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Is Venus ginsenoside a traditional Chinese medicine or a western medicine?

Title of article

Total ginsenoside

source

This product is a total saponin made from dried roots and rhizomes of Panax ginseng of Araliaceae.

prepare

Take ginseng, cut into thick slices, decoct in water twice, the first time is 2h, and the second time is1.5h, filter, combine filtrates, pass through D 10 1 macroporous adsorption resin column, elute with water until colorless, then elute with 60% ethanol, collect 60% ethanol eluate, and concentrate the filtrate until it is colorless.

Character; Role; letter

This product is yellowish white or light yellow powder; Slightly smelly and bitter; It is hygroscopic.

This product is soluble in methanol or ethanol, soluble in water, and almost insoluble in ether or petroleum ether.

distinguish

(1) Take 0. 1g of this product, put it in a test tube, add 2ml of water, and shake it vigorously to produce permanent foam.

(2) Take 0.65438 0 g of this product, add 65438±00ml of methanol and dissolve it as a test solution; Another ginseng 1g is taken as a reference substance, and 65438+20ml of water is added, which is decocted for 2h, filtered, and the filtrate is passed through a D10/macroporous adsorption resin column (inner diameter 1cm, column height 15cm), washed until colorless. Then take ginsenoside Rb 1 Reference substance, ginsenoside Rg 1 reference substance and ginsenoside re reference substance, and add methanol to dissolve them to prepare a mixed solution containing 2mg per kloc-0/ml as reference substance solution. According to the test of thin-layer chromatography (Appendix ⅵ b of Pharmacopoeia I, 20 10), absorb 2μl of each of the above three solutions, spot them on the same silica gel G thin-layer plate, and place chloroform-ethyl acetate-methanol-water below 15: 40: 22: 10℃. In the chromatogram of the test sample, the spots with the same color are displayed in sunlight, and the fluorescent spots with the same color are displayed in ultraviolet light, and their positions correspond to the chromatogram of the reference medicinal materials and the chromatogram of the reference substance.

cheque

granularity

According to the inspection (the second method in Appendix VII B of Pharmacopoeia 20 10), the powder that can pass through the 120 mesh sieve is not less than 95%.

air shrinkage

Take this product and dry it to constant weight at 105℃, and the weight loss shall not exceed 5.0% (Appendix ⅸ g of Pharmacopoeia I 20 10).

total ash

Shall not exceed 6.0%(20 10 pharmacopoeia, appendix ⅸ k).

Residue on ignition

It shall not exceed 6.0% (Appendix ⅸ J of Pharmacopoeia 20 10).

Heavy metals and harmful elements

According to the Determination Method of Lead, Cadmium, Arsenic, Mercury and Copper (Appendix ⅸ b of Pharmacopoeia I, 20 10), lead shall not exceed 3 parts per million; Cadmium shall not exceed two parts per million; Arsenic shall not exceed two parts per million; The mercury content shall not exceed two parts per million; The copper content shall not exceed 20 parts per million.

Organochlorine pesticide residues

According to the determination method of pesticide residues (determination of organochlorine pesticide residues in appendix ⅸ q of Pharmacopoeia I, 20 10 edition), the total amount of bhc should not exceed one in ten million; DDT (total DDT) shall not exceed one millionth; Pentachloronitrobenzene (PCNB) shall not exceed one in ten million.

Characteristic atlas

According to high performance liquid chromatography (Pharmacopoeia 20 10, Appendix VI D).

Chromatographic conditions and system adaptability test

The filler is octadecylsilane bonded silica gel (column length 25cm, inner diameter 4.6mm, particle size 5μm, carbon loading 1 1%). Using acetonitrile as mobile phase A and 0. 1% phosphoric acid solution as mobile phase B, gradient elution was carried out according to the following table; Column temperature 30℃; The flow rate is 1.3 ml per minute; The detection wavelength is 203 nm. The theoretical plate number should be not less than 6000 calculated by ginsenoside Re peak and not less than 200000 calculated by ginsenoside Rd peak.

