• 약학회지
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• 제55권1호
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• pp.45-48
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• 2011

Traditional medicines usually use combinational formula that are prepared by mixing different varieties of medicinal herbs and boiling them in water to yield a decoction. In recent years a modified method has been proposed and practiced wherein the individual herbs are boiled with water separately and later these extracts are mixed together for use. We attempted to evaluate their equivalence in terms of its polyphenol contents and DPPH radical scavenging activity. The polyphenol contents as well as the DPPH radical scavenging activities were very similar to each other.

• Journal of Pharmaceutical Investigation
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• 제34권3호
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• pp.223-228
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• 2004

A new medical system was started in Korea in 2000 and pharmaceutical affairs law was revised in 2001. According to the revised law, generic substitution is permitted only to the drug products which are proven to be bioequivalent to the reference listed drugs. To expand the list of bioequivalence-proven drug products and to ensure the credibility of the therapeutic equivalence of generic drug are the hot issues in Korea. Also, the KFDA has a plan to revise the pharmaceutical affairs law that bioequivalence reports of all the generic prescription drug products should be submitted to the KFDA for drug approval after July in 2004. Therefore, it is increasing the necessity to develop the bioequivalence-demonstrating methods for specific drug substances and preparations which require to conduct food-effect bioavailability or bioequivalence study. There are some differences between US and Japanese guidances of food-effect bioavailability and bioequivalence studies. In this paper, we examined the recently published US guidance about food-effect study and it will be a reference to make our own guidance about food-effect bioavailability and bioequivalence guidances in Korea.

• Journal of Pharmaceutical Investigation
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• 제34권4호
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• pp.333-340
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• 2004

A new medical system of separation of dispensary from medical practice was started in 2000 in Korea. To expand bioequivalence-proven drug products and to ensure the credibility of the therapeutic equivalence of generic drug are hot issues in Korea. The KFDA also has a plan to revise the pharmaceutical affairs law that bioequivalence reports of all the generic prescription drugs should be submitted to the KFDA in the application for drug approval. Therefore, it becomes more necessary to develop bioequivalence-demonstrating methods for specific preparations such as topical drug products. There are some differences between US and Japanese guidances of bioequivalence studies of generic drug products for topical use. In this paper, we examined the recently published Japanese guideline, Guideline for Bioequivalence Studies of Generic Products For Topical Uses, and Q&A of the guideline, which will be references to make a guidance on bioequivalence studies of topical drug products in Korea.

• 한국임상약학회지
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• 제15권2호
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• pp.82-88
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• 2005

A new medical system was started in Korea in 2000 and pharmaceutical affairs law was revised in 2001. According to the revised law, generic substitution is permitted only to therapeutically equivalent generic product. Bioequivalence studies are usually used to demonstrate therapeutic equivalence between reference listed drugs and generic drugs. The issues that are recently heating up in Korea are to increase bioequivalent drug products and at the same time to ensure the credibility of the therapeutic equivalence of generic drugs. Sometimes food can change the bioavailability (BA) of a drug and influence the bioequivalence (BE) between test and reference products as well. Food effects on BA can have clinically significant consequences. Food can alter BA by various means including delaying gastric emptying, stimulating bile flow and changing gastointestinal pH. This paper provides the recently published Korean guideline on food-effect BA and fed BE studies.

• 한국자원식물학회:학술대회논문집
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• 한국자원식물학회 2020년도 추계국제학술대회
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• pp.80-80
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• 2020

Glycyrrhizae Radix (GR), commomly known as liquorice, is a medicinal and edible plant widely used in East Asia with its pharmacological properties. Currently, Glycyrrhiza uralensis, G. glabra and G. inflata are used for pharmaceutical purposes in Korea and then the improved Glycyrrhiza varieties, WON-GAM (WG) has been developed by Korea Rural Development Administration. To evaluate equivalence of efficacy, several comparative studies between already-registered species and new cultivars have been conducted. To evaluate equivalence of efficacy, several comparative studies between already-registered species and new cultivars have been conducted. The aim of this study was to evaluate the effect of WG on fecal microbiota in DSS-induced colitis model. Fecal microbiota was analyzed by terminal restriction fragment length polymorphism (T-RFLP). The composition of the fecal microbiota did not show a specific pattern based on experimental groups; however, a tendency toward an increase in the proportion of Lactobacillales was observed. Glycyrrhiza varieties could change composition of fecal microbiota in DSS-induced colitis model. This work was carried out with the support of "Cooperative Research Program for Agriculture Science and Technology Development (Project No. PJ014246022020)" Rural Development Administration.

• Journal of Pharmaceutical Investigation
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• 제33권3호
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• pp.245-253
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• 2003

Dissolution profile comparsions can be done by virtue of the similarity factor $(f_2)$. It is a logarithmic reciprocal square root transformation of the sum of squared error of % dissolution differences between two profiles at several time points. It gives information on the degree of similarity between the two profiles: An $f_2$ value between 50 and 100 suggests the similarity/equivalence of the two dissolution curves being compared. The objective of this report was to provide a careful examination on the $f_2$ metrics in detail. It was shown that $f_2$ values exceeded 50, when relative differences in % dissolved between two products were less than 15% at all time points. The similarity factor value was also found to be greater than 50, in cases when absolute % dissolution differences were below 10% at all time points. Interestingly, the $f_2$ value was changed by the number of the time points selected for calculation. In particular, $f_2$ tended to have higher values, when the $f_2$ metrics used a large number of time points in which % dissolved reached plateau. Finally, since the similarity factor was a sample statistics, it was impossible to infer type I/II errors and sampling error. Despite certain limitations inherited in the $f_2$ metrics, it was easy and convenient to evaluate how similar the two dissolution profiles were.

