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Astragalus edge tablets and its quality control method

A quality control method, the technology of Qilentab, which is applied in the field of Qilentian and its quality control, can solve the problems of production control and quality supervision of unfavorable products, and achieve the supervision of product quality, good reproducibility, and drug safety Guaranteed effect

Active Publication Date: 2009-09-16
吉林万通药业集团梅河药业股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] The above quality standards only identify or determine the content of Curcuma and Mulberry, which is not conducive to the production control and quality supervision of the product.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0013] The method of quality control of Qilong tablets: Astragalus 570g, Sanleng (roasted with vinegar) 380g, Curcuma (cured with vinegar) 380g, Dilong (stir-fried with talcum powder) 380g, mulberry 570g, Trichosanthes 570g, Jiuxiangworm (slightly fried) ) 114g, and 570g raw material medicine of Xixuecao is made into 1000 tablets. This method includes:

[0014] (1) Identification of Curcuma: Take 20 tablets of this product, remove the coating, grind finely, add 30ml of petroleum ether (60-90°C), ultrasonicate for 30 minutes, filter, evaporate the filtrate to dryness, add petroleum ether (60-90°C) to the residue ℃) 0.5ml to dissolve, as the test solution. Another 1 g of curcuma reference medicinal material was taken, and the reference medicinal material solution was prepared in the same way. According to the test of thin-layer chromatography (Appendix VI B of the Chinese Pharmacopoeia 2005 edition), draw 5 μl of each of the above two solutions, respectively spot on the same s...

Embodiment 2

[0022] The method of quality control of Qilong tablets: Astragalus 570g, Sanleng (roasted with vinegar) 380g, Curcuma (cured with vinegar) 380g, Dilong (stir-fried with talcum powder) 380g, mulberry 570g, Trichosanthes 570g, Jiuxiangworm (slightly fried) ) 114g, and 570g raw material medicine of Xixuecao is made into 1000 tablets. This method includes:

[0023] (1) Curcuma identification: Same as Example 1.

[0024] (2) Mulberry identification: with embodiment 1.

[0025] (3) triangular identification: with embodiment 1.

Embodiment 3

[0027] The method of quality control of Qilong tablets: Astragalus 570g, Sanleng (roasted with vinegar) 380g, Curcuma (cured with vinegar) 380g, Dilong (stir-fried with talcum powder) 380g, mulberry 570g, Trichosanthes 570g, Jiuxiangworm (slightly fried) ) 114g, and 570g raw material medicine of Xixuecao is made into 1000 tablets. This method includes:

[0028] (1) Curcuma identification: Same as Example 1.

[0029] (2) Mulberry identification: with embodiment 1.

[0030] (3) Identification of Ulus chinensis: Same as in Example 1.

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Abstract

The invention relates to a Chinese medicine preparation, that is, astragalus edge tablets and its quality control method. 1000 astragalus edge tablets are prepared by a materail composed of 570g Astragalus, 380g of burreed (vinegar Sunburn), 380g of zedoary (vinegar Sunburn), 380g of earthworm (talc fried), 570g of mulberry, 570g of radix trichosanthis, 114g of aspongopus, 570g of Herba Siegesbeckiae. The method includes: identification of zedoary, mulberry, burreed and Herba Siegesbeckiae and Astragalus content measuring, each tablet containing no less than 0.08mg of Astragaloside IV C [41] H [68] O [14]. The quality standards of the invention can effectively monitor the production, in order to prevent the generation of wrong material casting, mistaken material casting and more or less casting, which is more conducive to product quality supervision, ensures product quality stability, and also protects the drug use safety of patients.

Description

technical field [0001] The invention relates to a traditional Chinese medicine preparation, i.e. Qilen tablet and its quality control method. Background technique [0002] In the prior art, Qileng Pian is a national protected variety of traditional Chinese medicine (protected variety number ZYB2072004168), formerly a national third-class new drug (Guoyao Zhunzi Z20020048, standard number: WS3-624(Z-124)-2004( Z). [Prescription] Astragalus 570g, Sanleng (stir-fried with vinegar) 380g, Curcuma (simmered with vinegar) 380g, Dilong (stir-fried with talcum powder) 380g, mulberry 570g, Trichosanthes 570g, Nine Fragrance Insect (slightly fried) 114g, Xishi Grass 570g. [Preparation method] Put the above eight flavors, triangular and zedoary in an extractor, add 10 times the amount of water to soak for 24 hours, heat and reflux, collect 6 times the amount of crude distillate for rectification, collect volatile oil, and set aside; Add 8 times the amount of water to decoct the slag an...

Claims

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Application Information

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IPC IPC(8): A61K36/9066A61K9/20A61P9/10A61P7/02G01N30/90A61K35/64A61K35/62
Inventor 孟昭敏
Owner 吉林万通药业集团梅河药业股份有限公司