Detection method of Liuweinengxiao preparation

A preparation and composition technology, applied in the field of quality inspection of pharmaceutical composition preparations

Active Publication Date: 2011-12-07
GANSU CHEEZHENG TIBETAN MEDICINE CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Since the standard issued by the ministry only has physical and chemical identification, there

Method used

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  • Detection method of Liuweinengxiao preparation
  • Detection method of Liuweinengxiao preparation
  • Detection method of Liuweinengxiao preparation

Examples

Experimental program
Comparison scheme
Effect test

Example Embodiment

[0034] Experimental example 1 TLC identification of myrobalan

[0035] The samples (Liuwei Nengxiao tablets) were processed according to the method under the item of "Chinese Pharmacopoeia" 2010 edition of Myrobalan, and it was found that the chromatograms of Myrobalan control medicinal material and gallic acid control substance had the same color spots on the corresponding position, and the test The spots in the corresponding position on the sample chromatogram are not clear. It may be caused by the acid-base neutralization reaction of alkaline components in the sample such as lysophila (mainly containing calcium carbonate) with gallic acid, so the experiment was directly extracted from ethanol in the pharmacopoeia Changed to ethanol extraction under acidic conditions to inhibit the reaction of gallic acid with alkaline components. According to this method, the test solution, gallic acid reference substance and myrobalan control medicinal material solution were prepared, and the ...

Example Embodiment

[0036] Experimental example 2 TLC identification of dried ginger

[0037] The sample (Liuwei Nengxiao tablets) was processed according to the method under the first section of the "Chinese Pharmacopoeia" 2010 edition of dried ginger, unfolded in accordance with the law, and the color was developed. It was found that the spots in the sample chromatogram did not correspond well with the reference medicinal material, and there was tailing phenomenon, which affected the judgment of the result. . After repeated experiments, when the developing agent is changed to cyclohexane-ethyl acetate (6:4), it is directly inspected under ultraviolet light (365nm), and the spots are completely separated and the effect is better. Prepare the dried ginger reference medicinal solution according to the extraction method in the standard, and prepare the negative reference solution (the lack of dried ginger) in the same way, and test according to the thin layer chromatography ("Chinese Pharmacopoeia" 20...

Example Embodiment

[0038] Experimental example 3 Determination method of emodin and chrysophanol in rhubarb

[0039] (1) Instruments and reagents

[0040] Aglient 1100 High Performance Liquid Chromatograph (HP Company, USA) CSF-IB Ultrasonic Cleaner (Shanghai Ultrasonic Instrument Factory).

[0041] Methanol (chromatographically pure); Trichloromethane (analytical pure).

[0042] Emodin and chrysophanol were purchased from China Pharmaceutical and Biological Products Laboratory (batch numbers: 110756-200110, 110796-200310, respectively);

[0043] Liuwei Nengxiao Tablet is a product of Gansu Qizheng Tibetan Medicine Co., Ltd.

[0044] (2) Chromatographic conditions

[0045] Octadecyl-bonded silica gel is a filler; Chromatographic column: XDB-C18 column (4.6×250mm, original column from Aglient);

[0046] Mobile phase: methanol-0.1 phosphoric acid solution (V:V=85:15);

[0047] Flow rate: 0.80ml / min;

[0048] Detection wavelength: 254nm;

[0049] Column temperature: room temperature.

[0050] (3) Applicability test...

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Abstract

The invention discloses a quality detection method of a pharmaceutical composition preparation prepared from 30-40 parts by weight of Tibet inula root, 50-70 parts by weight of dry ginger, 80-110 parts by weight of Medicine Terminalia Fruit, 100-140 parts by weight of Rheum officinale, 100-200 parts by weight of Gypsum Rubrum, and 150-210 parts by weight of trona. The method comprises a process for identifying Medicine Terminalia Fruit and dry ginger with thin layer chromatography, and a process for determining effective contents of emodin (C15H10O3) and chrysophanol (C15H10O4) in a medicinalmaterial Rheum officinale by high performance liquid chromatography. The total content of emodin (C15H10O3) and chrysophanol (C15H10O4) of each 1g of the preparation is not less than 0.60mg. The quality detection method of the present invention which has the advantages of simplicity, sensitivity and rapidness can more effectively control the quality of products.

Description

technical field [0001] The invention relates to a quality detection method, in particular to a quality detection method of a pharmaceutical composition preparation. Background technique [0002] Liuwei Nengxiao Pills (Tibetan medicine name: Xiqie Zhouba Ribu) is recorded on page 292 of the first volume of Tibetan medicine in the 1995 edition of "Drug Standards of the Ministry of Health of the People's Republic of China". Its functions and indications are: aid digestion, reduce swelling, regulate wind and stomach. It is used for food poisoning, indigestion, stomach pain, swelling of chest and abdomen, dry stool, dystocia, difficulty in shedding afterbirth, etc. The formula and preparation process recorded in the standard are: Tibetan woody fragrance 35g, dried ginger 60g, myrobalan 95g, rhubarb 120g, Hanshui stone 150g, alkali flower 180g, the above six flavors are crushed into fine powder, sieved, mixed evenly, and pilled with water. Serve dry. Each 10 pills weighs 6g. 2...

Claims

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Application Information

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IPC IPC(8): G01N30/95G01N30/88G01N1/28A61K36/9068A61P1/10A61P1/14A61P15/04A61P39/02A61K33/00A61K33/06
Inventor 包旭宏拉果才让桑杰东主张樱山张国霞陈丽娟
Owner GANSU CHEEZHENG TIBETAN MEDICINE CO LTD
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