2 Su Xing Zhike Granules Pharmacopoeia Standard 2. 1 Name Su Xing Zhike Granules
Su Xing Zhike Granule
2.2 prescription bitter almond 63g, dried tangerine peel 47g, perilla leaf 63g, peucedanum root 63g, platycodon grandiflorum 47g, licorice 16g.
2.3 To make the above six flavors, mash bitter almond, soak it in warm water for 24 hours, steam distill it, collect 50 ml of distillate to 0.8 ml of 90% ethanol, distill it again, collect an appropriate amount of heavy distillate, measure the content of hydrocyanic acid in the heavy distillate, and add water to dilute it to 3.0 mg of heavy distillate of bitter almond per kloc-0/ml for later use; Perilla leaf, peucedanum root and tangerine peel, extracting volatile oil; Decocting the above four residues with Radix Platycodi and Radix Glycyrrhizae in water for 2 hours each time, mixing decoctions, filtering, concentrating the filtrate to an appropriate amount, adding appropriate amount of sucrose, granulating, drying, cooling, spraying the above bitter almond heavy distillate 17ml and volatile oil such as Folium Perillae, and mixing well.
2.4 Characteristics This product is yellowish brown to yellowish brown granules; It is fragrant, sweet and slightly bitter.
2.5 Identification (1) Take 20g of this product, put it in a conical bottle, add 15ml of water, hang a trinitrophenol test paper in the bottle, plug it with a cork with a small gap at the edge, and slowly heat it to a slight boiling point. After a few minutes, the test paper turns red.
(2) Take 40g of this product, put it in a 500ml round-bottomed flask, add 250ml of water, connect it with a volatile oil analyzer, add water from the upper end of the analyzer to the scale and overflow it into the flask, then add 1.5ml of petroleum ether (60 ~ 90℃), connect it with a reflux condenser, heat it to boiling, keep it slightly boiling for 2h, and cool it to separate the petroleum ether layer. In addition, 0.7g perilla leaf was taken as the control medicinal material, and the control medicinal material solution was prepared by the same method. According to the test of thin-layer chromatography (Appendix ⅵ b of Pharmacopoeia I, 20 10), respectively absorb 10 ~ 20μ l of the test solution and 10μl of the reference medicinal solution on the same silica gel G thin-layer plate, and use cyclohexane-ethyl acetate (9: 1) as the developing agent, and unfold. 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.
(3) Take 20g of this product, add 60ml of methanol, heat and reflux for 65438 0 hours, filter, evaporate the filtrate to dryness, add 30ml of water to dissolve the residue, shake and extract with water saturated n-butanol for three times, 20ml each time, combine n-butanol layers, wash with n-butanol saturated water for two times, 65438±00ml each time, discard the water washing solution, evaporate the n-butanol layer, and add 65438 methanol to the residue. Take ammonium glycyrrhizinate reference substance [1] and add methanol to make 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), 2μl of each of the above two solutions was absorbed and spotted on the same silica gel GF254nm thin-layer plate prepared with 1% sodium hydroxide solution, and the upper solution of n-butanol-glacial acetic acid-water (6: 1: 3) was used as the developing agent. In the chromatogram of the test sample, spots with the same color appear at the position corresponding to the chromatogram of the control sample [1].
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; Acetonitrile -0.5% acetic acid (20: 80) was used as the mobile phase. The detection wavelength is 283 nm. According to the hesperidin peak, the theoretical plate number should be not less than 4000.
2.7.2 Preparation of reference solution Take about 65438±02.5mg of hesperidin reference substance, weigh it accurately, put it in a 65438±000ml volumetric flask, add methanol to dissolve and dilute it to scale, and shake well. Accurately measure 3ml, put it in a 25ml volumetric flask, add 50% methanol to the scale, and shake well to get the finished product (containing hesperidin per 1ml/5 μ g).
2.7.3 Preparation of test solution Take the contents of this product with different loading, grind, mix well, take about 2g, weigh it accurately, put it in a conical flask with a stopper, add 20ml of methanol accurately, plug it, weigh it, perform ultrasonic treatment (power 300W, frequency 40kHz) for 30min, take it out, let it cool, weigh it again, and make up the loss with methanol. Accurately measure 5ml of continuous filtrate, put it in a 10ml volumetric flask, add water to the scale, and shake well.
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.
The content of dried tangerine peel in each bag of this product is calculated as hesperidin (C28H34O 15), and shall not be less than 1.8mg.
2.8 Indications: dispersing lung and dispelling cold, relieving cough and resolving phlegm. Used for colds, coughs, and adverse qi.
2.9 Usage and dosage: Take it with boiled water. 12g once, three times a day, and children should reduce the amount as appropriate.
2. 10 specification 12g per bag.
2. 1 1 storage seal.
