The Research Of ChuanXiong Volatile Oil Soft Capsule

Cerebrovascular is a series of diseases caused by brain blood circulationdisorders, which characterized by the local neurological deficits with high incidence,high morbidity, high mortality, high recurrence rate and complications. In a sort ofhuman disease cause of death, cerebrovascular has been listed in the top three, so theprevention and treatment with the cerebrovascular have been an important subject incurrent medicine in the world. Ischemic cerebrovascular disease accounts for about70%to80%of all cerebral vascular diseases, it can be prevented the progression ofthe disease and reduce the neurological deficition if rescue the patient with propertherapy in time, thus enhancing the prevention and treatment of ischemiccerebrovascular disease have a very important clinical and social meaning.This study intends to extract the volatile oil with method of the sub-critical CO₂extraction. To keep the active ingredients are safety and effective subject accordingwith the clinical experience of30years and develop the fingerprint and qualitystandards of the volatile oil.The soft capsule’s content is composed by the method ofvegetable oil diluted volatile oil besides added surfactants and cosurfactants ifnecessary. Selected the best prescription by optimizing the ratio of capsule materialsand forming process, developed the fingerprint and quality standards of soft capsule.According to the research of national new drug guiding principles requirements,completed the datements of pharmacology and toxicology experiment. We canexpecet to receive a new drug named ChuanXiong volatile oil soft capsule which canprevent and treat Ischemic cerebrovascular disease to further improve the preventionand treatment of brain storke drug research level.The first part shows taking the yield as evaluation index, we adopt orthogonalexperiment to optimize the best extraction process of steam distillation andsub-critical CO₂extraction technology. The components of steam distillation andsub-critical CO₂extraction volatile oil were identified and compared by using theGC-MS method and NIST mass spectral. A total of40components are discriminatedin the steam distillation and sub-critical CO₂extraction volatile oil which including25kinds of same elements and each of its relative contents of93.97%and91.08%. Thereare9and6different components which account for2.06%and2.97%in each extract technology. The experimental result shows that there is no significant differencebetween steam distillation and sub-critical CO₂extraction volatile oil components. Forthe next step pharmacodynamics research results is necessary to ultimately determinethe extraction technology of volatile oil of Ligusticum Chuanxiong.The second part shows taking pharmacodynamics results as index to determinethe extraction process of volatile oil of Ligusticum Chuanxiong. Cerebralischemia/reperfusion model of middle cerebral artery occlusion was established in ratsusing the suture method. We have demonstrated that comparing by control group thevolatile oil which was extracted by vapor extraction and sub-critical CO₂extractionmeasures has protection effects on Ischemia and reperfusion injury obviously. Thevolatile oil which extracted by sub-critical CO₂extraction measure has betterprotection effects. Therefore, we chosen sub-critical CO₂extraction measure in thisresearch.The third part is to improve the delayed disintegration of soft capsules withprolong of storage time, we have investigated the container of soft capsules andprescription of capsule materials as well as preparation factors. We evaluated thecross-linking degree of gelatin used single factor investigated method which takingthe equilibrium swelling degree as an indicator to identified the formulation andprocess soft capsules. The container of soft capsules is soybean oil: volatile oil （4:3）and the formulation of capsule material is gelatin: glycerol: water: titanium dioxide:fumarate（1:0.4:1:0.005:0.01） which provided material basis to meet the qualityrequirements of ChuanXiong volatile oil soft capsule.The fourth part is chosen Ligustilide as examine item to study and formulate thequality criteria of ChuanXiong volatile oil soft capsules. In the TLC identification，thesample displayed the same spots as ligustilide standard sample shows while the blanksample did not which demonstrated that the specialization is good. In thedetermination test, ligustilide concentration presented a good linear range of0.01-0.5（mg/ml）,Y=1.3832X+0.0299,R2=0.9941.The RSD of precision andrepeatability as well as the average recovery results fulfill its quality standard. Thecontent of ligustilide in each soft capsule is no less than0.075gram per granule.In the fifth part, we carry out preliminary stability of the preparation byaccording to stability test requests for the new Chinese traditional medicine. The examining result of three batches of samples showed that the contentuniformity10ï¼…and that the disintegration time was in30minutes．Throughinspection on preliminary stability of this product for12months, the character,identification, disintegration time, content, determination were no great change．...