Standard Process And Quality Control Of Compound Capsules Bear Bile

Compound bear bile capsule is a prescription for clinical application and its components include artificial bear bile, artificial musk, astragalus, frankincense (vinegar), myrrh (vinegar), Paris polyphylla and pseudo-ginseng. It has the effects of clearing heat and dissipating binds, promoting blood circulation and dispersing concretions, and strengthening and consolidating body resistance. The capsule can be used as an adjunctive therapy for nasopharyngeal cancer, esophageal cancer, gastric cancer and colorectal cancer. Modern pharmacological experiments have concluded that the effect of clearing heat and detoxification reduces the temperature through heat dissipation by regulating heat center or through eliminating pathogenic microorganisms by antimicrobial effects and studies have shown that ursodesoxycholic acid, chenodeoxycholic acid and polyphyllin in the bear bile powder of this prescription have the effects of detoxification and bacteriostasis. In addition, it improves body immune function, or enhances the body’s ability to resist the bacterial and viral invasions. Modern research shows that many herbal medicines, such as artificial bear bile, musk, pseudo-ginseng, Paris polyphylla, frankincense and myrrh, have anti-tumor effect, while astragalus in the prescription can significantly enhance macrophage function in mice due to its polysaccharides and has significant immune-enhancing effects in low immunity of tumor-bearing animals, thus playing a role of indirect adjunctive treatment. Therefore, the research on its preparation process and the development of its quality standards are the important foundations for in-depth study of its effects for further clinical application.According to the natures of the drugs in the prescription, artificial bear bile and artificial musk are precious herbs and the amounts of them are small, so they can be used as the medicine with the original powder directly after being crushed into fine powder in order to avoid losses; main medicinal ingredients in astragalus and Paris polyphylla can be dissolved in water, so they can be used by concentrating and crushing after decoction in water; main medicinal ingredients in frankincense (vinegar), myrrh (vinegar) and pseudo-ginseng can be dissolved in ethanol, so they can be used by concentrating and crushing after reflux extraction in ethanol.Orthogonal design is used to optimize the extraction process, examine the impact of various factors on the main components in the extraction, and decide the appropriate level. The optimum extraction process of astragalus and Paris polyphylla is determined using12times amount of water, soaking for0.5hours and decocting for three times with two hours each; the optimum extraction process of pseudo-ginseng, frankincense (vinegar) and myrrh (vinegar) is determined as using6times amount of70%ethanol and refluxing for three times with three hours each.It is proposed to prepare capsules for the convenience of clinical use. Research on simple molding process of preparation was carried out, including study on excipient selection and preparation formula, flowability was decided by using the angle of repose as the indicator, the amount of ethanol and starch was determined, and the loading amount of each capsule was specified through studying the bulk density. The results showed that adding6%of the amount of the extract of the starch to95%ethanol, the amount of which was8%of the amount of the powder, giving uniform granulation and good flowability. No.0capsules were loaded with0.4g each. Based on the above process, three batches of samples were prepared to verify the results of the above process and test samples were provided for quality standard study.During the quality standard study, TLC was used as qualitative method of determining seven medicinal materials in the compound and the identification methods of the materials (excluding Paris polyphylla) were determined; HPLC was used to study the specificity, precision and accuracy of the method for determining the content of Tauro ursodesoxy cholic acid, the main composition of bear bile, and the content of the three test batches ranged from28-29mg/g. Together with the tests of moisture, loading volumes, disintegration, heavy metals, arsenic salt, etc., quality standard draft was developed on the determination results of three batches of samples.On the one hand, research on process and quality of compound bear bile capsules assures the quality of samples for clinical use and makes the statistics of clinical effect more objective; on the other hand, it lays the foundation for further material basis, activity studies and mechanism study.