T/SDAHA 003-2024 Bark Extract for Veterinary Drugs and Preparations

Scope

Main technical content: 1. **Shape observation of the sample**: Approximately 2.0 g of the sample was taken and observed on a watch glass under natural light. A total of 3 batches of production samples from Shandong Jin Zhuji Pharmaceutical Co., Ltd. were observed, and the results are shown in Table 2. **Table 2: Summary of the shape observation of Bo Ma extract** **Production batch number** **Shape observation** **Shandong Jin Zhuji Pharmaceutical Co., Ltd.** **20231201** **Brown-yellow paste** **20231202** **Brown-yellow paste** **20231203** **Brown-brown paste** Based on the observation results, the product shape was determined as a brown-yellow to brown-brown paste. 2. **Identification of Berberine Hydrochloride**: According to the *Veterinary Drug Quality Standards* (2017 Edition), the "Identification" section of the Bo Ma Oral Liquid specifies that the sampling amount should be 50 mL, corresponding to 25 g of Bo Ma extract. The sampling amount was determined as 25 g ± 2.5 g. The method was as follows: Add diatomite to mix evenly, dry at 80°C, add sufficient methanol, and reflux for 15 minutes in a water bath. Filter the solution and concentrate to 5 mL as the test solution. Prepare a 0.5 mg/mL solution of Berberine Hydrochloride control sample in methanol. Conduct thin-layer chromatography (Appendix 0502) by applying 5 μL of each solution to a silica gel G plate and elute with n-butanol-glacial acetic acid-water (7:1:3). View under UV light (365 nm). The test solution showed fluorescent spots of the same color as the control sample in the corresponding positions on the chromatogram. The results of thin-layer chromatography identification for the 3 batches produced by Shandong Jin Zhuji Pharmaceutical Co., Ltd. are shown in Figure 1. **Figure 1: Thin-layer chromatography identification of Berberine Hydrochloride** Based on the thin-layer chromatogram, it was determined that this method is sui

Development Information

Related Standards