Directory 1 Pinyin 2 standard issued by the Ministry of Traditional Chinese Medicine 2. 1 alias/generic name 2.2 Pinyin name 2.3 Standard No.2.4 Trait 2.5 Identification 2.6 Inspection 2.7 Content determination 2.8 Function and indication 2.9 Usage and dosage 2. 1/specification 2. 1/kloc

2.2. 1 pseudonym/generic name Ginkgo biloba injection standard issued by state administration of traditional chinese medicine.

2.2 Pinyin name Shuxuening injection

2.3 standard number WS3B370798

This product is a sterile aqueous solution prepared by extracting Ginkgo biloba leaves.

2.4 Characteristics This product is a yellow clear liquid.

2.5 Identification (1) Take 30ml of this product, add water saturated n-butanol and shake and extract it twice, 20ml each time, combine the n-butanol extracts, evaporate to dryness, add 1m ethanol to dissolve the residue, and take the supernatant as the test solution. Adding 20ml ethanol to 2g Ginkgo biloba leaves, heating and refluxing for 30min, filtering, evaporating the filtrate, adding 20ml water to the residue, stirring, filtering, evaporating the filtrate, dissolving the residue with 1ml ethanol, and taking the supernatant as the control medicinal material solution. According to the thin-layer chromatography test (Appendix ⅵ b), absorb 5μl of each of the above two solutions, respectively spot them on the same silica gel G thin-layer plate, use 4% sodium acetate solution as adhesive, use ethyl acetate butanone formic acid water (5: 3: 1: 1) as developing agent, unfold, take out, dry and spray 3% aluminum trichloride ethanol. In the chromatogram of the test sample, the spots of the same color are displayed in the sun and the fluorescent spots of the same color are displayed under the ultraviolet lamp at the position corresponding to the chromatogram of the control medicinal material.

(2) Take the test solution under the content determination of ginkgolide A as the test solution. Ginkgolide A and ginkgolide B were taken as reference substances, and methanol was added to prepare a solution containing 1ml as reference substance solution. According to the TLC test (Appendix ⅵ b), absorb 65438 00μ l of the above two solutions, respectively spot them on the same silica gel G thin-layer plate prepared with 4% sodium acetate solution and sodium carboxymethyl cellulose as adhesive, and use toluene ethyl acetate acetone methanol (5: 2.5: 2.5: 0.3) as developing agent, unfold, take them out, dry them, and steam them in acetic anhydride vapor for 65433. 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 Check that the pH value should be 4.5 ~ 5.8 (Appendix VII g). Peak area ratio of flavonoid glycosides The peak area ratio of quercetin to kaempferol calculated by chromatography under the determination of total flavonol glycosides should be 1: 1 20%. Ginkgol takes 65438±00ml of this product, concentrates it to dryness, and the residue is dissolved with 2ml of methanol as the test solution. In addition, 65438±0g of Ginkgo biloba L. was taken, and 65438±00ml of ethanol was added, which was extracted under reflux for 30min. The ethanol was volatilized, and 2ml of methanol was added to dissolve the residue as the control medicinal solution. Absorb 5μl of each of the above two solutions, spot them on the same silica gel GF254 sheet, spread them with benzene-n-hexane-ethanol (5: 3: 1), take them out, dry them, spray vanillin sulfuric acid test solution, and bake them at 105℃ for about 5 minutes. In the chromatogram of the test sample, there shall be no spots in the position corresponding to the chromatogram of the control medicinal materials. Take this product 1ml of protein, adjust the pH value to 6.5 ~ 7.0 with 1% sodium hydroxide, and add 1 ~ 3 drops of tannic acid without turbidity. Take 1ml tannin, add 5ml freshly prepared normal saline containing 1% egg white, and let it stand for10min (fresh preparation is required), without turbidity or precipitation. Take this product as pyrogen, check it according to law (Appendix VIII A), and inject 5ml per 1kg according to the weight of the rabbit, which should comply with the regulations. Accurately draw 2ml of this product from residue on ignition and check it according to law (Appendix Ⅶ j). The residue in each 1 ml shall not exceed 0.5 mg. Take the residual residue from heavy metal residue on ignition and check it according to law (Appendix ⅸ e, the second method), and the content of heavy metal shall not exceed 10 parts per million. Others shall comply with the relevant provisions under injections (Appendix I U).

