OBJECTIVE:To promote the international drug registration for Chinese pharmaceutical enterprises.METHODS:Based on the requirements on drug registration in Europe and the USA,we expounded the validation on analytical procedures and put forward some concrete methods.RESULT & CONCLUSION:Validation of analytical procedures plays an important role both in quality control and international drug registrations,to which Chinese enterprises should given great attention.

OBJECTIVE:To study the change of the content of ginsenosides in the decoction of Panax ginseng and Veratrum nigrum and to find out the change regularity of chemical components in the compatibility of P. ginseng and V. nigrum so as to introduce the mechanism of "P. ginseng and V. nigrum are incompatible with each other" which derives from compatibility theory of Traditional Chinese Medicine. METHODS:HPLC was adopted to determine the content of ginsenoside in decoction derived from the combination of P. ginseng with different amounts of V. nigrum,and colorimetry was applied to determine the content of the total ginsenosides in herbal esidues. RESULTS:The content of the total ginsenosides decreased in the decoction as long as the content of V. nigrum increased. Nevertheless,the content of ginsenosides didn't change as amount of V. nigrum increased. CONCLUSION:It is reasonable to some extent that ginseng and veratrum nigrum are incompatible with each other. With the amount of V. nigrum increasing,the decrease of the total ginsenosides content doesn't result from some components in V. nigrum inhibiting the dissolution of ginsenoside in water solution but result from some components in V. nigrum reacting with ginsenoside leading to the reduction of ginsenoside.

Objective To connect with provincial or even national report center for adverse events of medical instruments and set up a computer-aided system for supervision.Methods By designing software,setting up database and online connecting with report center,the computer-aided system for adverse events of medical instruments was utilized to automatic report,early-warning monitoring and report.Key technologies were analyzed.Results Based on computer network,adverse events of medical instruments were automatically reported,collected and managed.Information and consultation could be provided rapidly without error.Conclusion The system not only facilitates management department in medical instruments managing,producing and application,but set a theoretic basis for development and academic teaching of new medical instruments.

Objective To develop a medical tilting-table for recovery training of paralysis patients (including paraplegia, hemiplegia and quadriplegia). Methods Renesas 16-bit microcontroller, R8C/25, was used as controller. Danish Linak31 was used to drive the bed. Nixie tube was used to display prescription, angle of tilting table, treating time and music list. Results It worked stable with well-controlled angle. The error was only 1?. The display of nixie tube was good and stable. MP3 played well. Back-up power could provide power supply timely and stably in power failure. Conclusion Medical tilting-table has been successfully applied in clinic.

Objective　To study the factors effecting the formation of the ventricular aneurysm post myocardial infarction (MI) and evaluate the diagnostic methods.Methods　23 MI patients with ventricular aneurysm confirmed by left ventricular angiography were observed for electrocardiogram (ECG), echocardiogram (ECHO), coronary disease and collateral vessels formation. Results　All patients had LAD disease, 65.2% patients had three coronary disease, and those with class Ⅲ collateral vessels circulation only 17.4%. Compared to ECHO by which only 4 patients were found aneurysm, the positive rate by ECG was 82.6%. Conclusion　Patients with multiple coronary disease and without enough collateral vessels are expected to form ventricular aneurysm. ECG is more sensitive than ECHO for diagnosis of ventricular aneurysm post MI

OBJECTIVE: To provide references for domestic drug manufacturing enterprises' participation in laboratory accreditation as well as the enhancing of drug analysis capability. METHODS: Both international and domestic laboratory-ratified standards, the importance of laboratory accreditation and drug manufacturing enterprises' participation in laboratory accreditation were expounded. RESULTS & CONCLUSIONS: Domestic drug manufacturing enterprises' participation in laboratory accreditation is conducive to the enhancing of their drug analysis capability.

OBJECTIVE:To provide references for Chinese pharmaceutical enterprises in developing commissioning manufacture of overseas drugs.METHODS:The registration system of medicine commissioning manufacture in China,Japan and other countries were compared.The current status of Chinese drugs commissioning manufacture and the feasibility for Chinese pharmaceutical enterprises to gain commissioning manufacture of overseas drugs were analyzed.RESULTS & CONCLUSIONS:Both the government and pharmaceutical enterprises in China should take advantage of the amendment of the pharmaceutical affairs Law in Japan to contribute to the development of commissioning manufacture of overseas drugs.

Agriculture ; Female ; Humans ; Male ; Occupational Exposure ; Occupational Health ; Risk Factors

OBJECTIVE:To provide practical ideas and methods for facilitating the entry of traditional Chinese medicine into the international markets.METHODS:The favorable conditions and unfavorable factors for the traditional Chinese medicine entering into the international markets were studied extensively and thoroughly and contrasted analytically.RE?SULTS&CONCLUSION:Management on production and quality of the traditional Chinese medicine should be strengthened in China;laws and regulations on traditional Chinese medicine products of each country should be studied with great attention.Considering the condition and characteristics of our products,our country should find a suitable location in the international market and shoot the arrow at the target.The concerned parties should concentrate on the research and development of tra?ditional Chinese medicine and facilitate the entry of which into the international market by drawing assistance from the spreading of traditional Chinese medicine.