Contents 1 Pinyin 2 English Reference 3 Ginkgo Leaf Extract Pharmacopoeia Standard 3.1 Product name 3.2 Source 3.3 Preparation method 3.4 Properties 3.5 Identification 3.6 Inspection 3.6.1 Moisture 3.6.2 Heavy metals 3.6.3 Flavonoid aglycone peak area ratio 3.6.4 Total ginkgolic acid 3.6.4.1 Chromatographic conditions and system suitability test 3.6.4.2 Preparation of reference solution 3.6.4.3 Preparation of test solution 3.6.4.4 Determination method 3.7 Content determination 3.7.1 Total flavonol glycosides 3.7. 1.1 Chromatographic conditions and system suitability test 3.7.1.2 Preparation of reference solution 3.7.1.3 Preparation of test solution 3.7.1.4 Determination method 3.7.2 Terpenoid lactones 3.7.2.1 Chromatographic conditions and system suitability test 3.7.2.2 Preparation of reference solution 3.7.2.3 Preparation of test solution 3.7.2.4 Assay method 3.8 Storage 3.9 Preparation 3.10 Version 4 Instructions for Ginkgo flavonoid glycosides 4.1 Drug name 4.2 English name 4.3 Alias ??of Ginkgo leaf extract 4.4 Classification 4.5 Dosage form 4.6 Ginkgo flavonoids Pharmacological effects of Ginkgo flavonoid glycosides 4.7 Indications of Ginkgo flavonoid glycosides 4.8 Contraindications of Ginkgo flavonoid glycosides 4.9 Precautions 4.10 Adverse reactions of Ginkgo flavonoid glycosides 4.11 Usage and dosage of Ginkgo flavonoid glycosides 1 Pinyin
yín xìng yè tí qǔ wù 2 English reference
Ginaton [Xiangya Medical Professional Dictionary] 3 Ginkgo leaf extract Pharmacopoeia standard 3.1 Product name
Ginkgo leaf extract
Yinxingye Tiquwu
GINGKO LEAVES EXTRACT
3.2 Source
This product is Ginkgo biloba L. of the Ginkgo family. An extract made from processed dried leaves. 3.3 Preparation method
Take the ginkgo leaves, crush them, use dilute ethanol to heat and reflux to extract, combine the extracts, recover ethanol and concentrate to an appropriate amount, add it to the treated macroporous adsorption resin column, and use water and Elute with ethanol of different concentrations, collect the corresponding eluate, recover the ethanol, and spray dry it; or recover the ethanol, concentrate it into a thick paste, vacuum dry it, and crush it to obtain it. 3.4 Properties
This product is a light brown to tan powder; the taste is slightly bitter. 3.5 Identification
(1) Take 0.2g of this product, add 15ml of n-butanol, soak in a water bath for 15 minutes and shake from time to time, let cool, filter, evaporate the filtrate to dryness, add 2ml of ethanol to the residue. Dissolve and use as test solution. Take another 0.2g of ginkgo leaf control extract and prepare a control extract solution in the same way. According to the thin layer chromatography (Appendix VI B of the 2010 edition of Pharmacopoeia), draw 3 μl of each of the above two solutions and place them on the same silica gel G thin film containing 0.4% sodium acetate and carboxymethyl cellulose sodium solution as the binder. On the laminate, use ethyl butanone acetate-formic acid-water (5:3:1:1) as the developing agent, unfold, take out, dry, spray with 3% aluminum trichloride ethanol solution, and put in 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 control extract.
