Pharmaceutical Research Of JY Bioadhesive Gel

The paper is based on the guidance of Traditional Chinese Medicine theories, and with the help of the modern pharmaceutical technology, to investigate the prescription on pre-clinical pharmaceutical reasearch. The prescription formula consist of the drug of Fructus Cnidii, Fructus Gardeniae, etc., possesses the functions of clear away pathogenic heat and dampness, anthelminthic and relieving itching, and is indicated for the treatment of humid heat and fluor with colpitis mycotica, trichomonas and nonspecific vaginitis.The original form of the medication is lotion, with the common problems of short medication time, inconvenience for use. Therefore, we consider to change the dosage form and chose the vaginal gel drug delivery system to study, to aim at solve the problems of short medication time, uneasy adhesion to the vaginal wall, water liquid storage uneasy and inconvenience for use.Based on the functions and indications and the characteristics of the ingredients in the herbs, the optimum extraction and forming technology was determined as follows: Fructus Cnidii, Folium Artemisiae Argyi, etc. is socked in 10-fold volume of water for 30 minutes, then distill for 6 hours to extract volatile oil, collect the water solution after distillation in another container. Decoct the residue of Fructus Cnidii, Folium Artemisiae Argyi, etc., together with the rest herbs including Fructus Gardeniae, Radix Sophorae Flavescentis and so on, for twice, using 10-fold volume of water for 2 h each time; combine the decoctions, filter, then combine the filtrate and the above-mentioned water solution. Recover the water under reduced pressure and then concentrate to a thin extract with a relative density of 1.15, chill, add a proper volume of ethanol to reach the ethanol concentration of 70%, stand for 24 h, then combine the supernate, filter. Recover the ethanol in filtrate under reduced pressure and concentrate to a thick extract with a relative density of 1.25; take 20 g of HPMC K4M and make it swell in quantity sufficient water of 60℃, then add 200g of glycerine and thick extract above-mentioned into it, mix to even; grind the volatile oil 30min with 5g tween-80, then add to the above mixture; take 2g ethylparaben and dissolve with 50ml alcohol, then add to the above mixture; mix to even, and then make it up for 1000g with distilled water, grind it for even, subpackaged and sterilized, then made the gel.In the reseach of quality standard, every ingredient was studied respectively. The identification effect of Fructus Cnidii, Radix Angelicae Pubescentis, Radix Sophorae Flavescentis, Radix Scutellariae, Cortex Phellodendri and Rhizoma Atracylodis by TLC were good. The quantitative determination of jasminoidin in Cortex Phellodendri by HPLC was applied as the quality-controlling index, with the systematic methodology accomplished.Preliminary stability research had kept on 3 months, the further research is in progress. The results indicated that JY bioadhesive gel was stable.The experimental results suggest that the preparation process of this product is reasonable and practical, the standard is controllable, the quality of the sample is steady on the whole as well.