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• 2013 Volume 44 Issue 9
  Published: 10 September 2013

    

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  Preparation and in vitro Anti-tumor Activity of Doxorubicin Liposomes Decorated with RGD Peptide

  WEI Lin1, ZHOU Youxia2, CHENG Lifang1, CHENG Liang1, CHEN Dawei1,2*

  2013, 44(9): 892-896.

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  The cholesterol-polyethylene glycol-RGD (CHOL-PEG 2000-RGD) was successfully synthesized and its structure was confirmed by 1H NMR. The doxorubicin liposomes prepared by pH-gradient method were modifiedwith CHOL-PEG 2000-RGD as the ligand by post-insertion method. The mean particle size, ζ potential and encapsulation efficiency of the product were (122.5±2.8)nm, (-18.35±0.78)mV and (95.23±1.14)％, respectively. The observation of transmission electron microscope showed that the product was nanometer-sized spherical particles. The results of in vitro cytotoxicity study against B16 cells showed the IC50 values of the bulk drug, doxorubicin liposomes and RGD modified doxorubicin liposomes were 0.264, 0.191 and 0.106 μg/ml, respectively. And the blank liposomes decorated with CHOLPEG 2000-RGD had no significant inhibition effect.
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  Preparation and Properties of Curcumin-PLA Composite Membranes

  GUO Hui, WU Jihong*

  2013, 44(9): 896-899.

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  The biodegradable composite membranes of curcumin with the content of 0.8％ or 1％ were prepared by casting and solvent evaporation method with different contents (6％, 10％ and 15％) of polylactic acid (PLA) as the carrier. The morphology, infrared spectrum, porosity and mechanical property of the prepared composite membranes were investigated. The effects of PLA content and curcumin content on in vitro release were also discussed. The results showed that the release rate decreased with the increasing of PLA content and increased with the increasing of drug content.Compared with the curcumin powder, the prepared composite membranes demonstrated a sustained-release property.
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  Preparation and in vitro-in vivo Evaluation of Choline Fenofibrate Sustained-release Tablets

  LU Bushi1, HOU Jingwen1,2, ZHOU Lixin1, WANG Jing1, DONG Xuan1

  2013, 44(9): 900-903.

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  The choline fenofibrate sustained-release tablets were prepared with HPMC K4M as the gel matrix.The in vitro release behaviors of the product and the reference capsules (Trilipix) in pH 3.5, 6.0 and 6.8 phosphate buffer (PBS) and water were determined. The similarity factor (f2) was calculated to evaluate the similarity of the two preparations. The results showed that the cumulative release of the product at 2 h in pH 3.5 PBS was below 10％. While in other three media, the release behavior curves of the product were similar with the reference capsules because the f2 values were all above 50. The results of pharmacokinetics in Beagle dogs showed that the product was bioequivalent to the reference capsules.
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  Removing of Residual Monomers in Poly(lactic-co-glycolic acid)

  ZHANG Xiaohong1, YANG Li2, LUAN Hansen2, CAI Guoqiang1

  2013, 44(9): 904-906.

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  The poly(lactic-co-glycolic acid) (PLGA) was dissolved in dichloromethane, then the solution was treated by extraction method with diluted hydrochloric acid or precipitation method with ethanol as precipitation agent to remove the residual monomers in PLGA. The residual monomer contents of glycolide and lactide in PLGA treated by these methods were determined by GC. The results showed the effects of the two methods were both better than vacuumheating,
  and the diluted acid extraction method was better than precipitation method, but PLGA would be degraded by the dilute hydrochloric acid. Therefore, the precipitation method was more suitable.
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  Preparation and Anti-inflammatory Activity of Protopine Solid Lipid Nanoparticles

  Lü Yanxia1, MAO Shujun2, SUI Peng3

  2013, 44(9): 911-913.

