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Quality control method for Xianlinggubao preparation

A quality control method and technology of Xianling Gubao, which can be used in testing pharmaceutical preparations, pill delivery, bone diseases, etc., can solve the problems affecting product production and quality assurance, and cannot effectively control the quality of Xianling Gubao preparations.

Inactive Publication Date: 2006-11-08
JIANGXI HUIREN PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Therefore, the existing quality control methods cannot effectively control the quality of Xianlinggubao preparations, which will affect the production and quality assurance of products

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0148] The quality control of embodiment 1 Xianlinggubao pills (concentrated pills)

[0149] The quality control method of the present invention comprises the following steps:

[0150] The observation of traits, the steps are:

[0151] [Properties] This product is a concentrated pill of brownish yellow to tan color with slightly bitter taste.

[0152] Content identification, the steps are:

[0153] [Identification] (1) Take this product and observe under a microscope: calcium oxalate clusters exist in light brown shrunken parenchyma cells, and a constant number of them are arranged in rows. Stone cells are nearly colorless or light yellow, sub-round, sub-triangular, sub-rectangular or irregular in shape, with a diameter of 20-65 μm and uneven edges. Palisade cells of testa are light brown or reddish brown, polygonal in surface view, slightly thicker in wall, and contain reddish brown objects in the cell cavity.

[0154] (2) Take 2g of this product, grind it finely, add 30m...

Embodiment 2

[0164] The preparation of embodiment 2 Xianlinggubao pills (concentrated pills)

[0165] [Prescription] Epimedium 350.1g Dipsacus 50.1g Salvia 24.9g

[0166] Anemarrhena 24.9g Psoralen 24.9g Rehmannia 24.9g

[0167] The preparation method of Xianlinggubao pills (concentrated pills) is as follows: the above six flavors, Dipsacus, Danshen, and psoralen are crushed into fine powder, and the remaining three flavors, such as epimedium, are boiled in water for three times, each time for one hour, and the decoctions are combined and concentrated. When the relative density is 1.35-1.38 (30°C) to obtain a thick paste, add the above-mentioned fine powder, mix well, make 1000 pellets, dry, polish, and get ready.

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Abstract

The present invention relates to quality control method for Xianlinggubao preparation. The quality control method includes thin layer chromatography process for material identification and spectrophotometric method for content measurement. The quality control method is precise, sensitive and stable, and can ensure the high and stable product quality.

Description

Technical field: [0001] The invention relates to a quality control method for traditional Chinese medicine preparations, in particular to a quality control method for Xianling Gubao pill preparations. Background technique: [0002] Xianling Gubao Capsule is an existing drug for the treatment of osteoporosis. Osteoporosis is the absolute reduction of the total amount of bone tissue per unit volume, that is, the absolute reduction of bone mass, which changes the structure and function of the bone, resulting in pain in the surrounding bones. , body deformation and other symptoms, and prone to fracture lesions. Osteoporosis is a very serious and potentially fatal disease, which affects about hundreds of millions of people in the world. In the advanced stage of this disease; bone tissue will become extremely weak, even if you cough or turn over in bed Body fractures are possible. According to the estimate of the American Osteoporosis Foundation, 20% of female patients eventuall...

Claims

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Application Information

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IPC IPC(8): A61K36/8964A61K9/20A61P19/10G01N30/02G01N33/15
Inventor 沈丽琴耿炤
Owner JIANGXI HUIREN PHARMA CO LTD
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