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Quality control method of powerful dysentery relieving soluble powder preparation

A quality control method and soluble technology, applied in the direction of measuring devices, instruments, scientific instruments, etc., can solve problems such as inability to fully and effectively control the quality of Laotie Zhili soluble powder preparations, affecting product production and sales, quality assurance, and unquestionable curative effect , to achieve the effect of ensuring internal quality and curative effect, ensuring controllability and optimizing effect

Inactive Publication Date: 2017-06-13
QINGDAO BAIHUIZHIYE BIOTECH
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The curative effect of this prescription is unquestionable, but there is still a large gap compared with the current quality control requirements of traditional Chinese medicine products, and the quality of Laotie Zhili soluble powder preparation cannot be fully and effectively controlled, which will affect the production, sales and quality assurance of the product

Method used

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  • Quality control method of powerful dysentery relieving soluble powder preparation
  • Quality control method of powerful dysentery relieving soluble powder preparation
  • Quality control method of powerful dysentery relieving soluble powder preparation

Examples

Experimental program
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Effect test

preparation example Construction

[0052] ①Preparation of the test solution: Take 5g of Laotiezhidysentery soluble powder sample, add 25ml of methanol, ultrasonicate for 30min, filter, evaporate the filtrate to dryness, add 3ml of methanol to dissolve, and use it as the test solution;

[0053] ②Preparation of reference substance solution: take berberine hydrochloride and palmatine hydrochloride reference substances, add methanol to make a mixed solution containing 0.2mg per 1ml, as the reference substance solution;

[0054] ③ Identification: Take 5 μl of the two solutions of the test solution and the reference solution, respectively, and place them on the same silica gel G thin-layer plate, and use benzene-ethyl acetate-methanol-isopropanol-concentrated ammonia test solution according to the ratio of 6:3 : 1.5:1.5:0.5 mass fraction ratio is mixed as developing agent, puts in the chromatographic cylinder saturated with ammonia vapor, develops, takes out, dries, puts inspection under 365nm ultraviolet light lamp, ...

Embodiment 1

[0069] Example 1 Test

[0070] A kind of quality control method of old iron antidiarrheal soluble powder preparation, the steps of its method are:

[0071] 1. Identification project test:

[0072] 1 TLC identification test of ten major contributions:

[0073] Laotie Zhili soluble powder quality standard identification for TLC identification of the top ten contributions, the test is as follows:

[0074] 1.1 Experimental materials:

[0075] Berberine hydrochloride reference substance: China Food and Drug Control Institute provides (110713-201212 for content determination);

[0076] Palmatine hydrochloride reference substance: provided by China National Institutes for Food and Drug Control (110732-201510 for content determination);

[0077] Silicone G thin-layer board: Qingdao Shenghai Fine Silicone Chemical Co., Ltd., 5×10cm.

[0078] 1.2 Preparation of the test solution:

[0079] Take 5g of Laotiezhidiarrhea soluble powder sample, add 25ml of methanol, ultrasonicate for 3...

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Abstract

The invention provides a quality control method of a powerful dysentery relieving soluble powder preparation, and belongs to the field of the detection of medicines. The quality control method comprises the following steps of a first step, preparing the preparation; a second step, using berberine hydrochloride and palmatine hydrochloride as reference substances, and identifying whether ten great meritorious components are contained in powerful dysentery relieving soluble powder or not by thin layer chromatography; a third step, using cortex ilicis rotundae as a reference medicinal material and syringoside as a reference substance, and identifying whether a component of the cortex ilicis rotundae is contained in the powerful dysentery relieving soluble powder or not by the thin layer chromatography; a fourth step, using matrine and sophoridine as reference substances, and identifying whether a component of radix sophorae flavescentis is contained in the powerful dysentery relieving soluble powder or not by the thin layer chromatography; a fifth step, using the syringoside as the reference substance, and measuring the content of the cortex ilicis rotundae in a powerful dysentery relieving soluble powder formula by high performance liquid chromatography. The quality control method has the beneficial effects that an established quality standard control method has characteristics of high accuracy, good repeatability and the like. Meanwhile, the controllability of a quality standard of a preparation can be guaranteed; the inner quality and the curative effect of a product are guaranteed; the quality control method has guidance significance for clinical medication.

Description

technical field [0001] The invention relates to the technical field of analysis of pharmaceutical preparations, in particular to a method for quality control of Laotie Zhidiarrhea soluble powder preparation. Background technique [0002] Piglet pullorum is a common intestinal infectious disease of piglets caused by ETEC. The disease usually occurs in piglets aged 10-30 days. Clinically, it is characterized by the discharge of milky white or off-white sticky and smelly feces. The disease is widespread, spreads fast, and has a high incidence rate. Although the mortality rate is low, if it is not treated in time or treated properly, it will affect the growth and development of piglets in mild cases, and cause dead pigs in severe cases, causing huge losses to the pig industry. [0003] To treat piglets suffering from pullorum disease, it is necessary to clear away heat and detoxify, antibacterial and anti-inflammatory, astringe and stop dysentery. Lao Tie Zhi Dysentery Soluble ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/90
CPCG01N30/90
Inventor 王春元王苹苹杨芬芳
Owner QINGDAO BAIHUIZHIYE BIOTECH
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