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Preparation of qinkailing freeze-dried injection

A technology for freeze-dried powder injections and injections, which is applied in the field of preparation of Qingkailing freeze-dried powder injections for injections, and can solve problems such as uneven sample formation, low content of active ingredients in drugs, and unsatisfactory purification and refining.

Active Publication Date: 2008-09-10
GUIZHOU YIBAI PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The inventor found in the research that the extraction and purification of honeysuckle medicinal materials in the original product process is not good enough, so that the content of active ingredients of the drug is low and the amount of impurities is large; there is a problem of low nitrogen content in buffalo horn hydrolysis with acid; The purification and refining of other medicinal materials is not ideal; in addition, due to the long freeze-drying time in actual production, the obtained Qingkailing freeze-dried powder injection has problems such as uneven sample formation, darker color, and more insoluble particles. , and the production cost increases accordingly

Method used

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  • Preparation of qinkailing freeze-dried injection
  • Preparation of qinkailing freeze-dried injection
  • Preparation of qinkailing freeze-dried injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0158] Example 1: Cholic acid 11g, mother of pearl 175g, hyodeoxycholic acid 13g, gardenia 87g, buffalo horn 87g, isatidis 700g, baicalin 17g, honeysuckle 70g

[0159] The buffalo horn is hydrolyzed with 10 times the amount of 1.0mol / L barium hydroxide solution for 7 hours; the mother of pearl is crushed and hydrolyzed with 10 times the amount of 1.0mol / L sulfuric acid, the pH of the hydrolyzed solution is adjusted to 4.0, concentrated to a relative density of 1.10, and ethanol is added Make the alcohol content reach 50%, refrigerate for 48 hours, filter, recover ethanol, add pure water to 1000 ml, refrigerate for 48 hours, filter to obtain a hydrolyzate, and refrigerate for future use. Add 10 times the amount of water for Radix Isatidis and Gardenia and decoct for 0.5 hours. The decoction of Radix Isatidis and Gardenia decoction is concentrated to a relative density of 1.10. Add ethanol to make the alcohol content reach 50%, refrigerate for 48 hours, filter and recover Ethano...

Embodiment 2

[0161] Example 2: cholic acid 22g, mother of pearl 325g, hyodeoxycholic acid 25g, gardenia 163g, buffalo horn 163g, isatidis 1300g, baicalin 33g, honeysuckle 130g

[0162] The buffalo horn is hydrolyzed with 8 times the amount of 1.5mol / L barium hydroxide solution for 6 hours; after the nacre is crushed, it is hydrolyzed with 8 times the amount of 2.0mol / L sulfuric acid solution for 8 hours, the hydrolyzate is mixed and the pH is adjusted to 3.5-4.2, concentrated to 60-80°C with a relative density of 1.30, add ethanol to make the alcohol content reach 70%, refrigerate for 24 hours, filter, recover ethanol, add pure water to 1000 ml, refrigerate for 24 hours, filter, and refrigerate the obtained hydrolyzate for later use; Add 10 times the amount of water and decoct 3 times, each time for 1.5 hours, filter, the resulting decoctions are concentrated to 60-80 ° C relative density 1.30, add ethanol respectively to make the alcohol content reach 70%, refrigerate for 24 hours, filter,...

Embodiment 3

[0164] Example 3: cholic acid 16.25g, mother of pearl 250g, hyodeoxycholic acid 18.75g, gardenia 125g, buffalo horn 125g, isatidis 1000g, baicalin 25g, honeysuckle 100g

[0165] The buffalo horn is hydrolyzed with 12 times the amount of 1.2mol / L barium hydroxide solution for 7 hours; the mother of pearl is crushed and hydrolyzed with 10 times the amount of 1.5mol / L sulfuric acid solution for 7 hours, the hydrolyzate is mixed and the pH is adjusted to 3.8-4.0, concentrated To 70°C relative density 1.20, add ethanol to make the alcohol content reach 60%, refrigerate for 48 hours, filter, recover ethanol, add pure water to 1000 ml, refrigerate for 48 hours, filter, and refrigerate the obtained hydrolyzate for later use; Decoct with twice the amount of water for 1.0 hour each time, filter, and concentrate the obtained decoction to a relative density of 1.20 at 70°C, add ethanol to make the alcohol content reach 60%, refrigerate for 48 hours, filter, recover ethanol, and add purific...

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Abstract

The invention provides the preparation method of the freeze-dried powder injection of qingkailing, which is prepared by cholic acid, nacre, hyodeoxycholic acid, gardenia, buffalo horn, isatis root, baicalin and honeysuckle, which undergo the processes of extraction, alternative precipitation and multipole impurity removal to obtain extraction solution in which absolute ethyl alcohol is added. Compared with prior art, the invention increases the content of effective composition of the medicine, shortens the time of freeze drying, reduces production cost and optimizes processing technique. In addition, the examinations of insoluble particle and visible matter are greatly improved, so the bioavailability and stability of the medicine are improved. The preparation of the freeze-dried injection of qingkailing has the advantages of loose texture, good formability, low water content, good stability, and good appearance and color, reducing insoluble particles and being easy to store, so the clinical curative effect of the preparation can be ensured.

Description

technical field [0001] The invention relates to a preparation method of Qingkailing freeze-dried powder injection for injection, which belongs to the technical field of traditional Chinese medicine pharmacy. Background technique [0002] Qingkailing preparation is obtained by modifying the traditional famous and precious Chinese patent medicine "Angong Niuhuang Pills". It has the functions of clearing away heat and detoxifying, avoiding filth and opening the orifices, calming and calming the nerves, and is mainly used for the treatment of internal heat evil, coma, delirium, body heat and irritability, convulsions and convulsions, and convulsions in children; modern medicine is mainly used for the treatment of Satisfactory results have been achieved for upper respiratory tract infection, various fevers and acute diseases. Among them, "Qingkailing Injection" and "Qingkailing Oral Liquid" are recorded in Part One of the Chinese Pharmacopoeia 2005 Edition. [0003] The applica...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K36/744A61K9/19A61P25/20A61P25/00A61P29/00A61P31/00A61K35/56A61K35/32A61K31/575A61K31/7048A61K35/618
Inventor 窦啟玲江帆杨义朱亭潘牟兰进简高华周黎亚
Owner GUIZHOU YIBAI PHARMA CO LTD
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