I. Introduction of film-coating technique; II. Materials: films, pigments and solvents; III. Equipment: Modified coater, Fluidized-bed coater; IV. Formulating solution: Formulating, Calculating amount of solution; V. Types of film: Protective film, Bowel dissoluble film, longer releasing film; IV. Film coating technique using water instead of organic solvent; VII. Testing quality of film coat: Testing polymer and formula, Testing protective, bowel dissoluble and longer releasing film.
Pharmaceutical Preparations ; Meta-Analysis

OBJECTIVETo compare the contents of five anthraquinone components in five different processed products from Rheum palamatum.

METHODThe contents of aleo-emodin, rhein, emodin, chrysophanol and physcion were determined simultaneously by HPLC on plogilent TC-C18 (2) column at 35 degrees C with the methanol-0.1% phosphoric acid (85: 15). The detection wavelength was set at 254 nm and the flow rate was 1.0 mL x min(-1).

RESULTThe obtained linearity of the five components was better over 0.999 9 and the average recoveries were 96.44%, 98.11%, 99.30%, 98.00% and 97.86%, respectively.

CONCLUSIONThe results showed the remarkable variation regulations show in the five different processed products. Compared to the no-parched pieces, the contents of the five anthraquinone components have evidently increased in the braising with liquor and the charring products, and reduced in the vinegar and the liquor sauted pieces.

Anthraquinones ; analysis ; Pharmaceutical Preparations ; analysis ; Rheum ; chemistry

Used second order derivative UV (200-500nm) spectrum to determine the quantity of nimesulid in tablets without through process of deal with sample. Assess linear interval, limit of detection, limit of determine the quantity between level of nimesulid solution and value of second order derivative in interval of study level, degree of accuracy of the method and result of determine the quantity of nimesulid. The result showed that: process of quantitative nimesulid was built. The method was accurate, sensitive, precise, and reproducible and could be applied directly and easily to the pharmaceutical preparations.
Spectrum Analysis ; Pharmaceutical Preparations ; Adjuvants, Pharmaceutic ; tablets

Biological Factors ; analysis ; Drug Monitoring ; Drugs, Chinese Herbal ; analysis ; Humans ; Pharmaceutical Preparations ; analysis ; Technology, Pharmaceutical

Microdialysis (MD), as a living bio-sampling technique, can be utilizable in different tissues,organs or different parts of the same organs, in order to clarify the drug's pharmacokinetics, mechanism, and provide a basis for targeting. This article describes a number of points in recent years, the microdialysis technique in pharmacokinetic studies in the field of application of the status and significant progress.
Animals ; Humans ; Microdialysis ; Pharmaceutical Preparations ; analysis ; Pharmacokinetics ; Tissue Distribution

OBJECTIVETo prepare sustained-release pellets of active components from Ligusticun chuanxiong by coating in the fluid-bed.

METHODThe fast-release pellets were prepared by the extrusion-spheronization process. The coating formulation was optimized with the release of ferulic acid as criteria. The micromeritic properties and drug dissolution behaviors of the prepared pellets were evaluated.

RESULTThe pellets presented perfect sphericity. The obviously sustained-release effects were shown in 12 h. The coating weight gain was the major factor impacting drug release.

CONCLUSIONThe coating pellets show the obviously sustained-release effects.

Coumaric Acids ; analysis ; Delayed-Action Preparations ; Ligusticum ; chemistry ; Technology, Pharmaceutical

An economic evaluation is required in order to apply to the Health Insurance Review and Assessment Service (HIRA) for a listing in the national drug formulary. To assist companies in preparing the necessary documents, HIRA published guidelines for the economic evaluation of pharmaceuticals in 2006. The guidelines are composed of two parts: guidance an explanatory notes. Each guideline reflects the best practice which meets both the theoretical consensus within the academic community and local situations, like data availability. To enhance the transparency of evaluation, guidelines emphasize the reproducibility of data and analysis result. That is, all evaluation processes are required to be described in enough detail to be replicated by reviewers. With growing experience and theoretical development in this area, HIRA guidelines will be revised periodically.
Cost-Benefit Analysis ; Economics, Pharmaceutical/legislation & jurisprudence/*organization & administration ; *Guidelines as Topic ; Humans ; Korea ; Pharmaceutical Preparations/*economics

OBJECTIVETo develop a headspace gas chromatography method for determining dimethyl sulphate residual in granisetron hydrochloride.

