著者

寒河江 喜紀 福井 了三 吉岡 克己 近藤 克幸 松本 喜良 鈴木 敏夫

出版者

一般社団法人日本医療薬学会

雑誌

医療薬学 (ISSN:1346342X)

巻号頁・発行日

vol.27, no.2, pp.159-166, 2001-04-10 (Released:2011-03-04)

参考文献数

5

---

The ordering system for injections in the total medical informational system in the Akita University Hospital was established after modifying the old system in 1999. The Auto Ample dispense (AAD) system was combined with this ordering system by TCP/IP protocol and was also introduced in our department. The stable use of this total system has been underway for the dispensation of injections since November 1999. The usefulness and efficacy of this system was evaluated in our department based on the findings of working charts, time courses, and appropriate prescriptions of the injections.The smooth and stable dispensation of all injections using this AAD system was carried out not only for regular orders, but also for temporary orders. All nurses gave this system a favorable evaluation. The statistical data indicated that more prescription sheets were issued with this system than with the previous system, and it required much time for the packaging of injections in this system compared with the manual way. However, the efficient transport of the drugs was maintained in all wards using this system. A minor revision in this system was introduced in order to promote the appropriate dosage for every injection. The incidence of injection mistakes was thus reduced to less than 10 per month.

著者

祢宜田 和正 山下 雅代 久保田 敏行 杉浦 洋二 三浦 崇則 勝見 章男 太田 満 齋竹 達郎 戸澤 良夫 水谷 勝

出版者

一般社団法人日本医療薬学会

雑誌

医療薬学 (ISSN:1346342X)

巻号頁・発行日

vol.27, no.2, pp.123-131, 2001-04-10 (Released:2011-03-04)

参考文献数

17

被引用文献数

1 2

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Although vancomycin has been exclusively used for methicillin-resistant Staphylococcus aureus (MRSA) therapy, there are many patients recently observed to suffer from gram negative bacteria, Pseudomonas aeruginosa as well as MRSA.Arbekacin (ABK), an aminoglycoside antibiotic (AG) is an alternative medication for such patients with those infection disease. However, it seems that the dosage of ABK used according to the manufacture's recommendations is insufficient for MRSA therapy to obtain a sufficient patient outcomes. Moreover, the relationship between the effectiveness of ABK on MRSA infection and the serum ABK concentration remains unclear. For the long-term treatment of AG, we can not rule out the possibility that AG may induce nephrotoxicity and ototoxicity.Therefore, the present study was carried out to clarify the significance of therapeutic drug monitoring (TDM) of ABK for patients with an MRSA infection, and elucidate the relationship between the serum ABK level and its clinical outcomes, including its antibacterial action and side effects. We investigated 30 patients with an MRSA infection, who received ABK at the Anjo Kosei Hospital from September 1996 to June 1998. The treatment of the patients by ABK but without TDM showed a 46.6% (7/15) therapeutic efficacy, while the patients with drug monitoring had a remarkably successful therapeutic efficacy (100% : 21/21) with a peak serum ABK concentration over 10μg/mL. Dysphagia badly affected the efficacy of ABK therapy in patients with an MRSA infection even when the serum ABK level was well-controlled. The incidence of ABK induced nephrotoxicity was observed in all patients when ABK was administered at a total dose of over 5, 000mg, while it was 4% at a total dose of less than 5, 000mg. When the duration of ABK therapy was longer than 2 weeks, the incidence of nephrotoxicity also significantly increased.These results thus suggest that TDM of ABK is useful for increasing the efficacy of ABK therapy in patients with an MRSA infection. In light of nephrotoxicity, these results indicate that ABK therapy may be completed within 2 weeks with an ABK dose of less than 5, 000mg, as the total dose.

著者

宮津 大輔 江田 陽一 今給 黎修 桑名 寿幸 松浦 徹 竹下 龍次 與田 賢作 秋吉 正貴 手嶋 由加 田中 博和 長郷 あかね 平川 雅章 首藤 英樹 片岡 泰文

出版者

一般社団法人日本医療薬学会

雑誌

医療薬学 (ISSN:1346342X)

巻号頁・発行日

vol.43, no.1, pp.45-52, 2017-01-10 (Released:2018-01-10)

