A method for the determination of shikimic acid in Shengmai injection
A technique for Shengmai injection and a determination method, which is applied in the field of determination of shikimic acid in Shengmai injection, can solve the problems that quality control means cannot characterize biological substance components, and is difficult to control internal quality, and achieves good linearity and strong specificity. Effect
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Embodiment 1
[0071] Embodiment 1 (preparation of Shengmai Injection)
[0072] [Prescription] Red Ginseng 100g Ophiopogon japonicus 312g Schisandra 156g
[0073] [Preparation method] The above three flavors and red ginseng are cut into thin slices or crushed, soaked in more than 90% ethanol and heated to reflux for extraction 4 to 5 times, each time for 2 hours; or continuous reflux extraction for 6.5 hours, combined extracts, refrigerated, filtered, Recover ethanol until each 1ml contains 0.3-0.4g of crude drug, add an appropriate amount of activated carbon, stir, adjust the pH value of the filtrate to near neutral, let it stand still, concentrate the filtrate to a thick paste, add water for injection to 200ml, stir well, refrigerate, filter, Add an appropriate amount of activated carbon to boil, filter, and the filtrate is used for liquid preparation; Schisandra chinensis, if necessary, crush, collect 150ml of distillate by steam distillation, refrigerate, for liquid preparation, add wate...
Embodiment 2
[0074] Embodiment 2 (determination of shikimic acid content)
[0075] a. Take a sample of Shengmai Injection and dilute it by 20 times as the test product;
[0076] b. Take the shikimic acid reference substance and prepare it to about 80 μg / ml;
[0077] c. Carry out high-performance liquid chromatography determination, wherein the chromatographic conditions are: chromatographic column: Phenomenex Synergi 4μmHydro-RP 80A 250×4.60mm, 4micron, detection wavelength: 218nm; column temperature: 30°C; flow rate: 0.6ml / mim; mobile phase : 20mM / L KH 2 PO 4 Solution (H 3 PO 4 adjust the pH to 2.5);
[0078] d. Determination of shikimic acid content in Shengmai injection by external standard method.
Embodiment 3
[0079] Embodiment 3 (determination of shikimic acid content)
[0080] a. Take a sample of Shengmai Injection and dilute it by 20 times as the test product;
[0081] b. Take the shikimic acid reference substance and prepare it to about 80 μg / ml;
[0082] c. Carry out high-performance liquid chromatography determination, wherein the chromatographic conditions are: chromatographic column: Phenomenex Synergi 4μmHydro-RP 80A 250×4.60mm, 4micron, detection wavelength: 218nm; column temperature: 30°C; flow rate: 0.6ml / mim; mobile phase : 15mM / L KH 2 PO 4 Solution (H 3 PO 4 adjust the pH to 2.5);
[0083] d. Determination of shikimic acid content in Shengmai injection by external standard method.
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