• Title/Summary/Keyword: Administration and dosage

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Development of Dissolution Test Method for Acebrophylline Capsules and Bromhexine Hydrochloride Tablets in Korean Pharmaceutical Codex (고시수재 의약품 중 아세브로필린 캡슐 및 브롬헥신염산염 정의 용출시험법 개발)

  • Lee, Tae-Woong;Jeong, Rae-Seok;Jeong, Seung-A;Kim, Jeong-Hyun;Shim, Young-Hun;Kim, In-Kyu;Park, Chang-Won
    • YAKHAK HOEJI
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    • v.57 no.3
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    • pp.226-233
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    • 2013
  • Although the dissolution test can serve as an effective tool for quality control and predictor of in vivo performance, there are a number of drugs with no established dissolution specification in Korean Pharmaceutical Codex (KPC). So, with each reference and test drugs, the dissolution test method and an analytical procedure by HPLC were developed and validated to establish dissolution specification for acebrophylline capsules and bromhexine hydrochloride tablets. The dissolution condition was determined based on the "Guidelines on Specifications of Dissolution tests for Oral dosage forms" of Ministry of Food and Drug Safety (MFDS). The analytical method of HPLC was validated in specificity, linearity, precision and accuracy. Final dissolution test was performed with commercially available samples of 3 lots to establish specification. In addition, no difference was observed by the inter-laboratory evaluation. Dissolution specifications and conditions will be used for revising the monograph of acebrophylline capsules and bromhexine hydrochloride tablets in next supplement of KPC.

Psychosis in Parkinson's Disease-Treatment with 5-HT Receptor Antagonist (5-HT 수용체 길항제를 이용한 파킨슨 환자의 정신 증상의 치료)

  • Koh, Seong-Beom;Park, Kun-Woo;Lee, Dae-Hie
    • Korean Journal of Biological Psychiatry
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    • v.4 no.1
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    • pp.132-135
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    • 1997
  • Current treatment strategies for levodopa-induced psychosis in advanced Parkinson's disease have had limited success. Reduction or discontinuation of levodopa and coadministration with dopamine-blocking neuroleptics may attenuate the psychotic symptoms, but these strategies are associated with worsening of parkinsonian symptoms. Administration of 5-HT3 receptor antagonist ; ondansetron, a newer strategy to attenuate psychosis of Parkinson'disease without motor deterioration was introduced. A 41-year-old young-onset male, who was diagnosed as Parkinson's disease 7 years ago, was treated with levodopa therapy, and had levodopa-induced psychosis(delusion, hallucination, paranoid, insomnia). After trial of ondansetron, he showed improvement in the Brief Psychiatric Rating Scale(from 21 points to 9 points) in spite of increasing the dosage of levodopa. With ondansetron, we could increase the dosage of levodopa without psychotic complications(esp, hallucination), and he showed improvement in the motor fluctuation.

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Study on the Anti-allergic Effect of Armeniacae Semen Herbal Acupuncture Solution (행인약침(杏仁藥鍼)이 항알레르기에 미치는 영향)

  • Kim, Yu-Seung;Song, Choon-Ho
    • Korean Journal of Acupuncture
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    • v.24 no.4
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    • pp.151-162
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    • 2007
  • Objectives : The purpose of this study was to examine the anti-allergic effect in vivo, and to observe single toxicity in mice of Armeniacae Semen herbal acupuncture solution (ASHA). Methods : We investigated anti DNP IgE-mediated passive cutaneous anaphylaxis in rodents and compound 48/80-induced active systemic anaphylatic shock in mice after treatment at both BL13 with ASHA of 25 ${\mu}{\ell}$(mice) or 50 ${\mu}{\ell}$(rats) 3 times for 5 days. To ascertain safety and toxicity of ASHA, we examined single toxicity test. In single test, three groups were treated with different dosages of ASHA (ASHA250, ASHA500 and ASHA1000) according to on Korean Food and Drug Administration, respectively. We observed attentively motality, abnormal clinical sign, body weight change, and organ weight of mice after ASHA treatment. Results : ASHA inhibited passive cutaneous anaphylaxis and active systemic anaphylatic shock by oral administration. During toxicity experiment period, there was no difference in body weight change, and organ weight among different dose groups. Death were not found in single test i.p. group. (ASHA250, ASHA500 and ASHA1000). Several individuals of single test i.p. group were observed yellow brown discharge around anus in early period after administration. Conclusions : These results indicate that ASHA have inhibition effects on passive cutaneous anaphylaxis and active systemic anaphylatic shock, and suggest that has some toxicity in high dosage.

