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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 are some deficiencies, and it is difficult to carry out more effective quality control on the product

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

experiment example 1

[0034] TLC Identification of Experimental Example 1 Myrobalan

[0035] With reference to the method under the item of Myrobalan in the 2010 edition of "Chinese Pharmacopoeia" to process the sample (Liuwei Nengxiao Tablet), after unfolding according to the law, it was found that the chromatogram of the Myrobalan reference medicinal material and the gallic acid reference substance had the same color spots at the corresponding positions, while the test The spots on the corresponding position on the sample chromatogram are not clear. It is speculated that it may be caused by the acid-base neutralization reaction between the alkaline components in the sample such as alkali flower (mainly containing calcium carbonate) and gallic acid. Therefore, the ethanol in the pharmacopoeia method was directly extracted Change to ethanol and extract under acidic conditions, to inhibit gallic acid from reacting with alkaline components, prepare need testing solution, gallic acid reference substanc...

experiment example 2

[0036] TLC Identification of Experimental Example 2 Dried Ginger

[0037] Treat the sample (Liuweinengxiao Tablet) with reference to the method under the item of dried ginger in the 2010 edition of the "Chinese Pharmacopoeia", unfold it according to the law, and develop the color. It is found that the spots in the sample chromatogram do not correspond well to the reference medicinal materials, and there is a tailing phenomenon, which affects the judgment of the result. . After repeated tests, when the developer was changed to cyclohexane-ethyl acetate (6:4), the spots were completely separated and the effect was better when inspected directly under the ultraviolet light (365nm). Prepare the dried ginger reference drug solution by the extraction method in the standard, and prepare the negative reference substance solution (lacking dried ginger) with the same method, test according to thin-layer chromatography ("Chinese Pharmacopoeia" 2010 edition an appendix VIB), draw the abov...

experiment example 3

[0038] The content assay method of emodin and chrysophanol in experimental example 3 rhubarb

[0039] (1) Instruments and reagents

[0040] Aglient 1100 high-performance liquid chromatography (HP Company of the United States) CSF-IB ultrasonic cleaner (Shanghai Ultrasonic Instrument Factory).

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

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

[0043] Liuweinengxiao tablets are products of Gansu Qizheng Tibetan Medicine Co., Ltd.

[0044] (2) Chromatographic conditions

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

[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 t...

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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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