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Method for controlling quality of injection liquid or powder of

A quality control method and technology for injection powder for injection, which are applied in the field of improved preparation of Qingkailing injection or injection powder, and can solve the problems of complicated preparation method, unfavorable mass production, undisclosed quality control and the like

Inactive Publication Date: 2006-01-25
GUIZHOU YIBAI PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Nevertheless, we can see that the preparation method of the above-mentioned Qingkailing powder injection is very cumbersome, which is not conducive to large-scale industrial production, and the quality of Qingkailing powder injection needs to be further improved
Secondly, the quality control of Qingkailing injection or injection powder for cholic acid, hyodeoxycholic acid, geniposide and chlorogenic acid is not disclosed in the prior art.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] Cholic acid 32.5g Hyodeoxycholic acid 37.5g Baicalin 50g Mother of pearl powder 500g

[0031] Buffalo horn powder 250g gardenia 250g isatis root 2000g honeysuckle extract 50g

[0032] The detailed process step of preparing powder injection is as follows:

[0033] 1. Drug extraction and hydrolysis treatment:

[0034] ① Preparation of gardenia extract: Weigh gardenia according to the prescription, add 6 times the amount of water, boil for 1 hour, filter, add 4 times the amount of water to the filter residue, boil for half an hour, filter, combine the filtrates, heat and concentrate to the weight of the raw materials After cooling, add concentrated ethanol under stirring to make the alcohol content reach 60%, refrigerate for 2-3 hours, filter with suction, take the clarified filtrate, wash the precipitate with 60% cold ethanol, combine the lotion and filtrate, Ethanol was recovered under reduced pressure, ultra-centrifuged at 10,000 rpm, refrigerated for 24 hours, filtered...

Embodiment 2

[0053] Cholic acid 32.5g Hyodeoxycholic acid 37.5g Baicalin 50g Mother-of-pearl powder 500g

[0054] Buffalo horn powder 250g gardenia 250g isatis root 2000g honeysuckle extract 50g

[0055] The detailed process step of preparing injection is as follows:

[0056] 1. Drug extraction and hydrolysis treatment:

[0057] ① Preparation of gardenia extract: Weigh gardenia according to the prescription, add 6 times the amount of water, boil for 1 hour, filter, add 4 times the amount of water to the filter residue, boil for half an hour, filter, combine the filtrates, heat and concentrate to the weight of the raw materials After cooling, add concentrated ethanol under stirring to make the alcohol content reach 60%, refrigerate for 2-3 hours, filter with suction, take the clarified filtrate, wash the precipitate with 60% cold ethanol, combine the lotion and filtrate, Ethanol was recovered under reduced pressure, ultracentrifuged at 12000 rpm, refrigerated for 24 hours, filtered to obt...

Embodiment 3

[0076] Cholic acid 32.5g Hyodeoxycholic acid 37.5g Baicalin 50g Mother-of-pearl powder 500g

[0077] Buffalo horn powder 250g gardenia 250g isatis root 2000g honeysuckle extract 50g

[0078] The detailed process steps of preparing freeze-dried powder injection are as follows:

[0079] 1. Drug extraction and hydrolysis treatment:

[0080] ① Preparation of gardenia extract: Weigh gardenia according to the prescription, add 6 times the amount of water, boil for 1 hour, filter, add 4 times the amount of water to the filter residue, boil for half an hour, filter, combine the filtrates, heat and concentrate to the weight of the raw materials After cooling, add concentrated ethanol under stirring to make the alcohol content reach 60%, refrigerate for 2-3 hours, filter with suction, take the clarified filtrate, wash the precipitate with 60% cold ethanol, combine the lotion and filtrate, Ethanol was recovered under reduced pressure, ultracentrifuged at 16000 rpm, refrigerated for 24 ...

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Abstract

A process for preparing the liquid injection or powder injection of 'Qingkailing' is an improvement to existing process in such areas that high-speed centrifugal technique is used to prepare the liquid extracts of capejasmine fruit, isatis root and honeysuckle flower, and the ultra-filter technique is used for the collected liquid extract, resulting in high curative effect and long effective period. Its quality control method and product discriminating method are also disclosed.

Description

[0001] This case is a divisional application of application No. 03109422.8. The filing date of the original application was April 10, 2003. The invention and creation name of the original application was Qingkailing injection or injection powder preparation method and its quality control method. technical field [0002] The present invention relates to a preparation method of Qingkailing injection or injection powder and a quality control method of Qingkailing powder injection, specifically, an improved preparation method and Qingkailing injection or injection powder. The quality control method and identification method of Kailing injection or injection powder. Background technique [0003] Qingkailing Injection is based on the theory of traditional Chinese medicine by analyzing the dismantled formula of "Angong Niuhuang Pill" in Wu Jutong's "Warm Disease Tiaobian" in the Qing Dynasty. It is widely used clinically for patients with high fever and stroke, and is recognized an...

Claims

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Application Information

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IPC IPC(8): A61K36/744A61K9/14A61P11/04G01N30/02G01N33/15A61K35/413
Inventor 蔡剑前
Owner GUIZHOU YIBAI PHARMA CO LTD
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