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Novel method for controlling quality of abdominal Kefuan tablet

A technology of Fucoan tablets and a new method, applied in the directions of measuring devices, instruments, scientific instruments, etc., can solve the problems of insufficient control of the quality of the finished products of the Fucoan tablets, difficulty in controlling the quality of the finished products, low syringin, and the like. Conducive to quality control, simple composition, reliable results

Active Publication Date: 2020-12-08
GUANGDONG MEDIHEALTH PHARMA
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The original Ministry of Health standard only has physical and chemical identification, no content determination, too simple, and it is difficult to control the quality of finished products
Although there is a patent to measure the content of syringin in Fukean tablets, which is a component of the medicinal material syringin, in order to control the quality of Fuke’an tablets, the results showed that the content of syringin in ten batches of Fuke’an samples was significantly lower In the 2015 edition of the "Chinese Pharmacopoeia", the regulations on the medicinal materials of Jiubiying: the content of syringin in the medicinal materials of Jiubiying should not be less than 1.0%
It can be seen that the determination of the content of syringin alone may not be enough to control the quality of the finished product of Fukean Tablets

Method used

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  • Novel method for controlling quality of abdominal Kefuan tablet
  • Novel method for controlling quality of abdominal Kefuan tablet
  • Novel method for controlling quality of abdominal Kefuan tablet

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0039] The quality control method of embodiment 1 Fuke'an tablet

[0040] In this embodiment, Fukean Tablets (batch number: 180501 and other 6 batches) produced by Guangdong Zaitian Pharmaceutical Co., Ltd. were selected as materials.

[0041] The quality control method of this fuke'an tablet comprises following identification and assay two parts:

[0042] 1. TLC identification of Jiubing medicinal materials

[0043] (1) Preparation of the test solution: take 10 Fuconian tablets, remove the sugar coating, grind finely, add 30mL of ethanol, sonicate to make it fully dissolve, filter, and the filtrate evaporates to 1mL as the test solution. According to the prescription of Fuke'an Tablets, weigh other medicinal materials of Bing, and make a negative medicinal solution in the same way, and take 1g of the reference medicinal material of Bing, add 30mL of ethanol to ultrasonic treatment, filter, and concentrate the filtrate to 1mL as the reference medicinal solution. .

[0044] ...

Embodiment 2

[0065] Example 2 Methodological investigation of the content determination of isochlorogenic acid B and isochlorogenic acid C in the medicinal materials of Jiubing

[0066] In this embodiment, the instrument used is Shimadzu SHIMHDZU high performance liquid chromatograph; This chromatograph is equipped with: Quaternary pump (LC-20AT); Autosampler (SIL-20A); Column thermostat (CTO-20A ); PDA detector (SPD-M20A); controller (CBM-20A).

[0067] (1) System suitability test

[0068] Under the aforementioned chromatographic conditions, the number of theoretical plates based on isochlorogenic acid B and isochlorogenic acid C is both greater than 20,000, and the resolution is greater than 1.5, which meets the relevant requirements of the 2015 edition of the Chinese Pharmacopoeia.

[0069] (2) Specificity

[0070] According to the prescription, other medicinal materials of the lack of rescue Bing were prepared in the same way as the preparation method of the test solution to make a n...

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Abstract

The invention belongs to the technical field of medicine quality control, and particularly relates to a novel method for controlling the quality of an abdominal Kefuan tablet. For improving the effectiveness of the quality control of the abdominal Kefuan tablet, based on an original quality standard, thin-layer chromatography identification is carried out on ovateleaf holly bark by adopting a thin-layer chromatography identification developing solvent and a sample preparation method which are different from those in the prior art; the contents of two components, namely isochlorogenic acid B and isochlorogenic acid C, which are not reported in the ilex rotunda thunb medicinal material of the ilex rotunda thunb tablet are determined, and the contents of the isochlorogenic acid B and the isochlorogenic acid C in the ilex rotunda thunb are used as the quality control standard of the ilex rotunda thunb tablet; the method provided by the invention has strong specificity and reproducibility,provides a new method for the quality standard of the fukean tablet, can replace or supplement the existing quality control method, and can simultaneously determine the contents of the two componentsin the fukean tablet, so that the result is more reliable, and the quality control of the fukean tablet is better facilitated.

Description

technical field [0001] The invention belongs to the technical field of medicine quality control, and in particular relates to a new method for quality control of Fuke'an tablets. Background technique [0002] Fuke'an tablets are recorded in the eleventh volume of traditional Chinese medicine preparations in the "Drug Standards of the Ministry of Health". They are sugar-coated tablets and are used for abdominal pain, diarrhea, and vomiting caused by acute gastroenteritis and indigestion. Prescriptions included twirling vine, charcoal mother, plantain, biscuit, and pomegranate rind. Prescription rescue Bing, pomegranate peel, and plantain are all included in the first volume of the 2015 edition of the "Chinese Pharmacopoeia"; Twister and Fotanmu are local traditional medicinal materials, which are included in the first volume of "Guangdong Provincial Standards for Traditional Chinese Medicinal Materials" book. The original Ministry of Health standard only has physical and ch...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/90G01N30/94G01N30/02
CPCG01N30/90G01N30/94G01N30/02G01N2030/027Y02A50/30
Inventor 陈晓侠
Owner GUANGDONG MEDIHEALTH PHARMA
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