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 act

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

Example Embodiment

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

[0037] Prescription: Scutellaria 1667g, Ligustrum lucidum 1667g, Epimedium 1333g, Polygonum multiflorum 1333g, Rehmannia glutinosa 1333g, Polygonatum 1333g, madder 1000g, ginseng 333g.

[0038] Preparation method: The above eight flavors, ginseng is crushed into coarse powder, boiled twice with water for 2 hours each time, combined with the decoction, and filtered; the other seven flavors such as medicinal residues and Scutellaria baicalensis are boiled three times with water for 1.5 hours each time, combined The decoction is filtered, the filtrate is combined with the above-mentioned ginseng extract, concentrated to a clear paste with a relative density of about 1.35 (60 ° C), 3 parts of sucrose, 1 part of dextrin and an appropriate amount of ethanol are added to make granules, dried, and made into 1000 bags, that is.

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

Example Embodiment

[0044] Example 2: Thin-layer identification of Scutellaria baicalensis.

[0045] Take 15 g of the medicine of Example 1, grind it into a fine powder, add 20 ml of methanol, shake for 30 minutes, filter, and use the filtrate as the test solution. Another reference substance of baicalin was taken, and methanol was added to make a solution containing 1 mg per 1 ml, which was used as the reference substance solution. According to the thin-layer chromatography (Appendix VI B of Chinese Pharmacopoeia 2010 edition) test, draw 5 μl of the test solution and reference solution, respectively, point them on the same silica gel G thin-layer plate, and use ethyl acetate-butanone-formic acid. - The upper layer solution of water (5:3:1:1) is the developing agent, unfold, take out, dry, and spray with 1% ferric chloride ethanol solution. In the chromatogram of the test substance, there are spots of the same color at the position corresponding to the chromatogram of the reference substance.

Example Embodiment

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

[0047] Take 10 g of the medicine of Example 1, grind it into small pieces, add 40 ml of ether, reflux at low temperature for 1 hour, filter, evaporate the filtrate to dryness, add 1 ml of ethanol to the residue to dissolve it, and use it as the test solution. Another reference substance of oleanolic acid was taken, and ethanol was added to make 1ml of solution containing 1mg, which was used as the reference substance solution. According to the thin-layer chromatography (Appendix VI B of Chinese Pharmacopoeia 2010 edition) test, draw 15 μl of the test solution and 5 μl of the reference solution, respectively, point them on the same silica gel G thin-layer plate, and use cyclohexane-acetone-ethyl acetate. Ester (5:2:1) was used as developing agent, unfolded, taken out, air-dried, sprayed with 10% sulfuric acid ethanol solution, heated at 105 ℃ until the spot color became clear. In the chromatogram of the test substanc...

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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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