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A kind of detection method of pharmaceutical composition preparation

A quality inspection method and composition technology, which can be used in drug combinations, pharmaceutical formulations, antipyretics, etc., and can solve problems such as difficult product quality control.

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

Since the ministerial standard only has the microscopic identification method of safflower and balsamic medicinal materials, there are some deficiencies, and it is difficult to carry out more effective quality control on the products

Method used

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  • A kind of detection method of pharmaceutical composition preparation
  • A kind of detection method of pharmaceutical composition preparation
  • A kind of detection method of pharmaceutical composition preparation

Examples

Experimental program
Comparison scheme
Effect test

experiment example 1

[0033] TLC Identification of Frankincense in Experimental Example 1 Ruyi Zhenbao Tablets

[0034] Preparation of the test solution: Take 6 tablets of this product, grind finely, add 10ml of ethanol, ultrasonically treat for 30 minutes, filter, evaporate the filtrate to dryness, add 1ml of methanol to dissolve the residue, and use it as the test solution for later use.

[0035] Preparation of the reference medicinal material solution: take 0.5 g of the reference medicinal material frankincense (batch number: 907-200202), add 10 ml of ethanol, and prepare a reference medicinal material solution in the same way, and set aside.

[0036] Preparation of frankincense negative control solution: prepare a negative control substance without frankincense according to the formula ratio and preparation process of the tablet, and make a negative control solution according to the preparation method of the above-mentioned test solution.

[0037] Selection of chromatographic conditions: Accord...

experiment example 2

[0038] TLC Identification of Dalbergia in Experimental Example 2 Ruyi Zhenbao Tablets:

[0039] The original standard only included the microscopic identification method of the balsamic medicinal material, without the thin-layer identification of the medicinal material. The present invention adds a specific identification method for the balsamic medicinal material in this product. After stability investigation, it is found that the method is stable and feasible. As a quality control indicator, it conforms to the principles of simplicity, sensitivity and rapidity.

[0040] Take 6 tablets of this product, grind them finely, add 20ml of ethanol, ultrasonically treat for 30 minutes, filter, evaporate the filtrate to dryness, add 2ml of methanol to dissolve the residue, and use it as the test solution. Separately take 1 g of the reference medicinal material (batch number: 120952-200304) of Dalbergia, add 10 ml of ethanol, and prepare a solution of the reference medicinal material i...

experiment example 3

[0041] TLC Identification of Woody Fragrance in Experimental Example 3 Ruyi Treasure Tablets:

[0042] Woody is the dry root of Aucklandia lappa Decne. Its main active ingredients are coynelide and dehydrocoylidene. The invention adds a specific identification method for the woody medicinal material in the product, and it is found through stability investigation that the method is stable and feasible, and as a quality control index, it conforms to the principles of simplicity, sensitivity and speed.

[0043] Take 6 tablets of this product, grind them finely, put them in a stoppered Erlenmeyer flask, add 15ml of diethyl ether, seal it tightly, soak in cold for 1 hour, shake it from time to time, filter, and concentrate the filtrate to about 1ml as the test solution. Another dehydrocressin lactone plus chloroform made per 1ml solution containing 0.5mg, as the reference solution. Then take 3 g of the negative control substance without woody fragrance formulated according to the...

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Abstract

The invention discloses a detection method for quality of a pharmaceutical composition preparation. The method comprises a specific thin-layer identification method for frankincense, dalbergia heartwood and banksia rose medicinal materials; for content determination, hydroxysafflor yellow A in safflower is used as a content determination index; according to repeated tests, it is discovered that the detection method has strong specificity and good reproducibility and is negative and free of interference. The quality detection method provided in the invention has great improvements compared to original standard, having the advantages of simpleness, sensitivity, accuracy, good reproducibility and capacity of more effective control of quality of the pharmaceutical composition preparation.

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] Ruyi Zhenbao Pills are recorded on page 317 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: clearing away heat, refreshing the brain, relaxing the tendons and dredging the collaterals, and drying yellow water. For distemper, old fever, white vein disease, numbness of limbs, paralysis, crooked mouth and eyes, confusion, arthralgia, gout, rigidity of limbs, and unfavorable joints. It has a good effect on white pulse disease. The formula and preparation process recorded in the standard are: 100g of mother-of-pearl, 100g of agarwood, 100g of travertine, 30g of golden stone, 100g of safflower, 50g of crab, 40g of clove, 100g of myrobalan (pitted), 40g of nutmeg...

Claims

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Application Information

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IPC IPC(8): G01N30/95G01N30/88G01N1/28A61K36/9064A61P31/00A61P29/00A61P25/02A61P25/00A61P19/06A61P19/02A61P19/00A61K33/06A61K35/32A61K35/413A61K35/56A61K35/55A61K35/612A61K35/618
Inventor 包旭宏桑杰东主拉果才让张樱山陈丽娟张国霞
Owner GANSU CHEEZHENG TIBETAN MEDICINE CO LTD
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