The Research And Development Of Bo Xintong Soft Gelatin Capsule

Fistular onion bulb is the medicinal part of Allium fistulosum L.(Liliaceae), with acrid flavor and warm-natured. It has therapeutic effect to many diseases with the effects of inducing sweat,dispelling exogenous evils, eliminating cold to invigorate yang, and so on. We extracted the active parts from fistular onion bulb, and prepared Boxintong soft gelatin capsule using the mixture of the extract and some suitable adjuvant. Also, we evaluated the quality standard of the soft gelatin capsule.Fresh fistular onion bulb was dried and crashed into powder. Then the active part was extracted from the power by supercritical fluid extraction method (SFE). The content of active components in extract was elevated remarkably. The extract with strong odour of allium fistulosum, was unstable under environment of high temperature or illumination. Owing to the property of extract, soft gelatin capsule was the most suitable preparation for it. When the extract formulated into soft gelatin capsule, the loss of active component was decreased, the stability of extract was improved, and the unhappy odor of extract was covered up. The greatest advantages that the soft gelatin capsule offers are the increased bioavailability and the decreased adverse reaction.Glutin, glycerin and water were used in the manufacture of soft gelatin films. Besides, reservative and opacifying agent was added to improve the stability of gelatin film. PEG400 was used as main adjuvant for prescription of capsule content. The extract of fistular onion bulb was made into suspention. The dosage of surfactant and suspending agent was determined through investigating stability, disintegrating homogeneity and fluidity of suspention. In addition, a small quantity of vitamin E was added as oxidation inhibitor to increase the stability of the content. At last, the produce technique was optimized in the study of the influent factors, and the most suitable technology was adopted to produce ellipse soft gelatin capsule. The content determination of the Boxintong soft gelatin capsule included total sterides assaying and substance A assaying. After comparing several methods, vanillin chromatometry was chosen as the assaying method of total sterides in preparation. The orthogonal experiment was adopted to optimize the best reaction condition of vanillin colorimetric method. The investigation factors were reaction temperature, reaction time and volume of developer. At last, we determined the chromatometry method: the samples were heat for 30 minutes in water bath of 80 centigrade after adding 0.5% vanillin- glacial acetic acid 0.2 ml and glacial acetic 1.0ml,discontinued the reaction in iced bath, then determine absorptance at 540nm. This colorimetry method can be used to measure the concentration of total sterides in fistular onion bulb. The content of substance A was determined with high performance liquid chromatography. During the establishment of the detective method, the HPLC method, as well as the proper mobile and temperature were determined to identify the drug and to detect the content of sample accurately and precisely. Dikma Technologies Diamonsil TM C18 (4.6×250mm,5μm)column was used. Methanol was used as mobile phase and pumped at rate of 1.0 ml·min-1. The result was quantified by ultraviolet detection with wavelength set at 210 nm. Under such chromatographic condition, main peak separated well from other ingredient. The both methods were validated in the aspects of accuracy, stability, linearity and so on. The adjuvant used in soft gelatin capsule had non-interference to the determination of the total sterides and substance A.In the research of quality specification, the characters, identification, inspection, content determination of three patches of preparation were detected in accordance with the related regulation. The inspection determination, containing quantity disparation, disintegration time and microbial limit, were in accordance with requirement. The average content of total sterides in soft gelatin capsule was 25.67mg, the average content of substance A was 0.42mg.We prepared Boxintong soft gelatin capsule with the extract of fistular onion bulb and evaluated the quality standard of the soft gelatin capsule. The quality of Boxintong soft gelatin capsule can be controlled.