In this paper, the influence of working electrolyte on high-frequency electrical performance of wet tantalum capacitors is studied. Emphasis is especially put on the study of the contribution of depolariser in reducin...In this paper, the influence of working electrolyte on high-frequency electrical performance of wet tantalum capacitors is studied. Emphasis is especially put on the study of the contribution of depolariser in reducing Equivalent Series Resistance(ESR). According to the theory of depolarization in electrochemistry and the theory of cathode capacitance of electrolytic capacitor, different kinds of depolarisers are added separately into the foregone electrolyte. Then capacitors are assembled with tantalum cores dipped with the compounded electrolytes. The best depolariser and its concentration in the whole electrolyte could be selected according to the test results of the capacitance and ESR of the capacitors. The results of our experiment show that depolariser Fe 2(SO 4) 3 used in working electrolyte of 100 V/100 μF wet tantalum capacitors can help to obtain lower ESR and higher capacitance at frequency from 0.1 kHz to 100 kHz.展开更多
The intravenous formulation of levetiracetam (LEV)has been available in clinical practice worldwide for several years,but not in China.In the present study,we aimed to evaluate the bioequivalence of intravenous and or...The intravenous formulation of levetiracetam (LEV)has been available in clinical practice worldwide for several years,but not in China.In the present study,we aimed to evaluate the bioequivalence of intravenous and oral LEV (tablet), an antiepileptic drug,in healthy Chinese volunteers.Two randomized,single-dose (1500mg),open-label,2-period crossover trials were conducted as follows:study A,15-min infusion;study B,45-min infusion.A total of 22healthy men participated in study A,and 24healthy men and woman were enrolled in study B.In study A,blood samples were collected after termination of each treatment.In study B,samples were collected after oral or after the start of the intravenous administration.Safety and the ratio of intravenous/oral LEV for AUC 0-t and Cmax were evaluated.The 90% confidence intervals of Cmax and AUC0-t ratios for LEV 1500-mg tablets versus 15-min intravenous administration were outside the bioequivalence limits (80.00%-125.00%). For LEV 45-min intravenous administration,bioequivalence versus 1500-mg tablets was within the range for Cmax and AUC 0-t. The most frequently adverse event (AE)was somnolence.A total of eight subjects experienced nine mild AEs in study A, and 19subjects experienced 29mild AEs in study B.Intravenous infusions (15 and 45 min)of 1500-mg LEV were as well tolerated as the oral tablet.Bioequivalence was demonstrated by 45-min infusions.Therefore,direct conversion from oral to intravenous LEV 1500 mg (45-min infusion),or vice versa,was possible.展开更多
The Approved Drug Products with Therapeutic Equivalence Evaluations(commonly known as the Orange Book)includes the products approved by Food and Drug Administration(FDA)to be marketed in the USA,and it is an essential...The Approved Drug Products with Therapeutic Equivalence Evaluations(commonly known as the Orange Book)includes the products approved by Food and Drug Administration(FDA)to be marketed in the USA,and it is an essential source for the selection of suitable reference listed drugs(RLD)for a chemical generic medicinal product.The Orange Book assigns a therapeutic equivalence(TE)evaluation code for approved multisource prescription drug products to serve as public information in the area of medicinal product selection.In the present study,we introduced the TE coding system and its influence on the selection of the RLD in China by taking the Topiramate Extended-release Capsules as an example.As a result,it was suggested to determine its TE evaluation code in the Orange Book previously when we choose an RLD and select suitable RLD the first letter of whose TE evaluation code is A to carry out the research and development of a generic medicinal product,which can improve the probability of success of clinical bioequivalence(BE)test and reduce the risk of generic medicinal product development.展开更多
文摘In this paper, the influence of working electrolyte on high-frequency electrical performance of wet tantalum capacitors is studied. Emphasis is especially put on the study of the contribution of depolariser in reducing Equivalent Series Resistance(ESR). According to the theory of depolarization in electrochemistry and the theory of cathode capacitance of electrolytic capacitor, different kinds of depolarisers are added separately into the foregone electrolyte. Then capacitors are assembled with tantalum cores dipped with the compounded electrolytes. The best depolariser and its concentration in the whole electrolyte could be selected according to the test results of the capacitance and ESR of the capacitors. The results of our experiment show that depolariser Fe 2(SO 4) 3 used in working electrolyte of 100 V/100 μF wet tantalum capacitors can help to obtain lower ESR and higher capacitance at frequency from 0.1 kHz to 100 kHz.
文摘The intravenous formulation of levetiracetam (LEV)has been available in clinical practice worldwide for several years,but not in China.In the present study,we aimed to evaluate the bioequivalence of intravenous and oral LEV (tablet), an antiepileptic drug,in healthy Chinese volunteers.Two randomized,single-dose (1500mg),open-label,2-period crossover trials were conducted as follows:study A,15-min infusion;study B,45-min infusion.A total of 22healthy men participated in study A,and 24healthy men and woman were enrolled in study B.In study A,blood samples were collected after termination of each treatment.In study B,samples were collected after oral or after the start of the intravenous administration.Safety and the ratio of intravenous/oral LEV for AUC 0-t and Cmax were evaluated.The 90% confidence intervals of Cmax and AUC0-t ratios for LEV 1500-mg tablets versus 15-min intravenous administration were outside the bioequivalence limits (80.00%-125.00%). For LEV 45-min intravenous administration,bioequivalence versus 1500-mg tablets was within the range for Cmax and AUC 0-t. The most frequently adverse event (AE)was somnolence.A total of eight subjects experienced nine mild AEs in study A, and 19subjects experienced 29mild AEs in study B.Intravenous infusions (15 and 45 min)of 1500-mg LEV were as well tolerated as the oral tablet.Bioequivalence was demonstrated by 45-min infusions.Therefore,direct conversion from oral to intravenous LEV 1500 mg (45-min infusion),or vice versa,was possible.
基金Carry out quality evaluation research of generic medicinal product control based on domestic product,NMPA Key Laboratory for Quality Research and Evaluation of Chemical Drugs,Beijing,China。
文摘The Approved Drug Products with Therapeutic Equivalence Evaluations(commonly known as the Orange Book)includes the products approved by Food and Drug Administration(FDA)to be marketed in the USA,and it is an essential source for the selection of suitable reference listed drugs(RLD)for a chemical generic medicinal product.The Orange Book assigns a therapeutic equivalence(TE)evaluation code for approved multisource prescription drug products to serve as public information in the area of medicinal product selection.In the present study,we introduced the TE coding system and its influence on the selection of the RLD in China by taking the Topiramate Extended-release Capsules as an example.As a result,it was suggested to determine its TE evaluation code in the Orange Book previously when we choose an RLD and select suitable RLD the first letter of whose TE evaluation code is A to carry out the research and development of a generic medicinal product,which can improve the probability of success of clinical bioequivalence(BE)test and reduce the risk of generic medicinal product development.
