Danshen root extract, production, medicine preparation and inspection thereof

Abstract

An extract of red sage root for preparing the injection to treat coronary heart disease and angina pectoris contains danshensu, protocathechuic aldehyde and danshinolic acid. Its preparing process and test method are also disclosed.

Description

Technical field [0001] The invention relates to an extract of the effective part of Chinese medicinal materials, in particular to a new salvia miltiorrhiza extract, a preparation method thereof, a pharmaceutical preparation containing the same, and a detection method. Background technique [0002] With the increasing trend of population aging, the incidence of cardiovascular and cerebrovascular diseases is increasing, blood viscosity increases, chest tightness, coronary heart disease, angina pectoris and myocardial infarction are more common. Every year 60 million patients in the world receive heparin treatment (including more than 10 million in our country) to prevent various thromboembolic diseases. These symptoms are not fully treated with chemical drugs and can not be treated simultaneously. The traditional Chinese medicine Salvia miltiorrhiza is the labiatae plant Salvia miltiorrhiza The dry roots and rhizomes of Salvia Miltiorrhiza Bge. are bitter in taste, slightly cold in...

AI Technical Summary

Problems solved by technology

As far as the current Danshen preparation is concerned, because the content of active ingredients is low and unstable, coupled with the unstable quality of medicinal materials, the quality of Danshen preparations is uneven, and the clinical efficacy is greatly affected.

CN1352985 discloses a new preparation method of Salvia miltiorrhiza extract, although it is improved compared to the old technology, the content of the prepared extract is still very low, and the yield is also low (0.4%), and such content cannot be prepared into injection Liquid requirements, so limited in use

[0004] In the prior art, the content determination method of Salvia miltiorrhiza extract has large errors, and cannot truly reflect the content of each component, which is much higher than the actual

The method of quality control of Danshen: (1) In the early days, the method of controlling the quality of Danshen extract was to measure the ultraviolet absorption value of the solution, and use the ultraviolet absorption value not lower than a certain value as an indicator of quality control. Obviously, this method is very rough (2) Later, the national standard was raised by HPLC method, using danshensu and protocatechuic aldehyde as reference substances to calculate, 250ml (equivalent to 16g of medicinal materials) containing danshensu ≥ 80mg, containing protocatechuic aldehyde ≥ 12mg, this method only It is not comprehensive to use Danshensu and / or Protocatechualdehyde to evaluate the Danshen extract containing more than a dozen components, and its error is very large; (3) Use salvianolic acid A and / or B as the reference substance to determine Salvianolic acid A and / B or determination of total phenolic acid is used as a standard for quality control. This method still uses local evaluation of all, no matter using UV method or HPLC method, the reference substance salvianolic acid A / B and other components in the extract The response values ​​​​are different, so the overall error is still very large