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  The protopine solid lipid nanoparticles with different formulations for transdermal delivery were prepared by melt dispersion technique. The results showed that the particle size of the product prepared with glyceryl tristearate as lipid material and soybean phospholipid as emulsifier was the smallest [(126.2±1.7)nm] and its encapsulation efficiency was the highest (92.7％). The in vitro cumulative permeation amount at 12 h of the product was 78.5％, which was significantly higher than that of its solution (32.4％). In addition, it had a stronger effect on adjuvant arthritis rats caused by Freund's complete adjuvant. The anti-inflammatory activity of the product was similar with the Voltaren group.
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  Identification of Involucratolactone, Its β-D-Glucoside and Involucratine in Compound Xuelian Capsules by LC-Q-TOF MS

  JIAN Longhai, WEN Hongliang, SUN Jian, WANG Ke, JI Shen

  2013, 44(9): 914-921.

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  A method of liquid chromatography-quadrupole-time of flight mass spectrometry (LC-Q-TOF MS) was established for the identification of involucratolactone, its β-D-glucoside and involucratine in compound Xuelian capsules. A Zorbax RRHD C18 column was used with the mobile phase of acetonitrile-0.1％ formic acid by gradient elution. Electrospray ionization (ESI) source with positive mode was used in mass spectrometry. Both MS and MS/MS signals were acquired for all the analytes. The identification of involucratolactone, its β-D-glucoside and involucratine in Saussureae involucratae crude drug and compound Xuelian capsules were achieved based on the study of dehydrocostus lactone and proline.
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  Comparison of Two Methods for Determination of Budesonide Aerosol Droplet Distribution

  XU Yuwen1, LIANG Cuirong1, XIE Yuanchao1*, WANG Zhijun 2

  2013, 44(9): 921-924.

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  The droplet distribution of four batches of budesonide aerosol were measured by two stage impactor method in Chinese pharmacopoeia (ChP 2010) and next generation impactor (NGI) method in United States pharmacopoeia (USP 35), respectively. The comparison of the two methods was carried out. The results showed that the consistency of the two methods was basically confirmed. The NGI method could simulate the budesonide aerosol
  deposition in each part of the respiratory tract and the aerodynamic diameter parameters from the NGI method were identical with the data from the real respiratory tract system. In order to control the drug quality, it was necessary to add the test item of droplet distribution measured by NGI method in the quality standard of budesonide aerosol.
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  Determination of Nisoldipine in Rat Plasma after Transdermal Administration by LC-MS

  XIAO Yan, LIN Zhiyi, LIU Jianping*, ZHANG Wenli, WANG Ling

  2013, 44(9): 925-928.

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  A LC-MS method was established for the determination of nisoldipine in rat plasma and the pharmacokinetics of nisoldipine in rats was studied after transdermal administration of a microemulsion-based hydrogel.The electrospray ionization (ESI) was employed and the positive selected ion monitoring (SIM) mode was chosen. The ion combination of m/z 411 and m/z 441 was used to qualify nisoldipine and the internal standard (nimodipine), respectively.
  The method recoveries were 95％ - 102％, with RSDs no more than 5.8％. The extractive recoveries were above 70％. Male SD rats were employed to evaluate the pharmacokinetic behaviors of the microemulsion-based hydrogel after transdemal administration. The pharmacokinetics of the hydrogel and oral suspension were compared. After transdermal administration of the microemulsion-based hydrogel (containing 20 mg nisoldipine), the main pharmacokinetic parameters were as follows:tmax (42.00±6.92)h, cmax (27.53±1.88)ng/ml, AUC0→72 h (1 736.31±106.59)ng·h·ml-1, AUC0→∞ (1 999.66±119.26)ng·h·ml-1,MRT (44.02±0.77)h and t1/2 (7.61±0.70)h.
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  Determination of Alum in Danshi Litong Tablets by ICP-MS

  LI Limin, LU Jiwei, YANG Yingying, WANG Ke, JI Shen*

  2013, 44(9): 929-931.

