2 Fu Bao Granule Pharmacopoeia Standard 2. 1 was named Fu Bao Granule.
Fu Bao keli
2.2 Prescription Rehmannia glutinosa, Caulis Lonicerae, Radix Dipsaci, Folium Eucommiae (baked with salt), Radix Ophiopogonis, Fructus Toosendan, Radix Paeoniae Alba, vinegar Rhizoma Corydalis, Radix Glycyrrhizae, Folium Platycladi (fried), lotus seed charcoal, and Caulis Sargentodoxae.
2.3 Boil the above twelve herbs except vinegar corydalis tuber in water for two times, 2 hours each time. In the same way, another vinegar corydalis yanhusuo is decocted, the decoctions are combined, filtered, the filtrate is concentrated to a fluid extract with a relative density of 60℃1.08 ~1.18, and ethanol is added to make the alcohol content reach 65%, and the mixture is stirred evenly. Concentrate the filtrate to a thick paste with a relative density of 1.33 ~ 1.45 (60℃), add a proper amount of water, stir evenly, stand for 24 hours, take the supernatant, and concentrate to a relative density of1.36 ~1.4/kloc- Or concentrate that supernatant to a clear paste with a relative density of1.10 (60 DEG C), adding 5g steviosin and prop amount of dextrin, and spray granulating to prepare 500g (excluding sucrose).
2.4 Characteristics This product is brownish yellow to brown granules; Sweet, slightly bitter or bitter, slightly sweet (no sucrose).
2.5 Identification (1) Take 5g or 2.5g of this product (without sucrose), add 30ml of water and 3ml of hydrochloric acid, heat and reflux for 1 hour, filter, extract the filtrate with 25ml of ether, volatilize the ether solution, and dissolve the residue with 2ml of chloroform as the test solution. Another 65438 0 g of Ophiopogon japonicus was taken as the control medicinal material, and the control medicinal material solution was prepared by the same method. According to the test of thin-layer chromatography (Appendix ⅵ b of Pharmacopoeia I, 20 10), absorb 2μl of the above two solutions, respectively spot them on the same silica gel GF254nm thin-layer plate, unfold them with n-hexane-ethyl acetate (1: 1) as the developing agent, take them out, dry them in the air, and place them under the ultraviolet lamp (250). In the chromatogram of the test sample, spots with the same color appear at the positions corresponding to the chromatogram of the control medicinal materials; Spray with 10% sulfuric acid ethanol solution, and heat at 105℃ until the spots are clear. In the chromatogram of the test sample, the spots with the same color appear at the positions corresponding to the chromatogram of the control medicinal materials.
(2) Take 65438±00g or 5g (excluding sucrose) of this product, crush it, add 50ml of 80% ethanol, heat and reflux it for 65438 0 hours, filter, evaporate the filtrate, add 30ml of water to dissolve the residue, add 30ml of water-saturated n-butanol for shaking extraction, separate the n-butanol solution, add 20ml of ammonia test solution for washing, evaporate the n-butanol solution, and add 2ml of ethanol to dissolve the residue. In addition, paeoniflorin reference substance was added with ethanol to prepare a solution containing 1mg per 1ml as the reference substance solution. According to the test of thin-layer chromatography (appendix ⅵ b of Pharmacopoeia I, 20 10), absorb 5μl of each of the above two solutions, respectively spot them on the same silica gel G thin-layer plate, and use chloroform-methanol-water (14: 6: 1) as the developing agent, unfold, take out, dry and spray with 5. In the chromatogram of the test sample, spots with the same color appear in the position corresponding to the chromatogram of the control sample.
(3) Take tetrahydropalmatine reference substance and add ethanol 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), 5μl of the above control solution and the test solution under [Identification ](2) were respectively absorbed, spotted on the same silica gel G thin-layer plate, spread in an expansion bottle saturated with ammonia vapor with toluene-acetone (9: 2) as the developing agent, taken out, dried and smoked in iodine vapor. In the chromatogram of the test sample, fluorescent 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 Granules (Appendix I C 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; The mobile phase was acetonitrile -0.0 1 mol/L phosphoric acid solution (13: 87), and the detection wavelength was 230nm. The theoretical plate number should be no less than 1500 according to paeoniflorin peak.
2.7.2 Preparation of reference substance solution Take a proper amount of paeoniflorin reference substance, weigh it accurately, and add 50% methanol to make a solution containing 0.65438±0mg per 65438±0ml.
2.7.3 Preparation of test solution The contents of this product under different loading conditions are finely ground, accurately weighed about 2g or about 65438±0g (excluding sucrose), placed in a conical flask with a stopper, accurately added with 20ml of 50% methanol, plugged, shaken and dissolved, left overnight, shaken and filtered, and continuous filtrate is obtained.
2.7.4 Determination method Accurately absorb 5μl of control solution and 5 μ l of test solution respectively, inject them into liquid chromatograph, and determine to obtain the product.
Each bag of this product contains Radix Paeoniae Alba (calculated by paeoniflorin (C23H28O 1 1), which shall not be less than 8.0mg.
