2 Pharmacopoeia standard of Xiaoshuan Tongluo Capsule 2. 1 called Xiaoshuan Tongluo Capsule.
Xiaoshuan Tongluo Capsule
2.2 Prescription Chuanxiong 287g, Salvia Miltiorrhiza 2 15g, Astragalus 43 1g, Alisma orientalis 144g, Notoginseng 144g, Sophora japonica 72g, Ramulus Cinnamomi 144g, and Radix Curcumae 144g.
2.3 The preparation method includes the following steps: grinding Borneolum Syntheticum into fine powder, pulverizing Notoginseng Radix into fine powder, decocting the remaining nine Chinese medicinal materials such as Ligusticum Chuanxiong in water for three times, combining decoctions, filtering, and concentrating the filtrate under reduced pressure to obtain a fluid extract with a relative density of1.17 ~1.19 (80℃).
2.4 Properties This product is a hard capsule, and its contents are brownish-yellow to brownish-brown particles and powder; It smells fragrant and tastes slightly bitter.
2.5 Identification (1) Take 3g of the contents of this product, add 30ml of 2% potassium hydroxide methanol solution, heat and reflux 1 hour, let it cool, filter, evaporate the filtrate, add 15ml of water to dissolve the residue, shake and extract with water-saturated n-butanol for three times, 20ml each time, combine the n-butanol solutions, and use/kloc. Another astragaloside IV reference substance was added with methanol to prepare a solution containing 65438±0mg per 65438±0ml as the reference substance solution. According to the test of thin-layer chromatography (Appendix ⅵ b of Pharmacopoeia Part I, 20 10), 2 ~ 5μl of the test solution and 5μl of the reference solution were respectively absorbed, placed on the same silica gel G thin-layer plate, and the lower layer solution of chloroform-methanol-water (13: 7: 2) was used as the developing agent, then unfolded, taken out, dried and sprayed. 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 1.5g of the contents of this product, add 40ml of water, perform ultrasonic treatment for 30min, centrifuge, take the supernatant, adjust the pH value to 2-3 with dilute hydrochloric acid, shake and extract with ethyl acetate twice, 20ml each time, combine the extractive solutions, evaporate to dryness, and add 1ml of ethyl acetate to dissolve the residue as the test solution. In addition, Ligusticum chuanxiong1g. Add 20 ml of water and make a control drug solution in the same way. Then take ferulic acid reference substance and add methanol to make a solution containing 0.5mg per kloc-0/ml as reference substance solution. According to the test of thin-layer chromatography (Appendix ⅵ b of Pharmacopoeia Part I, 20 10), take 2 ~ 5 μ l of test solution, 2μl of control medicinal material solution and 2 μ l of control medicinal material solution, and spot them on the same silica gel G thin-layer plate, with toluene-ethyl acetate-formic acid (20:11) as the sample. 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.
(3) Take 65438±0.5g of this product, add 5ml of ethyl acetate, soak for 20min, shake and filter from time to time, and take the filtrate as the test solution. In addition, the borneol reference substance was added with absolute ethanol to prepare a solution containing 65438±0mg per 65438±0ml as the reference substance solution. According to the test of thin-layer chromatography (Appendix ⅵ b of Pharmacopoeia Part I, 20 10), absorb 5μl of the above two solutions, spot them on the same silica gel G thin-layer plate, and use petroleum ether (60 ~ 90℃)- toluene-ethyl acetate (9:1; 1) as developing agent, developing, taking out, drying, spraying 5% vanillin sulfuric acid solution, and heating at 105℃ until the spots are clear. In the chromatogram of the test sample, spots with the same color appear in the position corresponding to the chromatogram of the control sample.
2.6 the inspection shall comply with the relevant provisions of capsules (appendix Ⅰ L of Pharmacopoeia 20 10).
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; Using acetonitrile -0.05% phosphoric acid solution (2 1: 79) as the mobile phase; The detection wavelength is 203 nm. According to ginsenoside Rg 1 peak, the theoretical plate number should be not less than 5000.
