2 Weiyangling Granules Pharmacopoeia Standard 2. 1 Name Weiyangling Granules
Weiyangling granules
2.2 Prescription: Astragalus membranaceus 416.7g, Radix Glycyrrhizae Preparata 333.3g, Radix Paeoniae Alba 250g, Fructus Jujubae166.7g, Ramulus Cinnamomi133.3g, and Rhizoma Zingiberis Recens133.3g.
2.3 Make the above six medicines, add water to ginger, distill and extract the volatile oil for 5 hours, and collect the volatile oil for later use; Decocting the residue with Radix Astragali, Radix Glycyrrhizae Preparata, Radix Paeoniae Alba and Ramulus Cinnamomi in water twice, each time for 65,438 0.5 hours, combining decoctions, filtering, and concentrating the filtrate under reduced pressure to a relative density of about 65,438 0.65,438+00 ~1.65,438+05 (70 ~ 80℃). Chinese jujube is decocted in water twice, each time is 65438 0 hours, the decoctions are combined, filtered, the filtrate is concentrated under reduced pressure to a thick paste with a relative density of 65438 0.30 ~ 65438 0.35 (70 ~ 80℃), the thick paste is added, 830g of sucrose powder and proper amount of dextrin are added, mixed evenly, granulated, dried and sieved.
2.4 Characteristics This product is yellow to brownish yellow granules; Delicious, sweet and slightly pungent.
2.5 Identification (1) Take this product 10g, add 25ml of water to dissolve it, shake and extract it with water-saturated n-butanol twice, 25ml each time, combine n-butanol solutions, wash it with ammonia test solution for four times, 25ml each time, discard the alkali solution, evaporate the n-butanol solution, and add 1ml of methanol to dissolve the residue as the test solution. In addition, 0.5g of Astragalus membranaceus reference medicinal material is added with 100ml of water, decocted for 30min, cooled and filtered, and the filtrate obtained by "shaking extraction with water saturated n-butanol for 2 times" is taken, and the reference medicinal material solution is prepared by the same method. Then take astragaloside IV reference substance and add methanol to make a solution containing 65438±0mg per 65438±0ml as reference substance solution. According to the test of thin-layer chromatography (appendix ⅵ b of Pharmacopoeia I, 20 10), 5μl of each of the above three solutions was absorbed, respectively, on the same silica gel G thin-layer plate, and dichloromethane-ethyl acetate-methanol-formic acid (25: 5: 10: 0.2) was used as the developing agent, and then unfolded, taken out and dried. In the chromatogram of the test sample, fluorescent spots with the same color appear at the positions corresponding to the chromatograms of the reference medicinal materials and the reference substance.
(2) Take 65438 00 g of this product, add 30ml of water to dissolve it, shake and extract it with water saturated n-butanol for 2 times, 25ml each time, combine n-butanol solutions, evaporate to dryness, add 65438±0ml of methanol to dissolve it, and take the residue as the test solution. In addition, 0.5 grams of licorice. Add 65438±000ml of water, decoct for 30 minutes, cool and filter, and the filtrate is taken from "shake extraction with water saturated n-butanol for 2 times" and licorice solution. Prepared by the same method. According to the test of thin-layer chromatography (Appendix ⅵ b of Pharmacopoeia I, 20 10), absorb 5μl of the above two solutions, respectively spot them on the same silica gel G thin-layer plate, and use dichloromethane-ethyl acetate-methanol-formic acid (25: 5: 10: 0.2) as the developing agent, unfold, take out and dry. In the chromatogram of the test sample, fluorescent spots with the same color appear at the positions corresponding to the chromatogram of the control medicinal materials.
(3) Take paeoniflorin reference substance and add methanol to make a solution containing 65438±0mg per 65438±0ml as reference substance solution. According to the test of thin-layer chromatography (Appendix ⅵ b of Pharmacopoeia Part I, 20 10), 5μl of the sample solution under [Identification ]( 1) and the above-mentioned reference solution and each solution were respectively spotted on the same silica gel G thin-layer plate, and dichloromethane-ethyl acetate-methanol-formic acid (30: 5:/kloc-0) was used as the solvent. In the chromatogram of the test sample, spots with the same color appear in the position corresponding to the chromatogram of the control sample.
