Study On Preparation Technology And Quality Specification Of QLHY

On the previous research, 80 kinds of traditional Chinese medicine were bolted and defined by experiments in vitro and in vivo which included MTT of CEF cell and others. Astragalus root, isatis root, honeysuckle and other drugs were found to resist IBDV effectively.The protective ratio of this drugs on chicken embryo and chicken infected IBDV artificially was beyond 93.3%. Based on the traditional Chinese medicine theory ,one rescription was formation from the above drugs and the average curative effect rate of the rescription was 98.96% in the clinical application test.In this study, under the instruction of the pharmaceutics of chinese medicine theory ,we made the rescription into oral liquid called QLHY ,in order to be easy to utilize in the modern intensive poultry yard. We got the optimal production technology of QLHY through the orthogonal experiment; systematically studied the quality control of the crude drugs in QLHY and the praeparatum; studied the stability of the QLHY and formulated the condition of encasement, transportation and storage for QLHY, to lay a foundation for declaring new veterinary herbal medicine.In the study of the QLHY preparation technology, Astragalus mongholicus was decocted separately with isatis root and so on. Total sugar contents of Astragalus was used as Astragalus mongholicus evaluation index , 8 times dissolvent of pH 7,soaking 1 hours,decocting 1.5 hours at the first times and 1 hours at the second times, 100% concentrating degree were the preparation technology of Astragalus mongholicus.; the rate of extracta sicca of isatis root and so on as the evaluation index, 8 times dissolvent of PH 5,soaking 0.5 hours,decocting 1.5 hours at first the times and 1 hour at the second times, 50% concentrating degree were the preparation technology of isatis root. All of the evaluation index were higher than general decoction technology, which optimized the QLHY preparation technology and provides scientific basis for commercial production.On the establishment of QLHY quality criteria, origin detection, character identification and microscopic identification in crude drug were conducted, we also builted clear and accurate and high controllable morphology index, which provide the safeguard for qualitative identification of isatis root , and establishment of the content standard of chlorogenic acid and total sugar; thin-layer chromatogram of isatis root was clear, and negative control was obviously, which could use to qualitative identification QLHY; using the method of sulphuric acid-phenol, HPLC to determine the content of total sugar and caffeotannic acid, the contant of caffeotannic acid wasn't lower than 2.25 mg/ml and total sugar was more than 0.148 g/ml. This methods had high accuracy and precision.On the study of QLHY stability, through acceleration tests and light acceleration tests, the effect of temperature and light on physical and chemical properties were investigated.The result of the test shows: it must be pay attention to avoid light during production, packaging, transportation, and storage, because chlorogenic acid had sensitivity to light. It must be in the cool, because total sugar had sensitivity to temperature.In summary, the establishment to quality specification of QLHY based on the research of the fixed prescription and medicional materials, and preparation technology. It didn't only include source and character identification, but also microscopic and physical and chemical properties identification used by modern science and technology, and research of stability. It provided the exact basis for declaration of the third new veterinary medicine, which included pharmaceutical studies, such as preparation, investigation on formulation process, quality research, quality specification, stability of pharmaceutical preparations and selection of packaging containers.