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Preparation method of particles in formula of salvia miltiorrhiza bunge and quality detection method thereof

A technology of Danshen formula granules and a detection method, applied in the directions of pharmaceutical formulas, medical preparations containing active ingredients, measuring devices, etc., can solve the problem that the active ingredients cannot be guaranteed correspondingly, the properties are unstable, and it is difficult to ensure the safety and effectiveness of medicines for the masses. And other issues

Inactive Publication Date: 2011-02-02
SICHUAN FENGCHUN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, studies have shown that the properties of the main active ingredients of Danshen, tanshinone II A and salvianolic acid B, are unstable, so traditional Danshen decoction pieces not only contain large impurities, are inconvenient to carry and take, but also have low stability and are not easy to store
In addition, the traditional decoction method of Danshen decoction pieces is extremely troublesome. Patients do not know much about the amount of water added, soaking time, heat, decoction time, decocting first, and then lowering, etc., or are afraid of trouble, and do not decoct according to the requirements. Tanshinone IIA and salvianolic acid B are different in properties. Tanshinone IIA is a fat-soluble component, and the traditional method of boiling Chinese medicine with water cannot dissolve it. Although salvianolic acid B is a water-soluble component, the traditional method of boiling Chinese medicine with water The method can make it dissolve, but its thermal stability is not high, and it will lose more than 80% when it is decocted at a temperature higher than 60°C for about 10 minutes. Can't get full play or even no curative effect
At the same time, there is no relevant quality control standard, and its active ingredients cannot be guaranteed, making it difficult to ensure the safety and effectiveness of drug use for the masses.

Method used

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  • Preparation method of particles in formula of salvia miltiorrhiza bunge and quality detection method thereof
  • Preparation method of particles in formula of salvia miltiorrhiza bunge and quality detection method thereof
  • Preparation method of particles in formula of salvia miltiorrhiza bunge and quality detection method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0184] Example 1: Preparation method 1 of Danshen formula granules

[0185] Take 1000 grams of dried Salvia miltiorrhiza with no impurities, pulverize it into coarse powder with a pulverizer, put the Danshen coarse powder into an extraction tank, add 4000ml of ethanol with a concentration of 70%, heat to boiling, reflux for extraction for 1.5 hours, and collect the extract; The extract is filtered, and the filtrate is decompressed to recover ethanol at 55-65°C. After the ethanol is recovered, it can be spray-dried at about 85°C, and the obtained paste powder is collected for use; add water to the residual medicine residue in the extraction tank and heat it to boiling , Decoct for 1.5 hours, collect the decoction, filter, take the filtrate, concentrate under reduced pressure at 75~85℃ to a relative density of 1.03-1.20, spray dry at about 95℃, collect the obtained paste powder, and use it twice; For the prepared paste powder, add sucrose powder (or lactose powder) 1.5 times the to...

Embodiment 2

[0186] Example 2: Preparation method two of Danshen formula granules

[0187] Take 1000 grams of dried Salvia miltiorrhiza without impurities, pulverize it with a pulverizer into coarse powder, put the Salvia miltiorrhiza coarse powder into an extraction tank, add 4500ml of ethanol with a concentration of 75%, heat to boiling, reflux for extraction for 1.2 hours, and collect the extract; The extract is filtered. The filtrate is decompressed to recover ethanol at 55-60°C. After the ethanol is recovered, it can be spray-dried at about 85°C, and the obtained paste powder is collected for use; add water to the residual medicine residue in the extraction tank and heat it to boiling , Decoct for 1.2 hours, collect the decoction, filter, take the filtrate, concentrate under reduced pressure at about 80°C to a relative density of 1.05~1.10, spray dry at about 92°C, collect the obtained paste powder, and set aside; take twice to prepare Add sucrose powder (or soluble starch) with a weight...

Embodiment 3

[0188] Example 3: Detection method 1 of Danshen formula granules

[0189] Characters: should be yellow-brown to tan granules;

[0190] Ingredient identification:

[0191] Take 2g of this product, grind it finely, add 5ml of ether, shake, place for 1 hour, filter, evaporate the filtrate to dryness, add 1ml of ethyl acetate to the residue to dissolve it, as the test solution. Take 1g of Salvia miltiorrhiza reference medicinal material, and prepare the reference medicinal material solution in the same way. According to the Chinese Pharmacopoeia 2005 edition, an appendix VIB thin layer chromatography, draw 5μl of each of the above two solutions, and pour them on the same silica gel G thin layer plate. Ethyl ester = 19:1 is the developing agent, unfold, take out, and dry. In the chromatogram of the test product, spots of the same color appear on the corresponding position of the chromatogram of the control medicinal material;

[0192] Inspection: It should comply with the relevant regulat...

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Abstract

The invention provides a preparation method of particles in the formula of salvia miltiorrhiza bunge and a quality detection method thereof. The preparation method comprises the following steps: grinding the salvia miltiorrhiza bunge and extracting by two steps; firstly, adding alcohol, heating, extracting, spraying, drying and collecting powdered extract; secondly, adding water, heating, extracting, spraying, drying and collecting powdered extract; wherein the powdered extracts obtained by the two steps are added with auxiliary materials; and then adding proper water, granulating and drying to obtain a product. The method is simple, is low in cost and is suitable for industrial production. The detection method comprises part or whole items of characters, inspection, identification and content measurement, wherein the identification is carried out on the salvia miltiorrhiza bunge by using contrast drugs of the salvia miltiorrhiza bunge, and the content measurement is the content measurement of tanshinone IIA and / or content measurement of salvianolic acid B. The adopted identification is simple in method and strong in specificity; the content measurement is simple in method, high in accuracy and good in repeatability, and provides detection indexes, detection means and technical method and the like for production units and detection organizations, so that the production can be better guided, and the control of the production technique is more strict and reasonable. In the production process of products, the quality detection method can effectively control the quality of the products, thus ensuring clinical effects and safety of the particles in the formula of the salvia miltiorrhiza bunge.

Description

Technical field [0001] The invention relates to traditional Chinese medicine formula granules made of Danshen as raw materials instead of Danshen decoction pieces. Specifically, it relates to a preparation method of Danshen formula granules and a quality detection method of the Danshen formula granules. Background technique [0002] Salvia miltiorrhiza was first published in "Shen Nong's Materia Medica" and listed as top grade. "One flavor of salvia, power is the same as the four things" (rehmannia, angelica, white peony, chuanxiong), traditional medicine believes that: salvia integrates nourishing blood, promoting blood circulation, removing blood stasis, relieving pain, and producing new blood. It has significant effects and is gentle in nature and flavor. Tonic powder has no toxic side effects. Because Danshen has the effects of promoting blood circulation, regulating menstruation, removing blood stasis and relieving pain, cooling blood to eliminate carbuncle, clearing heart ...

Claims

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Application Information

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IPC IPC(8): G01N30/90A61P25/00A61K125/00A61P15/00A61P29/00A61K9/16A61K36/537A61P25/20A61P7/00G01N30/02A61P7/06
Inventor 钟茂团黎勇温国梁邹波古莉唐终国
Owner SICHUAN FENGCHUN PHARMA
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