2. The Pharmacopoeia Standard of Anzhong Tablets 2. 1 is called Anzhong Tablets.
Anzhong tablets
2.2 Prescription cassia twig 180g, vinegar corydalis yanhusuo 180g, calcined oyster 180g, fennel 120g, Amomum villosum 120g, galangal 60g and licorice 120g.
2.3 pulverize 36 grams of cassia twig and 72 grams of calcined oyster into fine powder, take 80 grams, and the rest for later use; Percolate vinegar rhizoma corydalis with 70% ethanol as solvent, collecting percolate, and recover ethanol to obtain fluid extract; Distilling Fructus Foeniculi, Fructus Amomi, Rhizoma Alpiniae Officinalis and the remaining Ramulus Cinnamomi, collecting volatile oil, decocting the residue with the above powder, Radix Glycyrrhizae, the remaining calcined oyster and the distilled liquid medicine for three times, mixing decoctions, filtering, concentrating the filtrate to about 65,438+/-000 ml, standing, filtering, mixing the filtrate with the above fluid extract, concentrating into soft extract, adding the fine powder of calcined oyster, mixing, and drying. Or adding adjuvants, mixing, granulating, drying, adding volatile oil, mixing, pressing into 1000 tablets, and coating with film.
2.4 Characteristics This product is a light brown tablet or film-coated tablet, and the film-coated tablet is light brown after the coating is removed; It smells fragrant and tastes slightly sweet, bitter and astringent.
2.5 Identification (1) Take this product and observe it under the microscope: the stone cells are scattered singly or in groups, colorless to brown, square or rectangular, with a diameter of 30 ~ 64 microns and thin wall (cassia twig). Irregular fragments are colorless or yellowish brown with fine surface texture (calcined oyster).
(2) Take 40 tablets of this product or 16 tablets (film-coated tablets), crush them, add 30ml of ether, perform ultrasonic treatment for 20 minutes, filter, evaporate the filtrate, add 1ml of ethyl acetate to dissolve the residue, take cinnamaldehyde as the test solution, and add ethyl acetate to make each 1ml contain 65438+. According to the thin-layer chromatography (Appendix ⅵ b of Pharmacopoeia I, 20 10), the10 ~/5 μ l test solution and 2μl reference solution were respectively spotted on the same silica gel G thin-layer plate, and petroleum ether (60 ~ 90℃)- ethyl acetate (17: 3 In the chromatogram of the test sample, spots with the same color appear in the position corresponding to the chromatogram of the control sample.
(3) Take this product 15 tablets or 6 tablets (film-coated tablets), pulverize, add 30ml of methanol, perform ultrasonic treatment for 30 minutes, filter, add 5g of neutral alumina to the filtrate, shake for several minutes, filter, evaporate the filtrate, add water to dissolve the residue, add concentrated ammonia solution to make it alkaline, and shake with ether for 3 times, each time. Another tetrahydropalmatine reference substance was added with methanol to prepare a solution containing 1mg per 1ml as the reference substance solution. According to the test of thin-layer chromatography (Appendix ⅵ b of Pharmacopoeia Part I, 20 10), absorb 5μl of the above two solutions and spot them on the same silica gel G thin-layer plate, with n-hexane-chloroform-methanol-diethylamine (10: 6:1:0/) as the ratio. In the chromatogram of the test sample, fluorescent spots with the same color appear in the position corresponding to the chromatogram of the control sample.
2.6 The inspection shall comply with the relevant regulations under tablets (Appendix I D of Pharmacopoeia I, 20 10).
2.7 Take 20 tablets of this product as extract, remove the coating of film-coated tablets, accurately weigh and grind, take about 2g, accurately weigh, measure according to the volatile ether extract determination method under the extract determination method (Appendix ⅹ a of Pharmacopoeia I, 20 10), and calculate with ether as solvent.
Each tablet of this product contains volatile ether extract, not less than 0.35mg and film-coated tablets not less than 0.80mg.
2.8 the content was determined by high performance liquid chromatography (appendix ⅵ D of Pharmacopoeia I, 20 10).
2.8. 1 chromatographic conditions and system applicability test: octadecylsilane bonded silica gel is used as filler; The mobile phase is methanol -0.2 mol/L ammonium acetate solution-glacial acetic acid (68: 32: 1). The detection wavelength is 252 nm. According to glycyrrhizic acid peak, the theoretical plate number should not be less than 2000.
