• 한국임상약학회지
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• 제8권2호
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• pp.143-146
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• 1998

Acetaminophen (APAP) suppositories with active ingredients, i.e., polyethylene glycol (PEG), Witepsol H-15 (WH), were prepared for hospital use and investigated on their drug release characteristics and pharmacokinetics. WH was employed as oil-soluble base with an aim of reducing fragility and mucosa irritancy that are common drawbacks found in PEG suppositories. Also hollow type suppository was tried as compared with conventional type suppository. Drug release tests revealed that in most formulations, more than $80\%$ of loaded APAP were released within 20 minutes, except for APAP-WH hollow type suppositories. Significant differences in the plasma concentration profile were observed among four type suppositories. $T_{max}$ of APAP-PEG and APAP-WH suppositories were 90 and 60 minutes, respectively, in hollow types. APAP-WH hollow type suppositories demonstrated fast absorption rates of APAP as compared with those of APAP-PEG suppositories. No burst effect was observed from APAP-WH suppository in contrast to APAP conventional type suppository, whereas AUCs of all the suppositories were similar. APAP-WH hollow type suppository may be an useful dosage form for hospital use.

• Journal of Dental Anesthesia and Pain Medicine
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• 제19권3호
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• pp.175-180
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• 2019

Although allergic reactions are not rare complications in drug use, anaphylaxis or anaphylactoid reactions to some widely used drugs can embarrass clinicians because anaphylaxis is not easily diagnosed at the time of the event and treatment is unfamiliar to many. Lidocaine is a very popular drug in dental procedures and anaphylactoid reaction to it has been rarely reported. Clinicians who use lidocaine daily should, however, be aware of the possibility of anaphylaxis after its use. Once it occurs, anaphylaxis can be fatal, but if it is quickly diagnosed or suspected, treatment is simpler than most clinicians believe. An 86-year-old woman experienced an anaphylactic reaction 30 min after local infiltration of lidocaine for retraction of retained teeth. The dentist called an anesthesiologist for assistance. Fortunately, an anaphylactic reaction was quickly suspected and after subsequent rapid treatment with the administration of fluid and drug therapy, the patient recovered completely.

• 의료법학
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• 제12권1호
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• pp.257-285
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• 2011

This thesis has studied about the legal characteristic of injection of the trial drug, the position of the pharmaceutical firm as a contractor of the clinical trial, the possibility of compulsory performance of consistent injection of the trial drug, and the damage claim caused in the process of the clinical trial from the viewpoint of protecting the trial subject in the clinical trial. According to court's judgement in the United States, the lawsuit of the trial subject, although the trial subject had expected consistent injections, was dismissed because there was no direct contract between pharmaceutical and trial subject. However, Helsinki Declaration prescribe the medical research as follows. 'All patients who participated in the research should be able to use the best precaution, diagnosis, and treatment proved by the final outcome of the research'. The trial subject is entitled to demand only the pharmaceutical firm which developed and provided the trial drug, and the pharmaceutical firm has the obligation to supply the trial drug to the trial subject. Therefore, it would be not enough to protect the trial subject if the pharmaceutical firm which makes the trial drug is ruled out. In addition, especially, in case the trial drug has a constant effect with the aim of treatment, if the injection of the trial drug is suddenly stopped, the trial subject would not have the benefit of treatment by the trial drug. In this case, the best remedy against the damage is to urge a constant injection of the trial drug. Thus, in certain case, it is reasonable to consider that the pharmaceutical firm has the obligation to supply the trial drug to the trial subject constantly, and it is also necessary to compel it through effective means in case the pharmaceutical firm do not fulfill its obligation to supply the trial drug. However, as an essential prerequisite for the assertion mentioned above, it should be judged under the principle of good faith considering the concrete situation, that is, what roles the pharmaceutical firm has played.

• 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.

• Natural Product Sciences
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• 제28권4호
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• pp.168-180
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• 2022

Ephedra is a genus of the Ephedraceae family and is found in temperate regions, such as Central Asia and Europe. Among the various ephedra species, Ma Huang (Ephedra herb) is derived from the aerial parts of Ephedra sinica S tapf, Ephedra equisetina Bunge, and Ephedra intermedia Schrenk & C.A. Mey. Ma Huang contains various ephedra alkaloids, including (-)-ephedrine, (+)-pseudoephedrine, (-)-norephedrine, (+)-norpseudoephedrine, (-)-methylephedrine, and (+)-methylpseudoephedrine, which are found naturally as single enantiomers, although they can be prepared as racemates. Although the use of Ma Huang in foods is prohibited in Korea, products containing Ma Huang can be imported, and so it is necessary to develop a suitable analytical technique for the detection of Ma Huang in foods. Herein, we report the development of analytical methods for the detection of ephedra alkaloids in products containing Ma Huang. Following sample purification by solid phase extraction, quantitative analysis was performed using ultra-performance liquid chromatography-triple quadrupole mass spectrometry (UPLC-MS/MS). Additionally, the enantiomers were successfully separated using HPLC-DAD. We successfully analyzed various food samples, where the ephedra alkaloids were qualitatively and quantitatively determined, and the enantiomers were separated. It is expected that these methods may contribute toward preventing the distribution of illegal products containing Ma Huang.

