2 English reference Paishi Granules [Chinese Medicine Terminology Examination and Approval Committee. Terminology of Traditional Chinese Medicine (2004)]
Chinese medicine terminology committee. Terminology of Traditional Chinese Medicine (2004)]
3 national essential drugs and Paishi Granules related national essential drugs retail guidance price information
Essential drug serial number
DirectoryNo. Drug name, dosage form and specification Retail unit refers to
Remarks on price category 9 10 79 Paishi Granule 5g (sugar-free) bag 2.8 Chinese patent medicine part * 9179 Paishi Granule 20g bag 2. 1 Chinese patent medicine part * Remarks:
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.
4 Overview Paishi Granule is a Chinese patent medicine, and its main components are Glechoma Gleditsiae, Semen Plantaginis (fried with salt water), Akebia Akebia, Xu Changqing, Folium Pyrrosiae, Herba Dianthi, Caulis Lonicerae, talc, Asari, and Radix Glycyrrhizae [1]. Has the effects of clearing away heat, promoting diuresis, dredging stranguria and removing calculus. It can be used for treating stranguria caused by damp-heat in lower energizer, with symptoms such as lumbago and abdominal pain, dysuria or hematuria. Urinary calculi with the above syndrome.
The drug standards of People's Republic of China (PRC) and the Ministry of Health of the People's Republic of China contain Paishi granules.
Pharmacopoeia of People's Republic of China (PRC) (version 20 10) records the pharmacopoeia standard of Paishi granules.
Paishi Granule is named Paishi Granule according to Pharmacopoeia Standard 5. 1.
Paishi granules
5.2 Prescription: Herba Glechomae, Semen Plantaginis, Caulis Akebiae, Xu Changqing, Folium Pyrrosiae and Flos Lonicerae. , talc, carnation. And licorice.
5.3 Take 65,438 0.56 grams of Glechoma Glechomae, add water and decoct it twice, the first time is 3 hours, and the second time is 2 hours, combine the decoctions, filter, and concentrate the filtrate to a fluid extract with a relative density of about 65,438 0.20 (50℃) for later use; Take the other nine medicines, such as Huoxue Dan and Plantago asiatica, and decoct them in water twice, the first time for 3 hours and the second time for 2 hours. Combining decoctions, filtering, concentrating the filtrate to a clear paste with a relative density of about 65438 0.24 (50℃), cooling, adding a proper amount of ethanol, standing, collecting supernatant, recovering ethanol, and concentrating to a relative density of about 65438 0.20. Spray drying the fluid extract, adding appropriate amount of sucrose, and granulating; Or adding sucrose and other adjuvants into the fluid extract, granulating, and drying to obtain1000g; Or adding dextrin into the fluid extract, granulating, and drying to obtain 250g (excluding sucrose).
5.4 Characteristics This product is light yellow to brown granules or suspended granules (excluding sucrose); Gas is slightly sweet, slightly bitter or slightly sweet, slightly bitter (no sucrose).
5.5 Identification Take 65438 0 bags of this product, grind it, add 50 ml of ethyl acetate, perform ultrasonic extraction for 30 minutes, filter, evaporate the filtrate, and dissolve the residue with 0.5 ml of absolute ethanol as the test solution. In addition, the ursolic acid reference substance was added with absolute ethanol to prepare a solution containing 0.5mg per 1ml as the reference substance solution. 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 toluene-ethyl acetate-formic acid (24: 10: 1) as the developing agent, unfold, take out, dry and spray. In the chromatogram of the test sample, spots with the same color appear in the position corresponding to the chromatogram of the control sample.
5.6 The inspection shall comply with the relevant provisions under Granules (Appendix I C of Pharmacopoeia 20 10).
5.7 Determination of Content 5.7. 1 Preparation of Reference Solution Take about 20mg of anhydrous rutin reference substance, weigh it accurately, put it in a 100ml volumetric flask, add a proper amount of 50% methanol, shake it evenly to dissolve it, dilute it to scale, and shake it evenly to get it (containing 0.2mg of anhydrous rutin per 1ml).
