2 English reference ciwujia tablets [Terminology Committee of Traditional Chinese Medicine. Terminology of Traditional Chinese Medicine (2004)]
Ciwujia pian [Terminology Committee 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 calming nerves. It can be used for treating spleen and kidney yang deficiency, asthenia, anorexia, soreness of waist and knees, insomnia and dreaminess.
Pharmacopoeia of the People's Republic of China (20 10 edition) records the pharmacopoeia standard of acanthopanax senticosus tablets.
4 Pharmacopoeia Standard of Acanthopanax Senticosus Tablets 4. 1 Name Acanthopanax Senticosus Tablets
Ciwujia Pian
4.2 prescription acanthopanax senticosus extract 150g
4.3 Method 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-coated is removed; It tastes slightly bitter and astringent.
4.5 Identification Take 4 tablets of this product, remove the coating, grind it, add 20ml of methanol, perform ultrasonic treatment 10 minute, filter, evaporate the filtrate, and add methanol 1ml to the residue to dissolve it, which will be used 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 1 hour, filtered, the filtrate was evaporated to dryness, and the residue was dissolved by adding methanol 1ml as a reference medicinal material solution. Then, the reference substance of Isopyramidine and syringin were taken, and methanol was added to prepare solutions containing 0.5mg and 1ml as reference substance solutions. According to the test of thin-layer chromatography (Appendix ⅵ b of Pharmacopoeia I, 20 10 edition), each sample solution, each reference medicinal material solution and each reference medicinal material solution (2ul) were absorbed, respectively, 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, and developed. 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; Fluorescent spots with the same color are displayed at the positions corresponding to the chromatogram of the reference substance of Isopyramidine; Spray 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 of 20 10 edition).
4.7 Take this product 10 tablet as the extract, remove the coating [3], weigh it accurately, grind it fine, take an appropriate amount (about 0.75g of Acanthopanax senticosus extract), weigh it accurately, and measure it according to the hot soaking method (Appendix ⅹ a of Pharmacopoeia I of 20 10 edition) under the alcohol-soluble extract determination method, and use methanol as the solvent. Each tablet shall contain no less than 80mg of extract.
4.8 The content shall be determined by high performance liquid chromatography (Appendix VI D of Pharmacopoeia I, 20 10 edition).
4.8. 1 chromatographic conditions and system applicability test with octadecylsilane bonded silica gel 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 regulations in the following table; The column temperature is 30℃ and the detection wavelength is 220nm. The theoretical plate number should be no less than 10000 calculated by syringin peak, and the separation degree between the peak of isoxazepinine and the 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 →10. Accurately weigh an appropriate amount of the reference substance of Isopyramidine, and respectively add methanol (the reference substance of Acanthopanax senticosus E is dissolved by adding 50% methanol first) to prepare a mixed solution containing syringin, Acanthopanax senticosus E and Isopyramidine140ug each.
4.8.3 Preparation of test solution Take 10 tablets of this product, remove the coating, accurately weigh them, grind them, 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, tightly plug them, weigh them, and perform ultrasonic treatment (power 250W, frequency 50 kHz)/kloc-.
4.8.4 Determination method Accurately suck the reference solution 10ul and the test solution10 ~ 20u1respectively, inject them into the liquid chromatograph, and determine to obtain the product.
The content of syringin (C 17H24O9), acanthopanax senticosus E (C3446O18) and Isopyramidine (C 1lH 10O6) in each tablet should not be less than 0.60mg. [2]
4.9 Functions and indications: 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.
4. Usage and dosage of10 for oral administration. 2 ~ 3 tablets at a time, twice a day.
4. 1 1 specification film-coated tablets? Each tablet weighs (1)0.26g? （2）0.3 1g
Sugar-coated tablets (core weight 0.25g)[2]
4. 12 storage seal.
4. 13 Edition of Pharmacopoeia of the People's Republic of China 20 10 Edition
5 acanthopanax senticosus tablets drug instructions 5. 1 drug name acanthopanax senticosus tablets
5.2 Chinese Pinyin Ciwujia Pian for Drugs
5.3 dosage form tablet: 0.3g.
5.4 Characteristics Acanthopanax senticosus tablets are sugar-coated tablets, which are brown after sugar-coated removal; It tastes slightly bitter and astringent.
5.5 The main component of Acanthopanax senticosus tablets is Acanthopanax senticosus root.
5.6 The function of Acanthopanax Senticosus Tablets is mainly to invigorate qi and spleen, tonify kidney and soothe the nerves. Used for spleen and kidney yang deficiency, asthenia, anorexia, waist and knee pain, 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. Anyone with yin deficiency and internal heat should not use it.
2. Avoid eating cold things.
5.9 Precautions 1. Avoid indigestible food.
2. Patients with cold and fever should not take it.
3. Those with serious chronic diseases such as hypertension, heart disease, liver disease, diabetes and kidney disease should take it under the guidance of a doctor.
4. 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 are not relieved, so you should 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 together with other drugs, drug interaction may occur. Please consult your doctor or pharmacist for details.
5. 1 1 Remarks