(2) According to the thin layer chromatography method (Appendix VI B of the 2010 edition of the Pharmacopoeia), absorb 15 μl each of the test solution and reference solution of terpenoid lactone under [Content Determination], Spots were placed on the same silica gel G thin-layer plate with sodium carboxymethyl cellulose solution containing 0.4% sodium acetate as the binder, and toluene-ethyl acetate-acetone-methanol (10:5:5:0.6) was used as the spreader. The agent should be unfolded below 15℃, taken out, dried, fumigated with acetic anhydride vapor for 15 minutes, heated at 140-160℃ for 30 minutes, allowed to cool, and inspected 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. 3.6 Inspection 3.6.1 Moisture content
shall not exceed 5.0% (Method 1 of Appendix IX H of the 2010 edition of the Pharmacopoeia). Ignition residue? shall not exceed 0.8% (Appendix IX J of the 2010 edition of the Pharmacopoeia). 3.6.2 Heavy metals
Take the residue left under the ignition residue category and check it according to the law (Appendix IX E of the 2010 edition of the Pharmacopoeia), and it shall not exceed 20 parts per million. 3.6.3 Peak area ratio of flavonol aglycones
According to the chromatographic calculation of total flavonol glycosides under [Content Determination], the peak area ratio of quercetin and kaempferol should be 0.8 to 1.2. The peak area ratio between Lisu and quercetin is greater than 0.15. 3.6.4 Total ginkgolic acid
Determine according to high performance liquid chromatography (2010 edition of Pharmacopoeia, Appendix VI D). 3.6.4.1 Chromatographic conditions and system suitability test
Use octadecylsilane bonded silica gel as the filler; methanol 1% glacial acetic acid solution (90:10) as the mobile phase; the detection wavelength is 310nm . The number of theoretical plates should not be less than 4000 based on the ginkgo acid peak. 3.6.4.2 Preparation of reference substance solution
Take an appropriate amount of ginkgocin acid reference substance, weigh it accurately, add methanol to make a solution containing 5 μg per 1 ml, and use it as the reference substance solution. In addition, take an appropriate amount of total ginkgolic acid reference substance, add methanol to make a solution containing 100 μg per 1 ml, and use it as a control solution for positioning. 3.6.4.3 Preparation of test solution
Take about 10g of this product powder, weigh it accurately, place it in a stoppered conical flask, add 50ml of petroleum ether (60~90℃) accurately, and seal the stopper. Determine the weight, reflux and extract for 2 hours, let cool, weigh again, make up for the lost weight with petroleum ether (60-90°C), shake well, and filter. Precisely measure 25 ml of the additional filtrate, recover the solvent under reduced pressure until it is dry, add 2 ml of methanol accurately, seal tightly, and shake well. 3.6.4.4 Determination method
Precisely draw 10 μl each of the test solution, reference solution and positioning control solution, inject it into the liquid chromatograph, and calculate the corresponding chromatogram of the test solution and the total ginkgolic acid reference solution. The total peak area of ??the peak is obtained by calculating the total ginkgolic acid content using the ginkgo acid reference standard external standard method.
The total ginkgolic acid content of this product shall not exceed 10 parts per million. 3.7 Content determination 3.7.1 Total flavonol glycosides
Determine according to high performance liquid chromatography (Appendix VI D of Pharmacopoeia 2010 edition). 3.7.1.1 Chromatographic conditions and system suitability test
Use octadecylsilane bonded silica gel as the filler; use methanol 0.4% phosphoric acid solution (50:50) as the mobile phase; the detection wavelength is 360nm. The number of theoretical plates should not be less than 2500 based on the quercetin peak. 3.7.1.2 Preparation of reference solution
Take appropriate amounts of quercetin reference substance, kaempferol reference substance, and isorhamnetin reference substance respectively, weigh them accurately, and add methanol to make a solution containing 30 μg per 1 ml. , 30 μg, 20 μg mixed solution as the reference solution; or take about 35 mg of the ginkgo leaf control extract with the marked quercetin, kaempferin, and isorhamnetin content, weigh it accurately, and prepare it according to the preparation of the test solution Method, prepare the control extract solution in the same way.
3.7.1.3 Preparation of test solution
Take about 35 mg of this product, weigh it accurately, add 25 ml of a mixed solution of methanol-25% hydrochloric acid solution (4:1), place it in a water bath and heat to reflux for 30 minutes , quickly cooled to room temperature, transferred to a 50ml measuring flask, diluted to the mark with methanol, shaken, filtered, and the remaining filtrate was obtained. 3.7.1.4 Determination method
Precisely draw 10 μl each of the reference solution (or control extract solution) and the test solution, inject them into the liquid chromatograph, measure, and calculate quercetin and kaempferol respectively. The content of isorhamnetin and isorhamnetin is converted into the content of total flavonol glycosides according to the following formula.
