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Quality control of compound Danshen root drops

A quality control method, the technology of compound salvia miltiorrhiza, applied in the direction of pill delivery, measuring device, pharmaceutical formula, etc.

Active Publication Date: 2008-04-16
TIANJIN TASLY PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Now, there are many methods for the determination of active ingredients in Danshen such as tanshinone and danshensu, and active ingredients in Sanqi such as notoginseng saponin R g1 , Ginsenoside R g1 There are many assay methods, but how to carry out the macroscopic quality control method of compound Danshen dripping pill preparation quality control from a more macroscopic point of view has not been reported yet.

Method used

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  • Quality control of compound Danshen root drops
  • Quality control of compound Danshen root drops
  • Quality control of compound Danshen root drops

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0144] Embodiment one (preparation example)

[0145] Weigh 41.06g of Salvia miltiorrhiza and 8.03g of Panax notoginseng, add water to decoct twice, measure water 4 times for 2 hours for the first time, measure water 3 times for 1 hour for the second time, filter, combine the filtrates, concentrate to a specific gravity of 1.19-1.20( 75±1°C), add ethanol with a concentration of about 90% until the ethanol content is 65% (20°C), let it stand for 12 hours, separate the supernatant, recover the ethanol, concentrate until the relative density of the liquid is 1.37 (55-60 ℃), to obtain the Radix Notoginseng Extract. Take the above-mentioned Danshen Sanqi extract and 0.46g of borneol, mix it with 18g of polyethylene glycol-6000 evenly, heat it to a temperature of 85°C, and after 80 minutes of mixing, move it to a dripping tank of a dripping machine whose tank temperature is kept at 86°C . Drop the drug liquid into liquid paraffin at 8°C, take out the dropping pills, remove the oil,...

Embodiment 2

[0146] Embodiment two (preparation example)

[0147] Weigh 59.36g of Salvia miltiorrhiza and 6.38g of Panax notoginseng, add water to decoct twice, measure 4 times of water for 2.5 hours for the first time, and measure 3 times of water for 1.5 hours for the second time, filter, combine the filtrates, and concentrate until the specific gravity is 1.19-1.20( 75±1°C), add ethanol with a concentration of about 85% until the ethanol content is 70% (20°C), let it stand for 10 hours, separate the supernatant, recover the ethanol, concentrate until the relative density of the liquid is 1.35 (55-60 ℃), to obtain the Radix Notoginseng Extract. Take the above-mentioned Danshen Sanqi extract and 0.34g of borneol, mix it with 23g of polyethylene glycol-6000 evenly, heat it to a temperature of 89°C, and after 100 minutes of mixing, move it to a dripping tank of a dripping machine whose tank temperature is kept at 85°C . Drop the liquid medicine into methyl silicone oil at 8°C, take out th...

Embodiment 3

[0148] Embodiment three (preparation example)

[0149] Weigh 31.12g of salvia miltiorrhiza and 9.21g of notoginseng, add 0.5% sodium hydroxide of the total amount of medicinal materials, decoct twice, the first time 4 times the amount of water for 1.5 hours, the second time 3 times the amount of water for 1.5 hours, filter, and the filtrate Combine and concentrate until the specific gravity is 1.19-1.20 (75±1°C), add ethanol with a concentration of about 88% until the ethanol content is 66% (20°C), let stand for 10 hours, separate the supernatant, reclaim the ethanol, and concentrate to The relative density of the liquid medicine is 1.40 (55-60° C.), and the extract of Danshen Sanqi is obtained. Take the above-mentioned Danshen Sanqi extract, 0.50 g of borneol, 90 g of mannitol, 15 g of edetate calcium sodium and 15 ml of distilled water, mix the above components, freeze-dry, and make a powder injection.

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Abstract

The invention relate to quality control method of compound Danshen root drops. The method comprises: measuring the fingerprint pattern of the compound Danshen root drops control sample by high efficiency liquid chromatography; measuring the fingerprint pattern of product to be measured of the compound Danshen root drops by the same method and in the same condition; comparing two results. When the absorption peak numbers of two results achieve the value described in the invention, the product to be measured is qualified.

Description

technical field [0001] The invention relates to a quality control method for compound danshen dripping pills, in particular to controlling the quality of compound danshen dropping pills by using a fingerprint detection method. Background technique [0002] Cardiovascular and cerebrovascular diseases are common diseases that seriously endanger human beings. In recent years, due to social development, changes in work, life, diet and environment, cardiovascular and cerebrovascular diseases are on the rise. For the treatment of cardiovascular diseases, although the single-target effect of traditional Chinese medicine is lower than that of western medicine, its multi-channel, multi-target, dynamic overall treatment, and less toxic and side effects are far beyond the reach of western medicine. Chinese patent medicine with definite curative effect The comprehensive treatment effect of traditional Chinese medicine is more than that of western medicine. Compound Danshen preparation...

Claims

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Application Information

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IPC IPC(8): G01N33/15A61K36/53A61K9/20A61P9/00G01N30/88G01N30/02
Inventor 程翼宇叶正良吴永江范骁晖王毅孙玉侠李淑菊
Owner TIANJIN TASLY PHARMA CO LTD
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