Contents 1 Pinyin 2 Huohuosu Oral Liquid Pharmacopoeia Standard 2.1 Product name 2.2 Prescription 2.3 Preparation method 2.4 Properties 2.5 Identification 2.6 Inspection 2.6.1 Relative density 2.6.2 pH value 2.6.3 Others 2.7 Content determination 2.7.1 Chromatographic conditions and system suitability test 2.7.2 Preparation of reference solution 2.7.3 Preparation of test solution 2.7.4 Determination method 2.8 Function and indication 2.9 Usage and dosage 2.10 Specification 2.11 Storage 2.12 Version 3 Huohuosu Oral Liquid Traditional Chinese Medicine Department Awarding standards 3.1 Pinyin name 3.2 Prescription 3.3 Preparation method 3.4 Properties 3.5 Identification 3.6 Inspection 3.7 Content determination 3.8 Function and indication 3.9 Usage and dosage 3.10 Specifications 3.11 Storage 4 Instructions for Huohuosu Oral Liquid 4.1 Drug name 4.2 Drug Chinese Pinyin 4.3 Dosage form 4.4 Properties 4.5 Vitality Main ingredients of Huohuo Su Oral Liquid 4.6 Functions and indications of Huohuo Su Oral Liquid 4.7 Usage and dosage of Huohuo Su Oral Liquid 4.8 Precautions 4.9 Interactions between Huohuo Su Oral Liquid and other drugs 4.10 Remarks: * Other versions of relevant drug instructions for Huohuo Su Oral Liquid 1 Pinyin
huó lì sū kǒu fú yè 2 Huolisu Koufuye Pharmacopoeia Standard 2.1 Product Name
Huolisu Koufuye Oral Liquid
Huolisu Koufuye 2.2 Prescription
Preparation method of Polygonum Multiflorum, Epimedium, Polygonatum (prepared), Lycium barbarum, Astragalus, and Salvia miltiorrhiza 2.3
Prepare the above six ingredients, add Polygonum multiflorum, Salvia miltiorrhiza, and Lycium barbarum and boil them in water for three times, the first time 2 hour, the second and third times are 1.5 hours each time, filter, combine the filtrate, concentrate to a clear paste with a relative density of 1.20 to 1.25 (60°C), let it cool, add ethanol to make the alcohol content reach 70%, let it stand, and filter Pass, add ethanol to the filtrate to make the alcohol content reach 80%, let it stand, filter, adjust the pH value to 8.0 with 10% sodium hydroxide solution, let it stand, filter, adjust the pH value of the filtrate with 10% hydrochloric acid solution to 7.0 , recover the ethanol, and keep the liquid for later use; decoct epimedium and polygonatum with water twice, the first time for 2 hours, the second time for 1 hour, filter, combine the filtrate, let stand, and take the supernatant and concentrate it to a relative density of 1.18 ~1.20 (50℃) clear paste, let it cool, add ethanol until the alcohol content reaches 65%, let it stand, and filter. Add ethanol to the filtrate until the alcohol content reaches 80%, let it stand, and filter. Use 10% for the filtrate. Adjust the pH value to 8.0 with sodium hydroxide solution, let it stand, and filter. Use 10% hydrochloric acid solution to adjust the pH value of the filtrate to 7.0. Recover the ethanol and keep the medicinal solution for later use. Add water to decoct astragalus three times, the first time for 2 hours, and the second and second times. Three times of 1.5 hours each time, filter, combine the filtrate and concentrate to about 95ml, and set aside the medicinal solution. Combine the above reserve medicinal solutions, stir well, place in a refrigerator, filter, add water to 1000ml, filter, adjust the pH of the filtrate to 7.0~7.5 with 10% sodium hydroxide solution, and you have it.
2.4 Properties
This product is a brown to brown liquid; it tastes sweet and slightly astringent. 2.5 Identification
(1) Take 20ml of this product, shake and extract it with ethyl acetate twice, 30ml each time, combine the ethyl acetate solution, evaporate to dryness, add 1ml of methanol to the residue to dissolve, and use it as a test product solution. Take another 2,3,5,4'tetrahydroxystilbene 2OβD glucoside reference substance, add methanol to make a solution containing 0.5mg per 1ml, and use it as the reference solution.
According to the thin layer chromatography test (Appendix VI B of Pharmacopoeia 2010 edition), draw 5 μl of each of the above two solutions, and place them on the same silica gel H thin layer plate with sodium carboxymethyl cellulose as the binder, and then use ethyl acetate. Ester-methanol-formic acid (25:1:1) is used as the developing agent, unfold, take out, dry, and inspect under ultraviolet light (365nm). In the chromatogram of the test product, fluorescent spots of the same color appear at the positions corresponding to the chromatogram of the reference substance.