• 한국임상약학회지
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• 제3권1호
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• pp.79-88
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• 1993

Bioequivalence(BE) test of commercially available sustained release tablets of diltiazem hydrochloride(DTZ) was performed to give some guidelines to BE test in korea in case of which drugs with low oral bioavaiiability(BA) due to substantial first-pass hepatic loss form pharmacologically active metabolites. In such cases, the pharmacologic activity after oral administration is greater than anticipated from BA data, based on chemical assay of drug alone. Therefore, this paper explores the use and meaning of area under the plasma concentration-time(AUC) data of parent and its metabolites to access BA if sustained release tablets. Normal healthy male volunteers(n=14) were randomly divided into 2 groups, and sustained release reference$(Herbesser^{(R)})$ and test$(Herben^{(R)})$ tablets of DTZ-30mg were given orally by balanced two-period cross-over dosing schedule. The plasma concentration of DTZ and and its active metabolite, desacetyldiitiazem(DAD), were determined by high performance liquid chromatography, and, $AUC_{DTZ},\;AUC_{DAD},\;AUC_{DTZ+DAD},\;C_{max}\;and\;T_{max}$ obtained. Analysis of varlance(ANOVA) showed that $AUC_{DTZ}\;and\;C_{max}$ passed the standard $(\alpha=0.05,\;1-\beta\geq0.8,\;\Delta\leq0.2)$ of BE test of korea, but $AUC_{DAD}$ was not satisfied from the standpoint of power. On the other hand, $AUC_{DTZ\midDAD}$ may be more avaliable than $AUC_{DAD}$ from the standpoint of statistics and pharmacologic equivalence.

• Journal of Pharmaceutical Investigation
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• 제34권6호
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• pp.529-540
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• 2004

After new medical system of separation of dispensary from medical practice was started in 2000 in Korea, to expand bioequivalence-proven drug products and to ensure the credibility of the therapeutic equivalence of generic drugs are hot issues in Korea. It will be obligatory to submit bioequivalence reports for getting licenses of all generic prescription drugs in the near future. Like other countries such as US and Japan, the KFDA also has a plan to re-evaluate the already approved drugs by bioequivalence studies. Therefore, it becomes more necessary to develop bioequivalence-demonstrating methods for specific preparations such as topical drug products among already approved drug products. There are some differences between US and Japanese guidances of bioequivalence studies of generic drug products for topical use. The information on Japanese guidance and the guidance's Q&As is already provided in our previous paper. In this paper, we examined the US guideline published in 1995 and compared with the Japanese guideline, which will give a useful information to make a guidance on bioequivalence studies of topical drug products in Korea.

• Archives of Pharmacal Research
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• 제4권1호
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• pp.33-41
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• 1981

The prepared dextran sulfates were characterized by measuring the reduced viscosisty at five different concentrations to obtain an intrinsic viscosity in both phosphate and tris buffers, pH 7.4, ionic strength of 0.1 Dextran sulfates having 0.81, 1.06 sulfate groups per hexose unit have reduced viscosity value below 40 ml/g whereas dextran sulfates having 1.21, 1.43, 1.69 sulfate groups per hexose unit have reduced viscosity value over 40 ml/g. Dextran sulfate having 1.21 sulfate groups per hexose unit had highest value of reduced viscosity. The reduced viscosity of dextran sulfate in tris buffer was always higher than that in phosphate buffer regardless of the sulfate content of dextran sulfate. The influence of the sulfation of the dextran sulfate. The influence of the sulfation of the dextran sulfate molecule on the dextran sulfate-LDL interaction was studied with three different dextran sulfate molecules. Dextran sulfate molecules having more than one sulfate group per hexose unit. The dextran sulfate having 0.81 sulfate groups per hexose unit showed considerably different precipitation curves in phosphate and tris buffers. This peculiar behavior of dextran sulfate having 0.81 sulfate groups per hexose unit in the two buffer systems was not noticed with dextran sulfate having more than one noticed with dextran sulfate having more than one sulfate group per hexose unit.

• 생약학회지
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• 제37권3호
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• pp.143-150
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• 2006

Decoction of oriental medicinal preparation is prepared in various manners, and changes of chemical constituents might be occurred depending on the processing techniques. The present study was undertaken to investigate the phγsio-chemical and pharmacological equivalence between two extraction methods of Nokyong-sagunja-Tang. Samples were Prepared as follows ; Sample-I was prepared by simultaneously extracting Sagunja-Tang and velvet antler in one vessel. Sample-lI was prepared by adding velvet antler exact to the water extract of Sagunja-Tang. Both sanples showed similar results of physiochemical parameters such as pH, yield, TLC and HPLC chromatogram, and contents of ginsenoside $Rb_1$ and glycyrrhizin. Also, there were little different between two samples in pharmacological effects such as DPPH free radical scavenging effect, and inhibitory effects on xanthine oxidase, hyaluronidase, trypsin, TBA-Rs formation and hemolysis in vitro. And both samples showed no significant difference in antifatigue activities in mice. These results suggest that there might be little difference between two extraction process when velvet antler added to Sagunia-Tang.