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Pharmacokinetics of Acebutolol and Diacetolol After Oral Administration of Acebutolol in Rabbits with Folate-Induced Renal Failure (신장장애 가토에서 경구투여시 아세부토롤과 활성대사체인 디아세토롤의 약물동태)

  • Choi, Jun-Shik;Lee, Jin-Hwan
    • Journal of Pharmaceutical Investigation
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    • v.31 no.3
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    • pp.161-165
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    • 2001
  • Acebutolol (ABT) is almost absorbed after oral administration, but its bioavailability is reduced because of considerable first-pass metabolism in the gastrointestine and liver. The purpose of this study was to report the pharmacokinetic changes of ABT and its metabolite, diacetolol (DAT) after oral administration of acebutolol to control rabbits and rabbits with mild and severe folate-induced renal failure (FIRRs). Both of the area under the plasma concentration-time curve $(AUC^0_{\infty})$ of ABT and DAT were significantly increased in mild (p<0.05) and severe FIRRs (p<0.01), but the $AUC^0_{\infty}$ of DAT was more influenced than that of ABT in severe rabbits. There was a good correlation between serum creatinine and both of $AUC^0_{\infty}$ of ABT and DAT. The elimination half-life of ABT and DAT was significantly prolonged in mild (p<0.05) and severe (p<0.01) FIRRs, but the half-life of DAT was more influenced than that of ABT in severe FIRRs. The results suggest that the dosage of acebutolol should be adjusted according to the degree of renal disorder on the base of the serum creatinine concentration.

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Update of minimally invasive surfactant therapy

  • Shim, Gyu-Hong
    • Clinical and Experimental Pediatrics
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    • v.60 no.9
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    • pp.273-281
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    • 2017
  • To date, preterm infants with respiratory distress syndrome (RDS) after birth have been managed with a combination of endotracheal intubation, surfactant instillation, and mechanical ventilation. It is now recognized that noninvasive ventilation (NIV) such as nasal continuous positive airway pressure (CPAP) in preterm infants is a reasonable alternative to elective intubation after birth. Recently, a meta-analysis of large controlled trials comparing conventional methods and nasal CPAP suggested that CPAP decreased the risk of the combined outcome of bronchopulmonary dysplasia or death. Since then, the use of NIV as primary therapy for preterm infants has increased, but when and how to give exogenous surfactant remains unclear. Overcoming this problem, minimally invasive surfactant therapy (MIST) allows spontaneously breathing neonates to remain on CPAP in the first week after birth. MIST has included administration of exogenous surfactant by intrapharyngeal instillation, nebulization, a laryngeal mask, and a thin catheter. In recent clinical trials, surfactant delivery via a thin catheter was found to reduce the need for subsequent endotracheal intubation and mechanical ventilation, and improves short-term respiratory outcomes. There is also growing evidence for MIST as an alternative to the INSURE (intubation-surfactant-extubation) procedure in spontaneously breathing preterm infants with RDS. In conclusion, MIST is gentle, safe, feasible, and effective in preterm infants, and is widely used for surfactant administration with noninvasive respiratory support by neonatologists. However, further studies are needed to resolve uncertainties in the MIST method, including infant selection, optimal surfactant dosage and administration method, and need for sedation.

Estimation of the Number of Optimal Dispensing Cases for the Community Pharmacist (개국약사의 적정조제건수 산출)

  • 이의경;박정영
    • Health Policy and Management
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    • v.11 no.4
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    • pp.88-108
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    • 2001
  • Separation of prescribing and dispensing practice in Korea has changed the service pattern of the pharmacy. The prescription dispensing activities, however, are concentrated excessively on the pharmacies near hospitals or clinics. Thus this study was conducted to estimate the number of optimal dispensing cases for the community pharmacy. Forty-six pharmacies were selected using systematic stratified random sampling method, and ninety-five pharmacists were interviewed on their workload of dispensing and other activities at pharmacies. One hundred and seventy prescriptions were chosen based on the length of drug administration and drug dosage form, and the dispensing time was measured by time-watch method. Also pharmacy benefit claims data were analyzed to identify the characteristics of the pharmacies which performed more than optimal dispensing cases. According to the study results, the average work time per pharmacist per day was found to be 10hours 32minutes and the dispensing activities occupied 7hours 36minutes. It took 5.72minutes on average for each dispensing case. The optimal dispensing case was estimated as 75 cases under the condition of 10hours 32minutes work time and 6% allowance rate. Even though the pharmacies near hospitals or clinics participated dispensing services actively, only pharmacies near clinics dealt with more than optimal dispensing cases. For the pharmacies near hospitals they dealt with less than optimal cases, but drug administration period per prescription was almost 3 times longer than that of pharmacies near clinics. Thus the intensity of dispensing activities such as drug administration period is to be considered to estimate optimal dispensing cases more accurately.

