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Preparation technology of radix salviae miltiorrhizae tablets

A preparation process, a technology of Danshen decoction pieces, applied to medical preparations with no active ingredients, medical preparations containing active ingredients, plant raw materials, etc., can solve the problem of unstable sources, large differences in the content of index components, and poor efficacy of taking medicines, etc. problems, to achieve the effect of stable content and yield, stable and controllable content, and neat appearance

Inactive Publication Date: 2019-11-26
上海蔡同德堂中药制药厂有限公司
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Problems solved by technology

It is manifested that the quality of qualified raw medicinal materials in the market is uneven (there are many sources of origin, and the contents of extracts and index components vary greatly); the source of medicinal herb pieces in the traditional Chinese medicine extraction process is unstable, and at the same time, the extraction process consumes a lot of energy and materials, and there are many impurities. The efficiency is low. In view of the fact that the active ingredient salvianolic acid B is unstable to heat, the functional ingredients are unstable, and degradation will also occur after being made into tablets. The degradation of salvianolic acid B in the tablet makes the drug effect poor for patients and affects drug effectiveness

Method used

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  • Preparation technology of radix salviae miltiorrhizae tablets

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preparation example Construction

[0047] ※Preparation of reference substance solution: Accurately weigh an appropriate amount of salvianolic acid B reference substance, add methanol-water (8:2) mixed solution to make a solution containing 0.10mg per 1ml, and obtain it.

[0048] ※Preparation of the test solution: Take about 0.15g of the powder of this product (passed through a No. 3 sieve), weigh it accurately, put it in a stoppered Erlenmeyer flask, add 50ml of methanol-water (8:2) mixed solution, and seal it tightly. , weighed, ultrasonically treated (power 140W, frequency 42kHz) for 30 minutes, allowed to cool, weighed again, and made up the lost weight with methanol-water (8:2) mixed solution, shake well, filter, and accurately measure Take 5ml of the continued filtrate, transfer it to a 10ml measuring bottle, add methanol-water (8:2) mixed solution to dilute to the mark, shake well, filter, take the continued filtrate, that is.

[0049] ※Determination method: Precisely draw 10μl each of the reference subst...

Embodiment 1

[0052] Every 1000 coated tablets is made of the following raw materials and auxiliary materials in the weight ratio: 1500g of spray-dried salvia miltiorrhiza root powder, 33g of calcium sulfate, 20.5g of starch, 16g of talcum powder, and 1% of the dry granule amount of magnesium stearate.

[0053] Its production process is as follows:

[0054] (1) Cut the two different medicinal materials of Salvia miltiorrhiza in total 1000g into inch segments, and detect the salvianolic acid B content and extract; the salvianolic acid B content is 6.5%; 8.8%; the extract is 82.9% and 64.5%.

[0055] (2) According to the test results, two different decoction pieces were prepared in proportion to extract 70.0% and salvianolic acid B 8.1%;

[0056] (6) Put the formula medicinal material in the extraction tank, add 3 times the volume of 90% ethanol to extract for 1.0 hour, filter, and concentrate the alcohol extract for later use;

[0057] (4) Add 3.5 times the volume of water to the dregs, ext...

Embodiment 2

[0063] Every 1000 coated tablets is made of the following raw materials and auxiliary materials in the weight ratio: 1500g of spray-dried salvia miltiorrhiza root powder, 33g of calcium sulfate, 20.5g of starch, 16g of talcum powder, and 1% of the dry granule amount of magnesium stearate.

[0064] Its production process is as follows:

[0065] (1) Cut the two different medicinal materials of Salvia miltiorrhiza in total 1000g into inch segments, and detect the salvianolic acid B content and extract; the salvianolic acid B content is 6.5%; 8.8%; the extract is 82.9% and 64.5%.

[0066] (2) According to the test results, two different decoction pieces were prepared in proportion to extract 70.0% and salvianolic acid B 8.1%;

[0067] (6) Put the formula medicinal material in the extraction tank, add 3 times the volume of 90% ethanol to extract for 1.0 hour, filter, and concentrate the alcohol extract for later use;

[0068] (4) Add 3.5 times the volume of water to the dregs, ext...

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Abstract

The invention provides a preparation technology of radix salviae miltiorrhizae tablets. The preparation technology comprises the steps of cutting radix salviae miltiorrhizae medicinal materials in different batches into segments, detecting the extracts of radix salviae miltiorrhizae decoction pieces, and detecting the content of effective components, wherein (Chinese Pharmacopoeia) the radix salviae miltiorrhizae medicinal materials contain 3.0% or above of Salvianolic acid B, the total extracts are not less than 50.0%, according to different extracts and the content of the effective components, preparation is performed, so that the total extracts are 65%-75%, and the content of the Salvianolic acid B is 7%-9%; placing the decoction pieces prepared in the proportion in an extracting tank,adding 90% alcohol, performing extraction for 1.0 hour, and concentrating outlet liquid; adding water, and performing extraction for 1.5 hours; concentrating outlet liquid; merging the concentrated liquid, and then performing concentration once again; and performing spray drying, collecting powder, then performing granulation, and performing tabletting so as to obtain the radix salviae miltiorrhizae tablets. The preparation technology is suitable for industrial production.

Description

technical field [0001] The invention relates to a preparation process of Danshen tablets, which belongs to the field of pharmaceutical preparations. Background technique [0002] Danshen tablet is a variety recorded in the Chinese Pharmacopoeia. It is a commonly used drug for treating coronary heart disease and cardiovascular disease. It has the characteristics of definite and certain curative effect and small side effects. The prescription of Danshen tablets included in the text of the 2015 edition of "Chinese Pharmacopoeia": Preparation method: Take 1000g of Danshen, add 90% ethanol to reflux for 1.5 hours, filter, recover the ethanol from the filtrate to a thick ointment; add water to decoct the dregs for 1 hour, filter The filtrate is combined with the above-mentioned thick paste, concentrated under reduced pressure to an appropriate amount, added an appropriate amount of auxiliary materials, mixed evenly, dried, made into granules, pressed into 1000 tablets, coated with...

Claims

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Application Information

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IPC IPC(8): A61K36/537A61K9/28A61K47/36A61P9/00A61P9/10
CPCA61K9/2059A61K9/28A61K36/537A61K2236/331A61K2236/333A61K2236/51A61P9/00A61P9/10
Inventor 汤洁厉鹏陶启民徐尤君卢年海
Owner 上海蔡同德堂中药制药厂有限公司
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