Contents 1 Pinyin 2 Anzhong Tablet Pharmacopoeia Standard 2.1 Product name 2.2 Prescription 2.3 Preparation method 2.4 Properties 2.5 Identification 2.6 Inspection 2.7 Extract 2.8 Content determination 2.8.1 Chromatographic conditions and system suitability test 2.8.2 Reference substance Preparation of solution 2.8.3 Preparation of test solution 2.8.4 Determination method 2.9 Function and indication 2.10 Usage and dosage 2.11 Note 2.12 Specification 2.13 Storage 2.14 Version 3 Anzhong Tablets Standard issued by the Ministry of Traditional Chinese Medicine 3.1 Pinyin name 3.2 Standard number 3.3 Prescription 3.4 Preparation method 3.5 Properties 3.6 Identification 3.7 Inspection 3.8 Function and main purpose 3.9 Usage and dosage 3.10 Attention 3.11 Specifications 3.12 Storage appendix: 1 Anzhong tablets in ancient books 1 Pinyin
ān zhōng piàn 2 Anzhong tablets pharmacopoeia standard 2.1 Product Name
Anzhong Pian
Anzhong Pian 2.2 Prescription
Guizhi 180g, Corydalis vinegar 180g, roasted oyster 180g, cumin 120g, Amomum villosum 120g, Gaoliang 60g ginger, 120g licorice 2.3 Preparation method
Crush the above seven flavors, 36g cassia twig and 72g calcined oyster into fine powder, use 80g, and set aside the rest; use 70% ethanol as the solvent for vinegar and Corydalis, percolate and collect Percolate the liquid, recover the ethanol, and obtain a clear paste for later use; distill cumin, Amomum villosum, galangal and remaining cassia twigs, collect volatile oil, and add the medicinal residue and the above-mentioned standby powder, licorice, remaining calcined oysters, and the distilled liquid to decoct in water. Boil three times, combine the decoction, filter, concentrate the filtrate to about 1000ml, let it stand, filter, combine the filtrate with the above clear paste, concentrate it into a thick paste, add calcined oyster and other fine powder, mix, dry, grind finely, add Take an appropriate amount of sucrose powder and starch, mix well, form into granules, dry, add volatile oil, mix well, press into 2500 tablets, and you have it; or add an appropriate amount of auxiliary materials, mix well, form into granules, dry, add volatile oil, mix well, and press Divide into 1000 tablets, wrap with film coating, and you have it.
2.4 Properties
This product is light brown tablets or film-coated tablets. Film-coated tablets are light brown after removing the coating; they have an aroma and a slightly sweet, bitter, and astringent taste. 2.5 Identification
(1) Take this product and observe it under a microscope: stone cells are scattered singly or in groups, colorless to brown, almost square or almost rectangular, with a diameter of 30 to 64 μm and a thin wall on one side (Guizhou). branch). Irregular pieces are colorless or light yellowish brown, with fine texture on the surface (burned oyster).
(2) Take 40 or 16 tablets (film-coated tablets) of this product, grind it finely, add 30 ml of ether, ultrasonicate for 20 minutes, filter, evaporate the filtrate to dryness, add 1 ml of ethyl acetate to the residue. Dissolve it and use it as the test solution. Take another cinnamic aldehyde reference substance and add ethyl acetate to make a solution containing 1μl per 1ml, which is used as the reference solution. According to the thin layer chromatography (Appendix VI B of Pharmacopoeia 2010 edition) test, take 10 to 15 μl of the test solution and 2 μl of the reference solution, respectively spot on the same silica gel G thin layer plate, and use petroleum ether (60 to 90°C) )-Ethyl acetate (17:3) is used as the developing agent, unfold, take out, dry, and spray with dinitrophenylhydrazine ethanol test solution. In the chromatogram of the test product, spots of the same color appear at the positions corresponding to the chromatogram of the reference substance.
