Brief introduction of Xinyi Biyan pill

Directory 1 Pinyin 2 Pharmacopoeia Standard of Xinyi Biyan Pills 2. 1 Name 2.2 Prescription 2.3 Preparation Method 2.4 Character 2.5 Identification 2.6 Inspection 2.7 Content Determination 2.7. 1 Chromatographic conditions and system suitability test 2 .7.2 Preparation of reference solution 2.7.3 Preparation of test solution 2.7.4 Determination method 2.8 Function and indication 2.9 Usage and dosage 2. 10 specification 2.65438+ 3rd edition 3rd edition Chinese medicine standard 3. 1 Pinyin Name 3.2 Standard Number 3.3 Prescription 3.4 Preparation Method 3.5 Character 3.6 Identification 3.7 Inspection 3.8 Function and Indication 3.9 Usage and Dosage 3. 10 Storage 4 Xinyi Biyan Pill Instructions 4. 1 Drug Type 4.2 Drug Name 4.3 Chinese Pinyin of Drugs 4.4 Components 4.5 Traits 4.6 Function Xinyi Biyan Pill Indications 4.7 Usage and Dosage 4./Kloc-0 0 Remarks 5 References Attachment: * Other versions of related drug instructions of Xinyi Biyan Pill 1 Pinyin xρnyíbíyán wán

2 Pharmacopoeia Standard of Xinyi Biyan Pill 2. 1 Name Xinyi Biyan Pill

Xinyi Biyan Pill

2.2 prescription: Flos Magnoliae 42g, Herba Menthae 433g, Folium Perillae 3 17g, Radix Glycyrrhizae 2 15g, Herba Pogostemonis 433g, Fructus Xanthii11g, Herba Centipedae 209g and Radix Isatidis 650g.

2.3 to prepare the thirteen medicines, centipede, divaricate Saposhnikovia root and houttuynia cordata105g are taken and crushed into coarse powder; Extracting volatile oil from Flos Magnoliae, Herba Menthae, Herba Agastaches and Folium Perillae, and collecting residues in another container; Decocting Fructus Xanthii, Radix Isatidis, Trident, Glycyrrhrizae Radix, Radix Angelicae Dahuricae and the rest Herba Centipedae in water for 65438+/-0.5 hours, filtering, collecting filtrate, and collecting residues in another container; Decocting Flos Chrysanthemi and the above residues in water for 65,438+/-0.5 hours, filtering, mixing filtrates with the above filtrates, concentrating into thick paste, mixing with the above coarse powder, drying, pulverizing into fine powder, sieving, mixing, making pills with water, drying, spraying volatile oil to make 65,438+/-0.000g, and mixing with iron oxide black-talcum powder (1:0).

2.4 Characteristics This product is a black concentrated water pill, which is brown after coating is removed. Aromatic, sweet and cool, slightly bitter.

2.5 Identification (1) Take this product and observe it under the microscope: the pollen grains are spherical, with a diameter of 18 ~ 35μ m and thorns on the surface (geese don't eat grass). The tubing contains golden yellow secretion with a diameter of about 17 ~ 60μ m (windproof).

(2) Take 4.5g of this product, grind it, add 30ml of methanol, perform ultrasonic treatment for 20min, filter, evaporate the filtrate, add 1ml of methanol to dissolve the residue, put it on neutral alumina column (100 ~ 200 mesh, 12g, inner diameter 2cm), and use 80% methanol. In addition, licorice1g. A control drug solution was prepared in the same way. According to the test of thin-layer chromatography (Appendix ⅵ b of Pharmacopoeia Part I, 20 10), absorb 5μl of the above two solutions, respectively spot them on the same silica gel G thin-layer plate, and use chloroform-methanol-water (40:1:1) as the developing agent, unfold, take out, dry and spray with 60. They were detected under sunlight and ultraviolet (365nm) respectively. In the chromatogram of the test sample, the spots of the same color are displayed in the sunlight and the fluorescent spots of the same color are displayed in the ultraviolet light at the position corresponding to the chromatogram of the control medicinal material.

(3) Take 3g of this product, grind it and add 30ml. Ultrasonic treatment of methanol for 30min, filtering, evaporating the filtrate, adding 10ml water to dissolve the residue, and passing through D1kloc-0/macroporous adsorption resin column (inner diameter 1.0cm, column height 12cm). Collect eluent, evaporate to dryness, and dissolve the residue with 1ml methanol as the test solution. Taking 65438 0 g Xanthium sibiricum as reference material, the reference material solution was prepared by the same method. According to the test of thin-layer chromatography (Appendix ⅵ b of Pharmacopoeia I, 20 10), 5μl of each of the above two solutions was absorbed, respectively, on the same silica gel G thin-layer plate, with chloroform-ethyl acetate-methanol-water-formic acid (3: 10: 2: 2) as the developing agent, unfolded, taken out and dried. 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.

