Preparation and quality evaluation of orodispersible film containing ginkgolide B novel nanosuspension lyophilized powder / 中国中药杂志

To prepare a new dosage form that can improve the drug loading of the film--ginkgolide B nanosuspension lyophilized powder orodispersible film(GB-NS-LP-ODF) and to evaluate its quality. Firstly, ginkgolide B nanosuspension(GB-NS) was prepared by media milling method, and then ginkgolide B nanosuspension lyophilized powder(GB-NS-LP) was prepared with freeze-drying method. The mannitol was used as lyoprotectant and its dosage was also investigated. GB-NS-LP-ODF was prepared by solvent casting method and its formulation was screened by single factor test method and optimized by orthogonal test. The appearance, mechanical properties, content uniformity and in vitro dissolution of the optimized GB-NS-LP-ODF were investigated. The particle size of prepared GB-NS was about 201 nm, and the optimal dosage of mannitol was 8%. According to the optimal formula, the GB-NS-LP-ODF was prepared with GB-NS-LP 35.6%, PVA 0588 49.4%, PEG 400 10.7% and CMS-Na 4.3%, and completely disintegrated in about 30 s, and the particle size of reconstituted GB nanoparticles from ODF was about 210 nm. The film with smooth appearance and good mechanical properties was stable within 30 days and the content uniformity(A+2.2 S<15) conformed to the regulations. Scanning electron microscope(SEM) showed that GB-NS-LP-ODFs were evenly distributed and the particle size was about 200 nm. X-rays diffraction(XRD) showed that its crystallinity was significantly lower than that of GB raw drug and GB-ODF. The results of in vitro release test showed that the drug film was completely dissoluted within 10 minutes. These results indicated that nanosuspension lyophilized powder was prepared by freeze drying of nanosuspensions, and then loaded into the orodispersible film to effectively increase the drug loading of the ODF and have broad application prospects.

Analysis of Drug-Induced Liver Injury in Clinical Pathway on Patients with Breast Cancer and Colorectal Cancer / 中国药学杂志

OBJECTIVE: To investigate drug-induced liver injury(DILI) in clinical pathway on patients with breast cancer and colorectal cancer and to explore whether the prophylactic use of hepatoprotective drugs can be included in the clinical pathway. METHODS: Two hundred and five cases from January 2015 to March 2017 were selected. The patients were divided into two groups according to the prophylactic use of hepatoprotective drug. The incidence, time, severity and outcome of DILI, prophylactic use of hepatoprotective drugs were investigated. DILI related risk factors were screened and analyzed by logistic linear regression to discuss the necessity and opportunity of prophylactic use of hepatoprotective drugs. RESULTS: Forty-three(20.98%) patients without DILI had prophylactic use of hepatoprotective drugs in 205 cases. The incidence of DILI in the non-prophylactic group was 4.88%. Both two groups hadn't occurred DILI during the first and second cycles of chemotherapy. However, there was a statistically significant difference in the rate of DILI between the prophylactic and non-prophylactic use of hepatoprotective drugs groups in the third cycles of chemotherapy(P<0.05). Multifactor analysis showed that prophylactic use of hepatoprotective drugs was a protective factor for the DILI. CONCLUSION: The liver function should be reinforced during the first and second cycles of chemotherapy. The hepatoprotective drugs could be used prophylactically before the next period of chemotherapy if patient with abnormal liver function.

Risk control system construction of Shenfu injection / 中国中药杂志

<p><b>OBJECTIVE</b>To ensure the stable quality of Shenfu injection, control potential risk and reduce risk damage.</p><p><b>METHOD</b>To screen and evaluate the risk in the production, GAP, research and development, circulation, clinical application, intellectual property, emergency treatment,control and prevente the potential risks.</p><p><b>RESULT</b>The risk-control system of Shenfu injection has been constructed initially.</p><p><b>CONCLUSION</b>It has a great significance for the establishment of traditional Chinese medicive injections' risk-control system. The keys of the risk-control in future are to make strategy, perfect the organization structure and collaborating among various departments.</p>

Studies on stability of chlorogenic acid in extract of Flos lonicerae / 中国中药杂志

<p><b>OBJECTIVE</b>To investigate the stability of chlorogenic acid in extract of flos lonicerae in different conditions.</p><p><b>METHOD</b>The stability of chlorogenic acid in extract of flos lonicerae in phosptat buffe with different pH values, methanol, ethanol and different base solutions(Ca(OH)2 and NaOH) was investigated by the classical isothermal method.</p><p><b>RESULT</b>The experiments showed the chlorogenic acid in extract of flos lonicerae was more stable in acidic water than in basic water. It was stable in these organic solutions and base solution[Ca(OH)2].</p><p><b>CONCLUSION</b>In different conditions, the stability of chlorogenic acid in extract of flos lonicerae was different. It provided a reference to the extraction and analysis of chlorogenic acid and production of chlorogenic acid preparation.</p>