参考文献数

14

被引用文献数

2

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Hypertensive emergency is a situation in which uncontrolled hypertension is associated with acute end-organ damage. Nicardipine hydrochloride is a calcium channel blocker indicated for the treatment of hypertensive emergencies. However, nicardipine infusion-related phlebitis is a common and significant problem in clinical practice. The aim of this study was to survey the incidence of nicardipine infusion-related phlebitis and to identify associated risk factors for phlebitis. We conducted a retrospective observational study at Fukuoka Tokushukai medical center. A total of 79 patients who received precision continuous infusion of nicardipine were enrolled in this study. Nicardipine infusion-related phlebitis occurred in 34 (25.7%) of 132 peripheral intravenous catheters. On multivariate logistic analysis, “the dosing period over 24 hours” and “no co-infusion of saline” were significantly associated with an increased risk of nicardipine infusionrelated phlebitis. The odds ratio (OR) and 95% confidence interval (95% CI) for the occurrence of phlebitis with respect to “the dosing period over 24 hours” and “no co-infusion of saline” were 5.04 (2.012 - 12.657) and 3.36 (1.190 - 9.514), respectively. In addition, the optimal cut-off level of the dilution rate of saline was determined to be 4.23 times (sensitivity 73.5%, specificity 58.8%) based on receiver operating characteristic (ROC) analysis for predicting the occurrence of phlebitis. To minimize the risk of peripheral phlebitis, we propose that medical professionals should consider changing the infusion site every 24 hours at least and co-infusing saline diluted more than 4-5 times.

著者

本間 真人 田辺 正樹 小宅 典子 幸田 幸直

出版者

一般社団法人日本医療薬学会

雑誌

医療薬学 (ISSN:1346342X)

巻号頁・発行日

vol.31, no.1, pp.77-80, 2005-01-10 (Released:2011-03-04)

参考文献数

10

被引用文献数

2 1

---

We report on a case of rhabdomyolysis induced by Shakuyaku-kanzo-To, a herbal medicine for spastic muscle pain. The patient was a 76-year-old female who received Shakuyaku-kanzo-To (TJ-68) and dichlofenac for lumbago. Fifteen weeks later, she was admitted to hospital because of liver dysfunction as determined from increases in AST, ALT and LDH. She was diagnosed with rhabdomyolysis due to marked elevation of CPK and myogloblin levels. The hypertension, hypokalemia and reduced renin and aldosterone levels that were also noted suggested that the rhabdomyolysis was associated with pseudoaldosteronism caused by the licorice extracts contained by Shakuyaku-kanzo-To. We confirmed that blood levels of glycyrrhetinic acid (257 ng/mL), a licorice component known to induce pseudoaldosteronism, were high and found the serum cortisone/cortisol ratio (O.09) to be low indicating reduced activity of 11 β-hydroxysteroid dehydrogenase, which catalyzes the conversion of cortisol to cortisone. The results we obtained suggested that blood glycyrrhetinic acid levels and cortisone/cortisol ratios could be used as diagnostic indicators for pseudoaldosteronism caused by herbal remedies containing licorice extracts.

著者

半谷 眞七子 柴田 章代 亀井 浩行 松葉 和久 浅井 雅浩 谷山 正好

出版者

一般社団法人日本医療薬学会

雑誌

医療薬学 = Japanese journal of pharmaceutical health care and sciences (ISSN:1346342X)

巻号頁・発行日

vol.33, no.8, pp.693-701, 2007-08-10

参考文献数

13

被引用文献数

2 8

---

It is an important task of the pharmacist to triage appropriate over-the-counter (OTC) drugs for patients to achieve efficacy and safety.In this study,we investigated the present situation regarding the triage of OTC drugs for patients based on pharmacists interviewing patients in a fact-finding survey which determined how pharmacists in a drugstore communicate with patients during such interviews.<br>We analyzed patterns of pharmacist communication with patients for the purpose of triaging OTC drugs in the drugstore and compared them with typical recommended communication patterns in the United States.In the drugstore,there were 3 patterns of initiating dialog with patients purchasing OTC drugs which were (1)&ldquo;What are your symptoms?&rdquo;2)&ldquo;What is the name of the drug that you want?&rdquo;and (3)&ldquo;What disease do you have?&rdquo; <br>Using the first pattern we conducted a role play simulating the triaging of OTC drugs by pharmacists actually working in drug stores to standardized patients.In response to the patient&rsquo;s description of his or her current symptoms,pharmacists used various speech patterns to explain the suitability of drugs selected and the cautions in use.In interviews conducted by inexperienced pharmacists,time was wasted in communication and there was no logical flow in them.Afterwards,some pharmacists said that they had not been able to obtain enough information from patients for triaging OTC drugs and others thought it was necessary to set algorithms for this purpose.These opinions suggest that pharmacy education in Japan should include training that makes pharmacists realize their responsibility in triaging OTC drugs for patients.

