| The current subject involves the pharmaceutical studies on the re-development of the released drug FRQ Oral Solution, which can clear heat and detoxicate, disperse the lung qi and release the exterior, relieve sore-throat and dissipate phlegm. However, the formulation of FRQ Oral Solution contains bear gall powder and indigo naturalis, which are very bitter in taste, the clinical applications of FRQ Oral Solution are thus limited. In order to expand its clinical applications, the dosage form of FRQ Oral Solution was transformed to capsules after consultation and demonstration as well as in accordance with the actual production situations. The basic pharmaceutical researches was carried out in this dissertation; the selection of manufacturing techniques, the establishment of quality standards and the evaluation of preliminary stability were achieved, establishing the foundation for the preparation marketing.According to the functions and indications of the prescription, together with the physico-chemical properties of the ingredients, through comparative researches and orthogonal experiments, the optimum extraction process was determined as follows: prepare bear gall into powder for use; extract Indigo naturalis with 80% alcohol for 12-hour percolation, with the rate of 3ml·min-1, then collect the percolate, keep the gruffs for use; add 6-fold water to soak flos lonicerae for 30 min, distill the strong aromatic water for 8 hours, keep the remaining water solution in another container, then distill the strong aromatic water for 6 hours to get the essential oils, include it withβ-dextrin, keep the gruffs for use; decoct the other herbs with the gruffs of flos lonicerae and Indigo naturalis twice, first with 10-fold water and then 8-fold water, each time for 1 hour, then combine all filtrates and the water solution after the distillation of flos lonicerae essential oils, filtrate, concentrate the filtrate to the relative density of 1.10 (90℃) , add ethanol to reach the alcohol content of 80%, stand for 12 hours, filtrate, combine the filtrate and percolate, recover the ethanol and concentrate to get the extract of the relative concentration between 1.25～1.30 (50℃) , add sufficient distilled water, and then adjust pH to 6.0～6.5 with 10% NaOH solution, stand, filtrate, concentrate the filtrate to the extract of a relative concentration between 1.25～1.30(50℃), then apply vacuum dehydration (55～65℃) , grind, addβ-dextrin inclusion, bear gall powder and microcry stalline cellulos (MCC), granulate, arescent, mix it even, encapsulate, prepare it to 1000 capsules. The quality standard of FRQ capsules was established. TLC was used to identify the ingredients in prescription respectively, among which bear gall, licorice root, indigo naturalis had comparatively better results, thus the methods were included into the normal test of quality standard.; the moisture content, difference of filling weight, disintegration time, heavy metal, arsenic salt, microbial limit were controlled; the total count of caffeoylquinic acid should not be lower than 9.5mg, the total count of Tauro-ursodesoxycholic Acid should not be lower than 3.4mg.The stability of samples was investigated by room temperature observations. The results of the preliminary stability research indicated the quality is steady and can ensure the quality that the clinical medicine required.The results of above tests indicate that the preparation technology is reasonable and practical, the standard is controllable, and the quality of the sample is stable on the whole as well. |
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