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Salvianolic acid A injection and preparation method thereof

A technology of salvianolic acid and injection preparations, applied in the field of injection preparations and preparations of salvianolic acid A, capable of solving problems such as uneven quality, complex components, and uncontrollability

Active Publication Date: 2012-10-03
CHIATAI QINGCHUNBAO PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Traditional Chinese medicine injections have complex ingredients, unclear active substances, uneven, unstable, and uncontrollable quality, unstable clinical efficacy, and many adverse reactions. It is difficult to adapt to the requirements of modernization and internationalization of traditional Chinese medicine. The in-depth research on the basis of effective substances in traditional Chinese medicine, that is, the research from the effective parts of traditional Chinese medicine to the standard active ingredients is continuously deepened, and the curative substances are becoming clearer. The development of injections will be the development direction of traditional Chinese medicine injections in the future, and the quality control standards of traditional Chinese medicine injections will also be more systematic and precise. Not only should the active ingredients be accurately quantified, but the related substances / hazardous substances should also be qualitatively and quantitatively researched and controlled, so that the products The quality is uniform and the curative effect is stable, so as to ensure the safety and reliability of traditional Chinese medicine injections in clinical application

Method used

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  • Salvianolic acid A injection and preparation method thereof
  • Salvianolic acid A injection and preparation method thereof
  • Salvianolic acid A injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0089] Extract the salvia miltiorrhiza with water to obtain the water extract, adjust the pH value to 3.5, the temperature at 110°C, the gauge pressure at 0.05MPa, and heat for 1 hour; the solution is filtered, and the filtrate is separated by HPD-100 macroporous resin column chromatography. Elute with dilute ethanol to remove impurities, then elute with 30% ethanol, collect the part containing salvianolic acid A, and concentrate the eluate until it has no alcohol smell; the concentrated solution is separated by polyamide chromatography column, firstly use water, 20% Elute with ethanol solution, discard the eluent, then elute with 95% ethanol solution, collect the eluent, concentrate the ethanol until it is exhausted; adjust the pH value of the concentrated solution to 2, extract with ethyl acetate, and separate the organic solvent phase to obtain The drug-containing solution is concentrated, dried or freeze-dried, the dried product is dissolved in water, and recrystallized to ...

Embodiment 2

[0097] Extract the salvia miltiorrhiza with ethanol solution to obtain the alcohol extract, concentrate the ethanol to the utmost, adjust the pH value to 6.0, 130°C temperature, gauge pressure 0.17MPa pressure, and heat for 6 hours; the solution is filtered, and the filtrate is separated by HPD-100A macroporous resin column chromatography , first eluted with water and 30% dilute ethanol to remove impurities, and then eluted with 70% ethanol to collect the part containing salvianolic acid A, and the eluate was concentrated until it had no alcohol smell; the concentrated solution used Sephadex LH -20, first eluted with water and 20% ethanol solution, discarded the eluent, and then eluted with 95% ethanol solution; collected the eluent, concentrated the ethanol to the utmost; Propyl ester extraction, separation of the organic solvent phase to obtain a drug-containing solution, concentration, drying or freeze-drying, adding water to dissolve the dried product, and recrystallization...

Embodiment 3

[0105] Salvia miltiorrhiza was extracted with water to obtain water extract, adjusted to pH 5.0, temperature 120°C, gauge pressure 0.10MPa, heated for 4 hours; the solution was filtered, and the filtrate was separated by HPD-300 macroporous resin column chromatography, firstly water, 20% Elute with dilute ethanol to remove impurities, then elute with 50% ethanol, collect the part containing salvianolic acid A, and concentrate the eluate until it has no alcohol smell; the concentrated solution is separated by polyamide chromatography column, firstly use water, 35% Elute with ethanol solution, discard the eluent, then elute with 75% ethanol solution, concentrate the ethanol to the utmost; adjust the pH value of the concentrated solution to 3, extract with organic solvent butyl acetate, and separate the organic solvent phase to obtain a drug-containing solution , concentrated, dried or freeze-dried, the dried product was dissolved in water, and recrystallized to obtain salvianolic...

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Abstract

The invention discloses a salvia miltiorrhiza salvianolic acid A injection formulation and a preparation method thereof. The invention is characterized in that: the impurities in a bulk drug, namely the salvia miltiorrhiza salvianolic acid A comprise salvia miltiorrhiza salvianolic acid F and salvia miltiorrhiza salvianolic acid C; after the preparation of the formulation, the impurities in the injection formulation including the salvia miltiorrhiza salvianolic acid F and the salvia miltiorrhiza salvianolic acid C are subjected to high performance liquid chromatography measurement, the ratio between the peak area of the impurity salvia miltiorrhiza salvianolic acid F and that of the salvia miltiorrhiza salvianolic acid A of the injection formulation is more than 0 and less than 0.015, wherein, the ratio between the peak area of the impurity salvia miltiorrhiza salvianolic acid C and that of the salvia miltiorrhiza salvianolic acid A is more than 0 and less than 0.015, wherein, the ratio between the sum of the peak areas of the impurities of the injection formulation and the peak area of the salvia miltiorrhiza salvianolic acid A is more than 0 and less than 0.05; shown by pharmacological tests, the injection formation has good pharmacological actions.

Description

technical field [0001] The invention relates to the technical field of traditional Chinese medicines, in particular to an injection preparation of salvianolic acid A and a preparation method thereof. Background technique [0002] Traditional Chinese medicine injections refer to sterilized preparations processed and prepared by modern scientific methods on the basis of traditional Chinese medicine, folk prescriptions and unilateral prescriptions, according to the properties of medicinal materials and clinical needs, and are mainly used for acute and severe clinical treatment. my country's original new dosage form has unique effects that cannot be replaced by chemical medicine products, and has advantages that other dosage forms of traditional Chinese medicine cannot possess. Chinese medicine injection will be a project with potential advantages for my country's pharmaceutical industry to open up the international market in the future. my country's research and production of Chi...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/216A61K36/537A61K9/08A61K9/19A61P9/10
Inventor 顾群李志刚渠守峰金治刚米长江林治荣阮爱华
Owner CHIATAI QINGCHUNBAO PHARMA
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