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Quality control method of kidney-replenishing blood-nourishing soft capsule

A quality control method and soft capsule technology, which can be used in capsule delivery, medical preparations containing active ingredients, blood diseases, etc., and can solve problems such as cumbersome processes

Inactive Publication Date: 2006-12-20
CSPC ZHONGQI PHARM TECH (SHIJIAZHUANG) CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This process needs to be weighed first, then reflowed, and finally weighed again, the process is cumbersome

Method used

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  • Quality control method of kidney-replenishing blood-nourishing soft capsule
  • Quality control method of kidney-replenishing blood-nourishing soft capsule
  • Quality control method of kidney-replenishing blood-nourishing soft capsule

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0140] Embodiment 1: the quality control method of Bushen Yangxue Soft Capsules

[0141] Weigh 480g Polygonum multiflorum, 120g Angelica, 240g Black Bean, 120g Achyranthes bidentata (salt), 120g Poria, 120g Cuscuta, 60g Psoralen (salt), 120g Lycium barbarum according to the prescription, and add 8 times the amount of the above eight herbs Extract with 70% ethanol three times, each time for 1.5 hours, combine the decoction, filter, and recover the filtrate from ethanol to obtain a clear ointment for later use; add 10 times the amount of water to decoct the medicinal residue twice, each time for 1 hour, filter, and recover the filtrate for later use . Combine the above two clear pastes, continue to concentrate to the clear paste with a relative density of 1.25 (50°C), spray dry, collect the dry powder, pass through a 120 mesh sieve, add vegetable oil, lecithin, beeswax and other auxiliary materials, stir well, and press 1000 soft capsules Grains, that is.

[0142] 10 batches o...

Embodiment 2

[0161] Embodiment 2: the quality control method of Bushen Yangxue Soft Capsules

[0162] The kidney-tonifying and blood-reinforcing soft capsules were prepared by the same preparation method as in Example 1.

[0163] 1. Determination according to the following high performance liquid chromatography:

[0164] Chromatographic conditions: the mobile phase acetonitrile-water volume ratio is 20:80; the detection wavelength is 320nm.

[0165] Preparation of the reference solution: the same as in Example 1 to prepare a solution with a concentration of 60 μg / ml.

[0166] The preparation of need testing solution: get this product content, mix, get about 0.50g, weigh accurately, all the other are with embodiment 1.

[0167] Determination method: the same as in Example 1, the calculated result is that the content of stilbene glycoside is 3.2mg / 0.65g.

[0168] 2. Identification by TLC

[0169] TLC Identification of Radix Polygoni Multiflori

[0170] (1) Preparation of the test soluti...

Embodiment 3

[0177] Embodiment 3: the quality control method of Bushen Yangxue Soft Capsules

[0178] The kidney-tonifying and blood-reinforcing soft capsules were prepared by the same preparation method as in Example 1.

[0179] 1. Determination according to the following high performance liquid chromatography

[0180] Chromatographic conditions and system suitability test: use octadecylsilane bonded silica gel as filler; mobile phase acetonitrile-water volume ratio 22:78; detection wavelength is 322nm.

[0181] Preparation of the reference solution: same as in Example 1, configured into a solution with a concentration of 10 μg / ml.

[0182] The preparation of need testing solution: get this product content 0.05g, with embodiment 1.

[0183] Assay method: same as in Example 1, the calculated stilbene glycoside content is 4.1mg / 0.65g.

[0184] 2. Identification by TLC

[0185] TLC identification of Radix Polygoni Multiflori:

[0186] (1) Preparation of the test solution Get about 0.5g ...

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Abstract

The invention relates to a quality control method for soft capsule preparation for kidney tonifying, which comprises distinguishing tuber of multiflower knotweed, Chinese angelica root and psoralea fruit, and measuring content of diphenyl ethylene glycosides.

Description

technical field [0001] The invention relates to a quality control method of kidney-tonifying and blood-nourishing soft capsules. More specifically, the present invention relates to the identification of Radix Polygoni Multiflori, Angelica, and Psoralen in the prescription of Bushen Yangxue Soft Capsules and the preparation of 2,3,5,4'-tetrahydroxystilbene-2-O-β-D in Polygonum multiflorum - Determination method of glucoside content. technical background [0002] "Drug Standards of the Ministry of Health of the People's Republic of China" (the fifth volume of traditional Chinese medicine preparations) announced the kidney-nourishing pills. The prescription is made of Polygonum multiflorum 80g, Angelica 20g, Black beans 40g, Achyranthes bidentata (salt) 20g, Poria cocos 20g, Cuscuta 20g , psoralen (salt) 10g, medlar 20g, the quality standard number is WS3-B-0948-91. It has the effects of nourishing liver and kidney, benefiting essence and blood. Stand...

Claims

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Application Information

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IPC IPC(8): A61K36/815A61K9/48A61P1/14A61P13/12A61P7/06G01N30/02G01N30/90G01N33/15
Inventor 王金戌汪玉梅梁敏刘翠艳申东民孟程军
Owner CSPC ZHONGQI PHARM TECH (SHIJIAZHUANG) CO LTD
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