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Red sage root salvianolic acid A injection formulation for treating cardiovascular diseases and preparation process thereof

A technology of salvianolic acid and injection preparations of salvia miltiorrhiza, applied in the field of traditional Chinese medicine pharmacy, can solve the problems of inability to have quantitative relationship, difficult preparation process, wide selection of excipients, etc.

Active Publication Date: 2007-05-30
CHIATAI QINGCHUNBAO PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Chinese patents CN1397276A and CN1352985A disclose the process of preparing salvianolic acid A into traditional Chinese medicine preparations, and mention that antioxidant protection should be added during the preparation process, but it is only a simple superposition of the basic properties of salvianolic acid A. And the added antioxidant is changed according to the total amount of the preparation, and its ratio cannot have a quantitative relationship during the preparation process, and the relationship between its amount is from 0.01% to 95%, with a difference of nearly 10,000 times. The selection range of excipients in the patent is too large, which will cause great difficulties in the preparation process, and the patent does not conduct in-depth research on the properties of the preparation, especially for the special requirements of traditional Chinese medicine injection preparations, the addition of antioxidants is not possible To ensure the long-term stability of the main drug, those skilled in the art cannot obtain safe preparations for clinical application

Method used

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  • Red sage root salvianolic acid A injection formulation for treating cardiovascular diseases and preparation process thereof
  • Red sage root salvianolic acid A injection formulation for treating cardiovascular diseases and preparation process thereof
  • Red sage root salvianolic acid A injection formulation for treating cardiovascular diseases and preparation process thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0127] Extraction and purification of salvianolic acid A:

[0128] Extract the salvia miltiorrhiza with water to obtain the water extract, adjust the pH value to 3.5, 110°C temperature, 0.05MPa pressure, and heat for 1 hour; the solution is filtered, and the filtrate is separated by HPD-100 macroporous resin column chromatography, firstly water, 10% dilute ethanol Elution, remove impurities, and then elute with 30% ethanol, collect the part containing salvianolic acid A, concentrate the eluate until it has no alcohol smell; the concentrated solution is separated by polyamide chromatography column, firstly use water, 20% ethanol solution Elution, the eluent was discarded, and then eluted with 95% ethanol solution, the eluent was collected, and the ethanol was concentrated to the utmost; the concentrated solution was adjusted to a pH value of 2, extracted with ethyl acetate, and the organic solvent phase was separated to obtain the drug-containing solution, concentrated, dried o...

Embodiment 2

[0130] Extraction and purification of salvianolic acid A:

[0131] Salvia miltiorrhiza was extracted with ethanol solution to obtain alcohol extract, the ethanol was concentrated until exhausted, the pH value was adjusted to 6.0, the temperature was 130°C, the pressure was 0.17MPa, and heating was carried out for 6 hours; the solution was filtered, and the filtrate was separated by HPD-100A macroporous resin column chromatography. Elute with water and 30% dilute ethanol to remove impurities, then elute with 70% ethanol to collect the part containing salvianolic acid A, and concentrate the eluate until it has no alcohol smell; use Sephadex LH-20 for the concentrate , first eluted with water and 20% ethanol solution, the eluent was discarded, and then eluted with 95% ethanol solution; the eluent was collected, and the ethanol was concentrated to the utmost; Extract and separate the organic solvent phase to obtain a drug-containing solution, concentrate, dry or freeze-dry to obta...

Embodiment 3

[0133] Extraction and purification of salvianolic acid A:

[0134] Extract the salvia miltiorrhiza with water to obtain the water extract, adjust the pH value to 5.0, 120°C temperature, 0.10MPa pressure, and heat for 4 hours; the solution is filtered, and the filtrate is separated by HPD-300 macroporous resin column chromatography, firstly water, 20% dilute ethanol Elution, remove impurities, and then elute with 50% ethanol, collect the part containing salvianolic acid A, concentrate the eluent until it has no alcohol smell; Elute, discard the eluent, and then elute with 75% ethanol solution, concentrate the ethanol to the utmost; adjust the pH value of the concentrated solution to 3, extract with the organic solvent butyl acetate, separate the organic solvent phase, and obtain the drug-containing solution, concentrate , dried or freeze-dried to obtain salvianolic acid A;

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Abstract

The invention discloses a salvianolic acid A for injection and its preparing process, wherein high efficiency liquid chromatography method is employed to determine salvianolic acid A in the raw material medicaments, the content of salvianolic acid A is between 92% and 100%, two foreign substances are present. The mass ratio of salvianolic acid A and anti-oxidizing agent in the preparation is 2-50:1, the pH of the injection is controlled to 3-7.

Description

technical field [0001] The invention relates to the technical field of traditional Chinese medicine pharmacy, in particular to a salvianolic acid A injection preparation for treating cardiovascular diseases and a preparation method thereof. Background technique [0002] The active ingredient is the material basis for the efficacy of traditional Chinese medicine. In recent years, the research on the active ingredient of traditional Chinese medicine has achieved fruitful results. More than 500 active monomers have been isolated from more than 190 kinds of traditional Chinese medicine. The pharmacological effects of these monomer components have been obtained. It is generally recognized that its content can generally reach about 80%, but its extraction rate is low and its druggability is low, and it can only be obtained in milligrams or micrograms. As a result, these active ingredients cannot be used in industrial production or in clinical practice. However, on the basis of for...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/216A61K36/258A61P9/00C07C69/732
Inventor 李志刚顾群金志刚渠守峰栗艳彬
Owner CHIATAI QINGCHUNBAO PHARMA
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