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Lily oral liquid and quality standard and test method of pharmaceutical preparation thereof

A detection method, oral liquid technology, applied in the direction of measuring devices, pharmaceutical formulations, medical preparations containing active ingredients, etc.

Active Publication Date: 2014-03-26
HANDAN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Moluodan recorded in the Pharmacopoeia is a drug for the treatment of chronic atrophic gastritis, but the quality control method of the drug still needs to be further improved and improved

Method used

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  • Lily oral liquid and quality standard and test method of pharmaceutical preparation thereof
  • Lily oral liquid and quality standard and test method of pharmaceutical preparation thereof
  • Lily oral liquid and quality standard and test method of pharmaceutical preparation thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0110] A, get 8ml of the oral liquid of the pharmaceutical composition preparation of the present invention, add hydrochloric acid to adjust the pH value to 2, extract 2 times with diethyl ether, each 22ml, merge diethyl ether, evaporate to dryness, add methanol 1ml to dissolve the residue, as need testing solution; Take another gallic acid reference substance, add methanol to make a solution containing 1mg per 1ml, as the reference substance solution; according to the thin-layer chromatography test, draw 0.002ml of each of the above two solutions, and point them on the same silica gel G thin-layer plate respectively. Use toluene-ethyl acetate-formic acid=5:0.8:0.5 as developing agent, develop, take out, dry in the air, spray with 1% ferric chloride ethanol solution; On, spots of the same color appear;

[0111] B, get 8ml of oral liquid of the pharmaceutical composition preparation of the present invention, add hydrochloric acid 0.8ml, ether 18ml, extract by ultrasonic treatme...

Embodiment 2

[0120] A. Get 10g of the pharmaceutical composition preparation granules of the present invention, add 20ml of water, adjust the pH value to 4 with hydrochloric acid, extract 2 times with petroleum ether with a boiling range of 60 to 90°C, 28ml each time, and the combined boiling range is 60 to 90°C Petroleum ether at ℃, evaporated to dryness, add 1ml of ethanol to the residue to dissolve, as the test solution; take another gallic acid reference substance, add methanol or ethanol to make a solution containing 1mg per 1ml, as the reference solution; according to thin-layer chromatography Method test, draw 0.005ml of each of the above two solutions, point them on the same silica gel G thin-layer plate, use toluene-ethyl acetate-formic acid=8:3:1.2 as the developing agent, develop, take out, dry in the air, spray with 1% ferric chloride ethanol solution; in the chromatogram of the test product, on the position corresponding to the chromatogram of the reference substance, spots of ...

Embodiment 3

[0130] A, get pharmaceutical composition preparation tablet 15g fine powder of the present invention, add water 20ml, adjust pH value to 3 with hydrochloric acid, shake and extract 1-3 times with chloroform, each 24ml, merge chloroform extract, steam Dry, add 1ml of methanol to the residue to dissolve, as the test solution; take another gallic acid reference substance, add methanol to make a solution containing 1mg per 1ml, as the reference solution; test according to thin-layer chromatography, absorb the above two solutions 0.003ml each, respectively spot on the same silica gel G thin-layer plate, use toluene-ethyl acetate-formic acid=6:1:0.8 as developing solvent, develop, take out, dry in the air, spray with 1% ferric chloride ethanol solution ; In the chromatogram of the test product, on the position corresponding to the chromatogram of the reference substance, there are spots of the same color;

[0131] B. Take 15g of the pharmaceutical composition preparation tablet of t...

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Abstract

The invention discloses a quality control method of Moluo oral liquid and a preparation thereof, wherein, the preparation is a plurality of dosage forms prepared by adding normal auxiliary materials according to the formula of the Moluo oral liquid in the statement in pharmacopoeia as well as according to a normal method. The quality control method includes one and / or a plurality of methods in content determination and / or content differentiation. Thin layer identification and researching is carried out for garden burnet root, radix ophiopogonis, rhizoma corydalis, radices pseudoginseng, scrophularia, herba artemisiae, angelica, and conioselinum univittatum turcz in the prescription of the quality control method, and determination of paeoniflorin (C23H28O11) in radices paeoniae alba is established. Through the quality control provided by the invention, the stability of the product is increased; the products have good exactness, high repeatability and recovery rate, thus facilitating industrialized quality control.

Description

technical field [0001] The invention relates to a quality control method and a detection method of a pharmaceutical composition preparation, in particular to a quality standard and a detection method of Moro Oral Liquid and its preparation. Background technique [0002] Chronic atrophic gastritis is a common and frequently-occurring disease. It is generally believed that atrophic gastritis is a precancerous lesion of the stomach or may be a latent factor of gastric cancer. Therefore, the disease has attracted extensive attention from the medical community both at home and abroad. For chronic atrophic gastritis, there is no satisfactory treatment at home and abroad so far, and there is also a lack of effective Chinese and Western medicines. Moluodan recorded in the Pharmacopoeia is a drug for treating chronic atrophic gastritis, but the quality control method of this drug still needs to be further improved and improved. Contents of the invention [0003] The object of the...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K36/8984A61P1/04G01N30/90G01N30/36
Inventor 陈致慜李春雷霍志金李红梅刘宇
Owner HANDAN PHARMA