Measurement method for content of atropine sulfate in traditional Chinese medicine suppository containing belladonna liquid extract

A technology of atropine sulfate and belladonna liquid extract, which is applied in the field of determination of atropine sulfate content, can solve the problems that atropine sulfate detection can only identify the presence or absence of content, and can not detect the content, so as to achieve high purity, improve extraction purity, and avoid interference Effect

Active Publication Date: 2010-10-27
MAYINGLONG PHARMA GROUP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The purpose of the present invention is to solve the above problems, provides a kind of assay method of atropine sulfate content in the Chinese medicine suppository containing belladonna liquid extract, solves the detection of atropine sulfate in the existing Chinese medicine suppository containing belladonna liquid extract It is especially suitable for detecting the content of atropine sulfate in musk hemorrhoid suppositories. The operation is simple and fast, accurate and reliable, and the sensitivity and precision are high, so it has important guiding significance for effectively controlling the quality of suppositories.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028]Control chromatographic conditions: column: Agilent octadecylsilane bonded silica gel (Anglient Zorbax Eclipse XDB C-18, 3.5um) manufactured by Agilent Technologies, Inc., USA.

[0029] Mobile phase: A: phosphate buffer 0.05M KH2PO4, adjusted to pH = 3 with phosphoric acid solution; B: acetonitrile; same solvent elution (isocratic elution) A: B = 72%: 28%

[0030] The detection wavelength is 210nm.

[0031] Preparation of reference solution

[0032] Accurately weigh 106mg of atropine sulfate (Chinese institute for the control of pharmaceutical and biological products, for content determination, batch number: 100040-200510)) reference substance is dissolved in 10% sulfuric acid 50ml, the solution 0.5ml that will obtain is added mobile phase to atropine sulfate The solution concentration was 0.0424mg / ml. The final solution was used as the reference solution.

[0033] Preparation of the test solution

[0034] Test product: "Musk Hemorrhoid Suppository" (batch number: 09...

Embodiment 2

[0043] Control chromatographic conditions: column: with embodiment 1.

[0044] Mobile phase: A: phosphate buffer 0.03M KH2PO4 pH = 3; B: acetonitrile; same solvent elution (isocratic elution) A: B = 90%: 10%

[0045] Detection wavelength 400nm

[0046] Preparation of reference solution

[0047] Accurately weighed 106mg of atropine sulfate reference substance was dissolved in 5% sulfuric acid 40ml, 0.5ml of the resulting solution was added to the mobile phase until the solution concentration of atropine sulfate was 0.01mg / ml. The final solution was used as the reference solution.

[0048] Preparation of the test solution:

[0049] Test product: "Musk Hemorrhoid Suppository" manufactured by Mayinglong Pharmaceutical Group Co., Ltd. (Lot number: 091101)

[0050] Preparation method: 10% sulfuric acid 50ml is replaced with 5% sulfuric acid 70ml, control residue is 2500mg / ml in solution concentration, all the other are with embodiment 1, the solution that obtains uses as need t...

Embodiment 3

[0054] Control chromatographic conditions: column: with embodiment 1.

[0055] Mobile phase: A: phosphate buffer 0.07M KH2PO4 pH = 1, B: acetonitrile; same solvent elution (isocratic elution) A: B = 65%: 35%

[0056] Detection wavelength 210nm

[0057] Preparation of reference solution

[0058] Accurately weighed 106mg of atropine sulfate reference substance was dissolved in 5% sulfuric acid 80ml, 0.5ml of the solution obtained was added to the mobile phase until the solution concentration of atropine sulfate was 500mg / ml. The final solution was used as the reference solution.

[0059] Preparation of the test solution

[0060] Test product: "Musk Hemorrhoid Suppository" manufactured by Mayinglong Pharmaceutical Group Co., Ltd. (Lot number: 091101) preparation method: 10% sulfuric acid 50ml is replaced with 15% sulfuric acid 30ml, control residue is 0.01mg / ml in solution concentration, all the other are with embodiment 1, the solution that obtains uses as need testing solut...

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Abstract

The invention relates to a measurement method for the content of atropine sulfate in traditional Chinese medicine suppository containing belladonna liquid extract. The invention solves the problem that only the existence of atropine sulfate in traditional Chinese medicine suppository containing belladonna liquid extract the traditional can be detected in the field of traditional Chinese pharmacy, and the content of the atropine sulfate cannot be detected. In the method, chromatograph conditions are controlled, comparison product and test article solutions are prepared, the comparison product solution and the test article solution are respectively absorbed, and the content of the atropine is measured by a high performance liquid chromatography method by adopting an external standard method by using a liquid chromatograph. The content of the atropine can be precisely measured. The main peak and front and back separation effect is good, and the number of theoretical plates is high. The invention has important meaning for controlling the quality of the traditional Chinese medicine suppository.

Description

technical field [0001] The invention relates to a detection method of a compound traditional Chinese medicine preparation, in particular to a detection method of atropine sulfate content in a traditional Chinese medicine suppository containing belladonna liquid extract. Background technique [0002] Belladonna liquid extract is a brown liquid with a slightly smelly gas. It is a preparation obtained from belladonna leaves according to the liquid extract method. It mainly contains alkaloids such as hyoscyamine and atropine. It has the functions of relieving spasm of smooth muscle, inhibiting gland secretion, relieving the inhibition of vagus nerve on the heart, accelerating heartbeat, dilating pupils, increasing intraocular pressure, and stimulating the respiratory center. Therefore, belladonna liquid extract also has the effect of relieving smooth muscle spasm and inhibiting gland secretion, and is often used to make various traditional Chinese medicine preparations. For exa...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K36/81A61K9/02G01N30/02G01N30/04A61P9/14A61K31/045A61K31/122A61K33/30A61K35/413A61K35/56A61K35/64A61K35/618
Inventor 陈平
Owner MAYINGLONG PHARMA GROUP
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