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Method of preparing red sage root injection and quality control method thereof

A quality control method, the technology of Danshen injection, applied in the preparation process and quality control field of Danshen injection, can solve the problem of lack of quality control of the key active ingredient salvianolic acid A, unstable clinical efficacy of the product, and incomplete removal of tannin and other issues, to achieve the effect of stable and reliable product quality, improved safety and effectiveness, and reliable quality

Active Publication Date: 2008-02-27
CHIATAI QINGCHUNBAO PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Because the technology of obtaining high content of salvianolic acid A has been difficult to break through for a long time, salvianolic acid A has not been used as a quality control index for Danshen preparations
[0017] In summary, the main defect of the current production technology of Danshen injection is that the preparation method is not very reasonable, resulting in a very large loss of the main active ingredients salvianolic acid A and B; the lack of quality control of the key active ingredient salvianolic acid A, resulting in The clinical efficacy of the product is unstable; the removal of tannin is not complete, and there is a big safety hazard in clinical application

Method used

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  • Method of preparing red sage root injection and quality control method thereof
  • Method of preparing red sage root injection and quality control method thereof
  • Method of preparing red sage root injection and quality control method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0070] Example 1 Preparation of Danshen Injection by Traditional Process

[0071] Take 1500g of Salvia miltiorrhiza, add water and decoct three times, the first time for 2 hours, the second and third times for 1.5 hours each, combine the decoction, filter, and concentrate the filtrate to 750ml under reduced pressure. Add ethanol for precipitation twice, the first time the alcohol content is 75%, the second time the alcohol content is 85%, each time it is refrigerated and then filtered. The filtrate recovers ethanol and concentrates it to about 250ml. Add water for injection to 400ml, mix well, refrigerate, filter, adjust the pH value to 6.8 with 10% sodium hydroxide solution, boil for half an hour, filter, add water for injection to 1000ml, potting, and sterilize to get ready.

[0072] Tested according to the quality control method of the present invention, every 1ml contains danshensu sodium 1.00mg; contains protocatechualdehyde 0.90mg; contains salvianolic acid B 0.10mg, co...

Embodiment 2

[0073] Example 2 Preparation of Salvia Miltiorrhiza Injection by Traditional Technology Combined with Alkaline Precipitation (Traditional Technology, pH=9.0)

[0074] It is basically the same as Example 1, except that during the second alcohol precipitation, the pH value is adjusted to 9.0 with 40% sodium hydroxide solution, fully stirred, and left to stand for about 1 hour. Refrigerate, filter the secondary alcohol precipitate after refrigeration, and recover ethanol by distillation under reduced pressure. Add water for injection to 400ml, add 1:1 hydrochloric acid to adjust pH to 6.8, boil for half an hour, filter, add water for injection to 1000ml, potting, and sterilize to get ready.

[0075] Tested according to the quality control method of the present invention, every 1ml contains danshensu sodium 0.95mg; contains protocatechualdehyde 0.80mg; contains salvianolic acid B 0.05mg, contains salvianolic acid A 0.02mg; tannin inspection clarification. Result judgment, tanni...

Embodiment 3

[0076] Example 3 Preparation of Salvia Miltiorrhiza Injection by Traditional Technology Combined with Alkaline Precipitation (Traditional Technology, pH=8.0)

[0077] It is basically the same as Example 2, except that during the second alcohol precipitation, the pH value is adjusted to 8.0 with 40% sodium hydroxide solution, and the others are the same.

[0078] Tested according to the quality control method of the present invention, every 1ml contains danshensu sodium 0.85mg; contains protocatechualdehyde 0.76mg; contains salvianolic acid B 0.09mg, contains salvianolic acid A 0.04mg; tannin test has a small amount of precipitation. Result judgment, by quality control method of the present invention, except that Danshensu sodium and protocatechualdehyde meet the requirements, tannin inspection and salvianolic acid A, B are all unqualified. Compared with Example 1, the contents of the four main components have little difference.

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Abstract

The invention discloses a making method of radix salvia miltiorrhizae injection and quality controlling method, which is characterized by the following: controlling the condensing temperature in the controlling technical course based on traditional technique; utilizing soluble salviol acid as main effective component of tanner and salvia miltiorrhizae to remove residual tanner according to the differential molecular weight. The quality controlling method is characterized by the following: controlling the effective content of alviol acid A, alviol acid B, sodium tanshinone and protocatechualdehyde as quality controlling index; elevating the quality of radix salvia miltiorrhizae injection effectively. The invention reaches the full-new level of safely and effectively controllable quality, which has little imperfect reaction, high security, exact curative effect and controllable quality.

Description

technical field [0001] The invention relates to a preparation method of a traditional Chinese medicine preparation and a quality control method thereof, in particular to a preparation technology of Danshen injection and a quality control method thereof. Background technique [0002] In recent years, with the improvement of people's living standards in our country, the extension of life expectancy and the change of dietary structure, the incidence and mortality of coronary heart disease are showing an upward trend. There are currently about 40 million patients with coronary heart disease in my country, and about 260 patients die of cardiovascular and cerebrovascular diseases every hour. The incidence of coronary heart disease has been rising sharply in my country in recent years. According to a report by the World Health Organization, even if effective preventive measures are taken from now on, the rising trend of the incidence of cardiovascular diseases in my country will c...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K36/537A61P9/10G01N30/02A61K125/00
Inventor 黎豫杭许正宇柴建国沈培强张建兵王木兰潘迎锋
Owner CHIATAI QINGCHUNBAO PHARMA
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