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Preparation method for bear bile powder

A technology of bear bile powder and bear bile, which is applied in the direction of medical preparations containing active ingredients, pharmaceutical formulas, and unknown raw materials, can solve problems such as inactivation of active enzymes, changes in the structure of active ingredients, and affect the effectiveness of drugs, so as to improve The effect of quality and safety assurance

Inactive Publication Date: 2015-12-16
YUNNAN DIANCHUAN IND & TRADE CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, high-temperature sterilization often inactivates various active enzymes in bile, and simultaneously causes the oxidation of various components (bear bile powder turns dark brown, and some are even dark green or light red), which affects the effectiveness of the drug; using high-strength Co -60 irradiation sterilization can effectively kill pathogenic bacteria, but the potential risk of radiation residues to patients taking medicine has yet to be evaluated. Developed countries do not recommend this method for sterilization. On the other hand, high-intensity irradiation may also lead to activity Enzyme inactivation, even lead to changes in the structure of active ingredients, thus bringing uncertainty to the safety, effectiveness and stability of clinical medication

Method used

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  • Preparation method for bear bile powder

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] Take 1 kg of freshly drained bear bile, vacuum filter it to obtain the filtrate; add ethanol to the filtrate to make the ethanol content in the liquid 75%, stir for 20 minutes, and let it stand for 24 hours; concentrate the liquid under reduced pressure at 35°C to remove ethanol , to obtain sterilized bear bile liquid; the sterilized bear bile liquid is cooled to -35°C at a cooling rate of 4°C / min, kept at a constant temperature for 0.5h, vacuumed to 1Pa, and then heated to room temperature at a heating rate of 3°C / min. Freeze-drying operation; after freeze-drying, pulverize to obtain bear bile powder.

[0024] After testing, the content of tauroursodeoxycholic acid in the obtained bear bile powder was 28.9%, and no Staphylococcus aureus, Bacillus aeruginosa and Salmonella were detected through hygienic inspection.

Embodiment 2

[0026] Take 2kg of freshly drained bear bile, filter it under reduced pressure to obtain the filtrate; add ethanol to the filtrate to make the ethanol content in the liquid medicine 85%, stir for 40 minutes, and let stand for 72 hours; concentrate the liquid medicine under reduced pressure at 45°C to remove Ethanol to obtain sterilized bear bile liquid; the sterilized bear bile liquid is cooled to -40°C at a cooling rate of 2°C / min, kept at a constant temperature for 3.5 hours, vacuumed to 15Pa, and then heated to room temperature at a heating rate of 3°C / min The freeze-drying operation is realized; after the freeze-drying is completed, it is pulverized into golden yellow bear bile powder with transparent luster.

[0027] After testing, the content of tauroursodeoxycholic acid in the obtained bear bile powder was 29.4%, and no Staphylococcus aureus, Bacillus aeruginosa and Salmonella were detected through hygienic inspection.

Embodiment 3

[0029] Take 4kg of freshly drained bear bile, filter it under reduced pressure to obtain the filtrate; add ethanol to the filtrate to make the ethanol content in the liquid medicine 80%, stir for 30 minutes, and let stand for 48 hours; concentrate the liquid medicine under reduced pressure at 40°C to remove Ethanol to obtain sterilized bear bile liquid; the sterilized bear bile liquid is cooled to -38°C at a cooling rate of 1°C / min, kept at a constant temperature for 2 hours, vacuumed to 10Pa, and then heated to room temperature at a heating rate of 2°C / min. Freeze-drying operation; after freeze-drying, it is pulverized into golden-yellow bear bile powder with transparent luster.

[0030] After testing, the content of tauroursodeoxycholic acid in the obtained bear bile powder was 29.2%, and no Staphylococcus aureus, Bacillus aeruginosa and Salmonella were detected through hygienic inspection.

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Abstract

The invention discloses a preparation method for bear bile powder, and relates to the technical field of medicine preparation. The preparation method comprises the following steps: filtration: obtaining fresh drained bear bile, and carrying out filtration to obtain a filtrate; sterilization: adding high-concentration ethanol into the filtrate till the ethanol content of a liquid medicine reaches 75-85%, and then carrying out 20-40 minutes' stirring and 24-72 hours' still standing; concentration: carrying out vacuum concentration to remove ethanol and obtain sterilized bear bile; freeze drying: conducting freeze drying on the sterilized bear bile. According to the preparation method, the characteristic that fresh bear bile is a liquid is adopted, so that ethanol and the fresh bear bile are miscible; the function of ethanol to kill viruses and pathogens is adopted, so that various pathogens and viruses can be killed through control of the content and existence time of ethanol in the liquid medicine, active ingredients in the bear bile are protected from damage; the safety and availability of clinical medication are guaranteed, and the defects in the conventional bear bile powder production process are overcome; the prepared bear bile powder is golden yellow in appearance and transparent in luster; through adoption of the preparation method, the quality of the bear bile powder is greatly improved.

Description

Technical field: [0001] The invention relates to a method for preparing bear bile powder through ethanol sterilization and freeze-drying, belonging to the technical field of medicine preparation. Background technique: [0002] Bear bile is a traditional medicinal material in my country. It can clear away heat and improve eyesight, detoxify the liver, and benefit the gallbladder. It has a good therapeutic effect on hyperlipidemia and hepatitis. At present, bear bile medicinal materials have been produced by drainage of live bear bile, and the bile is processed through subsequent drying steps to obtain bear bile powder medicinal materials. Because bear bile is easily contaminated by various microorganisms and pathogenic bacteria during production, Co-60 irradiation or high temperature is commonly used to kill these pathogenic bacteria to ensure the safety of clinical medication. However, high-temperature sterilization often inactivates various active enzymes in bile, and simu...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K35/413
Inventor 周志宏张新华赵志坚杨学兴杨天亮
Owner YUNNAN DIANCHUAN IND & TRADE CO LTD
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