Total flavonol glycoside content (quercetin content, kaempferol content and isorhamnetin content) × 2.51
This product contains total flavonol glycosides based on dry product. Not less than 24.0%. 3.7.2 Terpenoid lactones
Determine according to high performance liquid chromatography (2010 edition of Pharmacopoeia, Appendix VI D). 3.7.2.1 Chromatographic conditions and system suitability test
Use octadecylsilane bonded silica gel as the filler; use n-propanol-tetrahydrofuran-water (1:15:84) as the mobile phase; use Detected by evaporative light scattering detector. The number of theoretical plates should not be less than 2500 based on the bilobalide peak. 3.7.2.2 Preparation of reference solution
Take appropriate amounts of bilobalide reference substance, ginkgolide A reference substance, ginkgolide B reference substance and ginkgolide C reference substance respectively, weigh them accurately, and add Methanol was used to prepare a mixed solution containing 2 mg, 1 mg, 1 mg, and 1 mg per 1 ml as a reference solution. Or take about 0.15g of the ginkgo leaf control extract that has been marked with the contents of bilobalide, ginkgolide A, ginkgolide B and ginkgolide C, weigh it accurately, follow the preparation method of the test solution, and prepare the control in the same way. extract solution. 3.7.2.3 Preparation of test solution
Take about 0.15g of this product, weigh it accurately, add 10ml of water, warm it in a water bath to dissolve, add 2 drops of 2% hydrochloric acid solution, and dissolve with ethyl acetate Extract the ester by shaking 4 times (15ml, 10ml, 10ml, 10ml), combine the extracts, wash with 20ml of 5% sodium acetate solution, separate the sodium acetate solution, and wash with 10ml of ethyl acetate. Combine the ethyl acetate extract and washing liquid, wash twice with water, 20 ml each time, separate the water liquid, wash with 10 ml of ethyl acetate, combine the ethyl acetate liquid, recover the solvent to dryness, dissolve the residue with methanol and transfer to 5 ml In the bottle, add methanol to the mark, shake well, filter, and take the remaining filtrate to get it. 3.7.2.4 Determination method
Precisely draw 5 μl and 10 μl of the reference solution (or control extract solution) and 5 to 10 μl of the test solution, inject them into the liquid chromatograph, and measure using two external standards. Calculate the contents of bilobalide, ginkgolide A, ginkgolide B and ginkgolide C using the logarithmic equation.
Calculated as dry product, this product contains terpene lactones including bilobalide (C15H18O8), ginkgolide A (C20H24O9), ginkgolide B (C20H24O10) and ginkgolide C (C20H24O11) The total amount shall not be less than 6.0%. 3.8 Storage
Shade and seal.
3.9 Preparations
Ginkgo leaves version 3.10
"Pharmacopoeia of the People's Republic of China and the People's Republic of China" 2010 Edition 4 Instructions for Ginkgo Flavonoid Glycosides 4.1 Drug Name
Ginkgo Flavonoid Glycosides 4.2 English name
Ginkgo Biloba Flavonal Glycosides 4.3 Alias ??of Ginkgo leaf extract
Ginkgo leaf extract; Bioluda; Danacon; Coronary ketone; Gennatol; Shu Xuening; Tianbaoning; Teponin; Yinkeruo; Ginkgo leaf extract; 6911; Ginkgo Biloba Extract; Rokan; Tanakan; Tebonin; Teponin 4.4 Classification
Nervous system drugs> Nerve cell activators and Nutraceuticals > Other 4.5 Dosage Forms
1. Each tablet contains 40mg of main drug.
2. Injection: each 5ml, containing 17.5mg ginkgo leaf extract.
3. Oral liquid: 1ml (40mg) each. 4.6 Pharmacological effects of ginkgo flavonoid glycosides
Ginkgo flavonoid glycosides are derived from ginkgo leaf extracts and mainly contain ginkgo flavonoid glycosides. Ginkgo flavonoid glycosides can expand cerebral blood vessels, promote cerebral blood circulation, increase cerebral blood flow, improve and protect brain cells; improve energy metabolism and nutrition of hypoxic cells; increase red blood cell SOD activity, inhibit cell membrane lipid peroxidation; anti-platelet aggregation, Prevent thrombosis; expand coronary blood vessels, increase coronary circulation blood flow, and relieve blood vessel spasm. 4.7 Indications of Ginkgo flavonoid glycosides
Clinically, it is mainly used for cerebral insufficiency and Alzheimer's disease in middle-aged and elderly people, such as memory loss, mental decline, lack of concentration, headache, tinnitus, etc.; for arteriosclerosis It also has a significant improvement effect on coronary artery insufficiency, angina pectoris, myocardial infarction, etc. caused by hypertension. It can also be used for eye circulation disorders, diabetic retinopathy, age-related macular degeneration, etc. 4.8 Contraindications of Ginkgo flavonoid glycosides
Ginkgo flavonoid glycosides must not be combined with biological products such as calf serum. 4.9 Precautions
1. People who are allergic to ginkgo flavonoid glycosides, pregnant women and those with heart failure should use with caution.
2. During long-term intravenous injection, the injection site should be changed to reduce the occurrence of phlebitis.
3. Ginkgo flavonoid glycosides are not antihypertensive drugs, so antihypertensive drugs cannot be stopped. 4.10 Adverse reactions of Ginkgo flavonoid glycosides
Occasionally, gastrointestinal discomfort, dizziness, headache, decreased blood pressure and allergic reactions may occur. 4.11 Usage and dosage of Ginkgo flavonoid glycosides
1. 2 tablets each time, 3 times/d, 1 month as a course of treatment, 2 to 3 courses of treatment is optimal.