| Pediatric Lung Cough Particles(PLCPs) prescription composed of 22 kinds of traditional Chinese medicine, including Flos Farfarae(FF), Poria Cocos(PC), Danfu Tablet(DT) etc. 12 kinds of traditional Chinese medicine(TCM) is used as medicine directly after grinding. Research shows that most of TCM are not soluble in water, poor water dispersion and easy to aggregate, may be one of the main reasons for the problem of PLCPs.Grinding TCM mixed with grinding and dispersing agent, can improve the grinding efficiency and water dispersion. Effervescent tablet is a special tablet, effervescent tablet has the advantages of solid preparation and liquid preparation. Effervescent disintegrating agent is a mixture of sodium bicarbonate and organic acids pairs, the two chemical reactions produce large amounts of carbon dioxide gas in water, thus making the tablet disintegrate rapidly, easy dispersion of the medicine powder, very applicable in children, the elderly and swallowing pills in patients with difficult.Prepared PLCPs with TCM by grinding dispersion treatment, study on water dipersion of PLCPs often using absorbance change rate(β) and Zeta potential as index. Further, adding suspending agents for the preparation of PLCPs, using spectrophotometry turbidity, sedimentation and viscosity measurement experiment comprehensive characterization of particle dispersion stability of suspension. While grinding FF mixed with 2.5% sodium hexametaphosphate, grinding PC mixed with 1.0% lecithin, grinding DT mixed with 2.0% PEG4000, used the medicine powder to prepare the PLCPs, the β of the suspension was decreased by 10.3%, Zeta potential absolute value was increased by 15.1%. Chosen hydroxyethyl cellulose(HEC) as suspending agents, in an amount of 2.5%, the β of the suspension reduced by 9.9%, then the suspension has good dispersion stability and the viscosity is appropriate. Adding grinding and dispersing agent, suspending agents for the preparation of PLCPs, would improve the water dispersion stability.Pediatric Lung Cough Effervescent Tablets(PLCETs) is a new kind of pure TCM preparation, its preparation is based on PLCPs which has a wide range of clinical applications. In this study, screening of preparation method for effervescent tablets and effervescent disintegrants, filler, lubricant, flavoring agents, wetting or types of binder by single factor experiment. The amounts of effervescent disintegrating agent, SDS and PEG 6000 were optimized by orthogonal test using disintegration time and tablet hardness as index, to explore the preparation of PLCETs, then prepared PLCETs with TCM by grinding dispersion treatment. Chosen Method 3 for Preparation of PLCETs, the amount of PEG 6000 is 8%, granule drying temperature is 60℃, 3% SDS, 8%PEG 6000 were selected for the formulation of PLCETs. Selected 40% tartrate-NaHCO3 ratio of 1:1.5 as effervescent disintegrants, lactose as filler, 3.0% of SDS as lubricant, 0.4% of acesulfame as flavoring agents; purified water as wetting agent. Subsequently, prepared PLCETs with the three kinds of TCM by grinding dispersion treatment, finally obtained a optimization of PLCETs, compared with blank PLCPs suspension, the β of PLCETs suspension was decreased by 20.9%, Zeta potential absolute value was increased by 67.7%. The preparation of PLCETs is stable, and appearance, tablet weight differences, hardness and disintegration differences of PLCETs are in line with the "Chinese Pharmacopoeia" and related standards, and the water dispersion of PLCETs is well. |