Chenodeoxycholic Acid

Moledular Weight:392.6                 C24H40O4

Specification Value
Appearance tiny yellow Crystalline Powder
Content(%) 98.5min
Loss on drying(%): 2.0min
Residue On lgnition(%): 0.2max
Specific rotation(℃): +11.0 - +13.0
Melting point (℃) 140-160
Acidity(ml) 0.5max
Packaging: fibreboard drum
G.W.:20kg/drum
N.W.:22.5kg/drum

 

Name of product Chenodeoxycholic Acid
Name of pinyin Equyangdansuan
Name of English Acidum Chenodeoxycholicum
Kind of product raw material drug
Origin(moledular formula)/ prescription and standard C24H4004 392.58 Chenodeoxycholicum is extracted from bile of chicken, duck, goose. According to dry product calculation, the content with acidum chenodeoxycholicum is not less 98.0%.
[Character]

Acidum chenodeoxycholicum is a white or tiny yellow crystalline power, with flavor bitter and foreign odor . It is easy to dissolve in alcohol, chloroform, glacial acetic acid and not in water.

Optical rotation Take it and scale precisely and add alcohol to product the liquid of 10 mg drug per ml . Determine in accordance with law (Chinese drug code 1990 version 2 volume appendix page 17). Optical rotation is from 11 to 13.

[Identification] (1)Take item about 20mg, add 3ml mixture of ethyl acetate and sulphuric acid (15:1) to make dissolution , then add 2ml acetic anhydride to changing it from tiny red to dark green.
(2)Take item about 5mg, and place in the test tube. Add 3ml glacial acetic acid for solution , then add 2.5ml mixture of 1 ml trichloride ferric glacial acetic acid liquor(1-10) and 9ml sulphuric acid and misce bene to make solution amaranth.
[Examination] Acidity Take item 1.0g, add 20ml water, shake fully and filtration. Add 2 drops of phenolphthalein indicator in filter liquid. Titrate with sodium hydroxide(0.1mol/l) and not exceed 0.5ml.

Chloride Take item 0.5g, add 20ml water , shake and filter. Add water up to 25ml in the filter liquid and examine in accordance with law(Chinese drug code 1990 version 2 volume appendix page 48) . Compared it with contral liquid which is prepared by 8.0ml standard sodium chloride solution , it should not be more thickness(0.016%)

Barium salt Take item 1.0g and place in the pot crucible. Add 1g free-water sodium carbonate, charcoal with mini-fire and become cool after ablazing and burning, then add adequacy hydrochloric acid in the survivor to dissolve. Neutralize again with sodium hydroxide and filter. Add water up to 25ml in the filter liquid and add diluted hydrochloric acid so as not to take place muddy.

Loss weight by drying Take item and dry on low pressure at 80℃ up to constant weight. Loss weight do not exceed to 2.0%(Chinese drug code 1990 version 2 volume appendix page 55)
Ablazing and burning residue not exceed to 0.2%

Relevant substance Take item and add alcohol to make 0.05mg/ml liquid as test control liquid. In addition fetch bile control liquid and add the liquid which is made by alcohol with 0.05mg/ml liquid as test control. Test according to thin chromatogram(Chinese drug code 1990 version 2 volume appendix page 30). Take suction so-said two kinds of liquids 10ul per items , drop the same silica gel lamellar, use chloroform-aether-glacial acetic acid(4:5:1) as developing agent, then cool dry after expanding, spurt 10% phosphomolybdic acid-alcolhol liquid, color after dryness at 105℃ about 5 minutes , examine with visualize at once. Test solution (if coloration impurity dot do not exceed to more than 3 and compare one of dot color with main dot of control liquid ) should be not more dense.

[Content determination] Take item about 0.5g and weight precisely. Add 25ml neutro-alcohol (para-phenolphthalein indicator become neutrality). After resolving, add phenolphthalein indicator 2 drops and titrate with 0.1mol/l sodium hydroxide and complete. 0.1mol/L 1ml sodium hydroxide is equivalent to 39.26mg C24H4004.
[Action and function] Use for dissolving gallstone and for curing cholecystolithiasis
[Usage and dosage] Oral application 0.25~0.5g at a time , 2~3 times everyday
[Notice] Not use with pregnant woman, heavy hepatitis, biliary obstruction (bile duct bluck)
[Store] Keep shade and dry place
[Preparation] Acidum chenodeoxycholicum collocystis