2. Standard issued by state administration of traditional chinese medicine 2. 1 Pinyin name Fudekang Foam Agent
2.2 standard number WS3B358598 this product is a foaming agent made of total alkaloids of Sophora flavescens.
2.3 preparation method: 6000g of total alkaloids of Sophora flavescens are dissolved in water, and the pH value is adjusted to 6 with 5mol/L hydrochloric acid; Dissolve sodium dodecyl sulfate 150g, octadecanol 200g and lanolin 150g in water bath, then pour into the total alkali solution of Sophora flavescens, add glycerol 5000g, stir evenly, add water to the prepared amount, then put it into a pressure-resistant container with a special valve system, cover tightly, and press in dichlorodifluoromethane to make it100.
2.4 Characteristics This product is light brown emulsion; When the button of the original valve is lifted, the liquid medicine will bubble when it is ejected.
2.5 Identification (1) After removing dichlorodifluoromethane by micropore exhaust, open the aluminum cover and take about 0. 1g this product, add 2 drops of concentrated ammonia to dissolve it, put it in a separatory funnel, add 2 ~ 3ml chloroform, shake it evenly for several minutes, and let it stand; Take 0.5ml chloroform solution respectively, add 2 ~ 3 ml water and 2 ~ 3 drops 1mol/L hydrochloric acid solution, shake well, stand still, take the upper water solution, add silicotungstic acid test solution to generate white flocculent precipitate, and add bismuth potassium iodide test solution to generate orange-red precipitate.
(2) Take 0. Take 65438 0 g of this product, add 65438 0 mol/L sodium hydroxide solution, dissolve and mix evenly, shake and extract with chloroform for three times, combine chloroform solutions, evaporate in water bath, add absolute ethanol to dissolve and dilute to 65438±00ml, which is solution A. Take 5ml of solution A, dry it in water bath, add 5ml of 3% hydrogen peroxide solution, and place it in 50℃ water bath. Using chloroform-methanol-concentrated ammonia solution (65,438+05: 4: 0.5) as developing agent, developing, taking out, drying and spraying bismuth potassium iodide test solution. Solution a should show two spots.
2.6 Check the safety and explosion-proof test. Take this product 10 bottle, put it in a covered wire cage, and heat it at 40℃ 1 hour. No 1 bottle may explode.
2.7 Content determination After fully shaking the aerosol, spray it into a dry beaker, stir for 65438 00 minutes, and accurately weigh 0. Take 5g of this product, put it in a conical flask with a stopper, add 2-3 drops of concentrated ammonia and 20ml chloroform, shake well, move it into a separatory funnel, separate out chloroform solution, and extract it with 10ml chloroform for three times, with the same method each time. Then combine chloroform solutions, evaporate to dryness, accurately absorb 20 ml of 0.025 mol/L sulfuric acid solution, add 3 drops of methyl red-bromocresol green mixed indicator, and titrate with 0.05mol/L sodium hydroxide solution to dark green. Every 1ml 0.025mol/L sulfuric acid solution is equivalent to 12.42mg matrine (C 15H24N2O). The total alkaloids in this product are calculated by matrine (C 15H24NzO), which should be above 90% of the labeled amount.
2.8 Indications: clearing away heat and promoting diuresis, and killing insects. It can be used for chronic cervicitis, cervical erosion, and inflammation with downward flow of damp-heat.
2.9 Usage and dosage: First rinse your mouth with 0. 1% potassium permanganate solution or 0. 1% bromogeramine solution, and then spray this product on your neck, 2-3 times a week.
2. 10 Note (1) This product is not allowed to directly open the aluminum cover.
(2) Layering after placing, and shaking well before use.
(3) stop menstruation; Sexual life is forbidden during medication.
2. 1 1 Specification Each bottle has a net weight of 30g, and contains 6g of total alkaloids (calculated as matrine).
2. 12 Store in a cool and dry place to prevent heat and impact. Draft by Guizhou Institute for Drug Control
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