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Quality control method for toxin ingredient, yunaconitine in Yuannan Hongyao capsule

A quality control method, the technology of yunnanjing, is applied in the field of pharmaceuticals to achieve the effect of ensuring qualified processing, high accuracy and precision, and ensuring safety

Inactive Publication Date: 2009-04-01
YUNNAN PHYTOPHARML
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The Aconitum aconitum in Yunnan Hongyao Capsules is a poisonous medicinal material, and there is no national standard to control its toxicity. We formulated the enterprise internal control standard in 2002

Method used

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  • Quality control method for toxin ingredient, yunaconitine in Yuannan Hongyao capsule

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] Example 1 Toxicity Control of Aconitum Aconitum Made from Yunnan Hongyao Capsules

[0027] The dosage of the fine powder of the medicinal material of Aconitum aconitum is controlled on the basis of each kilogram of body weight of the mouse, and the toxic dose of the fine powder of the medicinal material of the production of Aconitum aconitum is controlled at ≤ 2g / kg, and the mice do not appear to die as follows in step 3. limit; when the mice died, the Aconitum aconitum medicinal material was further processed according to the conventional method for making Aconitum aconitum, and then operated through step 3, and the amount of the Aconitum aconitum medicinal material was controlled according to the weight of the mouse per kilogram. Toxic dose ≤ 2g / kg;

[0028] The tested mice were ICR mice, aged 25-30 days, weighing 18-22 g, half male and half male, provided by the Experimental Animal Center of Kunming Medical College, animal qualification certificate number SCXK (Su) 2...

Embodiment 2

[0030] Example 2 High performance liquid chromatography (HPLC) detects the content of the toxic component dianconitine

[0031] Waters company high performance liquid chromatograph; reference substance Dianconitine was provided by China Institute for the Control of Pharmaceutical and Biological Products (purity>98.0%); samples made of Huangcaowu medicinal material and Yunnan Hongyao capsule were provided by the applicant Yunnan Botanical Pharmaceutical Co., Ltd. Reagents: Methanol, ammonia water, anhydrous methanol, ether and sulfuric acid, etc., are all analytical reagents.

[0032] 1. Preparation of the test product:

[0033]Take 100 Yunnan Hongyao Capsules, put the powder in the capsules into a stoppered Erlenmeyer flask, add 50ml of diethyl ether and 1mL of ammonia test solution, seal it tightly, shake well, leave it overnight, filter; add 50mL of diethyl ether to the dregs, and shake continuously Shake for 1 hour, filter, and wash the filter residue 3-4 times with ether,...

Embodiment 3

[0037] Embodiment 3 The determination condition test of the high performance liquid chromatography (HPLC) of the present invention's method detects the content of toxic component dianconitine

[0038] 1. Chromatographic conditions

[0039] Chromatographic column: U-bondapak CN (7.8×300mm); mobile phase: methanol-water-ammonia (35:65:0.5); column temperature 30°C; detection wavelength: 260nm; flow rate: 2mLmin; (Calculation of peak area of ​​citrine) should not be lower than (≥) 4100.

[0040] 2. Investigation of the linear relationship: Accurately draw 5, 10, 15, 20, 30 μl of the reference substance solution, and measure the peak area according to the above chromatographic conditions; take the integral value of the peak area as the ordinate, and the injection volume of aconitine as the abscissa, draw The standard curve was used to calculate the regression equation, and the regression equation was obtained: Y=740538X-156707, r=0.9998. The results showed that the linear relatio...

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Abstract

The invention discloses a method for controlling the quality of yanaconitine which is toxic ingredient in Yunnan Hongyao capsule, and pertains to the technical field of drugs. The method comprises: controlling the toxicity of the crude drug prepared kusnezoff monkshood root, controlling the content of the yanaconitine in the capsule, controlling the toxicity of the crude drug prepared kusnezoff monkshood root by animal safety test, and detecting the content of the toxic ingredient yanaconitine by high performance liquid chromatography. The toxic dose of the crude drug prepared kusnezoff monkshood root is not more than 2g / kg, the content of the yanaconitine per capsule is not more than 0.01mg, a chromatographic column is U-bondapaKCN with the volume of 7.8 multiplied by 300mm; a mobile phase is methanol-water-ammonia water (35:65:0.5); the column temperature is 30 DEG C; the detection wavelength is 260nm; the flow rate is 2mL / min; and the theoretic number of column plates is not less than 4100. The method has the advantages of comprehensive monitoring means, simple and graspable operations, and high detection accuracy and precision; the method enhances the controllability of the toxic ingredient of the Yunnan Hongyao capsule, and better ensures the processing qualification of the crude drug prepared kusnezoff monkshood root and the drug safety.

Description

technical field [0001] The invention relates to the technical field of medicines, in particular to a quality control method for the toxic component dianconitine in Yunnan Hongyao capsules. Background technique [0002] Yunnan Hongyao, formerly known as Yunnan Qilong Powder, is a specialty drug produced by Yunnan Botanical Pharmaceutical Co., Ltd. It is a protected variety of traditional Chinese medicine and belongs to the Ministry of Standards. The main drug in the formula of Yunnan red medicine is a folk Chinese herbal medicine that is a special product in Yunnan. Its raw material components and weight ratio are: Panax notoginseng 100g, Zhonglou 250g, Zijinlong 50g, Jade grape root 100g, Sliding leaf Dieda 95g, Cannabis 75g Jintiesuo 50g Shichangpu 30g Southwest Scutellaria baicalensis 100g is used to make 150g of Huangcaowu. The above ten flavors are prepared according to the following method to obtain Yunnan Hongyao Capsules: each medicinal material is crushed into fine ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K36/888A61P7/04A61P1/04A61P29/00A61P19/02G01N30/36
Inventor 周敏黄春球吕小波武正才李文
Owner YUNNAN PHYTOPHARML
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