• 분석과학
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• 제36권1호
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• pp.22-31
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• 2023

As the use of e-liquid cigarettes is rapidly increasing worldwide, it multiplies the potential risk undisclosed to the health of non- and smokers. To reduce the hazard, each country has its own set of regulations for controlling e-liquids. In Korea, the narrow definition of tobacco makes it difficult and have been steadily occurring tax evasion exploiting the difference in natural and artificial nicotine. Therefore, it is very important to distinguish source of nicotine for their regulation. To find biochemical discriminant markers, this study established analysis methods based on high-performance liquid chromatography coupled with diode array detector (HPLC-DAD) and high-performance liquid chromatography coupled with triple Quadrupole mass spectrometry (HPLC-MS/MS) for nicotine enantiomers and tobacco alkaloids targeted using the difference in pathways of nicotine biosynthesis and chemical synthesis. The method was validated by experimenting linearity (R² > 0.999), recovery (80.99-108.41 %), accuracy (94.11-109.73 %) and precision (0.04-8.27 %). Then, the results for discrimination of the nicotine obtained from analysis of 65 commercial e-liquid products available in Korean market was evaluated. The method successfully applied to the e-liquids and one sample labelled 'synthetic nicotine' for tax exemption was found to contain a natural nicotine product. This method can be used to determine whether an e-liquid product uses natural or artificial nicotine and monitor non-taxable e-liquid products. The method is more scientific than the existing one, which relies only on field evidence.

• 한국식품위생안전성학회지
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• 제21권1호
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• pp.1-8
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• 2006

본 연구는 식품첨가물공전, 식품공전 및 Codex 에서의 첨가물관리현황을 비교 분석하여 첨가물공전 체계의 개선방향을 제시함으로서 국제적으로 조화가능한 과학적 및 체계적 기준 규격을 수립할 수 있도록 하기위해 착수되었다. 그 결과를 요약하면 국내에서의 식품의 분류 및 명칭을 Codex 식품분류체계와 비교, 검토한 후 우리나라 전통식품의 첨가물 사용과 관련하여 Codex 식품분류에 포함될 수 있도록 모색하였다. 식품공전에 있는 식품들을 검색한 결과 한과류, 엿류, 두부류와 묵류, 식용유지류, 다류, 조미식품, 김치전임식품, 인삼 및 홍삼제품의 8개 식품군에 속하는 식품들의 분류, 정의, 명칭, 첨가물 사용여부를 감안하여 Codex 기준과 조화시키기 위한 개별적인 개선방안을 제시하였다.

• The Korean Journal of Pain
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• 제20권1호
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• pp.46-49
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• 2007

Background: Cervical epidural injection, performed via the interlaminar approach, represents a useful interventional pain management procedure indicated in patients with a cervical herniated disk. Due to thedecreased epidural space in the cervical region, cervical epidural injections may result in potentially serious complications, especially during a large volume injection. Methods: Thirty-four patients with neck pain due to a cervical herniated disk that were referred to the pain clinic for cervical epidural steroid injection were randomized into two groups. One group received a cervical epidural injection of 4 ml drug and the other group received 2 ml drug. The injected mixture included triamcinolon, ropivacaine and omnipaque. Spread levels of the drug after injection were estimated with the use of C-arm fluoroscopy. Results: Spread levels to the cephalad for patients in the two groups were $4.88{\pm}0.78segments$ and $4.53{\pm}0.49segments$, respectively. Spread levels to the caudad for patients in the two groups were $4.59{\pm}0.93segments$ and $4.47{\pm}0.51segments$, respectively. The results showed no significant difference in the spread level between the two groups. Conclusions: Use of a small volume of drug (2 ml) can provide a sufficient spread level of the injected drug that is desirable for patients with a cervical herniated disk.

• 약학회지
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• 제50권3호
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• pp.145-153
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• 2006

The adverse events which do not appear in the approval process tend to occur more frequently at the early stage of the use. Therefore new drugs, drugs with different active substances or routes of administration, or drugs with explicitly different efficacy added are particularly chosen for re-examination, and go through a study, which is conducted on 600 to 3,000 subjects over 4 to 6 years. Since the re-examination system was implemented in January 1995, 880 drug products have been designated as the subject of re-examination and among them 194 drugs have been completed their re-examination as of until March 2005. Post Marketing Surveillance to insure drug safety should be correlated with re-examination of new drug, re-evaluation of drug, and adverse event monitoring system. And the first labeling change should reflect all information collected for a defined period of time after the marketing authorization is granted. Furthermore centralized management through spontaneous reporting system of adverse event for whole period of time would be the most desirable type of system.

• 한국임상약학회지
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• 제23권4호
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• pp.334-343
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• 2013

Purpose: This study aims to investigate consumers' demand of and perspective on drug information domestically available and uncover hurdles that they faced while utilizing information. Methods: We conducted a survey of 101 consumers, face-to-face after obtaining informed consent. Chi-squared, or Fisher's exact tests, and multivariate logistic models were used to investigate the association between participants' perceptions and characteristics. Results: As results, participants showed the highest demand for "Adverse effects >90%"; "Drug interactions/Dosage/Drug-food interactions/Indication >80%", and utilized package inserts (52%), doctors (41%) and pharmacists (36%) most often as information sources. Generally, the most common difficulty consumers suffered with was that "it is hard to understand (51%)". With public sources of drug information, sixty one percent of participants were "unaware of the provision of information", resulting in strikingly low usage rates (5~11%). Subgroup analyses indicated that the older (${\geq}50$ years) and the disadvantaged might have been placed in the blind spot of information mostly developed online (p<0.05).Conclusion: In conclusion, public sources of drug information that have been developed online might fail to meet consumers' demand. Greater efforts should be made to balance the development of the information sources between online and offline, and to increase accessibility of the established information sources.