(3) Take 15 or 6 tablets (film-coated tablets) of this product, grind it finely, add 30ml of methanol, ultrasonicate for 30 minutes, filter, add 5g of neutral alumina to the filtrate, shake for several times Minutes, filter, evaporate the filtrate to dryness, add water to the residue to dissolve, add concentrated ammonia test solution to make it alkaline, shake and extract with diethyl ether 3 times, 10ml each time, evaporate the diethyl ether liquid to dryness, add 1ml of methanol to the residue to dissolve, use as supply Test solution. Take another tetrahydropydalin reference substance, add methanol to make a solution containing 1mg per 1ml, and use it as the reference substance solution. According to the thin layer chromatography (Appendix VI B of the 2010 edition of the Pharmacopoeia), draw 5 μl of each of the above two solutions, respectively point on the same silica gel G thin layer plate, and use n-hexane-chloroform-methanol-diethylamine ( 10:6:1:0.1) is the developing agent, unfold it, take it out, dry it, fumigate it in iodine vapor until the spots are clearly colored, evaporate the adsorbed iodine on the plate, and inspect it under an ultraviolet light (365nm). In the chromatogram of the test product, fluorescent spots of the same color appear at the positions corresponding to the chromatogram of the reference substance. 2.6 Inspection
It should comply with the relevant regulations under tablets (Appendix I D of the 2010 edition of the Pharmacopoeia). 2.7 Extracts
Take 20 tablets of this product, remove the coating from the film-coated tablets, weigh them accurately, grind them finely, take about 2g, weigh them accurately, and measure the volatile ether extractables under the extractables determination method. Determination method (2010 edition of Pharmacopoeia Part 1, Appendix
Each tablet of this product contains volatile ether extracts, which shall not be less than 0.35 mg; film-coated tablets shall not be less than 0.80 mg. 2.8 Content determination
Determine according to high performance liquid chromatography (2010 edition of Pharmacopoeia, Appendix VI D). 2.8.1 Chromatographic conditions and system suitability test
Use octadecylsilane bonded silica gel as filler; use methanol-0.2mol/L ammonium acetate solution-glacial acetic acid (68:32:1) is the mobile phase; the detection wavelength is 252nm. The number of theoretical plates should not be less than 2000 based on the glycyrrhizic acid peak. 2.8.2 Preparation of reference solution
Take about 10mg of glycyrrhizinate monoammonium salt reference standard, weigh it accurately, put it in a 100ml measuring bottle, dissolve it with mobile phase and dilute to the mark, that is (per 1ml The reference substance containing 0.1 mg of glycyrrhizic acid monoammonium salt is equivalent to 97.9 μg of glycyrrhizic acid per 1 ml). 2.8.3 Preparation of test solution
Take 20 tablets of this product, remove the coating from the film-coated tablets, weigh them accurately, grind them into fine pieces, take about 1g, weigh them accurately, and place a stoppered Erlenmeyer flask , accurately add 10ml of mobile phase, seal tightly, weigh, ultrasonicate (power 300W, frequency 33kHz) for 30 minutes, let cool, weigh again, use mobile phase to make up for the lost weight, shake well, filter. Take the remaining filtrate and get it. 2.8.4 Determination method
Precisely draw 10 μl each of the reference solution and the test solution, inject them into the liquid chromatograph, and measure.
Each tablet of this product contains licorice, calculated as glycyrrhizic acid (C42H62O16), which shall not be less than 0.80 mg; film-coated tablets shall not be less than 2.0 mg. 2.9 Functions and Indications
Warms the middle and dispels cold, regulates qi and relieves pain, soothes the stomach and relieves vomiting. It is used for stomach pain caused by yang deficiency and cold stomach. Symptoms include continuous stomach pain, aversion to cold and preference for warmth, general vomiting of water, fatigue and cold limbs; chronic gastritis, gastric and duodenal ulcers with the above syndromes. 2.10 Usage and dosage
Take orally. 4 to 6 tablets at a time, 2 to 3 tablets for children; 3 times a day. Film-coated tablets: 2 to 3 tablets at a time, 1 to 1.5 tablets for children; 3 times a day. Or as directed by your doctor. 2.11 Note
It is contraindicated in acute gastritis and bleeding ulcers. 2.12 Specifications
(1) Each tablet weighs 0.2g
(2) Film-coated tablets? Each tablet weighs 0.52g 2.13 Storage
Sealed.
Version 2.14
"Pharmacopoeia of the People's Republic of China" 2010 Edition 3 Anzhong Pian Ministry of Traditional Chinese Medicine Standard 3.1 Pinyin Name
Anzhong Pian 3.2 Standard Number
WS3B092991 3.3 Prescription
Guizhi 180g Corydalis (made in vinegar) 180g oyster (burned? 80g Cumin 120g Amomum villosum 120g Galangal 60g Licorice 120g 3.4 Preparation method
The above seven flavors, cinnamon Crush 36g of branches and 72g of oysters into fine powder, use 80g, and keep the rest for later use. There is a percolation method under Corydalis Zhaoliu Extract and Extract (page 17 of the appendix). Use 70 ethanol as the solvent to percolate and collect the percolation liquid. , recover ethanol, steam cumin, Amomum villosum, galangal and remaining cinnamon twigs to distill volatile oil. The medicinal residue, the above-mentioned reserve powder, licorice and remaining oysters are boiled three times with water after distillation, combine the decoctions and filter. , concentrate the filtrate to about 1000ml, let it stand, filter, combine the filtrate and the filter liquid, concentrate into a thick paste, add oyster and other fine powder, mix, dry, grind finely, add 80g of sucrose powder, 200g of starch, mix well, and prepare Granules, dry, add volatile oil, mix well, and press into tablets to obtain. 3.5 Properties
This product is light brown tablets, with a slightly sweet, bitter and astringent taste. 3.6 Identification
>(1) Take this product and observe it under a microscope: the stone cells are rectangular, with a diameter of 60-80 μm, and are irregular and colorless on one side.
( 2) Take 3 tablets of this product, grind it finely, add 6ml of sulfuric acid solution (0.25mol/L), shake, filter, drop a little of the filtrate on the filter paper, add 1 potassium ferricyanide solution and 1 ferric chloride solution 1 drop of the same amount of mixture will show blue spots. 3.7 Inspection
It should comply with the relevant regulations under tablets (Appendix page 11).
Warming and dispersing cold, regulating qi and relieving pain, soothing the stomach and relieving vomiting. Used for epigastric pain, chronic gastritis, hyperacidity, gastric and duodenal ulcers.
Take 4 times orally. ~6 tablets, 2 to 3 tablets at a time for children; 3 times a day, or as directed by your doctor. 3.10 Note
Contraindicated in acute gastritis and bleeding ulcers. 3.11 Specifications
Each tablet weighs 0. . 2g 3.12 Storage
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