Quality control method of granules capable of strengthening and consolidating body resistance

A quality control method and a technology for strengthening the body and strengthening the foundation, which are applied in the fields of chemotherapy combined drugs and cancer patient radiotherapy, which can solve the problems of no chemical identification of the constituent drugs and a small number of quantitative determinations, and achieve strong specificity, easy operation and high precision. Effect

Inactive Publication Date: 2013-07-10
山西振东五和堂制药有限公司
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] The above-mentioned quality standards have relatively serious defects: first, the quantity of quantitative determination of the content of active ingredients of main drugs in this standard is relatively small; second, more than 50% of the constituent drugs have not been chemically identified

Method used

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  • Quality control method of granules capable of strengthening and consolidating body resistance
  • Quality control method of granules capable of strengthening and consolidating body resistance
  • Quality control method of granules capable of strengthening and consolidating body resistance

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0036] Example 1: Preparation of Fuzheng Guben Granules.

[0037] Prescription: Skullcap 1667g, Ligustrum lucidum 1667g, Epimedium 1333g, Polygonum multiflorum 1333g, Rehmannia glutinosa 1333g, Polygonatum 1333g, Rubia 1000g, Ginseng 333g.

[0038] Preparation method: crush the above eight flavors and ginseng into coarse powder, add water to decoct twice, each time for 2 hours, combine the decoction, and filter; add the remaining seven flavors such as medicinal dregs and scutellaria baicalensis, add water to decoct three times, each time for 1.5 hours, combine Decoction, filter, combine the filtrate with the above ginseng extract, concentrate to a clear paste with a relative density of about 1.35 (60°C), add 3 parts of sucrose, 1 part of dextrin and an appropriate amount of ethanol, make granules, dry, and make 1000 bags, that is.

[0039] Properties: This product is brown-yellow granules; sweet and slightly bitter.

[0040] Functions and indications: nourishing qi and nouri...

Embodiment 2

[0044] Example 2: TLC identification of Scutellaria baicalensis.

[0045] Get 15g of the medicine of Example 1, grind finely, add methanol 20ml, shake for 30 minutes, filter, and the filtrate is used as need testing solution. Take another baicalin reference substance, add methanol to make a solution containing 1mg per 1ml, as the reference substance solution. According to the thin-layer chromatography (Appendix VI B of the Chinese Pharmacopoeia 2010 edition), draw 5 μl of the test solution and the reference solution, respectively, and place them on the same silica gel G thin-layer plate, and use ethyl acetate-butanone-formic acid - The upper solution of water (5:3:1:1) is the developer, develop, take out, dry in the air, and spray with 1% ferric chloride ethanol solution. In the chromatogram of the test product, there are spots of the same color at the position corresponding to the chromatogram of the reference product.

Embodiment 3

[0046] Example 3: TLC identification of Ligustrum lucidum.

[0047] Take 10 g of the drug of Example 1, grind it finely, add 40 ml of ether, reflux for 1 hour at low temperature, filter, evaporate the filtrate to dryness, add 1 ml of ethanol to the residue to dissolve, and use it as the test solution. Take another oleanolic acid reference substance, add ethanol to make 1ml solution containing 1mg, as the reference substance solution. According to the thin-layer chromatography (Appendix VI B of the Chinese Pharmacopoeia 2010 edition), draw 15 μl of the test solution and 5 μl of the reference solution, respectively spot on the same silica gel G thin-layer plate, and mix with cyclohexane-acetone-ethyl acetate Ester (5:2:1) is used as a developing agent, develop, take out, dry in the air, spray with 10% sulfuric acid ethanol solution, and heat at 105°C until the spots are clearly colored. In the chromatogram of the test product, there are spots of the same color at the position c...

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PUM

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Abstract

The invention discloses a quality control method of granules capable of strengthening and consolidating body resistance. The quality control method comprises the steps of: respectively differentiating scutellaria root, ligustrum lucidum, polygonum multiflorum, epimedium and madder in medicaments by using a thin-layer chromatography; and determining the content of baicalin, icariin and emodin in the medicaments by using a liquid-phase chromatography. According to the quality control method disclosed by the invention, the medicinal material differentiation method is mature, feasible, negative and non-interfering and is strong in specificity, and the content determination method is easy to operate, high in precision and good in reproducibility, so that the quality control method disclosed by the invention can be used for controlling the quality of the medicaments accurately and stably, thereby being adaptable to the industrial stable production of the medicaments.

Description

technical field [0001] The invention relates to a drug combined with radiotherapy and chemotherapy for cancer patients, in particular to a quality control method for the drug. Background technique [0002] Fuzheng Guben Granules are medicines for nourishing qi and nourishing yin, cooling blood and detoxifying. For patients with esophageal cancer and gastric cancer with both qi and yin deficiency and heat-toxin syndrome combined with radiotherapy and chemotherapy. Its current implementation standard is the standard of the State Food and Drug Administration. The following are specified in this quality standard. [0003] 1) Take 15g of this product, grind it finely, put it in a conical flask, add 20ml of methanol, shake it for 30 minutes, filter it, and use the filtrate as the test solution. Take another baicalin reference substance, add methanol to make a solution containing 1mg per 1ml, as the reference substance solution. According to the test of thin-layer chromatograph...

Claims

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Application Information

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IPC IPC(8): G01N30/90G01N30/02
Inventor 王六贵吕建英
Owner 山西振东五和堂制药有限公司
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