2. Standards promulgated by the Ministry of Traditional Chinese Medicine 2. 1 Pinyin name Bitong medicinal liquor
2.2 standard number ws3-b-3722-98
2.3 According to the doctor's advice, Radix Aconiti Kusnezoffii 25g and Radix Angelicae Sinensis 8. 8 grams of Alpinia officinarum. 3g clove 8.3g g.
2.4 Make the above four medicines into coarse powder, respectively add five times the amount of Chinese liquor, soak for 2 hours, heat and reflux extract for 65,438 0.5 hours, filter, add five times the amount of Chinese liquor to the residue, reflux extract for 65,438 0.5 hours, filter, add five times the amount of Chinese liquor to the residue, reflux extract for 65,438 0.5 hours, filter, squeeze the residue, combine the filtrates and stand for 20 hours. Add 33g of brown sugar to the filtrate, shake it to dissolve, let it stand for 24 hours, filter the supernatant, and add Chinese liquor to adjust the total amount to 1000ml.
2.5 Properties This product is a brown-red clear liquid; It is fragrant with wine, slightly sweet in taste and slightly numb in tongue.
2.6 Identification (1) Take this product as the test solution. In addition, 65438 0 g of Angelica sinensis was taken as the control medicinal material, 20ml of cyclohexane was added, ultrasonic treatment was carried out for 65438±05min, filtration was carried out, the filtrate was evaporated, chloroform was added to the residue to dissolve it to 5ml, and the solution was shaken evenly as the control medicinal material. According to the thin-layer chromatography test (Appendix ⅵ b), absorb the above two solutions 10μl, and spot them on the same silica gel G thin-layer plate, using cyclohexane-ethyl acetate (9: 1) as the developing agent, unfold, take them out, 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.
(2) Take 20ml of this product, put it in a separatory funnel, shake it with chloroform and extract it twice, each time 65438±00ml, evaporate the chloroform in water bath, and add absolute ethanol to dissolve it to 2ml, which will be used as the test solution. Another eugenol reference substance was added with absolute ethanol to prepare a solution containing 1 microliter per 1 ml as the reference substance solution. Then, take 2g of clove, add 20ml of absolute ethanol, perform ultrasonic treatment for 65438±05min, filter, and concentrate the filtrate to 2ml, which will be used as the control medicinal solution. According to the thin-layer chromatography test (appendix ⅵ b), 2μl of test solution, 65,438+0 μ l of reference solution and 65,438+0 μ l of reference medicinal solution were respectively applied to the same silica gel G thin-layer plate, and benzene-acetone (9: 65,438+0) was used as the developing agent, and then spread, taken out, dried and sprayed for 65 days. In the chromatogram of the test sample, spots with the same color appear at the positions corresponding to the chromatograms of the reference substance and the reference medicinal materials.
2.7 check that the amount of ethanol should be 5 1 ~ 55% (appendix VII g). Aconitine * * * test accurately absorbs this product 100ml, volatilizes ethanol to about 10ml in a water bath at 80℃, transfers it to a separating funnel, washes the evaporating dish with 30 ml of 2% hydrochloric acid for several times, transfers it to a separating funnel, shakes and extracts it with ether twice, each time 10ml, and discards the ether solution. Shake and extract with ether for 4 times, each time 65438 00 ml, combine ether solutions, evaporate ether, dissolve with anhydrous ethanol to a constant volume of 65438 00 ml, and shake well as the test solution. Accurately weigh the constant weight of sub-aconitine reference substance 10mg, and prepare a solution containing 1mg per 1ml with absolute ethanol as the reference substance solution. According to the thin-layer chromatography test (Appendix ⅵ b), 65438 05 μ l of test solution and 65438 00 μ l of reference solution were respectively spotted on the same silica gel G thin-layer plate, developed with chloroform-ether (2: 5) saturated with ammonia vapor for about 7cm, taken out, dried, and sprayed with improved bismuth potassium iodide developer for color development. In the chromatogram of the test sample, the spots with the same color appear in the position corresponding to the chromatogram of the sub-aconitine reference substance, and the spots in the chromatogram of the test sample shall not be larger than those in the chromatogram of the reference substance.
2.8 Accurate absorption of 50 ml of test solution for content determination, volatilization of ethanol in water bath to about 65438 00 ml, washing with about 65438 00 ml of distilled water, and transfer to a separating funnel. Adjust the pH to 9 ~ 10 with ammonia test solution, extract with chloroform 10, 5 and 5ml respectively for three times, then wash the separatory funnel with 5ml chloroform, combine chloroform solutions, put them in a conical flask, steam them in water bath until they are nearly dry, and add sulfuric acid titration solution (0.01mol/L)/kloc-precisely. Titrate the remaining sulfuric acid with 0.02mol/L sodium hydroxide solution (0.0 1mol/L sulfuric acid is equivalent to12.91mg C37H27No1kloc-0/per 1ml sulfuric acid), and correct the titration result with blank test. This product contains 0.005 ~ 0.0 1 15% alkaloid (C37H27No65438) based on aconitine.
2.9 Indications: Warming channels to relieve pain, promoting blood circulation and expelling wind. It can be used for treating rheumatic numbness, lumbago and backache, rheumatism, rheumatoid arthritis, sciatica, hyperosteogeny, etc.
2. 10 Usage and dosage: Take orally, 5ml at a time, twice a day, and take it on an empty stomach in the morning and evening.
2. 1 1 Be careful not to eat hot food within two hours after taking it. Hypertension and heart disease are taboo for pregnant women.
2. 12 specifications of each bottle
(1) 100 ml
(2)250 ml
2. 13 Bitong medicinal liquor should be stored in a sealed and cool place. Drafted by Henan Institute for Drug Control
Bitong medicinal liquor in the ancient book Benyuan: [Volume Four Beasts] Horse