Decision No 322/BYT-Q§ of Ministry of Health dated February 28, 1997 about the regulative promulgation "the information, publicity of cosmetics, drug for human". Since these were promulgated, the management of drug, cosmetic information and publicity were more and the better, which contribute to the guide for people about using drug safely and rational.
Pharmaceutical Preparations ; Organization and Administration

By the method of capillary electrophresis with MEKC technique on the preparation without processing of samples such as celebrex, zycel. The procedure of quantifisation of celebroxib was established. Statintrics results found that after 6 times of electrophresis the Corr Area ratio between celebroxib and our standards gave RSD ≤ 3% and t/t is ≤ 2%. Thus the procedure altained systematic compatibility for quantifying the preparation. The method had high sensitivity and selectivity. The results was precis and repeatable
Pharmaceutical Preparations/administration & dosage ; Methods ; Electrophoresis

OBJECTIVETo prepare sinomenine hydrochloride delayed-onset sustained-release tablets.

METHODThe tablets containing sinomenine hydrochloride were prepared by dry-compression coating technique with the ratio of HPMC in core tablet and the ratio of HPMC in coating film as the influence factors and the lag-time and release rate as the evaluation parameters. Experiments were done on the central composite design, the data were simulated by using multi-linear equation and second-order polynomial equation. The possibly optimal formulation was predicted by response surface method. The dissolution date (lag-time and release rate) of the tablets prepared under the optimum condition were compared with the predicted. The drug released mechanism of the tablet were studied by Model-fitted of drug released within 6-15 h with zero-order, Higuchi and Peppas equation, respectively.

RESULTThe lag-time and release rate were simulated using second-order polynomial equation, regression coefficients of the two parameters were 0.9901 and 0.9876, respectively. Bias between the observed and predicted values of lag-time and release rate were -3.15% and -0.34%, respectively. The lag-time of the tablet prepared under the optimum condition in vitro was about 6 h, then drug released from the tablet within 6-15 h was found to conform to zero-order kinetics and was controlled by bulk erosion mechanism.

CONCLUSIONSinomenine hydrochloride delayed-onset sustained-release tablets release drug slowly after lag time. The models developed in this study are proved to be highly predictable.

Chemistry, Pharmaceutical ; Delayed-Action Preparations ; administration & dosage ; Drug Delivery Systems ; methods ; Excipients ; administration & dosage ; Morphinans ; administration & dosage ; Pharmaceutical Preparations ; administration & dosage ; Tablets ; administration & dosage ; Technology, Pharmaceutical

Microwaves can be directly transformed into heat inside materials because of their ability of penetrating into any substance. The degree that materials are heated depends on their dielectric properties. Materials with high dielectric loss are more easily to reach a resonant state by microwaves field, then microwaves can be absorbed efficiently. Microwave irradiation technique with the unique heating mechanisms could induce drug-polymer interaction and change the properties of dissolution. Many benefits such as improving product quality, increasing energy efficiency and reducing times can be obtained by microwaves. This paper summarized characteristics of the microwave irradiation technique, new preparation techniques and formulation process in pharmaceutical industry by microwave irradiation technology. The microwave technology provides a new clue for heating and drying in the field of pharmaceutics.
Chemistry, Pharmaceutical ; methods ; Drug Discovery ; instrumentation ; methods ; Microwaves ; Pharmaceutical Preparations ; administration & dosage ; chemistry ; Technology, Pharmaceutical ; methods

Crystallization has been widely applied in pharmaceutical formulations as an effective approach to improve the stability and efficacy of small agents. However protein crystals are suffered from limitation in the drug delivery system due to their complex crystallization behaviors. With development of crystallization technologies and their industrial application, protein crystals are receiving more and more attentions as a novel delivery system for biomacromolecules. Crystals with thermodynamic stable structure can improve the physical and chemical stability of protein drugs and present a sustained release behavior. On the basis of pertinent literatures, this review introduces the recent research situation and development process of protein crystals as drug delivery system. Moreover, the crystallization process of proteins, as well as the preparation and potential application are discussed systematically.
Crystallization ; Drug Delivery Systems ; Pharmaceutical Preparations ; administration & dosage ; Proteins ; chemistry

Through the analysis of the current drug testing market, this paper discussion the meeting of creating "Drug Testing in China" brand on the concept of scientific testing.
China ; Drug Industry ; organization & administration ; Pharmaceutical Preparations ; Pharmaceutical Services ; organization & administration ; Quality Control

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

Drugs, Chinese Herbal ; administration & dosage ; standards ; Humans ; Injections, Intravenous ; Pharmaceutical Preparations ; administration & dosage ; standards ; Quality Control

Since the positive listing system for prescription drug reimbursement has been introduced in Korea, the number of pharmacoeconomic evaluation studies has increased. However it is not clear if the quality of pharmacoeconomic evaluation study has improved. Due to the lack of randomized clinical studies in Korean health care setting, Korean economic evaluation studies have typically integrated the local cost data and foreign clinical data. Therefore methodological issues can be raised in regard to data coherence and consistency. But the quality of data was not questiened and the potential bias has not been investigated yet. Even though changes in policy have encouraged the undertaking of pharmacoeconomic evaluations, there is few public-side funding for validation study of cost-effectiveness models and data. Several companies perform economic evaluation studies to be submitted on behalf of their own products, but do not want the study results to be disclosed to the academic community or public. To improve the present conduct of pharmacoeconomic evaluations in Korea, various funding sources need to be developed, and, like other multidisciplinary areas, the experts in different fields of study should collaborate to ensure the validity and credibility of pharmacoeconomic evaluations.
Cost-Benefit Analysis ; Economics, Pharmaceutical/legislation & jurisprudence/*organization & administration ; Formularies as Topic ; Humans ; Korea ; Pharmaceutical Preparations/*economics ; Technology Assessment, Biomedical

To curb a rapid increase in expenditures for pharmaceuticals, the Korean government introduced a positive list system and a negotiation process for drug prices at the end of 2006. Economic evaluation of pharmaceuticals has begun to have a pivotal role in the listing and pricing of drugs for the Korean National Health Insurance. There are some points to discuss regarding the use of economic evaluation in the listing and pricing in the context of the Korean system. First, the listing and pricing processes have been fragmented, evoking complaints from pharmaceutical companies and delaying the access of new drugs to patients. Second, there is a concern that the positive list system may limit the range and availability of drugs for patients to choose for treatment. Third, the time schedule for de-listing of existing drugs may not be realistic. Fourth, it is not always easy to provide reliable evidence of cost-effectiveness due to a lack of materials. Fifth, there is no consensus on the range of the ICER (incremental cost-effectiveness ratio) acceptable to the Korean society. In conclusion, in the near future, it will be necessary to evaluate the achievements that the economic evaluation has provided to the Korean society.
Cost-Benefit Analysis ; Economics, Pharmaceutical/legislation & jurisprudence/*organization & administration ; Formularies as Topic ; Humans ; Korea ; Legislation, Drug ; Pharmaceutical Preparations/*economics