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Quality control method of Ninggong tablet containing bezoar

A technology for the quality of Niuhuang Ninggong tablets, applied in the field of quality control of Niuhuang Ninggong tablets, can solve problems such as inability to guarantee product quality reliability and uniformity, achieve quality assurance and uniformity, improve safety testing standards, Optimizing the effect of security testing standards

Inactive Publication Date: 2009-04-15
大连美罗中药厂有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] The inventor has successfully developed a quality control method for Niuhuang Ninggong Tablets through a large number of experiments, which overcomes the problems in the prior art that cannot guarantee the reliability and uniformity of the product quality, further optimizes the method of the original inspection items and Established new testing standards to improve product safety

Method used

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  • Quality control method of Ninggong tablet containing bezoar
  • Quality control method of Ninggong tablet containing bezoar
  • Quality control method of Ninggong tablet containing bezoar

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0049] Take Niuhuang Ninggong Tablets produced by Dalian Merro Traditional Chinese Medicine Factory Co., Ltd. with batch number 200607115 for the following inspection.

[0050] A. traits

[0051] After removing the coating, it is light brown to tan; the smell is fragrant, bitter and cool;

[0052] B. Identification

[0053] (1) Microscopic identification: Take this product and observe under a microscope: the diameter of calcium oxalate cluster crystals is 20-160 μm. Stone cells are bright yellow, scattered singly or in groups, in a round or square shape. Irregular fragments, colorless, translucent, shiny, dense layered lines or fine wavy textures can be seen;

[0054] (2) TLC identification of borneol: take 10 tablets of this product, remove the coating, grind finely, add 30 ml of chloroform, ultrasonicate for 15 minutes, filter, and take 1 ml of the filtrate as the test solution. Take another borneol reference substance, add chloroform to make a solution containing 0.4mg ...

Embodiment 2

[0061] The quality control method of Niuhuang Ninggong tablet also includes the following content except the content in embodiment 1:

[0062] Sample is with embodiment 1.

[0063] A. Inspection of pig gall paste

[0064] [Properties] Pig gall paste is brown or brownish-yellow block; slightly fishy, ​​bitter taste;

[0065] [Identification] Take about 10mg of the dry matter after the determination of the alcohol-soluble extract, add 1ml of water to dissolve, add a few grains of sugar to dissolve, add 2ml of sulfuric acid, and the deep purple color will appear;

[0066] [Check] Loss on Drying

[0067] Take the pig gall paste and grind it finely, then dry it to constant weight at 105°C, and the weight loss is 11%;

[0068] [Alcohol-soluble extract] Weigh 1g of finely ground pig gall paste, put it in a 100-150ml Erlenmeyer flask, add 20ml of ethanol, connect a reflux condenser, heat to boiling, keep boiling slightly for half an hour, let cool, and filter until In an evaporati...

Embodiment 3

[0078] The assay of Radix Scutellariae in the quality control method of Niuhuang Ninggong Tablets can also be except the method of embodiment 2:

[0079] Assay of Scutellaria baicalensis (sample is the same as embodiment 1)

[0080] Preparation of reference substance solution: take an appropriate amount of baicalin reference substance, weigh it accurately, add methanol to make a solution containing 30 μg of baicalin per 1 ml, and obtain it;

[0081] The preparation of need testing solution: get 20 tablets of this product, remove coating, accurately weighed, grind finely, get 0.5g, accurately weighed, put in 50ml measuring bottle, add 70% ethanol 30ml, ultrasonic treatment (power 250W, 33kHz) for 30 minutes, let it cool down, add 70% ethanol to the mark, shake well, centrifuge, take the supernatant, that is to say;

[0082] Chromatographic conditions: octadecyl bonded silica gel is used as filler; methanol-water-phosphoric acid (43:57:0.2) is used as mobile phase; detection wa...

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Abstract

The invention discloses a quality control method for Niuhuang Ninggong tablet. The method comprises the following steps: morphological identification, histological and thin layer chromatography identification, arsenic trioxide detection, content measurement. The content of Baikal skullcap root in form of scutelloside in each tablet is no less than 0.8 mg, preferably no less than 1.0 mg, and most preferably no less than 1.1mg. The invention optimizes the prior examination method, establishes new examination method, ensures the reliability and uniformity of product quality and further improves the safety of products.

Description

technical field [0001] The invention relates to a quality control method of a traditional Chinese medicine composition, in particular to a quality control method of Niuhuang Ninggong Tablets. Background technique [0002] Mental illness is a common disease of brain dysfunction caused by various reasons. The most common clinical manifestations are high emotions, sleepless nights, provocative quarrels, nonsense, arrogant beatings, hallucinations, delusions, and behavioral disorders. Schizophrenia is a common mental illness whose etiology has not yet been fully elucidated. According to data released by the Ministry of Health in 2005, the total number of severe mental illness patients in my country is as high as 16 million, of which the number of schizophrenia patients is the largest, reaching 6 million. There is one case in every 60 households, and this number is still increasing at a rate of 100,000 per year. This has constituted a serious social problem, which has brought hea...

Claims

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Application Information

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IPC IPC(8): A61K36/9066A61P25/18G01N30/90G01N30/02A61K31/045A61K33/06A61K33/26A61K33/28A61K33/36A61K35/10A61K35/413A61K35/56
Inventor 张成海周文波陈心石桂芳姜伟李晓艳
Owner 大连美罗中药厂有限公司
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