2. Information on retail guidance price of national essential drugs and related national essential drugs of Hugan Capsule.
Essential drug serial number
DirectoryNo. Drug name, dosage form and specification Retail unit refers to
Price Category Description: 207 17 Hugan Capsule 0.35g*48 capsules (bottles) 18.6 Chinese patent medicine part * 208 17 Hugan Capsule 0.35g* 12 capsules (bottles) 4.9 Chinese patent medicine part 20910. 20 boxes (bottles) 8 Chinese patent medicine part 2 10 17 Hugan capsule capsule 0.35g*24 boxes (bottles) 9.5 Chinese patent medicine part 2 1 17 Hugan capsule 0.35g* 36 capsules (bottles)14.
1. The dosage form specifications marked with "*" in the remarks column in the table are representative products.
2. Specifications of dosage forms with "△" in the remarks column in the table, and other specifications of the same dosage form are tentative prices.
3. The dosage form specifications are indicated in the remarks column. The prices of other specifications in this dosage form are based on the same usage and dosage, and are calculated according to the drug price comparison rules.
4. The "honey pills" marked in the column of dosage form in the form include small honey pills and big honey pills.
3 Pharmacopoeia Standard of Hugan Capsule 3. 1 Name Hugan Capsule
Hugan capsule
3.2 Prescription: Radix Bupleuri 3 13g, Herba Artemisiae Scopariae 3 13g, Radix Isatidis 3 13g, Fructus Schisandrae Chinensis 168g, pig bile powder 20g and mung bean 128g.
3.3 Making the above six kinds of food materials, and pulverizing mung beans into fine powder; Decoct Bupleuri Radix, Herba Artemisiae Scopariae and Radix Isatidis in water for 2 hours each time, filter the decoctions, combine the filtrates, stand for 48 hours, collect the supernatant, concentrate to a relative density of 1.26 ~ 1.28 (80℃), and mix with mung bean powder101g. Schisandra chinensis was crushed into coarse powder and extracted with 75% ethanol under reflux for three times, the first time was 3 hours, the second time was 2 hours and the third time was 1 hour. Mixing extractive solutions, standing for 24 hours, collecting supernatant, recovering ethanol and concentrating to an appropriate amount, mixing with the remaining mung bean powder, drying under reduced pressure, pulverizing into fine powder, mixing with pig bile powder, the fine powder and appropriate amount of adjuvants, and encapsulating.
3.4 Properties This product is a hard capsule, and its contents are brown to brownish powder; It tastes bitter.
3.5 Identification (1) Take 1.4g of the content of this product, grind it, add 30ml of water-saturated n-butanol, leave it overnight, perform ultrasonic treatment for 30min, filter, wash the filtrate with ammonia test solution 15ml, then wash it twice with n-butanol saturated water, each time 10ml, and steam. Another 0.5g Bupleurum reference medicinal material is added with 30ml water, heated and refluxed for 65,438 0 hours, cooled and filtered, and the filtrate is extracted with water-saturated n-butanol by shaking for three times, each time with 65,438 05ml, and the n-butanol extracts are combined, and the reference medicinal material solution is prepared by the same method from "washing with ammonia test solution 65,438 05ml". According to the test of thin-layer chromatography (appendix ⅵ b of Pharmacopoeia I, 20 10), absorb 3 ~ 8 μ l of the above two solutions, respectively spot them on the same silica gel G thin-layer plate, and use ethyl acetate-ethanol-water (8: 2: 1) as the developing agent, unfold, take out, dry and spray 40% and 2%. In the chromatogram of the test sample, in the sunlight, the main spots with the same color appear at the positions corresponding to the chromatogram of the control medicinal materials; Main spot of ultraviolet homochromatic fluorescence.
(2) Take 2. 1g of this product, crush it, add 20ml of methanol, ultrasonic 15 minutes, filter it, evaporate the filtrate, add 10ml of water to dissolve the residue, and pass through D 1 kloc-0/macroporous adsorption resin column (column inner diameter According to the test of thin layer chromatography (Appendix ⅵ b of Pharmacopoeia I, 20 10), 65438 0 μ l of the above two solutions were absorbed respectively, and placed on the same polyamide film to make strips. In the chromatogram of toluene-ethyl acetate-formic acid-glacial acetic acid-water (1: 15: 1: fluorescent spots with the same color appeared in the position corresponding to the chromatogram of the reference substance.