著者

船越 順子 濱名 則子 岩城 晃一 松林 照久 西庄 京子 栄田 敏之 奥村 勝彦

出版者

一般社団法人日本医療薬学会

雑誌

医療薬学 (ISSN:1346342X)

巻号頁・発行日

vol.27, no.6, pp.548-552, 2001-12-10 (Released:2011-03-04)

参考文献数

4

被引用文献数

1 1

---

Follow-up case by telephone was conducted for the discharged patients, who had received the medication consulting services from clinical pharmacists of Kobe university hospital. In this trial, we focused on the patients in the Department of Circulation and Respiratory Diseases. The follow-up case by telephone was carried out from the time of discharge until the next visit (almost 2 weeks after discharge). The patients consisted of 30 men and 17 women (average age was 66.9 years old). By telephone, the following issues were questioned; 1 : medication compliance, 2 : side effects and/or the changes of physical condition, 3 : other issues (such a when an inappropriate use of medicine had been suspected during hospitalization). When the patients so desire they could come in for a check-up anytime. More than about 90% of patients reported to keep good medication compliance and to have no significant side effects. However, 34% of patients claimed a slight of change in their physical condition including dropsical swelling, boiling and gasping. The claims were found more frequency in patients who had been suspected of inappropriately taking their medication. Follow-up care by telephone was found to be an effective way to avoid any kind of risks including the discontinuation of medicine. As a result, although further examinations should be addressed, follow-up care by telephone appears to be a good way to ensure the appropriate use of medicine.

著者

中村 敏明 岩尾 岳洋 東 高士 谷 大輔 矢野 良一 政田 幹夫

出版者

一般社団法人日本医療薬学会

雑誌

医療薬学 (ISSN:1346342X)

巻号頁・発行日

vol.37, no.9, pp.551-558, 2011 (Released:2012-09-10)

参考文献数

13

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Paclitaxel injection [NK] (PTX [NK]) is a generic of Taxol® Injection (Taxol) but no non-clinical study comparing the safety of the 2 drugs has been conducted because the active ingredient is the same.We compared the safety of PTX [NK] and Taxol in rats to see if there were any differences. PTX [NK] and Taxol were intravenously administered to CD (SD) male rats at doses of 2.0 and 4.0 mg/kg/day for 9 days. There were very slight differences in toxicological findings regarding such items as clinical observations, food consumption, gross necropsy, organ weight and histopathology. These differences, however, were generally observed after administration of a cytocidal anticancer drug. Therefore, such differences were not thought to be toxicologically significant and we concluded that the safety of PTX [NK] was no different from that of Taxol in rats.

著者

渡辺 享平 矢野 良一 五十嵐 敏明 塚本 仁 中村 敏明 政田 幹夫

出版者

一般社団法人日本医療薬学会

雑誌

医療薬学 (ISSN:1346342X)

巻号頁・発行日

vol.35, no.9, pp.622-628, 2009 (Released:2011-01-14)

参考文献数

12

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As the effect of the filling process of portable pumps on the homogeneity of drug concentrations had not been investigated,in this study,we examined the influence of the filling process of the anticancer agent 5-fluorourcil (5-FU) and saline in this respect.We used 3 types of pump and filled the pump in 3 different ways (5-FU first and then saline,saline first and then 5-FU,and mixing 5-FU and saline beforehand and then filling).There was a significant variation in the 5-FU concentration when 5-FU and saline were added separately but the drug concentration did not vary when 5-FU and saline were mixed before filling the pumps.The result also varied with the type of pump.Our findings suggested that the drug and saline were not mixed uniformly in some types of pump when 5-FU and saline were added separately.Therefore,it is important to mix the drug and saline well before filling pumps.

著者

根來 寛 矢野 良一 谷 大輔 渡辺 享平 塚本 仁 五十嵐 敏明 中村 敏明 脇屋 義文 後藤 伸之 横山 照由 政田 幹夫

出版者

一般社団法人日本医療薬学会

雑誌

医療薬学 (ISSN:1346342X)

巻号頁・発行日

vol.34, no.4, pp.320-327, 2008 (Released:2009-09-04)

参考文献数

23

被引用文献数

2 1

---

During cancer chemotherapy,myelosuppression is a frequently observed toxicity manifestation which may sometimes cause severe infections.In this regard,though leukopenia-induced infections are more closely related to neutrophil counts than leukocyte counts,it is important to evaluate both leukocyte counts and neutrophil counts as markers of myelosuppression.Neutrophil counts,however,are sometimes estimated to be half leukocyte counts without conducting differential leukocyte counts.In the present study,the authors evaluated the necessity of differential leukocyte counts during cancer chemotherapy using pooled laboratory data at the University of Fukui Hospital.Variation in the percentage of neutrophils in leukocytes was observed in each leukocyte range,with the neutrophil count decreasing in pace with decreases in the leukocyte count.As an alternative index to the neutrophil count,the utility of the leukocyte count is thus considered to be low in cancer chemotherapy.There was also a divergence between adverse event grade between neutrophil and leukocyte numbers.In addition,neutrophil counts in 14.8% of the patients (26)were less than 1000/μL in spite of the fact that their leukocyte counts were higher than 3000/μL,and it was noted that 23 of them had undergone a paclitaxel-containing regimen.These results suggested that leukocyte differential counts should be measured during cancer chemotherapy,especially during the nadir period and when receiving chemotherapy containing paclitaxel.