(4) Take 2g of this product, grind it, add 20ml of ethyl acetate, perform ultrasonic treatment for 30min, filter, evaporate the filtrate to dryness, and add 2ml of ethyl acetate to dissolve the residue as the test solution. In addition, 2g centipede control medicinal material was taken 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 Part I, 20 10), 5μl of the test solution and 2μl of the control medicinal solution were respectively absorbed, and petroleum ether (90 ~120: 0.5) was added to the same silica gel G thin-layer plate. 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.

(5) Take 3g of this product, grind it, add 30ml of acetone, perform ultrasonic treatment for 65,438 0.5min, filter and evaporate the filtrate, and add 65438±0ml of acetone to dissolve the residue as the test solution. In addition, 65438 0 g of Saposhnikovia divaricata was taken as the control medicinal material, and the control medicinal material solution was prepared by the same method. Then, take the reference material of Cimicifuga rhizome, add ethanol to make a solution containing 0.5mg per kloc-0/ml as the reference material solution. According to the test of thin-layer chromatography (Appendix ⅵ b of Pharmacopoeia I, 20 10), 2μl of each of the above three solutions were absorbed, spread on the same silica gel G thin-layer plate with the upper solution of ethyl acetate-formic acid-water (12: 2: 3) as the developing agent, taken out, dried and placed in an ultraviolet lamp (254nm). In the chromatogram of the test sample, spots with the same color appear at the positions corresponding to the chromatograms of the reference medicinal materials and the reference substance.

(6) Take 20g of this product, grind it, add 50ml of ether, heat and reflux it for 30min, let it cool, filter it, evaporate the filtrate, and add 5ml of ethyl acetate to the residue to dissolve it as the test solution. In addition, 3 grams of houttuynia cordata. A control drug solution was prepared in the same way. According to the test of thin-layer chromatography (Appendix ⅵ b of Pharmacopoeia Part I, 20 10), absorb each 10μl of the above two solutions, respectively spot them on the same silica gel G thin-layer plate, unfold them with toluene-ethyl acetate (9: 1) as the developing agent, take them out, dry them, and place them under an ultraviolet lamp (365. 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.

(7) Take 65438+/-0g of Chrysanthemum as the reference medicinal material, and prepare the reference medicinal material solution by the same method as [identification ](3). In addition, chlorogenic acid reference substance was added with ethanol to prepare a solution containing 0.5mg 1ml as reference substance solution. According to the test of thin-layer chromatography (Appendix ⅵ b of China Pharmacopoeia, Part I, 20 10), take 2μl of the sample solution under [Identification ](3) and the above-mentioned reference medicinal solution and reference medicinal solution, respectively, and spot them on the same polyamide film. In the sample chromatography, fluorescent spots with the same color appear at positions corresponding to the reference medicinal material chromatography and reference medicinal material chromatography.

2.6 The inspection shall comply with the relevant provisions under Pills (Appendix of Pharmacopoeia 20 10/A).

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; Use acetonitrile as mobile phase A and water as mobile phase B, and perform gradient elution according to the following table; The detection wavelength is 254 nm. According to the Cimicifuga peak, the theoretical number of plates should not be less than 6000.

? Time (minutes)? Mobile phase A(%) mobile phase B(%) 0~ 15? 15 ? 85 ? 15~35 ? 15→30 ? 85→70 2.7.2 Preparation of reference solution Take appropriate amounts of cimicifugoside reference substance and 50-methyl misoprostol reference substance, weigh them accurately, and add 80% methanol to make a mixed solution containing 50ug per kloc-0/ml.

2.7.3 Preparation of test solution Take an appropriate amount of this product, grind it, weigh about 2g, accurately weigh it, put it in a round-bottomed flask, add 50ml of methanol accurately, plug it, weigh it, heat and reflux it for 65,438+/-0h, let it cool, weigh it again, make up the weightlessness with methanol, shake it evenly, filter it, accurately measure 25ml of continuous filtrate, and evaporate it. Add neutral alumina column (100 ~ 200 mesh, 5g, inner diameter 1.5cm), elute with 80ml 80% 80% methanol, collect eluate, evaporate to dryness, add 80% methanol to dissolve residue, transfer to 10ml measuring bottle, add 80% methanol to scale, and.

2.7.4 Determination method Accurately absorb 10ul control solution and test solution respectively, inject them into liquid chromatograph, and determine to obtain the product.

Every 1g of this product contains not less than 0.60mg of Cimicifuga foetida (C22H28O 1 1) and 50- methyl visamethasone (C22H28O 10). [ 1]

2.8 Indications: expelling wind, inducing resuscitation, clearing away heat and toxic materials [2]. It is used to treat nasal congestion, runny nose, clear or turbid nose, fever, headache and other symptoms caused by wind-heat invading the lung and heat toxin accumulating in the lung. Chronic rhinitis, allergic rhinitis, nervous headache, see the above syndromes.

2.9 Oral administration and dosage. 3g once, three times a day.

2. 10 specifications each 10 pill weighs 0.75g

2. 1 1 storage seal.