5.7.2 Preparation of standard curve Accurately measure 1ml, 2ml, 3ml, 4ml and 5ml of control solution, put them into 10ml volumetric flask, add 50% methanol to 5ml respectively, add 0.3ml of 5% sodium nitrite solution, shake well, let stand for 6min, and add 0./kloc-0. Take the corresponding solution as a blank. According to ultraviolet-visible spectrophotometry (Appendix V A of Pharmacopoeia I, 20 10), the absorbance was measured at the wavelength of 5 10nm, and the standard curve was drawn with absorbance as the ordinate and concentration as the abscissa.
5.7.3 Determination method Take different volumes of this product, grind it, weigh about 5g or about 65438±0g (excluding sucrose), accurately weigh it, put it in a conical flask with a stopper, accurately add 65438 50ml methanol, plug it, weigh it, and extract 25ml by heating and refluxing. Let it cool, weigh it again and make up the lost weight with methanol. Accurately measure 2ml, put it in a 10ml volumetric flask, add 50% methanol to the scale, and shake well as a blank control. Accurately measure 2ml, put it in a 10ml volumetric flask, and immediately measure the absorbance according to the law from "adding 50% methanol to 5ml" according to the method under the standard curve preparation, and read the amount of anhydrous rutin in the test solution from the standard curve and calculate it.
The total flavonoids in each bag of this product shall be calculated as anhydrous rutin (C27H30O 16), and shall not be less than 0. 12g.
5.8 Indications: clearing away heat and promoting diuresis, relieving stranguria and removing stones. It can be used for treating stranguria caused by damp-heat in lower energizer, with symptoms such as lumbago and abdominal pain, dysuria or hematuria. Urinary calculi with the above syndrome.
5.9 Usage and dosage: Take it with boiled water. 65438+ 0 bags at a time, 3 times a day; Still follow the doctor's advice.
5. 10 specification (1) 20g per bag? (2) 5 grams per bag (excluding sucrose)
5. 1 1 storage seal.
5. 12 Edition People's Republic of China (PRC) Pharmacopoeia 20 10 Edition
The traditional Chinese medicine standard of 6 Paishi Granules is 6. 1 Pinyin Mingpaishi Granules.
6.2 standard number WS3B348798
6.3 Prescription Gleditsia sinensis (fried with salt water), Guanmutong Xu Changqing Shiwei pulse-removing honeysuckle. Talc, bicuculline and licorice.
6.4 Characteristics This product is a flake sugar-free granule from grayish white to light brown, with a slightly sweet and bitter taste; Or yellow-brown sugar granules, sweet.
6.5 Identification (1) Take this product 1 bag, add ether 100ml, put it in Soxhlet extractor for 3 hours, take ether solution, evaporate it, and add anhydrous ethanol 1ml to dissolve it as test solution. In addition, the ursolic acid reference substance was added with absolute ethanol to prepare a solution containing 0.5mg per 1 ml as the reference substance solution. According to the thin-layer chromatography test (Appendix ⅵ b), absorb 5μl of the above two solutions, spot them on the same silica gel G thin-layer plate, use cyclohexane chloroform ethyl acetate (20:5:8) as developing agent, unfold, take out, dry, spray 10% sulfuric acid ethanol solution, and bake at 105℃ for about 5 ~ 7. In the chromatogram of the test sample, spots with the same color appear in the position corresponding to the chromatogram of the control sample.
(2) Take 65438 0 bags of this product, add 25ml chloroform and 65438±0ml hydrochloric acid, reflux in water bath for 2h, cool, filter, evaporate the filtrate, and dissolve the residue with 2ml absolute ethanol as the test solution. The other glycyrrhetinic acid reference substance was added with absolute ethanol to prepare a solution containing 1mg per 1 ml as the reference substance solution. According to the thin-layer chromatography test (Appendix ⅵ b), absorb 2μl of the above two solutions, respectively spot them on the same silica gel G thin-layer plate, use petroleum ether (30 ~ 60℃) ethyl phenylacetate glacial acetic acid (10:20:7:0.5) as the developing agent, unfold, take out, dry and spray with1. In the chromatogram of the test sample, spots with the same color appear in the position corresponding to the chromatogram of the control sample.
