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Quelity control method of Chinese medicinal preparation for hepatatitis toxin resolving

A quality control method, hepatitis B detoxification technology, applied in the direction of testing pharmaceutical preparations, pharmaceutical formulas, antiviral agents, etc., can solve problems such as backward quality control standards, difficult product quality control, and inability to effectively control the quality of hepatitis B detoxification preparations

Inactive Publication Date: 2006-08-30
GUIZHOU YIBAI PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Among them, "Yigan Jiedu Capsule" is recorded in the first volume of traditional Chinese medicine prescriptions issued by the Ministry. This medicine has been used clinically for many years. , dry stool, less and yellow urine, yellow and greasy tongue coating, slippery pulse or stringy pulse and other symptoms have achieved satisfactory therapeutic effects. However, our research found that the quality control standards of "Hepatitis B Jiedu Capsules" are simple and backward, and the product quality is not easy. disadvantages of control
Phellodendron Phellodendron, Rhubarb and Scutellaria baicalensis are all drugs that play a major role in hepatitis B detoxification preparations, but the existing preparation quality standards do not carry out content or identification studies on the above drugs, so the existing quality control methods cannot effectively control the quality of hepatitis B detoxification preparations. This will affect the production and quality assurance of products

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0072] traits:

[0073] For capsules: the product content is gray-black or dark brown powder; bitter;

[0074] For tablets: drug appears grayish black or dark brown; tastes bitter;

[0075] For granules: the product is gray-black or dark brown granules;

[0076] Identification:

[0077] (1) Take capsules, tablets or granules respectively, and observe under a microscope: there are many starch granules, single granules are round or polygonal, with a diameter of 8-48 μm, and the umbilicus is crack-shaped, trident-shaped, cross-shaped or Star-shaped, with obvious large grain layer pattern; compound grains are composed of 2-4 grains, calcium oxalate needle crystals are 40-180 μm long and about 5 μm in diameter; there are many stone cells, light brown or colorless, short round, square-like , Sub-polygonal, rectangular or triangular-like, with slightly uneven or pointed edges, 25-28 μm in diameter, 8-48 μm in wall thickness, some of them are uneven in thickness, most of the pores ...

Embodiment 2

[0084] traits:

[0085] For capsules: the product content is gray-black or dark brown powder; bitter;

[0086] For tablets: drug appears grayish black or dark brown; tastes bitter;

[0087] For granules: the product is gray-black or dark brown granules;

[0088] Identification:

[0089] (1) Take capsules, tablets or granules respectively, and observe under a microscope: there are many starch granules, single granules are round or polygonal, with a diameter of 8-48 μm, and the umbilicus is crack-shaped, trident-shaped, cross-shaped or Star-shaped, with obvious large-grain pattern; compound grains are composed of 2-4 grains, calcium oxalate needle crystals are 40-180 μm long and about 5 μm in diameter. There are many stone cells, light brown or colorless, short round, square, polygonal, rectangular or triangular, with slightly uneven or sharp edges, diameter 25-28 μm, wall thickness 8-48 μm, some The thickness is uneven, the pores are mostly dense and branched, and the width...

Embodiment 3

[0097] traits:

[0098] For capsules: the product content is gray-black or dark brown powder; bitter;

[0099] For tablets: drug appears grayish black or dark brown; tastes bitter;

[0100] For granules: the product is gray-black or dark brown granules;

[0101] Identification:

[0102] (1) Take capsules, tablets or granules respectively, and observe under a microscope: there are many starch granules, single granules are round or polygonal, with a diameter of 8-48 μm, and the umbilicus is crack-shaped, trident-shaped, cross-shaped or Star-shaped, with obvious large-grain pattern; compound grains are composed of 2-4 grains, calcium oxalate needle crystals are 40-180 μm long and about 5 μm in diameter. There are many stone cells, light brown or colorless, short round, square, polygonal, rectangular or triangular, with slightly uneven or sharp edges, diameter 25-28 μm, wall thickness 8-48 μm, some The thickness is uneven, the pores are mostly dense and branched, and the width...

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Abstract

A quality control method for the Chinese medicine to treat hepatitis B and detoxicate is disclosed, which features high correctness and advanced technique, so ensuring the high quality.

Description

Technical field: [0001] The invention relates to a quality control method of a traditional Chinese medicine preparation for detoxifying hepatitis B, and belongs to the field of medicine technology. technical background: [0002] Hepatitis B is a common disease that endangers the health of people today. The hepatitis B detoxification preparation is composed of Phellodendron Phellodendron, Caoheche, Scutellaria baicalensis, rhubarb, Coptis chinensis, Smilax smilax, Alum, and Guanzhong. It has the functions of clearing away heat and detoxifying, The effect of soothing the liver and benefiting the gallbladder is used to treat hepatitis B, and the syndrome differentiation belongs to those with damp-heat accumulation in the liver and gallbladder. Among them, "Yigan Jiedu Capsule" is recorded in the first volume of traditional Chinese medicine prescriptions issued by the Ministry. This medicine has been used clinically for many years. , dry stool, less and yellow urine, yellow and...

Claims

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Application Information

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IPC IPC(8): A61K36/9066A61K9/10A61K9/08A61K9/16A61K9/20A61K9/48A61P1/16A61P31/20G01N30/02G01N30/90G01N33/15A61K33/06
Inventor 叶湘武张梅
Owner GUIZHOU YIBAI PHARMA CO LTD
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