2. 12 Note: Angelica dahurica is Buch. Ham. )DC。

2. 13 Edition First Supplement to China Pharmacopoeia 20 10 Edition

3. Standard issued by the Ministry of Traditional Chinese Medicine 3. 1 Pinyin name Xinyi Biyan Pill

3.2 standard number WS3B 194395

3.3 Prescription Flos Magnoliae 63g mint 650g perilla leaf 475g licorice 323g Pogostemon 650g Xanthium 1667g centipede 3 13g Radix Isatidis 975g Radix Angelicae Dahuricae 650g Radix Saposhnikoviae 470g Herba Houttuyniae 225g Flos Chrysanthemi 650g Trident 650g.

3.4. Prepare the thirteen medicinal materials mentioned above, and extract the volatile oil from Flos Magnoliae, Herba Agastaches, Herba Menthae and Folium Perillae; Decocting Fructus Xanthii, Trident, Glycyrrhrizae Radix, Radix Angelicae Dahuricae, Radix Isatidis and Herba Centipedae 156. 5g water once, and filtering; Mixing the residue with the residue after extracting volatile oil, adding Flos Chrysanthemi, decocting in water once, filtering, mixing filtrates, and concentrating into soft extract; 156. pulverize radix Saposhnikoviae, ANABAENA, and Scolopendra 5g each into coarse powder, mix with the soft extract, dry, pulverize into fine powder, sieve, add water, spray the above volatile oil, coat it with iron oxide red (1: 1), polish and dry.

3.5 Characteristics This product is a black coated concentrated water pill, which is brown after coating is removed; Aromatic, sweet and cool, slightly bitter.

3.6 Identification (1) Take this product and observe it under the microscope: the pollen grains are spherical, with a diameter of 18 ~ 35μ m, a thick wall and thorns on the surface. There is a golden yellow lump secretion in the tube, with a diameter of17 ~ 60μ m. ..

(2) Take 2g of this product, grind it, add ether 15ml for leaching, filter it, shake it to 2ml, and use it as the test solution. In addition, 2g centipede control medicinal material was taken and the control medicinal material solution was prepared by the same method. According to the thin-layer chromatography test (page 57 of the appendix), absorb 65,438 0 μ m of the above two solutions, respectively spot them on the same silica gel G thin-layer plate, use petroleum ether (90 ~ 65,438 0.20) and ethyl acetate (8.5: 65,438 0.5) as developing agents, unfold, take out, dry and spray with 65,438+. 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, grind it, add proper amount of ether, heat and reflux for 30min, let it cool, filter, evaporate the filtrate, and dissolve the residue with 5ml of ether as the test solution. 20 grams of houttuynia cordata each. Take control medicinal materials, and prepare control medicinal materials solution by the same method. According to the thin-layer chromatography test (page 57 of the appendix), absorb 65438 00μ l of the above two solutions, respectively spot them on the same silica gel G thin plate, take them out with butyl toluene acetate (9: 1) as the developing agent, dry them, and examine them under an ultraviolet lamp (365nm). 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.

3.7 The inspection shall comply with the relevant regulations of Pills (Appendix 8).

3.8 Indications: dispelling wind and clearing heat, diminishing inflammation and detoxicating. Can be used for treating rhinitis (including allergic rhinitis and chronic rhinitis). ), nervous headache, common cold with runny nose and stuffy nose.

3.9 Usage and dosage Take orally, 3g at a time, three times a day.

3. 10 storage seal.

4. Instructions for Xinyi Biyan Pill 4. 1 Drug Type Traditional Chinese Medicine

4.2 Drug Name Xinyi Biyan Pill

4.3 Pharmaceutical Chinese Pinyin Xinyi Biyan Pills

4.4 Ingredients: Flos Magnoliae, Herba Menthae, Folium Perillae, Radix Glycyrrhizae, Herba Pogostemonis, Fructus Xanthii, Herba Centipedae, Radix Isatidis, Radix Angelicae Dahuricae, Radix Saposhnikoviae, Herba Houttuyniae, Flos Chrysanthemi, and Trigemma.

4.5 Features Xinyi Biyan Pill is a black concentrated water pill, which is brown after the coating is removed; Aromatic, sweet and cool, slightly bitter.

4.6 The main functions of Xinyi Biyan Pill are expelling wind, clearing away heat and detoxifying. Used for rhinitis.

4.7 Usage and dosage of Xinyi Biyan Pill: Take orally, 3g at a time, 3 times a day.

4.8 Precautions 1. Avoid spicy and fishy food.

2. If you feel that your lips are numb after taking the medicine, you should stop taking the medicine.

After taking the medicine for three days, the symptoms have not improved, or there are other symptoms, so I will go to the hospital.

4. Take it according to usage and dosage, and children should take it under the guidance of a doctor.

5. It is forbidden for those who are allergic to Xinyi Biyan Pill, and should be used with caution for those who are allergic.

6. Xinyi Biyan Pill is prohibited when its properties change.

7. Children must use it under the supervision of adults.

8. Please keep Xinyi Biyan Pill out of the reach of children.

9. If you are using other drugs, please consult a doctor or pharmacist before using Xinyi Biyan Pill.

4.9 Drug Interaction If used together with other drugs, drug interaction may occur. Please consult a doctor or pharmacist for details.

4. 10 Remarks