60%; mixed gallbladder extract 10-50%; aminoacid 3-7%; trace element 1-3%, cholesterol 0.2-0.5%, lecithin 0.5-2.0%; Animal fat 2-3%, vitamin E 0.1-0.5%.
3. external biological Fel Ursi powder according to claim 1 and preparation method, is characterized in that the preparation method of external biological Fel Ursi powder is as follows: by appropriate purified water stirring and dissolving for above-mentioned water solublity each component, and intensification 70-80 ℃, heat filter, filtrate for later use; Oil-soluble each component adds appropriate medicinal alcohol stirring and dissolving, and 70-80 ℃ makes it fully emulsified, then by two large component mix and blends, within 8 hours, makes that it is fully emulsified, homogenizing, heat filter, drying under reduced pressure, obtains described external biological Fel Ursi powder.
4. external biological Fel Ursi powder according to claim 1 and preparation method, the mixed gallbladder extract preparation method that it is characterized in that external biological Fel Ursi powder is as follows: by chicken or Fel Anseris domestica fragmentation, gauze leaches gallbladder juice, washing, merge, 10 times of thin ups, adjust PH8.0-9.0, intensification 80-90 ℃, add 1+1 natural clarifying agent (production of Yao Sheng bio tech ltd, Chengdu) 1%, stir insulation, 2 hours, cooling, filter, adjust PH3.0, with after 95% dissolve with ethanol, add 2% 767# active carbon, adjust PH7.5, reflux 2 hours, cooling filter pressing, filtrate recycling ethanol, adjust PH7.0-7.5 with dilute sodium hydroxide, be evaporated to thick paste shape, now density is 1.4g/cm3.
5. external biological Fel Ursi powder according to claim 1 and preparation method, it is characterized in that the face shaping of external biological Fel Ursi powder is equal to " JINDAN " standard-required of the natural Fel Ursi powder of Chinese Pharmacopoeia, be that face shaping is dark brown or faint yellow irregular fragment, tool glassy lustre, semi-transparent phaneroplasm is crisp, the easily moisture absorption, the extremely bitter Hui Tian of taste, has refrigerant sense, the phenomenon of flying in circles in water, yellow line is vertically not loose, and in fire, calcination is bubbled without being charred smoke.
6. external biological Fel Ursi powder according to claim 1 and preparation method; it is characterized in that external biological Fel Ursi powder is applied to injection; can directly reduce some adjuvant components, only retain and mainly contain effective constituent, TUDCANa or be further hydrolyzed to ursodesoxycholic acid.And guarantee Main Ingredients and Appearance TUDCANa content of monomer >=97.00% adding, to guarantee effectiveness, repeatability, the stability of clinical efficacy.
7. according to external biological Fel Ursi powder and preparation method described in claim 1,2, it is characterized in that the active ingredient tauroursodeoxycholic acid of external biological Fel Ursi powder is minimum more than 50%, and be the more than 2 times of Taurochenodeoxycholic Acid.
8. according to external biological Fel Ursi powder and preparation method described in claim 1,6, the method for hydrolysis that it is characterized in that Main Ingredients and Appearance is sodium hydroxide 10-15%, 10 times of amounts of water, and 105 ℃ are hydrolyzed 24 hours.
9. according to external biological Fel Ursi powder and preparation method described in claim 1,2, it is characterized in that amino acid whose proportionate relationship is as follows: taurine 0.75kg, aspartic acid 0.6kg, glutamic acid 0.45kg, alanine 0.45kg, serine 0.3kg, threonine 0.3kg, glycine 0.15kg, in added total amino acid content 3kg; The ratio of trace element is as follows: calcium lactate 0.5kg, magnesium oxide 0.2kg, copper sulfate 0.1kg, zinc lactate 0.5kg, ferrous sulfate 0.5kg, manganese sulfate 0.5kg, Rich chromium yeast powder 0.5kg, in added trace element total amount 2.8kg, the two is all the allotment consumption of 100kg external biological Fel Ursi powder.
10. according to external biological Fel Ursi powder and preparation method described in claim 1-9, it is characterized in that active ingredient, outward appearance, character, the clinical effectiveness of external biological Fel Ursi powder all reaches the standard-required of < < Chinese Pharmacopoeia > > natural Fel Ursi powder " JINDAN ", can equivalent equivalent application in clinical.
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN109331040A (en) * | 2018-11-08 | 2019-02-15 | 延边大学 | A kind of preparation method and bear gall powder of bear gall powder |
| CN110354143A (en) * | 2018-03-26 | 2019-10-22 | 长春长庆药业集团有限公司 | A kind of extracting method of bear bile powder eye drop stoste |
| CN114748509A (en) * | 2021-10-14 | 2022-07-15 | 黑龙江野宝药业有限公司 | Refined biological bear gall powder and production method thereof |
-
2012
- 2012-10-14 CN CN201210410213.2A patent/CN103720718A/en active Pending
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110354143A (en) * | 2018-03-26 | 2019-10-22 | 长春长庆药业集团有限公司 | A kind of extracting method of bear bile powder eye drop stoste |
| CN109331040A (en) * | 2018-11-08 | 2019-02-15 | 延边大学 | A kind of preparation method and bear gall powder of bear gall powder |
| CN114748509A (en) * | 2021-10-14 | 2022-07-15 | 黑龙江野宝药业有限公司 | Refined biological bear gall powder and production method thereof |
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