Study On Preparation Process Of Piper Longum L.and Piper Nigrum L. Prescription Buccal Tablets

Objective: To screen proper extraction method of Piper longum L.and Piper nigrum L.prescription and optimize the extraction process; To screen proper prepartion technics ofPiper longum L.and Piper nigrum L. prescription tablets and study its quality andpreliminary stability.Methods: In-vitro antibacterial test, acetic acid-induced writhing test and xylene-inducedear swelling test were employed to compare the efficacy strength of extracts obtainedwith different extaction method; The method of determination with HPLC was set upwith evaluation quota of piperine to optimize the extraction process; Piper longum L.andPiper nigrum L. prescription buccal tablets was prepared; Effect of prescription andtechnics on tablets formability, in-vitro adhesion, in-vitro adhesion time and in-vitrodiffusion distance was studied. Composite design test was conducted to optimize theprescription. Initial quality standards were set up by studing the identification, assay,dissolution and appearance and weight differences of the final preparations. Impact factorstest was used to explore the factors affecting the quality of Piper longum L.and Pipernigrum L. prescription buccal tablets by using appearance, content, in-vitro adhesion andin-vitro dissolution as the evaluation indicators to select proper packaging materials.Results: Ethanol extraction method was chosen as the proper extraction method of Piperlongum L.and Piper nigrum L. prescription according to the efficacy trials. The optimumextraction was listed as follows:8times the amount of herbs of70%ethanol was added toround-bottomed flask with herbs meal in the first time, the extraction time was1h.6timesthe amount of herbs of70%ethanol was added to the residue in the second time, theextraction time was45min. The optimized prescription was determined according to the interaction results of effect surface and single factor test: alcohol extractum: SiO2=3:1,L-CMC-Na:L-HPC=1.04:1, the amount of bioadhesive agents was23.33%, the amount oflactose was10.28%, prepare tablets by direct compression. This product was brown, roundbuccal tablets; Each tablet contains approximately11.00mg of piperine. Dissolution ofpiperine should not be less than70%using paddle method in2hours. The buccal tabletswere stable to high temperature, but unstable to illumination and very sensitive to humidity.Conclusion: Extraction process and preparation process is stable and feasible.Moistureproof, lightproof and sealed packaging should be used for Piper longum L.andPiper nigrum L. prescription buccal tablets.