T/SDAHA 004-2024 Yellow Indigo Extract for Veterinary Drug Preparations

Scope

Main technical content: 1. **Appearance observation of samples**: Approximately 2.0 g of samples were taken and observed under natural light in a Petri dish. A total of 3 batches of production samples from Shandong Jinzhuoji Pharmaceutical Co., Ltd. were observed, and the results are shown in Table 2. Table 2: Summary of appearance observation of Huangzhi extract **Batch number** **Appearance** **Shandong Jinzhuoji Pharmaceutical Co., Ltd.** **20231201** **Brown-yellow paste** **20231202** **Brown-yellow paste** **20231203** **Brown-brown paste** Based on the observation results, the product appearance was determined as brown-yellow to brown-brown paste. 2. **Identification of Huanglian (Coptis chinensis)** According to the *Veterinary Drug Quality Standards* (2017 Edition), the identification of Huangzhi oral solution includes the following steps: - **Sample preparation**: A 10 mL sample (equivalent to 5 g of Huangzhi extract) was taken. - **Extraction and purification**: The sample was dried over a water bath, extracted with 20 mL methanol, refluxed for 15 minutes, filtered, and dried over a water bath. The residue was dissolved in 5 mL ethanol to prepare the test solution. - **Reference standards**: A 5 g Huanglian reference material was extracted and dissolved in 10 mL methanol. A standard solution of 0.5 mg berberine hydrochloride in 1 mL methanol was also prepared. - **Thin layer chromatography (TLC) analysis**: The three solutions were applied to a silica gel G plate (developing solvent: benzene-ethyl acetate-methanol-isopropanol-concentrated ammonia solution (6:3:1.5:1.5:0.5)) and visualized under UV light (365 nm). The results showed fluorescent spots of the same color as the reference materials in the same position on the TLC plate. The TLC analysis confirmed the identification of Huanglian in the three batches produced by Shandong Jinzhuoji Pharmaceutical Co., L

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