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Effect of STEL-toluene on Metabolism of Benzene in Rats (단시간 허용농도의 toluene이 benzene대사에 미치는 영향)

  • Roh, Jae-Hoon;Shin, Dong-Chun;Park, Jung-Gyun;Moon, Young-Hahn;Chung, Ho-Keun
    • Journal of Preventive Medicine and Public Health
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    • v.21 no.1 s.23
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    • pp.152-162
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    • 1988
  • Benzene and toluene, which are widely used aromatic hydrocarbons in workplace, are recently proved to cause health hazards due to their toxic effects. This study investigated the influence of toluene on the urinary excretion of benzene metabolite by administering short term exposure limit(STEL) of these compounds(i.e., 13.8mg/kg of benzene and 108.8 mg/kg of toluene) intraperitoneally into Sprague-Dawley rats. After administration, urinary phenol concentration of rat was measured by gas chromatography for every three hours. Data were analyzed by non-parametric statistical methods using Kruskal-Wallis multi-sample test and Mann-Whitney U test. The following results were obtained : 1. Administration of STEL-benzene increased urinary phenol concentration in lats. 2. Urinary phenol concentration was increased logarithmically according to the dosage of benzene. 3. Excretion of phenol in urine was decreased when benzene and toluene were administered simultaneously compared with administering benzene alone. In summary, these results reveal that administration of STEL of toluene has antagonistic effect of urinary excretion of benzene metabolite in rats.

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Effect of Recombinant Bovine Somatotropin on Growth of Olive Flounder, Paralichthys of olivaceus

  • Rho, Sum-Rho;Kim, Pil-Youn;Lee, Young-Don;Choi, Kwang-Sik;Song, Choon-Bok
    • Journal of Aquaculture
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    • v.12 no.2
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    • pp.79-89
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    • 1999
  • The recombinant bovine somatotropin (rBST) was administered to the oliver flounder, Paralichthys olivaceus, to know the effects and optimal administration frequency and dosage of the hormone. The experiment was conducted with three different treatment groups (A, B and C) designated based on the duration and administration frequency of rBST and one control (D) from April 14, 1996 to March 16, 1997. The fish of hormone treated groups grew 7.86 to 10.07% (47.45 to 60.75 g in weight) better than the control at the end of the experiment (P<0.05). No significant differences in their growth were detected among treatment groups. The distinct growth improvement was recognized four weeks after completion of the first four hormone administration. When considering water temperatures measured from the experimental tanks, the effect of rBST on the flounder was greater during the period showing relatively lower temperature. The survival rates were higher in treatment groups than in the control, revealing 98.3% (A), 98.4% (B), 97.7% (C) and 93.1% (D) during the first stage of culture; 92.7% (A), 91.3% (B), 86.7% (C) and 80.0% (D) during the second stage of culture.

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Four-Week Repeated Dose Safety Test of Rhus-II Orally Administrated to Rats (랫드에서 옻나무 추출액(Rhus-II)의 4주 반복 투여 안정성 평가)

  • Choi Changsun;Han Dong Un
    • Journal of Food Hygiene and Safety
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    • v.20 no.1
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    • pp.7-12
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    • 2005
  • The purpose of this study was to examine the four week repeated toxicity in Sprague-Dawley rats orally administrated with Rhus-II (water fraction of Rhus Veniciflua). In acute toxicity test, three groups (40 rats of both sex) were administrated different dosages of Rhus-II, 2 g/kg (high dosage group), 1 g/kg, 0.5 g/kg and one group (10 rats of both sex) were received by orally only saline according to the Regulation on Korea Food and Drug Administration, respectively. There was no difference in body weight change, feed intake and water consumption among different dose groups. There was no alteration in relative organ weight by the administration of Rhus-II. No death of abnormal clinical signs was observed during the experimental period. Between the groups orally administered Rhus-II and the control group, there was no statistical significance in urinalysis, hematological test or serum biochemical values. There were no gross findings at final sacrifice. There was no evidence of histopathological alteration mediated by four week treatment with Rhus-II. These results suggest that no observable effect level(NOEL) of the test orally administration was considered to be more than 2g/kg in rats under the conditions employed in this study.

Respiratory Depression during Oral MS-Contin Administration for Pain Management of Gall Bladder Cancer (말기 담낭암 환자의 통증조절을 위해 MS Contin 투여중 발생한 호흡억제 -증례 보고-)

  • Lee, Chul-Woo;Lee, Byung-Ho;Lee, Yong-Hee
    • The Korean Journal of Pain
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    • v.9 no.1
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    • pp.239-243
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    • 1996
  • MS-Contin is an oral controlled-release preparation of morphine sulfate that has been used widely in the management of advanced cancer pain. It prolongs plasma concentration of morphine with no observable accumulation properties following repeated dosing, thereby promoting uninterrupted sleep and hopefully improving patient's quality of life. The common side effects of MS Contin are nausea, vomiting, drowsiness and constipation. But these symptoms are usually mild and respiratory depression is a rare problem. We experienced respiratory depression during oral administration of MS contin for the pain management of advanced gall bladder cancer of 76 years old male patient with metastasis at liver, intestine and cervical lymph node. After we increased the dosage of MS Contin from 160mg to 220mg per day, due to abdominal pain, we observed morphine reaction of MS Contin overdose such as pinpoint pupil, deeply slow respiration below 8/minute, and drowsiness. After intravenous bolus injection of 0.4 mg naloxone followed by continuous administration of 0.2 mg/hr for 4 hours, the patient regained consciousness. The administered route of morphine was changed to intravenous PCA (patient controlled analgesia). There was no aspiration sign as confirmed by chest x-ray. The patient was comfortable and delayed no signs of respiratory depression until now.

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