METHODSAn Angilent INNOWAX capillary column with nitrogen gas as carrier and FID as detector was applied in this study. Dimethyl sulphate was tested under a constant column temperature.

RESULTDimethyl sulphate had different retention time from other organic solvents such as alcohol,acetoacetate, isopropanol, dichlormethane and chloroform, which might exist in granisetron hydrochloride. The detection limit of dimethyl sulphate;s was 0.0016%.

CONCLUSIONThe method can be used for the determination of dimethyl sulphate residual in granisetron hydrochloride.

Chromatography, Gas ; methods ; Drug Contamination ; prevention & control ; Granisetron ; analysis ; Pharmaceutical Preparations ; analysis ; Sulfuric Acid Esters ; analysis

OBJECTIVETo develop an assay methodology for determination of lumbrukinase potency in Rongshuan capsules.

METHODThe agarose-fibrin plate assay methodology for determination of Lumbrukinase potency in Rongshuan capsules was studied including durability, specificity, linearity range, product's handling method, accuracy , repetitiveness, solution stability, recovery and statistical method. The method of parallel line assay based on quantitative responses in statistical methods for biological assays was used in the statistics of potency assay.

RESULTThe durability and specificity of assay accord with the requirement; The linearity range was 12.5 to approximately 400 U, the RSD of accuracy tests was 3.2%, the RSD of repetitiveness tests was 8.3%, the solution is stable under 4 degrees C for 72 hours, the recovery rate was 97.0% and the RSD of recovery assays was 16.5%.

CONCLUSIONThe agar-fibrin plate assay is rapidly, feasible, simple, convenient and accurate way for determining the Lumbrukinase potency. The method of parallel line assay based on quantitative responses in statistical methods for biological assays can control the error of determination.

Animals ; Biological Assay ; methods ; Capsules ; analysis ; Endopeptidases ; analysis ; Pharmaceutical Preparations ; analysis

This study aims to explore the evaluation model for the proficiency testing of heavy metal and harmful element residues in pharmaceuticals,and to provide reference for the proficiency testing program and proficiency testing result in the field of residue analysis. The proficiency test result of cadmium determination in honeysuckle as an example. The algorithm A,NIQR,and Horwitz function are used to calculate the assigned value and the standard deviation. Z was obtained at the same time. If | Z | ≤2,the result is satisfactory. If 2< | Z | <3,the result is questionable. If | Z | ≥3,the result is unsatisfactory. In addition,the median value is the assigned value,and deviation(D%) is used. If D% is not more than 16%,the result is satisfactory; if D% is more than 16%,the result is unsatisfactory. After analysis,in the results of questionable or dissatisfied laboratories calculated by algorithm A and NIQR,the deviation error of some data is within the scope of the standard. In the results of the satisfactory laboratory evaluated by the Horwitz function,some data deviation errors far exceed the standard range. The evaluation result of the D% meets the requirements. According to heavy metal and harmful element trace analysis methods,this study is the first to apply D% to the evaluation of the detection ability of heavy metals and harmful elements in pharmaceuticals. This method makes the evaluation result more reasonable,and has important reference significance for the evaluation of other proficiency test results.
Cadmium ; analysis ; Laboratories ; Laboratory Proficiency Testing ; Lonicera ; chemistry ; Pharmaceutical Preparations ; standards ; Plant Preparations ; standards ; Trace Elements ; analysis