2.8 Indications: tonifying kidney and blood, regulating qi and relieving pain. Used for lumbago and leg pain, abdominal distension and pain, leucorrhea and menstrual leakage caused by kidney deficiency and blood stasis; Chronic pelvic inflammatory disease and adnexitis with the above syndrome.
2.9 Usage and dosage: Take it with boiled water. 20g once or 10g (without sucrose), twice a day.
2. 10 specification (1) 10g per bag? (2) 5 grams per bag (excluding sucrose)
2. 1 1 storage seal.
2. 12 Edition People's Republic of China (PRC) Pharmacopoeia 20 10 Edition
3. Standard issued by Chinese Medicine Department of Fu Bao Granules 3. 1 Pinyin name Fu Bao Granules.
3.2 standard number WS3B339998
3.3 Prescription of Radix Rehmanniae and Flos Lonicerae. Radix Dipsaci (parched with salt water), Radix Ophiopogonis Lotus House (charcoal), Fructus Toosendan Radix Paeoniae Alba (parched with wine), Rhizoma Corydalis (processed with vinegar), and Folium Platycladi (parched with red vine).
3.4 Characteristics This product is brownish yellow to brown granules; It tastes sweet and slightly bitter.
3.5 Identification (1) Take this product 10g, grind it, add 50ml of 80% ethanol, heat and reflux it 1 hour, let it cool, filter it, evaporate the filtrate, add water 10ml to dissolve the residue, and add concentrated ammonia test solution about1. Another photograph of tetrahydropalmatine was taken, and ethanol was added to make a solution containing 1ml as a control solution. According to the thin-layer chromatography test (Appendix ⅵ b), 5μl of each of the above two solutions was absorbed and spotted on the same silica gel G thin-layer plate, with 0.5% sodium carboxymethyl cellulose as adhesive and n-hexane-chloroform-methanol-diethylamine (10:6: 1: 1 drop) as developing agent. In the chromatogram of the test sample, the same yellow spots appear in the position corresponding to the chromatogram of the control sample.
(2) Take 5g of this product, grind it, add 20ml of ethanol, shake it evenly for 5 ~10min, filter it, evaporate the filtrate, and add 2ml of ethanol to the residue to dissolve it, which will be used as the test solution. In addition, paeoniflorin reference substance was added with ethanol to prepare a solution containing 1mg per 1ml as the reference substance solution. According to the thin-layer chromatography test (Appendix ⅵ b), absorb the above two solutions 10μl, respectively, and spot them on the same silica gel G thin-layer plate, with 0.5% sodium carboxymethyl cellulose as adhesive and chloroform-ethyl acetate-methanol-formic acid (40:5: 10:0.2) as developing agent, unfold and take them out. In the chromatogram of the test sample, the same blue-purple spots appear in the position corresponding to the chromatogram of the control sample.
3.6 The inspection shall comply with the relevant provisions under the item of particles (Appendix I C).
3.7 Indications: tonifying kidney and blood, regulating qi and relieving pain. Can be used for treating abdominal distension and pain, backache, leucorrhea, menstrual blood leakage and other symptoms caused by pelvic inflammatory disease and adnexitis in women.
3.8 Usage and dosage Take it with boiling water, 20g at a time, twice a day.
3.9 specifications 10g per bag
3. 10 storage seal.
Drafted by Zhejiang Institute for Drug Control
4 Instructions for Fu Bao Granules 4. 1 Drug Type Traditional Chinese Medicine
4.2 Drug Name Fu Bao Granules
4.3 Chinese Pinyin of Drugs 4.4 English Name of Drugs 4.5 Components 4.6 Traits 4.7 Action Category 4.8 Indications/Functions Indications: tonifying kidney and blood, regulating qi and relieving pain. It can be used for treating lumbago and leg pain, abdominal distension and pain, and excessive leucorrhea caused by kidney deficiency and blood stasis. Chronic pelvic inflammatory disease and adnexitis with the above syndrome.
4.9 specifications 10g per bag
4. Usage and dosage of10 Fu Bao granules should be taken with boiled water. 20 grams twice a day.
4. 1 1 contraindications 4. 12 Adverse reactions 4. 13 Precautions 1. Avoid spicy, cold and greasy food.
2. Diabetic patients and those suffering from serious chronic diseases such as hypertension, heart disease, liver disease and kidney disease should be taken under the guidance of a doctor.
3. Teenagers, pregnant women and postmenopausal patients should take it under the guidance of a doctor.
4. Those with leucorrhea should go to the hospital.
Patients with severe abdominal pain should go to the hospital in time.
6. If the symptoms are not relieved after taking the medicine for 2 weeks, you should go to the hospital.
7. It is forbidden for those who are allergic to this product, and should be used with caution for those who are allergic.
8. It is forbidden to use this product when its characteristics change.
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.
4. 14 drug interaction If used with other drugs, drug interaction may occur. Please consult a doctor or pharmacist for details.
4. 15 Pharmacological Effects of Fu Bao Granules 4. 16 Remarks