Study On The Preparation And Quality Of The Fennel Soft Capsules

Objective:To study the quality of Foneiculum vulagre from Xinjiang, to optimized the extraction process of fennel volatile oil, and to research the preparation procedure and quality standard of fennel soft capsules.Methods:(1) The compositions in fennel from ten different origins were collected and analyzed by GC and GC/MS to establish the fingerprinting of fennel oil. (2) The single-factor test was conducted using size, soak time, extraction time, multiples of water as factors. The water distilled extraction process of fennel oil was optimized using L9(34) orthogonal test. (3) The physical constants were determined in three pilot batches of fennel volatile oil, such as relative density, optical rotation and rotation et al. The content of trans-Anethole which is main active ingredient in fennel oil was determined by HPLC, trans-Anethole was identified by TLC, and validate a methodology. In the last, the quality standard of fennel volatile oil was established. (4) The prescription contents in fennel oil soft capsules were optimized by choosing the diluents and researching the compatibility of raw materials. The prescription of soft capsules shell was optimized using L9(34) orthogonal test. The quality standard fennel soft capsules was established and the quality of three batches of fennel soft capsules was researched. Results:(1) The fennel oil in ten different origins were analyzed by GC. The results showed that the ten common peaks in GC fingerprints were recognized, nine of them were identified and trans-Anethole was the highest composition in fennel oil which was used as detection index of fennel oil. The established fingerprint analysis method conformed all regulations and the similarity of each sample was over 0.95. (2) The results of single factors test indicated that the factors which affected the extraction rate of volatile oil were water multiples, extraction time and size. The optimum extraction process using orthogonal test was 40 mesh,10 times water and steam distillation for 5 h. (3) The ρ of fennel volatile oil was 0.9682, the rotation was 0.08, the specific rotation was 0.07, and refractive index was 1.55. The established HPLC detection methods of trans-Anethole conformed all the regulations, and validate a methodology. The trans-Anethole was set not less than 0.7g per gram in Fennel volatile oil. (4) O.D.O was chosen as the diluent of fennel soft capsule; The composition of soft capsules shell was gelatin:glycerin:water= 2:1:2; The pilot test was conducted on 30 000 soft capsules; the results of affected factors test showed that fennel soft capsules were stable in high temperature, high humidity and high light for 10 days; The quality of three batches pilot products were not significantly changed in stability experiments, and the quality standard of fennel soft capsules was established according to the results of the stability test.Conclusion:The preparation process of fennel soft capsules was stable and quality standard was controlled.