(3) Take 2.5g of the content of this product, grind it, add 50ml of n-hexane, cold soak it overnight, heat and reflux it at 80 ~ 85℃ for 2h, filter it, filter the residue for later use, evaporate the filtrate at low temperature, and dissolve the residue with 2ml of ethyl acetate as the test solution. In addition, 65438 0 g of Schisandra chinensis was taken as the control medicinal material, and 25ml of n-hexane was added to prepare the control medicinal material solution by the same method. Then take schisandrin A reference substance, schisandrin A reference substance and schisandrin B reference substance, and add methanol to make a mixed 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), 2μl of each of the above three solutions was absorbed and spotted on the same silica gel GF254nm thin-layer plate, and the upper solution of petroleum ether (30 ~ 60℃)- ethyl formate-formic acid (14: 5: 1) was developed. 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.
(4) Take 0.5g of the filter residue retained in [Identification] (3), evaporate it, add 20ml 10% sodium hydroxide solution, hydrolyze it at 120℃ for 4h, adjust the pH value to 2-3 with hydrochloric acid after cooling, transfer it to a centrifuge tube, wash the container with water, and combine the washing liquids into the centrifuge tube. In addition, ethanol was added to the reference substance of hyodeoxycholic acid to prepare a solution containing 1ml as the 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 two solutions was absorbed and spotted on the same silica gel G thin-layer plate, and the upper solution of isooctane-diethyl ether-n-butanol-glacial acetic acid-water (10: 5: 3: 5: 1) was used as the developing agent. 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.
3.6 The inspection shall comply with the relevant regulations of capsules (Appendix Ⅰ L of Pharmacopoeia 20 10).
3.7 The content was determined by high performance liquid chromatography (Appendix ⅵ D of China Pharmacopoeia I, 20 10).
3. 7. 1 ACQUITY uplchs T3 (column length: 100mm, inner diameter: 2. 1mm, particle size: 1.8μm) column, used for chromatographic conditions and system suitability test; Use acetonitrile as mobile phase A and water as mobile phase B, and perform gradient elution according to the following table; The flow rate is 0.4ml per minute; The detection wavelength is 250 nm; ; The column temperature is 40℃. According to the peak of schisandrin B, the theoretical plate number should be not less than 150000.
Time (minutes)
Mobile phase A(%)
Mobile phase B(%)
0~3
45
55
3~ 15
45→80
55→20
3.7.2 Preparation of Reference Solution Take appropriate amounts of Schisandrin A reference substance, Schisandrin A reference substance and Schisandrin B reference substance, weigh them accurately, and add methanol to make a mixed solution containing 80μg of Schisandrin A, 20μ g of Gynostemma pentaphyllum A and 50μg of Schisandrin B per kloc-0/ml, thus obtaining the product.
3.7.3 Preparation of test solution Take the contents of this product with different contents, mix them evenly, grind them, weigh about 0.7g, weigh them accurately, put them in a conical flask with a stopper, add 25ml of water-saturated ethyl acetate accurately, plug them, weigh them, perform ultrasonic (power 500W, frequency 59 kHz) for 30min, let them cool, weigh them again, and use acetic acid.
3.7.4 Determination Method Accurately absorb 2μl of reference solution and test solution, inject them into liquid chromatograph, and determine to obtain the product.
Each tablet of this product contains Schisandra chinensis in terms of schisandrin A (C24H32O7), which shall not be less than 0.28mg；; In terms of schisandrin A (C24H32O6), it shall not be less than 0.05mg；; The content of schisandrin B (C23H28O6) shall not be less than 0. 15mg.
3.8 Indications: soothing the liver and regulating qi, invigorating the spleen and promoting digestion. Has that effect of reduce transaminase. Used for chronic hepatitis and early cirrhosis.
3.9 Oral administration and dosage. Take four tablets at a time and three times a day.
3. 10 specification contains 0.35g per piece.
3. 1 1 storage seal.
Version 3. 12