2. 12 note: for the determination of hydrocyanic acid content, take an appropriate amount of heavy distillate, add 20ml of water, 2 ml of potassium iodide test solution and 2ml of ammonia test solution, and titrate the solution with silver nitrate (0. 1mol/L) slowly until the yellow-white turbidity of the solution does not disappear. Every 1ml silver nitrate titration solution (0. 1mol/L) is equivalent to 5.405mg hydrocyanic acid (HCN).
2. 13 edition of China Pharmacopoeia 20 10 edition.
3 Su Xing Zhike Granules state administration of traditional chinese medicine issued standards 3. 1 Pinyin name Su Xing Zhike Granules
3.2 standard number WS3B270397
3.3 prescription bitter almond 63g tangerine peel 47g perilla leaf 63g immature bitter orange 47g peucedanum root 63g licorice 16g
3.4 To make the above six flavors, mash bitter almonds, soak them in warm water for 24 hours, heat and distill, introduce the distillate into a container filled with 90% ethanol, stop distilling when the distillate reaches 50 ml, then distill again, and collect the heavy distillate about 17 ml. Determine the content of amygdalin (C20H27NO 1 1) in the heavy distillate (the method under China Pharmacopoeia 1995 175), and dilute it to 5 1mg amygdalin according to 1ml. Distilling Folium Perillae, Radix Peucedani and Pericarpium Citri Tangerinae to extract volatile oil, and storing the distilled aqueous solution in another container; Decocting Platycodon grandiflorum, Glycyrrhiza uralensis Fisch, bitter almond, perilla leaf, Peucedanum root and tangerine peel in water twice, each time for 2 hours, mixing decoctions, filtering, standing the filtrate, taking supernatant, mixing with distilled water solution, concentrating to a proper amount, adding appropriate amount of sucrose powder, granulating, drying, cooling, spraying volatile oil such as bitter almond distillate 17ml and perilla leaf, and mixing well.
3.5 Characteristics This product is yellow-brown granules; It is fragrant, sweet and slightly bitter.
3.6 Identification (1) Take 20g of this product, put it in a conical flask, add 15ml of water, hang trinitrophenol test paper in the tube, plug it with a cork with a small gap at the edge, and slowly heat it to a slight boiling point. After a few minutes, the test paper turns red.
(2) Take 2g of this product, add 10ml of water, and shake vigorously 1 min. It should produce lasting foam, which will not disappear within 10 min.
3.7 The inspection shall comply with the relevant provisions under the item of particles (Appendix I C).
3.8 Indications: dispersing lung and dispelling cold, relieving cough and resolving phlegm. Used for colds, wind chill, cough, and adverse healthy qi.
3.9 Usage and dosage: Take it with boiling water once, 12g, three times a day, and reduce the dosage for children.
3. 10 specification 12g per bag.
3. 1 1 storage seal.
Drafted by Hubei Institute for Drug Control
4 Instructions for Su Xing Zhike Granules 4. 1 Drug Type Traditional Chinese Medicine
4.2 Drug Name Su Xing Zhike Granule
4.3 Chinese Pinyin of Su Xing Zhike Granules
4.4 Ingredients: bitter almond, dried tangerine peel, perilla leaf, peucedanum, platycodon grandiflorum and licorice.
4.5 Features Su Xing Zhike Granules are light yellow-brown to yellow-brown granules; It is fragrant, sweet and slightly bitter.
4.6 The main functions of Su Xing Zhike Granule are dispersing lung, dispelling cold, relieving cough and resolving phlegm. Used for colds, wind chill, cough, and adverse healthy qi.
4.7 specifications 12g per bag.
4.8 Usage and dosage of Su Xing Zhike Granule: Take it with boiled water once 12g, three times a day.
4.9 Precautions 1. Avoid spicy and greasy food.
2. Su Xing Zhike Granule is suitable for wind-cold cough, characterized by heavy cough, shortness of breath, thin and white expectoration, often accompanied by nasal congestion and watery nasal discharge.
3. Patients with bronchiectasis, lung abscess, cor pulmonale, tuberculosis and diabetes should take it under the guidance of a doctor.
If the symptoms don't improve after taking it for a week, you should stop taking the medicine and go to the hospital.
5. During the medication, if the patient has high fever, body temperature above 38℃, or shortness of breath, or cough aggravates, the amount of sputum increases obviously, and the sputum turns from white to yellow, he should go to the hospital for treatment.
6. If you take it for a long time, you should consult a doctor or pharmacist.
7. Su Xing Zhike Granule is forbidden for those who are allergic, and should be used with caution for those who are allergic.
8. It is forbidden to use Su Xing Zhike Granule when its properties change.
9. Children must use it under the supervision of adults.
10. Please keep Su Xing Zhike Granules out of the reach of children.
1 1. If you are using other drugs, please consult a doctor or pharmacist before using Su Xing Zhike Granules.
4. 10 drug interaction If used with other drugs, drug interaction may occur. Please consult a doctor or pharmacist for details.
4. 1 1 Remarks