香连化滞水丸剂的制备及质量检测OA

This study aimed to optimize the manufacturing process and established quality evaluation for the Xianglian Huazhi water-pills formulation.Based on the traditional prescription(12 crude drugs including Coptidis Rhizoma and Aucklandiae Radix),pills were prepared by the molding method with corn starch as excipient,controlled at 5 mm in diameter,and dried with hot air at 60℃to obtain uniform and round pellets.Product stability was assessed via appearance/consistency,pill weight,and moisture content.Identity was confirmed by microscopy and TLC,with characteristic microscopic features and Rf/color reactions consistent with references.Quantification employed C18-HPLC with the external-standard method(λ=350 nm,acetonitrile-0.1%phosphoric acid=42∶58,V/V,containing 0.10%sodium dodecyl sulfate);system suitability met the preset criteria,and a berberine peak consistent with the reference was detected at tR≈ 19.24 min,giving a content of 4.0 mg/g,which complies with the Chinese Pharmacopoeia(2020)specification(≥2 mg/g).These results indicate that the established process reliably produces Xianglian Huazhi water pills suitable for companion animals,with clear prescription identity,controllable marker content,and uniform quality,supporting good manufacturability and prospects for broader application.