ABSTRACT
The optimal process conditions for preparing icariin nanosuspension(ICA-NS) and lyophilized powder were determined to initially investigate their stability and characterize the prepared nanosuspension. The anti-solvent precipitation-high shear method was used in the experiment, and the particle size(size), polydispersity index(PDI), and sedimentation ratio(H_0/H) were used as indicators to determine the optimal process conditions of ICA-NS by single-factor test method. Lyophilized powder of nanosuspension was prepared by freeze-drying method, and its crystalline morphology was observed by transmission electron microscope. The equilibrium solubility of icariin, nanosuspension and lyophilized powder was determined by shake flask method and their stability was initially investigated. The crystal structure of nano-lyophilized powder was characterized by differential scanning calorimetry(DSC) and X-ray powder diffraction(XRD). Finally, the dissolution in vitro of nano-lyophilized powder was determined by the small cup method to prepare the ideal icariin nanoparticles. Soy lecithin(SPC) was used as the main stabilizer and povidone was used as the steric stabilizer. The prepared ICA-NS was nearly round in shape, uniform in size, and stable at room temperature. The average particle size was(62.51±7.11) nm. The drug loading was 16% and the solubility was 50 times higher than that of the original drug. Drugs in suspension and lyophilized powder were dispersed in nanoparticles in an amorphous state. The in vitro dissolution experiments showed that the cumulative release rate of nano-lyophilized powder reached 100% at 10 min, indicating that the dissolution rate of lyophilized powder was significantly increased after preparing into nano-lyophilized powder. Preparation of ICA-NS lyophilized powder by antisolvent precipitation-high shear method is simple, easy to operate, and can significantly improve its water solubility. However, the process conditions have some influence on its stability, which needs further study.
Subject(s)
Nanoparticles , Biological Availability , Flavonoids , Particle Size , Powders , Solubility , Suspensions , X-Ray DiffractionABSTRACT
Objective To investigate the influence of TCM Xueshuantong Injection on the clinical benefit and risk factors; To promote rational medication. Methods HIS system of Gansu Province Hospital of Traditional Chinese Medicine was used, and the medical records and information of patients who used Xueshuantong Injection from August 1st,2015 to August 1st,2016 were selected,including patient information, medicine information, and medicine application information. SPSS19.0 software statistics was used for rational analysis on the clinical application of Xueshuantong;two-class Logistic regression analysis was used to look for adverse reactions related factors. Results Totally 1229 patients with 10 974 medical records were included in the study. Irrational use of medicine was mainly for inappropriate indications (accounted for 21.11%), time of unreasonable administration (accounted for 1.87%), and too large dosage (accounted for 0.9%). Regression analysis showed: 1. Patients with history of allergies to food, medicine, and other substances, increased the risk of adverse reactions 8.725 times after application of Xueshuantong Injection; 2. The medicine combination increased the risk of adverse reaction of Xueshuantong Injection 1.799 times; 3. Medicine combination with Xiaozhong Zhitong Mixture, Jianwei Xiaoshi Mixture, ossotide injection, cobamamide, dextran injection, polyene lipid phosphoryl acid choline injection, and glucosamine hydrochloride tablets, may have potential risk factors for adverse reaction of Xueshuantong Injection. Conclusion Clinical irrational medicine use factors of Xueshuantong Injection mainly manifest in the indications are not suitable, the dosage of the drug medicine is too large and the course of treatment is too long. Adverse reactions occur mainly in patients with allergic history,combination of medication and large dosage.
ABSTRACT
Objective To analyze the rationality of the combined application prescriptions of traditional Chinese and Western medicine; To discuss the problems in the evaluation of the combined application of traditional Chinese and Western Medicine. Methods A total of 12 issue monthly outpatient combination application prescriptions of traditional Chinese and Western medicine were randomly selected in Gansu Provincial Hospital of Traditional Chinese Medicine (Here in after referred to as "this hospital"). According to the relevant laws and regulations, evaluation rules of the combined application traditional Chinese and Western medicine was developed, reviewed and statistically summarized. Results Totally 1900 prescriptions were sampled in the study and accounted for 8.67% in all prescriptions (including prescription of traditional Chinese herbal medicine) and accounted for 20.87% of all prescription of pure Western medicine and pure traditional Chinese patent medicine in the same period, which meet the requirements of sampling rate. Prescriptions of department of orthopedics accounted for the majority. The average number of drugs and the average amount of each prescription of department of orthopedics were lower than the overall average. The sample consisted of 1852 patients, 796 males and 1056 females. Middle-aged patients (36-60 years old) of combined medication were up to 49.46% of the total number of patients. 3990 terms of diagnosis were involved, including 1908 terms of traditional Chinese medicine diagnosis and 2082 terms of Western medicine diagnosis. Orthopedics disease diagnosis accounted for more than 50%. The main problems of the combined application of traditional Chinese and Western medicine were the non syndrome differeentiationg use of medicine, inappropriate usage and dosage, and the lack of attention to medicine interactions. Conclusion The combined application prescriptions of traditional Chinese and Western medicine of this hospital account for a small proportion. Prescription structure adapts with the size of the department, patient age and disease diagnosis. In the future, the prescription evaluation and intervention of syndrome differeentiationg application and dosage and medicine interaction should be strengthened.
