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Method for detecting quality of Xinning capsule

A quality inspection method and capsule technology, which can be used in measuring devices, pharmaceutical formulas, cardiovascular diseases, etc., can solve problems such as the failure of sample recovery rate to meet the requirements and the inability to effectively control the quality, so as to achieve easy quality control and stable methods , good reproducibility

Active Publication Date: 2012-05-30
GUIYANG XINTIAN PHARMA CO LTD
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AI Technical Summary

Problems solved by technology

The determination of the content in the quality standard of Yuanxinning Tablets is to detect the danshensu sodium contained in the Danshen medicinal materials in the prescription. The methodological research on the content of danshensu sodium is carried out. The recovery rate of the sample addition does not meet the requirements, so its quality cannot be effectively controlled.

Method used

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  • Method for detecting quality of Xinning capsule
  • Method for detecting quality of Xinning capsule
  • Method for detecting quality of Xinning capsule

Examples

Experimental program
Comparison scheme
Effect test

preparation example Construction

[0069] 3.2 Preparation of reference solution

[0070] Reference substance stock solution: Accurately weigh 18.15mg of salvianolic acid B reference substance, put it in a 50ml measuring bottle, add 75% methanol solution, dissolve and dilute to the mark, shake well, and obtain a solution containing 0.363mg per 1ml.

[0071] Reference substance solution ① Precisely measure 10ml of the above-mentioned reference substance stock solution, put it in a 50ml measuring bottle, add 75% methanol solution to dissolve the bottle to dilute to the mark, shake well, and obtain a solution containing 72.6μg per 1ml.

[0072] Reference substance solution ② Precisely measure 2ml of the above-mentioned reference substance stock solution, put it in a 5ml measuring bottle, add 75% methanol solution to dissolve the bottle to dilute to the mark, shake well, and obtain a solution containing 145.2μg per 1ml.

[0073] 3.3 Chromatographic condition test

[0074] method one

[0075] Chromatographic column...

Embodiment

[0135] A quality detection method for Xinning Capsules, comprising the steps of:

[0136] (1) Identification:

[0137] a. Take 3g of the content of this product, add 50ml of ether, ultrasonically treat for 20 minutes, filter, and use the dregs for later use. The filtrate was evaporated to dryness, and the residue was dissolved in 1ml of ethyl acetate as the test solution. In addition, take 1 g of Chuanxiong as a reference drug, add 20 ml of ether, and make a solution of the reference drug in the same way. According to the test of thin-layer chromatography (Appendix VI B, Chinese Pharmacopoeia 2005 Edition), draw 5 μl of each of the above two solutions, respectively spot on the same silica gel G thin-layer plate, and use n-hexane-ethyl acetate (9:1) as Developing agent, develop, take out, dry, and inspect under ultraviolet light (365nm). In the chromatogram of the test product, at the position corresponding to the chromatogram of the control medicinal material, there are flu...

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Abstract

The invention discloses a method for detecting quality of a Xinning capsule, which comprises the following steps: identification: carrying out TLC checking on szechuan lovage rhizome, notoginseng, rutin and paeoniflorin; content determination: determining a high-efficient liquid-phase chromatography; a. test on chromatographic condition and system adaptability test; b. preparation of contrast solution, precisely weighing salvianolic acid B with suitable amount; adding 50% carbinol in the salvianolic acid B to prepare a solution (namely the contrast solution) of 70 mug / ml; c. preparation of solution to be detected; and d. determination method. The checking shall comply with all provisions of the capsule items. The method has good stability and good repeatability and is beneficial to controlling the quality of a product.

Description

technical field [0001] The invention belongs to the field of quality control of traditional Chinese medicine preparations, in particular to a quality detection method for Xinning capsules. Background technique [0002] Xinning capsule is composed of 300g of salvia miltiorrhiza, 150g of Sophora japonica, 150g of Chuanxiong, 54g of notoginseng, 150g of safflower, 150g of Jiangxiang, and 150g of red peony. The above seven flavors, Panax notoginseng, and Chuanxiong are crushed into fine powder, sieved, and set aside; for the other five flavors such as salvia miltiorrhiza, add 8 times the amount of water to decoct for 3 hours for the first time, add 6 times the amount of water to decoct for 2 hours for the second time, and decoct for the third time Add 6 times the amount of water to decoct for 1 hour, combine the decoction, filter, and concentrate the filtrate into a clear paste with a relative density of 1.05-1.15 (60-70°C), dry it, mix it with the above fine powder, granulate, ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/90G01N30/36A61K36/71A61P9/10
Inventor 董大伦
Owner GUIYANG XINTIAN PHARMA CO LTD
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