(2) Take icariin reference substance and add methanol to make a solution containing 0.5mg per 1ml as the reference substance solution. According to the thin layer chromatography (Appendix VI B of Pharmacopoeia 2010 Edition) test, take 1 μl of the test solution under [Identification] (1) and 5 μl of the above reference solution, and spot the same sodium carboxymethylcellulose respectively. On the silicone H thin-layer plate of the adhesive, use ethyl acetate-butanone-formic acid-water (10:1:1:1) as the developing agent, unfold, take out, dry, and spray with 5% aluminum trichloride ethanol. The solution was heated at 105°C until the spots were clearly colored and inspected under a UV lamp (365nm). In the chromatogram of the test product, fluorescent spots of the same color appear at the positions corresponding to the chromatogram of the reference substance.
(3) Take 30ml of this product, shake and extract it with ether twice, 30ml each time, combine the ether solutions, evaporate to dryness at low temperature, add 1ml of methanol to the residue to dissolve, and use it as the test solution. Take another 1g of wolfberry reference medicinal material, add 40 ml of ether, ultrasonic treatment for 30 minutes, let cool, filter, and prepare the filtrate into a reference medicinal material solution in the same way. According to the thin layer chromatography test (Appendix VI B of Pharmacopoeia 2010 Edition), draw 5 μl of each of the above two solutions, respectively point on the same silica gel G thin layer plate, and use toluene-ethyl acetate-formic acid (6:4:0.2 ) is the developing agent, unfold, take out, dry, and inspect under ultraviolet light (365nm). In the chromatogram of the test product, fluorescent spots of the same color appear at positions corresponding to the chromatogram of the control medicinal material.
(4) Take 20ml of this product, shake and extract with water-saturated n-butanol 3 times, 20ml each time, combine the n-butanol solution, and wash 3 times with 4% sodium hydroxide solution, each time 20ml, discard the alkaline liquid, and wash with water 3 times, 20ml each time, discard the water liquid, separate the n-butanol liquid, evaporate to dryness, add 1ml of methanol to the residue to dissolve, add neutral alumina (100~200 mesh) 2g, mix well, evaporate, stir and wash with 50ml of 40% methanol in batches, filter, evaporate the filtrate to dryness, add 1ml of methanol to the residue to dissolve, and use it as the test solution. Take another astragaloside IV reference substance, add methanol to make a solution containing 0.5mg per 1ml, and use it as the reference substance solution. According to the thin layer chromatography (Appendix VI B of Pharmacopoeia 2010 edition) test, draw 10 μl of each of the above two solutions, respectively point on the same silica gel G thin layer plate, and use chloroform-methanol-water (13:7:2 ) The lower solution left overnight below 10°C is used as a developing agent. Unfold, take out, dry, spray with 10% sulfuric acid ethanol solution, and heat at 105°C until the spots are clearly colored. In the chromatogram of the test product, spots of the same color appear at the positions corresponding to the chromatogram of the reference substance; when viewed under an ultraviolet light (365nm), fluorescent spots of the same color appear.
(5) Take 30ml of this product, add 10% hydrochloric acid to adjust the pH value to 2~3, shake and extract with ether twice, 20ml each time, combine the ether liquid, evaporate to dryness at low temperature, add no ether to the residue Dissolve it in 1 ml of water and ethanol to prepare the test solution. Take another 1.5g of the Salvia miltiorrhiza reference medicinal material, add 50 ml of water, ultrasonicate for 10 minutes, soak in hot water for 2 hours, let stand, filter, and prepare the filtrate into a reference medicinal material solution in the same way. Then take the protocatechuic aldehyde reference substance and add absolute ethanol to make a solution containing 0.5mg per 1ml as the reference solution. According to the thin layer chromatography test (Appendix VI B of the 2010 edition of the Pharmacopoeia), draw 10 μl of each of the above three solutions, respectively point on the same silica gel G thin layer plate, and use toluene-ethyl acetate-formic acid (10:10:1 ) as the developing agent, unfold, take out, dry, spray with a mixed solution of 2% phloroglucinol ethanol solution-sulfuric acid (1:1) (prepared for use), and heat until the spots are clearly colored. In the chromatogram of the test product, spots of the same color appear at the positions corresponding to the chromatogram of the control medicinal material and the reference substance. 2.6 Inspection 2.6.1 Relative density
should not be less than 1.05 (2010 edition of Pharmacopoeia, Appendix VII A).