(4) Take 65438 00 g of this product, grind it, add 50ml of ether, perform ultrasonic treatment for 5min, filter and evaporate the filtrate, and dissolve the residue with 65438±0ml of ethanol as the test solution. In addition, add 1g jujube reference medicinal material into 100ml water, boil for 2 hours, filter, concentrate the filtrate to about 20ml, add 50ml ether for shaking extraction, separate ether solution, evaporate, and dissolve the residue with 1ml ethanol as reference medicinal material solution. According to the test of thin-layer chromatography (appendix ⅵ b of Pharmacopoeia I, 20 10), 5μl of the test solution and 2μl of the control medicinal material solution were respectively absorbed, and then spread on the same silica gel G thin-layer plate with petroleum ether-ethyl acetate (3: 1) as the developing agent, taken out, dried and sprayed with 5% vanillin sulfuric acid solution at 65438. In the chromatogram of the test sample, the spots with the same color appear at the positions corresponding to the chromatogram of the control medicinal materials.
2.6 The inspection shall comply with the relevant provisions of Granules (Appendix I C of Pharmacopoeia 20 10).
2.7 the content was determined by high performance liquid chromatography (appendix ⅵ D of Pharmacopoeia I, 20 10).
2.7. 1 chromatographic conditions and system applicability test, using octadecylsilane bonded silica gel as filler; The mobile phase was acetonitrile -0.5% glacial acetic acid (10: 90). The detection wavelength is 276 nm. Calculated by liquiritin peak, the theoretical plate number should not be less than 2000.
2.7.2 Preparation of reference solution Take appropriate amount of liquiritin reference substance, weigh it accurately, and add methanol to make a solution containing 20μg per kloc-0/ml.
2.7.3 Preparation of test solution According to the different loading, take a proper amount of this product, grind it, weigh about 3g, weigh it accurately, put it in a conical flask with a stopper, add 50ml of methanol accurately, plug it, weigh it, perform ultrasonic treatment (power 300W, frequency 25kHz) for 30min, let it cool, weigh it again, make up for the weightlessness with methanol, and shake it evenly.
2.7.4 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 bag of this product contains glycyrrhizin (C21H2O9), which shall not be less than 5.0mg.
2.8 Indications: warming middle warmer, benefiting qi and relieving pain. It can be used for treating stomachache caused by weakness of spleen and stomach and deficiency of middle qi, with symptoms of epigastric distension and pain, eating hot and oppressive feeling, anorexia fatigue, pale tongue and weak pulse; Patients with gastric and duodenal ulcers and chronic gastritis see the above syndromes.
2.9 Usage and dosage: Take it with boiled water. 20g at a time, three times a day.
2. 10 Pay attention to burning the stomach, and it is not suitable for those who swallow acid with bitter taste.
2. 1 1 20g per bag.
2. 12 storage seal.
2. 13 Edition The Third Supplement to China Pharmacopoeia 20 10 Edition
3. Standard issued by the Ministry of Traditional Chinese Medicine 3. 1 Pinyin name Weiyangling Granule
3.2 standard number WS3B256397
3.3 Prescription Astragalus membranaceus 250g Glycyrrhiza uralensis Fisch (honey-baked) 200g Radix Paeoniae Alba150g Jujube100g Ramulus Cinnamomi 80g Ginger 80g.
3.4 Take the above six medicines, extract the volatile oil from ginger, decoct the residue with Radix Astragali, Ramulus Cinnamomi, Radix Paeoniae Alba and Radix Glycyrrhizae in water twice, each time for 65,438 0.5 hours, combine the decoctions, filter, concentrate the filtrate under reduced pressure, cool, add ethanol until the alcohol content is 50%, stir evenly, stand still, filter, recover ethanol from the filtrate under reduced pressure, and concentrate to the relative density of 65,438 0.30. Decocting Fructus Jujubae in water twice for 65,438+/-0 hours each time, combining decoctions, filtering, concentrating the filtrate under reduced pressure to a relative density of 65,438+/-0.30, combining the above fluid extract with the above fluid extract, adding 500 grams of sucrose and appropriate amount of dextrin, uniformly mixing, granulating, drying, sieving, spraying appropriate amount of the above ginger volatile oil, uniformly mixing, and making into granules of about 600 grams or pressing into cubes.
