Preparation method and quality control method of sugar-free stranguria-treating and calculus-removing particles

A quality control method and sugar-free technology, which can be applied to medical preparations without active ingredients, medical preparations containing active ingredients, pharmaceutical formulas, etc., which can solve the uncertainty of drug safety and effectiveness, and it is difficult to ensure drug quality. , control of total flavonoid content of active ingredients, etc.

Inactive Publication Date: 2013-03-20
GUANGXI JIANFENG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, since the granules use sucrose as an auxiliary material and have high sugar content, they are not suitable for patients with diabetes, hypertension, hyperlipidemia and obesity.
[0004] At present, the drug standard implemented by Shilintong Granules is WS3-B-1520-93. This standard does not control the content of total flavonoids in the active ingredients in the drug. There are hidden dangers of uncertain drug safety and effectiveness, and it is difficult to guarantee the quality of the drug.

Method used

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  • Preparation method and quality control method of sugar-free stranguria-treating and calculus-removing particles

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] (1) Extraction Take 1500g of Desmodium glabra, put it into a multi-functional tank after pre-treatment, and heat it to 95-100°C under normal pressure to extract twice, add 8 times the weight (w / w) of water for the first time, Add 6 times the weight (w / w) of water for the second time, extract for 1 hour each time, filter with a 200-mesh filter cloth, and combine the filtrates;

[0027] (2) Concentration Concentrate the filtrate from step (1) to a clear paste with a relative density of 1.20 (thermal measurement, 70-80°C), collect the concentrated solution, and filter it with a 200-mesh filter cloth;

[0028] (3) Alcohol precipitation Move the concentrated solution of step (2) to the ethanol precipitation tank, cool to room temperature, add 95% ethanol about 2.2 times the amount of clear paste to make the alcohol content reach about 65%, stir evenly, and let it stand 24 hours;

[0029] (4) Recover the ethanol and take the supernatant of step (3), filter it through a 200-m...

Embodiment 2

[0033] The relative density in step (5) is 1.24, 700 g of maltodextrin, 750 g of calcium hydrogen phosphate, 3 g of protein sugar, 7 g of xylitol, and 4 g of cyclamate in step (6), and the others are basically the same as in Example 1.

Embodiment 3

[0035] The relative density in step (5) is 1.26, maltodextrin 1430g, stevioside 10g in step (6), and others are basically the same as in Example 1.

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Abstract

The invention discloses a preparation method and quality control method of sugar-free stranguria-treating and calculus-removing particles. Based on the original preparation process of stranguria-treating and calculus-removing particles, the inventor removes a large amount of sugar powder in the original process, and uses a proper amount of non-sugar adjuvant instead; the particles are prepared after materials are stirred to be soft, thus not only reducing the viscosity of the medicine, but also being beneficial to particle preparation; and the prepared particles are good in granularity, uniform in color and good in dissolvability. In addition, to alleviate the bitter taste, a proper amount of glycoprotein, steviosin, xylitol or sodium cyclamate which contains no heat and has no side effect is selected to be added as the corrigent, so the stranguria-treating and calculus-removing particles are comfortable in mouthfeel, convenient to take, and also applicable to patients suffering from diabetes, hypertension, hyperlipemia and obesity; and worry about side effects is unnecessary when the particles are taken. To ensure the medicine use safety and effectiveness of the stranguria-treating and calculus-removing particles product, the inventor maintains the original qualitative identification and adds quantitative measurement, and through measuring the quantity of total flavones in the particles, the medicine use safety and effectiveness are ensured, and the quality level of the relevant product of the stranguria-treating and calculus-removing particles are improved.

Description

technical field [0001] The invention belongs to the field of traditional Chinese medicine preparations, in particular to a preparation method and quality control method of sugar-free Shilintong granules. Background technique [0002] Traditional Chinese medicine preparations are easy to take and effective, and are deeply loved by patients. However, with the increase of people's diseases caused by excessive consumption of sugar, especially patients with diabetes, hypertension, hyperglycemia and obesity, when taking traditional Chinese medicine preparations, they are more eager to satisfy the premise of high sweetness and low calorie. , a sugar-free non-nutritive sweet traditional Chinese medicine preparation that is safe, healthy and does not participate in human metabolism. [0003] Shilintong granule is a variety recorded in the eighth volume of standard traditional Chinese medicine preparations issued by the Ministry. It is a granule extracted and processed from Desmodium...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K36/53A61K9/16A61K47/42A61K47/26A61P13/04A61P13/12A61P1/16G01N21/33G01N31/02
Inventor 黄大权梁可文韦丽萍
Owner GUANGXI JIANFENG PHARMA
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