Preparation and detection methods of salvia miltiorrhiza shuxin capsule

Abstract

The invention provides preparation and detection methods of a salvia miltiorrhiza shuxin capsule. The preparation method comprises the steps of soaking salvia miltiorrhiza serving as a raw material, and extracting by using ethanol to prepare clear paste; and adding auxiliary materials, and encapsulating to obtain the salvia miltiorrhiza shuxin capsule. The preparation method is simple, capable of completely retaining effective components and ensuring relatively-high effective component content and the quality of the salvia miltiorrhiza shuxin capsule, low in cost and also suitable for industrial production. The detection method comprises the steps of detecting effective components by taking a salvia miltiorrhiza reference medicine, a tanshinone IIA reference substance, a cryptotanshinone reference substance, a tanshinol reference substance, a salvianolic acid B reference substance and a protocatechualdehyde reference substance as references; and detecting content by taking salvianolic acid B as a reference substance. The adopted detection method for the components is strong in specificity, high in content detection accuracy, complete in effective component retention and capable of ensuring stable effective component content and the quality of the salvia miltiorrhiza shuxin capsule, so that all the components in salvia miltiorrhiza can take a synergistic effect, the curative effect is ensured, and the health of people is protected.

Description

technical field [0001] The invention relates to a method for preparing capsules from salvia miltiorrhiza as a raw material and a detection method for the capsules, in particular to a preparation method for Danshen Shuxin capsules and a detection method thereof. Background technique [0002] The original standard of Danshen Shuxin Capsules is recorded in the seventh volume of the Ministry of Health's drug standard "Chinese Medicine Prescriptions", the standard number is WS3-B-1294-93, and the prescription is a traditional Chinese medicine of Danshen medicinal material. After extracting the active ingredients, Danshen extract is obtained. Then add appropriate auxiliary materials to prepare pure Chinese medicine capsules, which have the functions of promoting blood circulation, removing blood stasis, calming the mind, and are clinically used to treat angina pectoris, chest tightness and palpitations caused by coronary heart disease. One of the commonly used medicines for angina...

AI Technical Summary

Problems solved by technology

However, people found that Danshen Shuxin Capsules, which should have a good effect on treating such diseases, are not satisfactory and the effect is very unstable. The reason is that the original standard of Danshen Shuxin Capsules was established in the 1980s It was formulated and included in the seventh volume of the Ministry of Health's drug standard "Prescriptions of Traditional Chinese Medicine" in 1993. Due to the technological level at that time, the standard was very low. Among the detection methods, there was only one TLC identification of tanshinone IIA reference substance. To test one of the index components, there is no more comprehensive detection method, and there is no content detection measure. In addition, the preparation method of Danshen Shuxin Capsules also has a big problem. Limited by the level of understanding at the time, the main components of Danshen were not clarified. and the properties and functions of the corresponding ingredients, and there is no advanced equipment and facilities, so the extraction, concentration and drying process of Danshen is not well controlled, and the process conditions such as temperature, time, extraction solvent and pressure during the entire preparation process are not controlled. The method is to decoct with water first, remove the water-soluble ingredients, and lose the ingredients that have a good therapeutic effect

In addition, the temperature of the decoction process is high, which destroys a lot of alcohol-soluble components.

Secondly, the method of heating and refluxing was also used for the extraction of alcohol-soluble components, and the method of heating and refluxing was used for 3 times for as long as 5 hours. 10 times the amount of water for precipitation, and then drying, the drying process can not completely avoid the loss of active ingredients, so the resulting drug is not comprehensive active ingredients, the content of active ingredients is very low, the quality of the drug is very poor , can not achieve a better therapeutic effect, not only wasting resources, but also delaying the treatment of patients, so it is necessary and urgent to find a better extraction and preparation method

[0003] Modern studies have shown that Danshen contains tanshinone ⅡA, cryptotanshinone, danshensu, salvianolic acid B, protocatechualdehyde and other components, which have the effects of expanding coronary arteries, improving coronary circulation, and inhibiting thrombus. Together they have a synergistic effect, so Salvia miltiorrhiza has the effects of promoting blood circulation and removing blood stasis, regulating qi and relieving pain, and has a good effect on the cardiovascular system, such as strengthening myocardial contractility, improving heart function, expanding coronary arteries, increasing myocardial blood flow, Anti-thrombosis, lower blood viscosity, etc., generally show the effects and effects of Danshen on nourishing blood, promoting blood circulation, removing blood stasis, relieving pain, and generating new blood, but the main active ingredients of Danshen, such as tanshinone Ⅱ A and salvianolic acid B, are unstable , are not resistant to high temperature, and even at a temperature higher than 60 ° C, it will lose more than 50% when heated for about 20 minutes at a low concentration

[0004] There are big problems in the preparation method of the original standard Danshen Shuxin Capsules, and there is no good detection method for the prepared capsules, so the quality of the product cannot be guaranteed at all, and the curative effect of the product cannot be guaranteed. It is a waste of resources and a waste of patients. The treatment is also a kind of delay. It is people's expectation and wish to find a preparation method and detection method that can solve the above problems, ensure the quality of the drug, ensure the safety and effectiveness of the drug, make the patient recover soon, and protect the health of the people.

[0005] For the extraction of the active ingredients of Salvia miltiorrhiza, there are still great limitations, such as the loss of active ingredients during the extraction process, the inability to make high-concentration extracts after extraction, the drying process of the extracts causes further loss of active ingredients, and the extraction process is too Complicated, flammable and explosive hazards in the extraction process, etc.

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