2.7 the content of total flavonol glycosides was determined by high performance liquid chromatography (appendix ⅵ d). Octadecylsilane bonded silica gel is used as a filler for chromatographic conditions and system suitability test. The mobile phase was methanol and 0.4% phosphoric acid (55: 45). The detection wavelength is 368 nm; ; The theoretical plate number should be no less than 2500 calculated by quercetin peak, and the resolution should be greater than 1.5 calculated by quercetin and isorhamnetin peak.

Preparation of reference solution Accurately weigh quercetin, kaempferol and isorhamnetin dried by phosphorus pentoxide, and add methanol to make mixed solutions containing 0.03mg, 0.03mg and 0.02mg per 1ml as reference solutions (or make mixed solutions containing 0. 1mg quercetin and 0.02 mg kaempferol per 1ml respectively) Accurately measure 1ml before use, and mix well).

Preparation of test solution Accurately measure 65438±00ml of this product, add 65438±06ml of methanol and 6 ml of 65438 08% hydrochloric acid, put in a water bath, heat and reflux for 65438 0.5 hours, quickly cool to room temperature, transfer to a 50ml volumetric flask, dilute to scale with methanol, mix well, and filter with a 0.45μm microporous membrane to obtain the test solution.

The determination method accurately absorbs the reference solution and the test solution 10μl respectively, and injects them into a high performance liquid chromatograph for determination, and calculates the contents of three flavonoid glycosides respectively, which are converted into the contents of total flavonol glycosides according to the following formula: total flavonol glycosides content = (quercetin content+kaempferol content+isorhamnetin content) ×2.5 1 the total flavonol glycosides in this product should be 90.0 of the labeled amount. Ginkgolide A was determined by high performance liquid chromatography (Appendix ⅵ d). Octadecyl bonded silica gel is used as filler for chromatographic conditions and system suitability test. Using methanol-water (3: 7) as the mobile phase, it was determined by differential refractive detector. According to the calculation of ginkgolide A peak, the theoretical plate number should be not less than 2500.

Preparation of Reference Solution Accurately weigh Ginkgolide A reference substance and add methanol to make a solution containing 65438±0mg per 65438±0ml as reference substance solution. Preparation of test solution: accurately measure 25ml of this product, add 1 ~ 2 drops of dilute hydrochloric acid, adjust the pH value to 2, shake well, extract with ether for 4 times, 20ml each time, wash the ether extract with the same 5% sodium chloride solution 15ml twice, and extract the washing solution with ether for 20ml 1 time. Combine ether solutions, evaporate to dryness, dissolve with methanol, quantitatively transfer to a 2ml volumetric flask, add methanol to dilute to scale, shake well, and serve as the test solution.

The determination method accurately absorbs 65438 00μ l control solution and test solution respectively, and injects them into the liquid chromatograph for determination. The content of ginkgolide A in this product shall not be less than 80% of the marked amount.

2.8 Functions and indications: dilate blood vessels and improve microcirculation. Used for ischemic cardiovascular and cerebrovascular diseases, coronary heart disease, angina pectoris, cerebral embolism, cerebral vasospasm, etc.

2.9 usage and dosage intramuscular injection, 2 ~ 4 ml at a time, 65438+ 0 ~ 2 times a day. Intravenous drip, 5ml daily, diluted with 250ml or 500ml 5% glucose injection, or as directed by the doctor.

Each 2. 10

(1)2ml (containing total flavonol glycosides1.68mg; ; Ginkgolide A 0.12mg)

(2)5ml (containing 4.2mg of total flavonol glycosides; Contains ginkgolide A 0.30mg mg)

2. 1 1 Storage sealed from light.

Draft by Beijing Institute for Drug Control

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