Time (minutes) Mobile phase A (%) Mobile phase B(%)

0~30 19 8 1

30~35 19 →24 8 1→ 76

35~60 24 → 40 76 →60

Preparation of reference solution

Take appropriate amounts of ginsenoside Rg 1 Reference substance, ginsenoside re reference substance and ginsenoside Rd reference substance, weigh them accurately, and add methanol to prepare solutions containing ginsenoside rg 1.3mg, ginsenoside Re 0.5mg and ginsenoside Rd 0.2mg per 1ml respectively.

Preparation of test solution

Take 30mg of this product, weigh it accurately, put it in a 10ml volumetric flask, add methanol for ultrasonic dissolution and dilute it to scale, shake it evenly, filter it, and take the filtrate.

measure

Accurately suck 65438 00μ l of control solution and 65438 00μ l of test solution, and inject them into liquid chromatograph for determination.

There should be seven characteristic peaks in the characteristic spectrum of the test sample, and the retention time of three peaks should be the same as that of the corresponding reference peaks; The reference peak of ginsenoside Rd is S peak, and the relative retention time of characteristic peaks 3-7 should be within 5% of the specified value, which are 0.84 (peak 3), 0.9 1 (peak 4), 0.93 (peak 5), 0.95 (peak 6) and 65438 respectively.

Contrast characteristic diagram

Peak 1: ginsenoside Rg 1 peak 2: ginsenoside Re peak 3: ginsenoside Rf peak 4: ginsenoside Rb 1 peak 5: ginsenoside Re peak 6: ginsenoside Rb2 peak 7(S): ginsenoside Rd.

Content determination

Preparation of reference solution

Take a proper amount of ginsenoside Re reference substance, weigh it accurately, and add methanol to make a solution containing 1mg per 1ml.

Preparation of standard curve

Accurately suck 20μl, 40μl, 80μl, 120μl, 160μl and 200μl of control solutions respectively, put them in a test tube with a plug, evaporate the solvent at low temperature, add 0.5ml 1% vanillin perchloric acid test solution, put them in a constant temperature water bath at 60℃, and heat them to 60℃. Use reagent as blank. After bubbles are eliminated, the absorbance is measured at the wavelength of 540nm by ultraviolet-visible spectrophotometry (Appendix V A of Pharmacopoeia I, 20 10), and the standard curve is drawn with absorbance as the ordinate and concentration as the abscissa.

measure

Take about 50mg of this product, weigh it accurately, put it in a 25ml volumetric flask, add a proper amount of methanol to dissolve and dilute it to scale, shake it evenly, and accurately absorb 50μl l. According to the method under the standard curve preparation, start from "putting it in a test tube with a stopper", measure the absorbance, read the amount of ginsenoside re in the test solution from the standard curve, and multiply the calculation result by 0.84.

This product contains 65% ~ 85% total ginsenoside based on ginsenoside Re(C48H82O 18).

Ginsenoside Rg 1, Re, Rd

According to high performance liquid chromatography (Pharmacopoeia 20 10, Appendix VI D).

Chromatographic conditions and system adaptability test

Octadecylsilane bonded silica gel is used as filler; Using acetonitrile as mobile phase A and 0. 1% phosphoric acid solution as mobile phase B, eluting according to the gradient in the table of [characteristic map]; The detection wavelength is 203 nm. Calculated by ginsenoside Re peak, the theoretical plate number should be not less than 3000.

Preparation of reference solution

Take appropriate amounts of ginsenoside Rg 1 Reference substance, ginsenoside re reference substance and ginsenoside Rd reference substance, weigh them accurately, and add methanol to prepare a mixed solution of 1.30mg, ginsenoside Re 0.50mg and ginsenoside Rd 0.20mg.

Preparation of test solution

Take the sample solution under the characteristic spectrum.

measure

Accurately suck 10 ~ 20μl of the crystal solution to be tested and 20μl of the control solution respectively, and inject them into a liquid chromatograph for determination.

This product contains ginsenoside Rg 1(C42H72O 14), ginsenoside Re(C48H82O 18) and ginsenoside Rd(C48H82O 18), which should be15% ~ 20%.

store

Sealed and placed in a dry place.

source

People's Republic of China (PRC) Pharmacopoeia 20 10 Edition

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