| Yinqiaolanqin oral liquid was produced from many kinds of Chinese medicinal materials including Lonicera japonica Thunb., Forsythia suspensa(Thunb.) Vahl, Scutellaria baicalensis Georgi and Isatis indigotica Fort. It had the effect of antibacterial, antivirus and anti-inflammatory, which can be used in avian respiratory illness prevention. This study focused on quality standard and targeted Animal Safety of Yinqiaolanqin oral liquid, which made experimental and theoretical basis for clinical applications.1. According to Chinese Veterinary Pharmacopoeia(2010 edition),Thin Layer Chromatograpghy analysis(TLC) was used to identify Chinese medicinal materials including Lonicera japonica Thunb., Forsythia suspensa(Thunb.) Vahl, Scutellaria baicalensis Georgiand Sophora Flavescens Ait in Yinqiaolanqin oral liquid. The results revealed that the four Chinese medicinal herb could be separated effectively under the experiment conditions. The methods were simple, repetitive and can be used in quality control of the oral liquid.2. According to Chinese Veterinary Pharmacopoeia(2010 edition), High Performance Liquid Chromatography(HPLC) methods for determination of chlorogenic acid, baicalin and forsythin was established in Yinqiaolanqin oral liquid. The investigation of above method was developed. The results indicated that the method was well with system adaptability and the negative control had no interference. The results of linear correlations, precision and recovery could meet the standard requirements. These methods were simple, sensitive, accurate, and available for quality control of Yinqiaolanqin oral liquid.3. According to microbial limit test method in Chinese Veterinary Pharmacopoeia(2010 edition, Version Ⅰ), the microbial limit test of Yinqiaolanqin oral liquid was performed. The microbial limit test method was established and validated. The method of bacterial solution, the adaptability of culture medium and the method validation of counting were investigated. The same operation was done with control bacteria(Escherichia coli). The results showed that the conventional method could be used for microbial limit test and control bacteria examination. Test results indicated that the microbial limit of Yinqiaolanqin oral liquid was met the requirements of Chinese Veterinary Medicine.4. In order to build the basis on storage conditions and the term of validity of Yinqiaolanqin Oral Liquid, the stability tests were investigated. The stability tests included stress test, accelerated test and long-term test. During the experiment, the determination of chlorogenic acid and baicalin in Yinqiaolanqin Oral Liquid was done, at the same time the inspection of characteristics, clarity, related substances and other changes was done too. With the prolong of time, content of chlorogenic acid and baicalin was stable in the fluctuations, its content was still be kept within bounds. Other parameters had no significant changes in the examination, in line with the provisions of pharmaceutical quality standards. The Yinqiaolanqin Oral Liquid could meet the needs of clinical medicine with quality control easy and excellent stability.5. According to the Requirement of Veterinary Research Guidance, the safety studies of Yinqiaolanqin oral liquid on chicken were carried out in the experiment. These studies could provide relevant materials for its safety in clinical application. In the experiment, 1, 3 and 5 times of clinical recommended doses were administrated to chicken in water for seven days. After administration, the data of body weight, clinical hematology, blood biochemistry, organ indices and histopathology were obtained. When compared with control group, the results showed that there were no significant difference of these indexes among these groups(P >0.05). Meanwhile, no histopathology change was observed in all organs in treated groups. In conclusion, the administration of Yinqiaolanqin oral liquid by drinking water to chicken was safe. |
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