2 English reference acanthopanax senticosus tablets [Chinese medicine terminology Committee. Terminology of Traditional Chinese Medicine (2004)]
Committee on terminology of traditional Chinese medicine. Terminology of Traditional Chinese Medicine (2004)]
3 Summary Acanthopanax senticosus tablets are Chinese patent medicines, and the main component is Acanthopanax senticosus extract [1]. Has the effects of invigorating qi, invigorating spleen, tonifying kidney and tranquilizing mind. Can be used for treating spleen and kidney yang deficiency, asthenia, anorexia, soreness of waist and knees, insomnia and dreaminess.
Pharmacopoeia of People's Republic of China (PRC) (20 10 edition) records the pharmacopoeia standard of acanthopanax senticosus tablets.
4 acanthopanax senticosus tablets 4. 1 Pharmacopoeia standard named acanthopanax senticosus tablets.
Acanthopanax senticosus tablets
4.2 prescription acanthopanax senticosus extract 150g
4.3 Methods Take acanthopanax senticosus extract, add starch, magnesium stearate and other auxiliary materials [2], mix well, make granules, dry, press into 1000 tablets, and coat with sugar or film [3] to get the final product.
4.4 Properties This product is a sugar-coated tablet or a film-coated tablet [3], which is brown after sugar removal; The taste is slightly bitter and astringent.
4.5 Identification Take 4 tablets of this product, remove the coating, grind, add 20ml of methanol, ultrasonic for 65438 00 minutes, filter, evaporate the filtrate, and dissolve the residue with 65438±0ml of methanol as the test solution. In addition, 2.5g of Acanthopanax senticosus was taken as a reference medicinal material, added with 20ml of methanol, heated and refluxed for 65,438 0 hours, filtered, the filtrate evaporated, and the residue was dissolved with 65438±0ml of methanol as a reference medicinal material solution. Then, the reference substances of iprodione and syringin were taken, and methanol was added to make a solution containing 0.5mg and 65,438+0 mg per 65,438+0 ml as the reference substance solution. According to the test of thin-layer chromatography (Appendix ⅵ b of Pharmacopoeia Part I, 20 10), the test solution 10ul and the reference solution 2ul were respectively spotted on the same silica gel G thin-layer plate, and the lower layer solution of chloroform-methanol-water (6: 2: 1) was used as the developing agent, which was unfolded, taken out and dried. In the chromatogram of the test sample, the fluorescent main spots with the same color are displayed at the positions corresponding to the chromatogram of the control medicinal materials; At the position corresponding to the chromatogram of the imipramine reference substance, fluorescent spots with the same color are displayed; Spray with 10% sulfuric acid ethanol solution, and heat at 105℃ until the spots are clear. In the chromatogram of the test sample, the same blue-purple spots appear in the position corresponding to the chromatogram of the syringin reference substance. [2]
4.6 The inspection shall comply with the relevant regulations under tablets (Appendix I D of Pharmacopoeia I, 20 10).
4.7 Take this product 10 tablet as the extract, remove the coating [3], accurately weigh it, finely grind it, take an appropriate amount (about 0.75g of acanthopanax senticosus extract), accurately weigh it, and measure it according to the hot soaking method (Pharmacopoeia I, version 20 10) under the alcohol-soluble extract determination method, with methanol as the solvent. Each tablet should contain not less than 80 mg of extract.
4.8 The content was determined by high performance liquid chromatography (Appendix ⅵ D of Pharmacopoeia I, 20 10).
4.8. 1 chromatographic conditions and system applicability test: octadecylsilane bonded silica gel is used as filler; Using acetonitrile as mobile phase A and 0. 1% phosphoric acid solution as mobile phase B, gradient elution was carried out according to the following table; The column temperature is 30℃ and the detection wavelength is 220nm. According to the syringin peak, the theoretical plate number should be no less than 10000, and the separation degree between isoxazine peak and adjacent impurity peak should be no less than 1.5.
Time (minutes) mobile phase A(%) mobile phase B (%) 0 ~ 2010 → 20 90 → 80 20 ~ 30 20 → 25 80 → 75 30 ~ 40 25 → 40 75 → 60 40 ~ 50 40 → 65 438+00 60.
4.8.3 Preparation of test solution Take 10 tablets of this product, remove the coating, accurately weigh, grind, take the amount equivalent to 2 tablets, accurately weigh them, put them in a conical flask with a stopper, accurately add 25ml of 50% methanol, plug them tightly, weigh them, and perform ultrasonic treatment (power 250W, frequency 50 kHz)/kloc-0.
4.8.4 The determination method accurately absorbs the control solution 10ul and the test solution 10 ~ 20U 1 respectively, and injects them into the liquid chromatograph for determination, thus obtaining the product.
The contents of syringin (C 17H24O9), acanthopanax senticosus E (C3446O 18) and iprodione (C 1lH 10O6) in each tablet of this product shall not be less than 0.60mg[2].
4.9 Functional indications: invigorating qi and spleen, tonifying kidney and calming nerves. Can be used for treating spleen and kidney yang deficiency, asthenia, anorexia, soreness of waist and knees, insomnia and dreaminess.
4. 10 Administration and dosage taken orally. 2 ~ 3 tablets at a time, twice a day.
4. 1 1 film-coated tablets? Each tablet weighs (1)0.26g? (2)0.3 1 g
Sugar-coated tablets (core weight 0.25g) [2]
4. 12 storage seal.
4. 13 edition of China Pharmacopoeia 20 10 edition.
5 drug description of acanthopanax senticosus tablets 5. 1 drug name acanthopanax senticosus tablets
5.2 Chinese Pinyin Acanthopanax Senticosus Tablets for Drugs
5.3 dosage form tablet: 0.3g
5.4 Characteristic Acanthopanax senticosus tablets are sugar-coated tablets, which are brown after sugar-coated removal; The taste is slightly bitter and astringent.
5.5 The main component of acanthopanax senticosus tablet is acanthopanax senticosus root.
5.6 The main functions of Acanthopanax Senticosus Tablets are invigorating qi and spleen, tonifying kidney and calming nerves. It can be used for treating spleen and kidney yang deficiency, asthenia, anorexia, soreness of waist and knees, insomnia and dreaminess. Anti-aging.
5.7 Usage and dosage of acanthopanax senticosus tablets are taken orally. 2 ~ 3 tablets at a time, twice a day.
5.8 Contraindications of Acanthopanax Senticosus Tablets 1. Yin deficiency and internal heat should not be used.
2. Avoid eating cold food.
5.9 Precautions 1. Avoid indigestible food.
2. Patients with cold and fever should not take it.
3. People suffering from serious chronic diseases such as hypertension, heart disease, liver disease, diabetes and kidney disease should take it under the guidance of a doctor.
Children, pregnant women and lactating women should take it under the guidance of a doctor.
5. After taking the medicine for 4 weeks, the symptoms have not eased, so I have to go to the hospital.
6. It is forbidden for those who are allergic to this product, and should be used with caution for those who are allergic.
7. It is forbidden to use this product when its characteristics change.
8. Children must use it under the supervision of adults.
9. Please keep this product out of the reach of children.
10. If you are using other drugs, please consult a doctor or pharmacist before using this product.
5. 10 drug interaction If used with other drugs, drug interaction may occur. Please consult a doctor or pharmacist for details.
5. 1 1 Remarks