T/SDAHA 008-2024 Extract of Platycodon grandiflorum for use in veterinary preparations

Scope

Main technical content: It shall comply with the provisions of Table 2. Table 2 Technical Indicator Items Identification In thin-layer chromatography, at the position corresponding to the control drug material chromatogram, a spot of the same color shall be observed. Geniposide content ≥ 0.10% Water content ≤ 10.0% 5.2.1 Confirmation of thin-layer identification method: Based on the identification methods of Geniposide in Glycyrrhizae materia medica and Qingfei Granules in the Second Edition of the Pharmacopoeia of the People's Republic of China, and the identification method of Geniposide in Jupei Granules in the 2017 Edition of the Veterinary Drug Quality Standards, a comparative screening was conducted. Different batches of samples were also identified. 5.2.1.1 Thin-layer identification method: Take 0.15g ± 0.015g of the product, add 3mL of hydrochloric acid and 30mL of water, heat and reflux for 1h, cool, filter, and extract the filtrate with ethyl acetate three times, each time 30mL. Combine the ethyl acetate extracts and filter through a filter paper coated with anhydrous sodium sulfate. Evaporate the filtrate under water bath and dissolve the residue in 1ml of methanol to obtain the sample solution. Take 0.5g ± 0.05g of control drug material Geniposide and prepare the control drug material solution in the same manner. Test by thin-layer chromatography (Appendix 0502), and absorb 8μL to 10μL of each solution onto the same silica gel G thin-layer plate. Develop with chloroform-ether (1: 1) as the developing solvent, remove, dry, and spray with a 10% ethanol solution of sulfuric acid (10mL of sulfuric acid diluted to 100mL with ethanol and shake well). Heat at 105℃ until the spots show clear color. In the chromatogram of the sample, a spot of the same color shall be observed at the position corresponding to the control drug material chromatogram. 5.2.2 Geniposide content: According to the detection method of Geniposide in Glycyrrhizae materia med

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