6.6 The inspection shall comply with the relevant provisions under the item of particles (Appendix I C).
6.7 Preparation of reference substance solution for content determination Accurately weigh 20mg of rutin reference substance which is dried to constant weight under reduced pressure at 65438 020℃, put it in a 65438±000ml volumetric flask, add appropriate amount of 50% methanol, shake it until it is completely dissolved, dilute it to scale, and shake it evenly. Preparation of standard curve Accurately absorb 0.0 ml, 1.0 ml, 2.0 ml, 3.0 ml, 4.0ml and 5.0ml of control solutions, put them in a 10 ml volumetric flask, add 50% methanol to 5.0ml, add 0.3 ml of 5% sodium nitrite solution, shake well, stand for 6 minutes, and add/kloc. Add 50% methanol to the scale, shake it evenly, take the first tube as a blank, measure the absorbance at the wavelength of 5 10nm by spectrophotometry (Appendix V B), and draw a standard curve with absorbance as the ordinate and concentration as the abscissa. Determination method: Take 5 packages of this product, grind them evenly, accurately weigh 65438±0g, put them in a 65438±000ml volumetric flask, add appropriate amount of methanol, ultrasonic for 20min, add methanol to dilute to scale, shake well, filter, discard the initial filtrate, accurately measure 25ml continuous filtrate, put them in a 50ml volumetric flask, add water to dilute to scale, and shake well. Accurately measure 2ml, put it in a 10ml volumetric flask, measure the absorbance from "add 50% methanol to 5.0ml" according to the method under the standard curve preparation, read the weight of rutin in the test solution from the standard curve and calculate. The total flavonoids of this product are calculated as rutin (C27H30O 16), and the sugar-free granules shall not be less than 24 mg per1g; Sugar granules shall not be less than 6mg per1g.
6.8 Indications: clearing away heat and promoting diuresis, relieving stranguria and removing stones. Can be used for treating ureteral calculus, bladder calculus and other diseases with damp-heat syndrome.
6.9 Usage and dosage: Take it with boiled water once 1 bag, three times a day. Still follow the doctor's advice.
6. 10 specifications of each bag
(1) 5g
(2)20 grams
6. 1 1 storage seal.
Drafted by Jiangsu Institute for Drug Control
7 Paishi Granule Drug Instructions 7. 1 Drug Name Paishi Granule
7.2 Chinese Pinyin Paishi Granules for Drugs
7.3 dosage form per bag: 20g, 5g (sugar-free). The total flavonoids in each bag of Paishi granules shall be calculated as rutin (C27H30O 16) and shall not be less than 0. 12g.
7.4 Characteristic stone-discharging particles are light yellow to brown particles or suspended particles (without sucrose); Gas is slightly sweet, slightly bitter or slightly sweet, slightly bitter (no sucrose).
7.5 Paishi Granules are mainly composed of Glechoma Gleditsiae, Plantago asiatica (roasted with salt), Akebia stem, Pyrrosia, Dianqu, Lonicera japonica Thunb., Talcum, Cassia seed, Glycyrrhiza uralensis, etc.
7.6 The pharmacological actions of Paishi Granule mainly include diuretic, cholagogic, anti-inflammatory, analgesic and bacteriostatic actions.
7.7 The function of Paishi Granules is to clear away heat and promote diuresis, and to relieve stranguria and expel stones. It can be used for treating stranguria caused by damp-heat in lower energizer, with symptoms such as lumbago and abdominal pain, dysuria or hematuria. Urinary calculi with the above syndrome.
7.8 Usage and dosage of Paishi Granules: Take it with boiling water. 65438+ 0 bags at a time, 3 times a day; Still follow the doctor's advice.
7.9 Precautions: Drink plenty of water when taking medicine, and pregnant women should take it according to the doctor's advice.
7. 10 Expert opinion