2.8.2 Preparation of control solution Take about 65438±00mg of monoammonium glycyrrhizinate as reference substance, weigh it accurately, put it in a 65438±000ml volumetric flask, dissolve it with mobile phase and dilute it to scale, and get it (0.65438±0mg of reference substance containing monoammonium glycyrrhizinate per 65,438 0 ml, equivalent to 97.9 μ of glycyrrhizic acid per 65,438 0 ml).
2.8.3 Preparation of test solution Take 20 tablets of this product, remove the coating of film-coated tablets, accurately weigh and grind, take about 65438±0g, accurately weigh it, put it in a conical flask with a stopper, accurately add 65438±00ml of mobile phase, plug it tightly, weigh it, and perform ultrasonic (power 300W, frequency 33 kHz) for 30 min.
2.8.4 Determination method Accurately absorb 65,438+00μ l of control solution and test solution respectively, inject them into liquid chromatograph, and determine to obtain the product.
Each tablet of this product contains glycyrrhizic acid (C42H62O 16), not less than 0.80mg；; Film coated tablets shall not be less than 2.0 mg.
2.9 Indications: warming middle warmer to dispel cold, regulating qi to relieve pain, regulating stomach to stop vomiting. It can be used for treating stomachache caused by yang deficiency and stomach cold, with symptoms of persistent stomachache, aversion to cold and warmth, vomiting of clear water, listlessness and cold limbs. Chronic gastritis, gastric and duodenal ulcer with the above syndrome.
2. 10 Administration and dosage taken orally. 4 ~ 6 tablets at a time, 2 ~ 3 tablets for children at a time; Three times a day. Film-coated tablets: 2 ~ 3 tablets at a time, children once 1 ~ 1.5 tablets; Three times a day. Still follow the doctor's advice.
2. 1 1 Note: Acute gastritis and hemorrhagic ulcer are prohibited.
2. 12 specification (1) each tablet weighs 0.2g
(2) Film-coated tablets? Each tablet weighs 0.52g.
2. 13 storage seal.
2. 14 edition of China Pharmacopoeia 20 10 edition.
3. Standard for Anzhong Tablet issued by the Ministry of Traditional Chinese Medicine 3. 1 Pinyin Name Anzhong Tablet
3.2 standard number WS3B09299 1
3.3 Prescription Ramulus Cinnamomi 180g Rhizoma Corydalis (processed with vinegar) 180g Oyster (calcined? 80g fennel 120g Amomum villosum 120g Alpinia officinarum 60g licorice 120g.
Above 3.4, 36 grams of cassia twig and 72 grams of oyster are ground into fine powder, 80 grams is taken, and the rest is reserved. There is a percolation method (appendix 17) under the fluid extract and extract of corydalis yanhusuo. 70% ethanol is used as the solvent to percolate, and the percolate is collected, and the ethanol is recovered. The volatile oil is distilled from fennel, Amomum villosum, Alpinia officinarum and its Ramulus Cinnamomi. Decocting the residue, the above powder, Glycyrrhiza uralensis Fisch and the rest Oyster in water for three times, mixing decoctions, filtering, concentrating the filtrate to about 1000ml, standing, filtering, mixing the filtrate with percolate, concentrating into soft extract, adding fine powder such as Oyster, mixing, drying, pulverizing, adding 80g of sucrose powder and 200g of starch, and mixing.
3.5 Characteristics This product is a light brown tablet, fragrant, slightly sweet, bitter and astringent.
3.6 Identification (1) Take this product and observe it under the microscope: the stone cells are rectangular with a diameter of 60 ~ 80μ m and a thin edge. Irregular fragments are colorless and have fine texture on the surface.
(2) Take 3 tablets of this product, grind them, add 6 ml of sulfuric acid solution (0.25 mol/L), shake them evenly, filter them, take a little filtrate on the filter paper, and add the equivalent mixture of 1% potassium ferricyanide solution and 1% ferric chloride solution/drop to show blue spots.
3.7 The inspection shall comply with the relevant regulations under tablets (appendix 1 1 page).
3.8 Function of regulating middle energizer, dispelling cold, regulating qi and relieving pain, regulating stomach and stopping vomiting. Used for epigastric pain, chronic gastritis, hyperacidity, gastric and duodenal ulcer.
3.9 Usage and dosage: 4-6 tablets each time, 2-3 tablets for children; Three times a day, or as directed by a doctor.
3. 10 Note that acute gastritis and hemorrhagic ulcer are prohibited.
3. 1 1 specifications Each piece weighs 0.2g.
3. 12 storage seal.
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