Research progress in quality control of Bufonis Venenum in preparations / 中国中药杂志

Bufonis Venenum, an animal medicinal material, is widely used for treating cardiovascular diseases and pain induced by rheumatics or malignant tumors. In view of the high activity and high toxicity, it is of great significance to pay attention to the quality control of Bufonis Venenum to ensure the safety and effectiveness of its preparations. China's drug standards involve 102 preparations(474 batch numbers) containing Bufonis Venenum approved for sale, including 14 preparations in the Chinese Pharmacopoeia(2020 edition) and 68 preparations in the standards issued by the Ministry of Health Drug Standard of the People's Republic of China. Bufonis Venenum is mostly used in pill and powder preparations in the form of raw powder, with the main functions of clearing heat, removing toxin, relieving swelling and pain, replenishing qi, activating blood, opening orifice, and awakening brain. Except the high level of quality control for Bufonis Venenum in the preparations in the Chinese Pharmacopoeia(2020 edition), the quality control standards of Bufonis Venenum in other preparations are low or even absent. Therefore, it is urgent to conduct research on the improvement of quality standards for the preparations containing Bufonis Venenum. This study retrieved the reports focusing on the quality evaluation and quality control of the preparations containing Bufonis Venenum from CNKI, PubMed, and Web of Science. Qualitative and quantitative analysis methods for 64 preparations containing Bufonis Venenum have been reported, mainly including thin-layer chromatography, HPLC fingerprint, and multi-component content determination. The index components mainly involved bufadienolides, such as gamabufalin, arenobufagin, bufotalin, bufalin, cinobufagin, and resibufogenin. According to the literature information, this paper suggests that attention should be paid to the correlations between the analysis methods and detection indexes of medicinal materials, decoction pieces and preparations, the monitoring of indole alkaloids, and the content uniformity inspection for further improving the quality standards for the preparations containing Bufonis Venenum.

The nerve protection and in vivo therapeutic effect of Acalypha indica extract in frogs.

Aim To demonstrate nerve protection and/or treatment effect of Acalypha indica Linn. extract on nerve paralysis induced by subcutaneus injection of pancuronium bromide on frog’s back. Methods The study was performed on sixty frogs (Bufo melanostictus Schneider) that divided into two groups, i.e. the neuro-protection and neuro-therapy group. Each group was divided further into 6 sub-treatment groups: negative control group treated by water and positive control group treated by piracetam, treatment groups received the extracts 200, 300, 400, 500 mg/kgBW. Pancuronium bromide 0.2% (1 : 20 dilutions) were injected subcutaneously as muscle relaxant. The protective effect was studied by giving the extract orally, 1 hour prior to injection; while the therapeutic effect of the extract was studied by 10 minute treatment after injecting pancuronium bromide solution. The parameters measured were the onset and duration of paralysis (in minutes) and the recovery time (time needed to recover into normal condition). Results The study showed signifi cantly different protective effect of Acalypha indica Linn. root water extract at 400 and 500 mg/Kg.BW compared to negative control group and positive control group (piracetam (p<0.05); while the therapeutic effect was obvious at the dose 200-500 mg/Kg.BW compared to negative control group (p=0.000). There was no signifi cant difference compared to positive control group (piracetam), except at 300 mg/Kg.BW (p=0,012). Conclusion These results have proven that the water extract of Acalypha indica Linn. root has comparable protective and treatment effect on nerves system, as piracetam, but further studies should be performed to provide more evidences particularly pharmacokinetic and pharmacodynamic studies on two animal models that commonly used.