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Compound brain activation and comfort capsule and quality control method thereof

A quality control method and technology of Huonaoshu Capsules, applied in the field of traditional Chinese medicine preparations, can solve problems such as being unfavorable to product production control and quality supervision, unfavorable to patient medication safety, etc., and achieve the prevention of wrong feeding, the method is simple, and the reproducibility is good. Effect

Inactive Publication Date: 2009-09-02
吉林省辉南长龙生化药业股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] The original quality standard did not carry out the identification or content determination of the drug, which is not conducive to the production control and quality supervision of the product, and is not conducive to the drug safety of patients.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] The quality control methods of Fufang Huonaoshu Capsules (Z20026288) include:

[0023] (1) Identification of ginseng: take 4g of the product content, add 40ml of chloroform, sonicate for 20 minutes, discard the chloroform layer, evaporate the residue to dry the solvent, add 30ml of n-butanol saturated with water, sonicate for 40 minutes, absorb the supernatant, Add 2 times the amount of ammonia test solution to wash once, then add 20ml of water to wash, discard the water layer, evaporate the n-butanol solution to dryness, add 2ml of methanol to the residue to dissolve, and use it as the test solution. Take another ginsenoside Rgl, Re reference substance, add methanol to make a mixed solution containing 2mg per 1ml, as the reference substance solution. According to the test of thin-layer chromatography (Appendix VIB, 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 chlo...

Embodiment 2

[0038] The quality control methods of Fufang Huonaoshu Capsules (Z20026288) include:

[0039] (1) Ginseng Identification: Same as Example 1.

[0040] (2) Lycium barbarum identification: with embodiment 1.

[0041] (3) Identification of Salvia miltiorrhiza: same as Example 1.

Embodiment 3

[0043] The quality control methods of Fufang Huonaoshu Capsules (Z20026288) include:

[0044] (1) Determination of total nitrogen content: the same as in Example 1.

[0045] (2) Determination of amino nitrogen content: same as in Example 1.

[0046] (3) Schisandra content determination: same as Example 1.

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Abstract

The invention relates to a traditional Chinese medicine preparation, in particular to a compound brain activation and comfort capsule and a quality control method thereof. The method comprises one of the following steps or some of the following steps: (1) ginseng authentication, (2) medlar authentication, (3) Salvia miltiorrhiza authentication, (4) total nitrogen content measurement, (5) amino nitrogen content measurement and (6) shizandra berry content measurement. In the Salvia miltiorrhiza authentication process, positions on a chromatogram of a tested sample, which correspond to the positions on a chromatogram of a contrast sample show spots with same colors; in the total nitrogen content measurement process, the nitrogen (N) content of each capsule is no less than 15 mg; in the amino nitrogen content measurement process, the amino nitrogen content of each capsule is no less than 1.0 mg; and in the shizandra berry content measurement process, the shizandra berry content counted as shizandra berry schizandrin (C24H32O7) of each capsule is not less than 30 microgrammes. The quality control method has more quality control items so as to better control the quality of the product and effectively supervise the production, is beneficial to the supervision of the quality of the product and ensure the stability of the quality of the product and the safety of patients taking medicine.

Description

technical field [0001] The invention relates to a traditional Chinese medicine preparation, namely compound Huonaoshu capsule and a quality control method thereof. Background technique [0002] In the prior art, Fufang Huonaoshu jiaonang (Fufang Huonaoshu jiaonang) is approved by the Chinese Medicine Z20026288, and the prescription is: pig brain 2000g, schisandra 200g, Radix Ophiopogon japonicus 100g, ginseng 50g, medlar 50g, rehmannia glutinosa 50g, salvia miltiorrhiza 50g, dextrin 2.5 g, pepsin 60g. Preparation method: The above seven flavors and ginseng are crushed into fine powder and set aside. Add 1100ml of pig brain water to homogenate, adjust the pH value to 1.5-2.0 with hydrochloric acid, add pepsin, stir well, incubate at 37°C-40°C for 8-10 hours, then incubate at 100°C for 40 minutes, let stand, centrifuge, Take the supernatant, spray dry, and set aside. Add water to decoct the rest of Schisandra chinensis and other five-flavored medicinal materials twice, the ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K36/8968A61K9/48A61P25/28A61P1/14G01N30/36G01N30/90A61K35/30
Inventor 张弘
Owner 吉林省辉南长龙生化药业股份有限公司
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