2.6.2 pH value
should be 5.0~7.0 (2010 edition of Pharmacopoeia, Appendix VII G). 2.6.3 Others
Should comply with the relevant regulations under the mixture (Appendix I J of the 2010 edition of the Pharmacopoeia). 2.7 Content determination
Determine according to high performance liquid chromatography (2010 edition of Pharmacopoeia, Appendix VI D). 2.7.1 Chromatographic conditions and system suitability test
Use octadecylsilane bonded silica gel as the filler and acetonitrile-water (30:70) as the mobile phase; the detection wavelength is 270nm. The number of theoretical plates should not be less than 2500 based on the icariin peak. 2.7.2 Preparation of reference substance solution
Take an appropriate amount of icariin reference substance, weigh it accurately, and add methanol to prepare a solution containing 15 μg of icariin per 1 ml. 2.7.3 Preparation of test solution
Precisely measure 1ml of this product, place it in a 25ml measuring bottle, add methanol to the mark, shake well, filter, and take the filtrate to obtain. 2.7.4 Determination method
Precisely draw 10 μl each of the reference solution and the test solution, inject them into the liquid chromatograph, and measure.
Each 1ml of this product contains epimedium, calculated as icariin (C33H40O15), which shall not be less than 0.40mg. 2.8 Functions and Indications
Replenishes qi and blood, nourishes the liver and kidneys. It is used for the elderly and frail, listless, insomnia and forgetfulness, blurred vision and deafness, hair loss or premature graying of hair due to insufficient Qi and blood, liver and kidney deficiency. 2.9 Usage and dosage
Take orally. Take 10ml once a day, before going to bed. Three months is a course of treatment. 2.10 Specifications
Each bottle contains 10ml 2.11 Storage
Sealed. Version 2.12
"Pharmacopoeia of the People's Republic of China" 2010 Edition 3 Huolisu Koufuye Oral Liquid Ministry of Traditional Chinese Medicine Standard 3.1 Pinyin Name
Huolisu Koufuye 3.2 Prescription
Preparation of polygonum multiflorum, epimedium polygonatum (preparation), wolfberry, astragalus and salvia 3.3 Preparation method
For the above six ingredients, prepare polygonum multiflorum, salvia miltiorrhiza, and wolfberry, add water and decoct three times, combine the decoctions, filter, and concentrate the filtrate to syrup like, let cool, add ethanol to make the alcohol content reach 70%, let it stand, filter, add ethanol to the filtrate to make the alcohol content reach 80%, let it stand, filter, adjust the pH value to 8.0 with 10% sodium hydroxide solution. Place and filter. Use 10% hydrochloric acid to adjust the pH of the filtrate to 7.0. Recover the ethanol and keep the liquid for later use. Add epimedium and polygonatum to boil twice in water, combine the decoctions, filter, let stand, and concentrate the supernatant. to an appropriate amount, let cool, add ethanol until the alcohol content reaches 65%, let it stand, filter, add ethanol to the filtrate to make the alcohol content reach 80%, let it stand, filter, adjust the pH value of the filtrate with 10% sodium hydroxide solution to 8.0, let stand, filter, adjust the pH value of the filtrate to 7.0 with 10% hydrochloric acid solution, recover ethanol, and use the medicinal solution for later use; add water to decoct Astragalus three times, combine the decoctions, filter, and concentrate the filtrate to about 95 ml, and use the medicinal solution for later use . Combine the above reserve liquids, mix well, refrigerate, filter, add water to 1000ml, add an appropriate amount of sugar-free sweetener, filter, adjust the pH of the filtrate to 7.0~7.5 with 10% sodium hydroxide solution, and you have it. 3.4 Properties
This product is a brown liquid; it tastes sweet and slightly astringent. 3.5 Identification
(1) Take 20ml of this product, shake and extract with chloroform three times, 15ml each time, combine the chloroform solutions, recover the chloroform, add 1ml of ethanol to the residue to dissolve, and use it as the test solution. Take another emodin reference substance, add ethanol to make a solution containing 0.05mg per 1ml, and use it as the reference substance solution. According to the thin layer chromatography (Appendix VI B) test, take 10 μl of each of the above two solutions and spot them on the same silica gel G thin layer plate. Use ethyl phenyl acetate methanol (15:2:0.2) as the developing agent to develop. Take it out, dry it, and inspect it under ultraviolet light (365nm).
In the chromatogram of the test product, the same orange-yellow fluorescent spots appear at the positions corresponding to the chromatogram of the reference substance; after being fumigated in ammonia gas and inspected under sunlight, the spots turn red.