3.5 Characteristics This product is brown granules or long squares; The smell is fragrant, the taste is sweet and slightly spicy.
3.6 Identification (1) Take this product 10g, soak it in 20ml n-butanol 1 hour, filter it, put the filtrate in water to dry, add 1ml acetic anhydride to the residue to dissolve it, and drop 1 ~ 2 drops of sulfuric acid to turn it into cherry red, and then brown red.
(2) Take 30g of this product, grind it, add 60ml of ether, soak it for 65438 0 hours, filter it, take 65438 00 ml of filtrate, evaporate it, add 65438±0ml of water to dissolve the residue, drop 1 ~ 2 drops of magenta sulfurous acid test solution, and let it stand for 2 minutes, showing a rosy color.
(3) Take identification
Evaporating the remaining filtrate under item (2), dissolving the residue with 65438±0ml ethanol as the test solution, and taking ginger volatile oil as the reference solution, and conducting the test according to the thin layer chromatography (Appendix VI B). Absorb each 10 μl of the above two solutions, respectively spot them on the same silica gel G thin-layer plate, and use n-butanol 5% ammonia solution anhydrous ethanol (5:2: 1) as developing agent, unfold, take out and dry. In the chromatogram of the test sample, the same yellow spots appear in the position corresponding to the chromatogram of the control sample; Spraying dilute sulfuric acid; 1 10℃ baked for 5 ~ 10 minutes, the color of yellow spots deepened.
3.7 The inspection shall comply with the relevant provisions under the item of particles (Appendix I C).
3.8 Indications: warming middle warmer, benefiting qi and relieving pain. It can be used for abdominal distension and pain, warm feeling, oppressive feeling, anorexia, weak tongue and weak pulse, and is suitable for chronic gastritis, duodenal ulcer and other symptoms.
3.9 Usage and dosage Take it with boiling water, 20g at a time, three times a day.
3. 10 Pay attention to burning the stomach, and it is not suitable for those who swallow acid with bitter taste.
3. 1 1 specifications each bag or piece weighs 20g.
3. 12 storage seal.
Draft by Hunan Institute for Drug Control
4. Instructions for Weiyangling Granules 4. 1 Drug Type Traditional Chinese Medicine
4.2 Drug Name Weiyangling Granules
4.3 Chinese Pinyin of Weiyangling Granules
4.4 Ingredients of Weiyangling Granule: Radix Astragali, Radix Glycyrrhizae Preparata, Radix Paeoniae Alba, Fructus Jujubae, Ramulus Cinnamomi, and Rhizoma Zingiberis Recens.
4.5 Characteristics Weiyangling granules are yellow to brownish yellow granules; Delicious, sweet and slightly pungent.
4.6 Weiyangling Granule has the effects of warming middle warmer, benefiting qi and relieving pain. It is used for abdominal distension and pain, warmth, oppression and anorexia, and is suitable for chronic gastritis with the above symptoms.
4.7 specifications 20 grams per bag
4.8 Usage of Weiyangling Granules: Take it with boiling water. 20g at a time, three times a day.
4.9 The contraindication of Weiyangling Granule is heartburn, and it is forbidden for those who swallow acid with bitter taste.
4. 10 Precautions 1. Avoid cold, greasy and indigestible food.
2. Not suitable for spleen and stomach yin deficiency, mainly manifested as dry mouth, little body fluid and dry stool.
3. Pregnant women should use it with caution.
4. Take according to usage and dosage. Children, the elderly and the infirm should take it under the guidance of a doctor.
5. It is forbidden for those who are allergic to Weiyangling granules, and should be used with caution for those who are allergic.
6. It is forbidden to use Weiyangling granules when their properties change.
7. Children must use it under the supervision of adults.
8. Please keep Weiyangling granules out of the reach of children.
9. If you are using other drugs, please consult a doctor or pharmacist before using Weiyangling granules.
4. 1 1 drug interaction If it is used with other drugs at the same time, drug interaction may occur. Please consult a doctor or pharmacist for details.
4. 12 remarks: Please read the instructions carefully and use them according to the instructions or purchase them under the guidance of pharmacists.
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