XÂY DỰNG TIÊU CHUẨN CHẤT LƯỢNG VÀ KHẢO SÁT TÍNH AN TOÀN CỦA CAO CHIẾT NƯỚC BÀI THUỐC SÂM LINH BẠCH TRUẬT TÁN

Abstract

Objectives: Sam Linh Bach Truat Tan (SLBTT) or Shen Ling Bai Zhu San is an ancient formula, which has been used in traditional medicine to effectively treat the “Spleen qi deficiency” disorder with symptoms of fatigue, weakness in limbs, unwillingness to eat, full stomach, and loose diarrhea many times… Currently, the quality control of the ingredients related to SLBTT extract has almost not been implemented, leading to the failure to control the quality, effectiveness and safety of the extract. Therefore, the study was conducted to develop quality standards and evaluate the toxicity of the SLBTT remedy. Methods: Prepare herbal ingredients according to the standards of the Ministry of Health; conduct extraction; survey standard of the extract on sensory analysis, water solubility, moisture content, total ash, qualitative by thin layer chromatographic method for active ingredient groups in herbal extracts, conducted according to Vietnam Pharmacopoeia IV. Determine acute oral toxicity of medicinal concentrates dissolved in distilled water, survey LD₅₀ by Karber-Behrens method. Results: Determine the standards of the SLBTT extract as follows: sensory appearance, water solubility 20ml, moisture content 8.09 ± 0.01, total ash 4.98% ± 0.07, ash not soluble in hydrochloric acid 0.6% ± 0.01, qualitative extracts of SLBTT have the presence of 4 medicinal herbs: Panax ginseng, Poria cocos, Atractylodes macrocephala, Glycyrrhiza glabra, and 4 ginsenosides: Ginsenoside G1, Ginsenoside B1, Ginsenoside Rf, Ginsenoside Rd. The determination of the D_max of SLBTT is 23.16g extract/ kg of mice/ 20ml of water, 3-5 times higher than the pharmacologically effective dose, equivalent to 2.66 times the human dose. Conclusion: The study has successfully built an extraction process to standardize the quality of SLBTT extract. SLBBT has a D_max of 23.16 g/kg mice (equivalent to 118.12g extract per 60kg person).