(2) Take 10ml of this product, shake and extract with ethyl acetate three times, 10ml each time, combine the ethyl acetate liquid, recover the ethyl acetate, add 4ml of ethanol to the residue to dissolve it, and use it as a test product solution. Take another icariin reference substance, add ethanol to make a solution containing 0.5mg per 1ml, and use it as the reference substance solution. According to the thin layer chromatography (Appendix VI B) test, draw 4 μl of each of the above two solutions, place them on the same silica gel G thin layer plate, and use ethyl acetate butyl ketone formic acid water (10:1:1:1) as the unfolder Agent, unfold, take out, dry, spray with 5% aluminum trichloride ethanol solution, bake at 105°C for 5 to 10 minutes, and inspect under ultraviolet light (365nm). In the chromatogram of the test product, the same yellow-green fluorescent spot appears at the position corresponding to the chromatogram of the reference substance. 3.6 Inspection
The relative density should not be less than 1.05 (Appendix VII A Pycnometer method). The pH value should be 5.0~7.0 (Appendix VII G). Others should comply with the relevant regulations under the mixture (Appendix I J). 3.7 Content determination
Determine according to high performance liquid chromatography (Appendix VI D). The chromatographic conditions and system suitability test used octadecylsilane bonded silica gel as the filler; methanol 0.2% phosphoric acid solution (57:43) as the mobile phase; the detection wavelength was 271nm; the column temperature was 40°C; the number of theoretical plates was The calculated peak value of icariin should not be less than 2500. Preparation of the reference solution: Precisely weigh about 10 mg of the icariin reference solution, place it in a 100 ml volumetric flask, dissolve it in methanol and dilute to the mark, shake well, and get it (each 1 ml contains 100 μg of icariin). Preparation of the test solution: Precisely measure 1.0ml of this product, add it to the polyamide column [take 5g of polyamide (75~180nm), pack the column (column diameter 20mm) by wet method, wash and set aside], and elute with 100ml of water , discard the eluate, and then elute with 150 ml of ethanol. The eluate is evaporated to dryness under reduced pressure below 50°C. Dissolve the residue with methanol, place it in a 25 ml measuring flask, add methanol to the mark, and shake well. Determination method: Precisely measure 10 μl each of the reference solution and the test solution, inject them into the liquid chromatograph, and measure. This product contains no less than 0.5 mg of icariin (C33H40O15) per 1 ml. 3.8 Functions and Indications
Replenishes qi and blood, nourishes the liver and kidneys. It is used for the elderly and frail, listless, insomnia and forgetfulness, blurred vision and deafness, hair loss or premature graying of hair due to insufficient Qi and blood, liver and kidney deficiency. 3.9 Usage and dosage
Take orally, 10ml once a day, before going to bed, for three months as a course of treatment. 3.10 Specifications
Each bottle contains 10ml 3.11 Storage
Seal and store in a cool place. Sichuan Provincial Institute for Drug Control drafted 4 Huolisu Koufuye Instructions 4.1 Drug Name
Huolisu Koufuye 4.2 Drug Chinese Pinyin
Huolisu Koufuye 4.3 Dosage Form
Each bottle Contains 10ml. 4.4 Properties
Huohuosu Oral Liquid is a brown to brown liquid; it tastes sweet and slightly astringent. 4.5 The main ingredients of Huihuosu Oral Liquid
Polygonum multiflorum, epimedium, Polygonatum (prepared), wolfberry, astragalus, salvia, etc. 4.6 Functions and Indications of Huohuosu Oral Liquid
Replenishing qi and blood, nourishing the liver and kidneys. It is used for the elderly and frail, listless, insomnia and forgetfulness, blurred vision and deafness, hair loss or premature graying of hair due to insufficient Qi and blood, liver and kidney deficiency. 4.7 Usage and dosage of Huohuosu Oral Liquid
Take orally, 10ml once a day, before going to bed, for 3 months as a course of treatment. 4.8 Precautions
1. Avoid greasy food.
2. People suffering from external symptoms or excess heat should not take it.
3. This product should be taken before meals.
4. Take it according to the usage and dosage. Pregnant women, patients with high blood pressure and diabetes should take it under the guidance of a physician.
5. If the symptoms do not improve significantly after taking the medicine for two weeks or during the period of taking the medicine, or if the symptoms worsen, the medicine should be stopped immediately and go to the hospital for treatment.
6. People who are allergic to this product should not use it, and people with allergies should use it with caution.
7. It is prohibited to use this product when its properties change.
8. Please keep this product out of reach of children.
9. If you are using other drugs, please consult your physician or pharmacist before using this product. 4.9 Drug interactions
Drug interactions may occur if used together with other drugs. Please consult your physician or pharmacist for details. 4.10 Remarks