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  An inductively coupled plasma-mass spectrometry (ICP-MS) method was established for the determination of alum in Danshi Litong tablets. The calibration curve of aluminum was linear in the concentration range of 0 - 1 μg/ml. The RSD was 2.95％. The average recoveries in the blank and in the sample were 105.3％ and 106.0％.
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  Determination of the Related Substances in Latanoprost Eye Drops by NP-HPLC

  PAN Duanjin, CHEN Qiufen, ZHANG Jundong*, LIAN Yunfei, ZHOU Zhiqiang

  2013, 44(9): 932-934.

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  A NP-HPLC method was established for the determination of the related substances in latanoprost eye drops. A Zorbax Rx-SIL column was used with the mobile phase of n-hexane-absolute ethylalcohol (96︰4) at the detection wavelength of 210 nm. Its low limit of detection was 8 ng.
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  Determination of Clindamycin Illegally Adulterated into Cosmetics for Acne Treatment by HPLC-DAD and LC-MS

  PANG Xuebin, YU Yue, QIU Yingheng, WU Xiaoou, LI Qiaomei

  2013, 44(9): 935-937.

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  The HPLC-DAD and LC-MS methods were used to determine clindamycin added illegally in cosmetics for acne treatment. The calibration curve of clindamycin was linear in the concentration range of 0.01 -2 mg/ml. The average recoveries were 96.2％, 98.5％ and 99.1％, with RSDs of 3.0％, 2.1％ and 1.3％. The limited detection concentration was 40 μg/g.
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  Preparation and Quality Evaluation of Oral Soluble Films by Solvent Casting Technique

  CHEN Fang, XIA Yiran, ZHANG Huiping, ZHANG Hua, HOU Huimin

  2013, 44(9): 938-942.

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  Novel laboratory film-forming machine for formulation optimization and small amount of sample preparation and drug film drying machine of scale-up were designed and developed. The voglibose oral soluble films were prepared by solvent casting technique with above two machines. The processing technology from small-scale to scaleup was investigated. The results showed that the films prepared by both laboratory scale and scale-up equipments were
  dissolved within 45 s and the drug was completely released in 3 min. The mechanical properties, content and content uniformity also met the requirements.
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  Effects of Type and Enlargement of Distributor on Hydrodynamics of Expanded Bed and Preliminary Application to Adsorption of Prothrombin Complex Concentrates

  LI Zhixiong1, ZHAO Hongwei1, QIU Jiashan2, HE Qi3, LI Changqing4*

  2013, 44(9): 943-947.

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  The effects of distributor types (including tapered and rocking-type) at 25 mm scale of expanded bed on hydrodynamics were compared under the apparent flow rate of 250 cm/h and sinking height of 15 cm. The results showed that the device with rocking-type distributor had the optimal performance, which axial mixing coefficient (Dax) was 3.8×10-6 m2·s-1. When the rocking-type distributor was enlarged to 100 mm scale, the Dax could also reach 4.8×10-6 m2·s-1. The human plasma prothrombin complex concentrate (PCC) was adsorbed respectively with above two expanded bed with CG-6 resin. The results showed that the adsorption yields of four blood coagulation factors (FⅡ,FⅦ, FⅨ and FⅩ) in PCC were about 90％ and the recoveries by elution were about 70％.
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  Progresses in Sampling Methods for Ocular Pharmacokinetic Studies

  XIE Shuang, CHEN Zhongya, ZHAO Yan, TAO Tao*

  2013, 44(9): 948-953.

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  Ocular pharmacokinetics is a very important part of development of an ophthalmic delivery system.Sampling method is the key point in the study of ocular pharmacokinetics. Based on a literature review, the ocular diseases and novel ophthalmic drug delivery systems are briefly introduced. This paper puts emphasis on the review of different ocular sampling methods and their advantages and disadvantages.
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  Research on the Trends in Clinical Medicine by Analyzing the Hospital Prescriptions

  HAN Zhe1, FAN Huaiping2, LIU Yang3, GAN Rongfu4

  2013, 44(9): 954-958.

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