2.7.2 Preparation of reference solution Take a proper amount of ginsenoside Rg 1 reference, weigh it accurately, and add methanol to make a solution containing 0.5mg per kloc-0/ml.
2.7.3 Preparation of test solution Take the contents of this product with different loading amounts, mix them evenly, grind them, take about 2g, weigh them accurately, put them in a conical flask with a stopper, add 30ml of methanol accurately, weigh them, heat and reflux for 2h, let them cool, weigh them again, make up for the weightlessness with methanol, shake them evenly, filter them, accurately measure 25ml of continuous filtrate, and put them in a water bath. Shake and extract with ether for 2 times, 20ml each time, discard the ether solution, shake and extract the water solution with water-saturated n-butanol for 4 times, 20ml each time, combine the n-butanol solutions, wash with ammonia test solution for 2 times, 30ml each time, and then wash with n-butanol saturated water for 2 times, 20ml each time, separate the n-butanol solution, recover it to dryness, dissolve the residue with methanol, transfer it to a 10ml volumetric flask, and add methanol.
2.7.4 The determination method accurately absorbs 65438 00μ l of the control solution and 5 ~ 65438 00μ l of the test solution, respectively, and injects them into the liquid chromatograph for determination.
Each capsule of this product contains Panax Notoginseng, calculated by ginsenoside Rg 1 (C42H72O 14), not less than 2.0mg.
2.8 Indications: activating blood circulation to remove blood stasis, warming meridians and dredging collaterals. It can be used for treating apoplexy caused by blood stasis blocking collaterals, with symptoms of dull expression, poor speech, cold hands and feet, and limb pain. Ischemic stroke and hyperlipidemia are seen in the above syndrome.
2.9 Oral administration and dosage. 6 capsules at a time, 3 times a day; Still follow the doctor's advice.
2. 10 Pay attention to fasting cold, spicy and animal fat foods.
2. 1 1 specifications each containing 0.37g.
2. 12 storage seal.
2. 13 edition of China Pharmacopoeia 20 10 edition.
3 Instructions for Xiaoshuan Tongluo Capsule 3. 1 Drug Name Xiaoshuan Tongluo Capsule
3.2 dosage form 0.35g per capsule.
3.3 Character contents are brownish yellow to brownish brown particles and powder; It smells fragrant and tastes slightly bitter.
3.4 The main components of Xiaoshuan Tongluo Capsule are Chuanxiong, Salvia Miltiorrhiza, Astragalus, Alisma orientalis, Panax Notoginseng, Sophora japonica, Ramulus Cinnamomi, Radix Curcumae, Radix Aucklandiae, Borneolum Syntheticum and Fructus Crataegi.
3.5 The function of Xiaoshuan Tongluo Capsule is mainly to promote blood circulation and remove blood stasis, and to warm meridians and dredge collaterals. It can be used for treating apoplexy caused by blood stasis blocking collaterals, with symptoms of dull expression, poor speech, cold hands and feet, and limb pain. Ischemic stroke and hyperlipidemia are seen in the above syndrome. Stroke (cerebral thrombosis) recovery period (within one year) hemiplegia, limb numbness.
3.6 Usage and dosage of Xiaoshuan Tongluo Capsule 6 capsules at a time, 3 times a day.
3.7 The adverse reactions of Xiaoshuan Tongluo Capsule are unclear.
3.8 Contraindications of Xiaoshuan Tongluo Capsule are prohibited for pregnant women.
3.9 Precautions 1. Avoid cold, spicy and animal fat foods.
2. Patients with liver disease, kidney disease, hemorrhagic disease and diabetes, or patients receiving other treatments, should take it under the guidance of a doctor.
3. It should be taken according to usage and dosage, and the elderly and infirm should take it under the guidance of a doctor.
4. It is forbidden for those who are allergic to this product, and should be used with caution for those who are allergic.
5. It is forbidden to take this product when its nature changes.
6. Please keep this product out of the reach of children.
7. If you are using other drugs, please consult a doctor or pharmacist before using this product.
3. 10 drug interaction