Red sage root A magnesium injection preparation and preparation method thereof

Abstract

The present invention discloses a salvianolic acid A injection preparation and the preparation method, the components are salvianolic acid A and pharmaceutical excipients, the present invention is characterized in that the pharmaceutical excipients are vitamin C, the weight ratio of the salvianolic acid A and the vitamin C is 16 to 25 :1, the preferential weight ratio of the salvianolic acid A and the vitamin C is 20:1; the toxicological experiments show that the salvianolic acid A injection preparation of the application has better safety; and the pharmacological experiments indicate that all the groups of the preparation of the application have great pharmacological effects.

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 and a preparation method thereof. Background technique [0002] Salvianolic acid A is formed by the condensation of one molecule of danshensu and two molecules of caffeic acid, and contains multiple active groups such as phenolic hydroxyl groups, hydroxyl groups, and ester bonds. The raw material of salvianolic acid A is basically stable under long-term storage at room temperature, but It is easy to oxidize and degrade in aqueous solution, mainly because it is very sensitive to pH value under the condition of aqueous solution, it is easily hydrolyzed under neutral to alkaline conditions, relatively stable at room temperature and low temperature, and basically stable to light. Therefore, when salvianolic acid A is made into injection preparations, its stability has become an insurmountable technical barrier. ...

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Problems solved by technology

[0003] 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

[0004] Our patent application CN1969822A discloses that salvianolic acid A and antioxidants are formulated into injection preparations. Preliminary studies have been conducted on the weight ratio of antioxidants to salvianolic acid A, and salvianolic acid A has been preliminarily determined. The ratio of A to antioxidant is 1-50:1. Although the stability of salvianolic acid A has been solved to a certain extent, the best combination has not been selected according to the pharmaceutical characteristics and biological characteristics of the preparation. Further creative work by R&D personnel is required to arrive at the best choice

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