Quality detection method of novel healing formulation

A quality inspection method and preparation technology, which can be applied to measurement devices, instruments, scientific instruments, etc., can solve problems such as poor reproducibility, inability to control the quality of Kangfuxin fluid, and reduction of chromatographic column efficiency.

Active Publication Date: 2008-12-10
SICHUAN KELUN PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In the quality standard of Kangfuxin Liquid, only the content determination of total amino acids and the identification of amino acids and uracil are carried out. None of the above methods can control the quality of Kangfuxin Liquid well, especially the quality control of the main active ingredient alkaloids.
And the HPLC method determination of the alkaloids in the new rehabilitation pre

Method used

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  • Quality detection method of novel healing formulation
  • Quality detection method of novel healing formulation
  • Quality detection method of novel healing formulation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0083] Embodiment 1: the uracil content determination method of Kangfuxin capsule of the present invention, the method comprises the steps:

[0084] A. Preparation of the test solution: Pour out the content of Fufuxin Capsules, accurately weigh 1.0 g of the content, put it in a 25 ml measuring bottle, add 20 ml of water, ultrasonicate for 30 minutes, dilute with water to the mark, shake well, filter After passing through, the filtrate is obtained; take the cation exchange resin, grind it, pass through a 50-mesh sieve to remove coarse particles, and then pass through a 150-mesh sieve to remove fine particles, soak in water for 24 hours, pour off the water, and use 2 to 3 times the amount of 2mol / L hydrochloric acid Soak in the solution for 2 hours, stir 4 times at intervals, remove the acid solution, wash with water until nearly neutral, add 4 times the amount of 1mol / L sodium hydroxide solution for 2 hours, stir 4 times at intervals, remove the lye, wash with water until nearly...

Embodiment 2

[0087] Embodiment 2: the uracil content determination method of Kangfuxin tablet of the present invention, the method comprises the steps:

[0088] A. Preparation of test solution: Grind Kangfuxin tablet finely, accurately weigh 1.0g of powder, put in a 25ml measuring bottle, add 20ml of water, ultrasonically treat for 30 minutes, add water and dilute to the scale, shake well, filter, and obtain Continue the filtrate; take the cation exchange resin, grind it, pass through a 50-mesh sieve to remove coarse particles, and then pass through a 150-mesh sieve to remove fine particles, soak in water for 24 hours, pour off the water and soak with 2 to 3 times the amount of 2mol / L hydrochloric acid solution for 2 hour, stir 4 times at intervals, remove the acid solution, wash with water until nearly neutral, add 4 times the amount of 1mol / L sodium hydroxide solution to soak for 2 hours, stir 4 times at intervals, remove the lye, wash with water until nearly neutral, add 3 Double the am...

Embodiment 3

[0091] Embodiment 3: the uracil content determination method of Kangfuxin liquid of the present invention, the method comprises the steps:

[0092] A. Preparation of the test solution: Take the cation exchange resin, grind it, pass through a 50 mesh sieve to remove coarse particles, then pass through a 150 mesh sieve to remove fine particles, soak in water for 24 hours, pour off the water and use 2 to 3 times the amount of 2mol Soak in / L hydrochloric acid solution for 2 hours, stir 4 times at intervals, remove acid solution, wash with water until nearly neutral, add 4 times the amount of 1mol / L sodium hydroxide solution for 2 hours, stir 4 times at intervals, remove lye, wash with water To near-neutrality, add 3 times the amount of 2mol / L hydrochloric acid solution, soak for 2 hours, stir 4 times at intervals, remove the acid solution, wash with water until near-neutral, soak in water and place it for later use; accurately absorb 10ml of Kangfuxin liquid preparation, add to O...

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Abstract

The invention relates to a quality detection method of a rehabilitation new preparation which is made from barbaric cockroach (American cockroach) drug material and the extract thereof. The quality detection method of the rehabilitation new preparation is constructed through a plurality of experiments. In said method, octadecylsilane chemically bonded silica is used as filling agent; diammonium phosphate is used as mobile phase; uracil is added with to be dissolved as reference solution; high performance liquid chromatography is used for detecting the sample solution of the rehabilitation new preparation to obtain the content determining method of the uracil in the rehabilitation new preparation. The method is relatively simple, is provided good precision, reproducibility and reliability and can be applied to the quality control of the rehabilitation new preparation.

Description

technical field [0001] The invention relates to a quality detection method, in particular to a quality detection method of a new rehabilitation preparation. Background technique [0002] Kangfuxin Liquid is recorded in the Nineteenth Volume of Drug Standards (Chinese Patent Medicine) of the Ministry of Health of the People's Republic of China and WS3-B-3674-2000 (Z) "Kangfuxin Liquid", which is a preparation made from the extract of Periplaneta americana. It has the effects of Tongli blood vessels, nourishing yin and promoting muscle growth. It is used for blood stasis, stomach pain and bleeding, gastric and duodenal ulcers; as well as adjuvant treatment of yin deficiency pulmonary tuberculosis and tuberculosis. Because of its good curative effect and quick effect, it is widely used in clinical practice. [0003] The main components of Kangfuxin liquid are amino acids (alanine, leucine, isoleucine, etc.) and alkaloids (uracil, etc.). In the quality standard of Kangfuxin L...

Claims

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Application Information

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IPC IPC(8): G01N30/88
Inventor 王利春孔繁贵瘳军魏胄梁隆程志鹏
Owner SICHUAN KELUN PHARMA CO LTD
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