Evaluation of toxicological safety and quality control of Luobufukebiri pill

Abstract

Ethnopharmacological relevanceThe Luobufukebiri pill is one of the characteristic medicines of Uygur nationality in Xinjiang. It has the effect of warming and tonifying the brain and kidney, benefiting the heart and filling the essential functions, mainly used to treat impotence, depression, spermatorrhea, premature ejaculation, bodily weakness, emaciation, and neurasthenia.Aim of the study: This study evaluated the toxicology and developed a quality control protocol of Luobufukebiri pill to ensure its safety and effectiveness in clinical applications. Materials and methodsAcute toxicity in mice was studied by the maximum-dose method, and the toxic reactions in mice were observed within two weeks. In the study of Sub-chronic toxicity, SD rats were randomized into four groups: three drug groups which were treated with 8.00, 2.67, and 0.80 g/kg of Luobufukebiri pill, respectively, and one control group which was treated with the same volume of distilled water. Subsequently, at 30 days of medication and 30 days of drug withdrawal, the hematologic indexes, biochemical indexes, organ coefficient, and pathological sections of main organs were detected, respectively. According to the prescription, the contents of 8 active components in the pill were quantified simultaneously. The chromatographic conditions were as follows: Stepwise gradient elution was carried out using 0.1% formic acid (solvent A) and acetonitrile (solvent B), 0–8 min, 80% → 60% B; 8–25 min, 60% → 25%B. The flow rate was 1.0 mL/min, the column was maintained at 25 °C, and the injected sample volume was 10 μL. ResultsThe acute toxicity experiment documented a large dose of Luobufukebiri pill had no significant effect on organ and body weight and did not cause apparent damage to parenchymal organs. At Sub-chronic toxicity, the behavior of rats was as normal as the control group. There were some differences in hematologic indexes, serum biochemical indexes, and organ coefficient tests between the drug and control groups, but they had no toxic significance. No obvious pathological changes were observed in the pathological sections of major organs. In conclusion, this study demonstrated that the clinical dose of Luobufukebiri pill was far less than its toxic dose, and it had reliable safety. The contents of eight index components of Luobufukebiri pill were measured. All calibration curves exhibited good linearity with correlation coefficients better than 0.9997. The relative standard deviations of precision, reproducibility, stability, and recovery were less than 2.0%, demonstrating the stability and reliability of the method. ConclusionsThis study further confirmed the safety of Luobufukebiri pill in clinical practice. A rapid, accurate, and convenient RP-HPLC-PDA detection method has been developed for the simultaneous detection of eight active compounds in the pharmaceutical samples of Luobufukebiri pill. This study provided a reference for the safety and enhancement of the quality standards of Luobufukebiri pill.