著者

吉田 仁 甲田 茂樹 吉田 俊明 西田 升三 熊谷 信二

出版者

一般社団法人日本医療薬学会

雑誌

医療薬学 (ISSN:1346342X)

巻号頁・発行日

vol.37, no.3, pp.145-155, 2011 (Released:2012-04-25)

参考文献数

25

被引用文献数

4 5

---

This study was conducted to develop a tool for evaluating the work environment for the preparation of antineoplasticdrugs and identify issues in safety assessment.We prepared a checklist for the safe handling of antineoplastic drugs,whichincluded the following items : A) safety equipment and its maintenance,B) training and training documentation,C) devicesfor ensuring safety,D) personal protective equipment and E) emergency care.Further,we examined relationships betweenattainment levels for checklist items and occupational contamination levels for cyclophosphamide (CPA),fluorouracil (5FU),gemcitabine (GEM) and platinum-containing drugs (Pt) based on wipe samples from equipment in the preparationroom (wipe test).Next,pharmacists in a particular hospital were asked to improve their work environment using the checklist.To evaluate their improvements,we collected wipe samples and one-day urine samples from them,before and afterthey took improvement measures.The results showed that an increase in safety attainment scores was reflected in a decrease in CPA,GEM and Pt contaminationlevels in the wipe test,as well as one in urinary levels of CPA.However,the 5FU level in the wipe test increased,probably due to a 6-fold increase in the amount of 5FU prepared,compared to before the improvement measures weretaken.From these findings,we concluded that the checklist would be useful for improving the hospital work environment.

著者

小林 由佳 岩根 裕紀 中西 弘和

出版者

一般社団法人日本医療薬学会

雑誌

医療薬学 (ISSN:1346342X)

巻号頁・発行日

vol.40, no.6, pp.352-359, 2014-06-10 (Released:2015-06-10)

参考文献数

12

---

Onco-TainTM Vial, which was developed to prevent occupational exposures to hazardous drugs such as antineoplastic drugs, is a vial preparation equipped with sheathings (a PVC reinforced base and a shrink wrapping of a protective PET sleeve on the vial). The shatter-resistance of the Onco-Tain™ vial was evaluated with a free fall test. Four types (9 strengths in total) of Onco-Tain™ vials, which contain antineoplastic agents and are available worldwide, were used in the test. Vials with the PVC bases and PET sleeves removed from the Onco-Tain™ vial were used as the control. Mimicking the fall of vials in the medical setting, the falling heights were set at 70, 135 and 180 cm, and the breakage ratios of vials and the scattering area of contents were measured.In the control group (Non-OT group), 3.5, 9.4 and 8.9 percent of vials were broken at the heights of 70, 135 and 180 cm, respectively, and the scattering of contents was observed in all broken vials. The breakage ratios of vials in the Onco-Tain™ vial group (OT group) were statistically significantly lower (0.0 and 2.4%) at the heights of 70 and 135 cm, and tended to be lower (3.3%) at the height of 180 cm. No leakage was observed in vials broken in the OT group. The significant improvement of shatter-resistance of vials was confirmed by applying the protection sleeves to the surface of the vials. By applying these concepts in the future, a decrease of occupational exposures to hazardous drugs caused by the breakage of containers is expected.

著者

田辺 公一 竹内 都子 池崎 友明 北澤 英徳 豊本 貴嗣 中林 智之

出版者

一般社団法人日本医療薬学会

雑誌

医療薬学 (ISSN:1346342X)

巻号頁・発行日

vol.34, no.4, pp.347-354, 2008 (Released:2009-09-04)

参考文献数

7

被引用文献数

4 3

---

Pravastatin sodium tablets are widely used for the treatment of hyperlipidemia,and 22 generic products of this compound have been approved in Japan.A few studies have compared the clinical efficacy of the original and generic forms,and 1 study has questioned the reliability of biological equivalency tests.We therefore retrospectively examined the effect of substituting a generic product (Mevan TM ; Nichi-iko Pharmaceutical Co.,Ltd.) for the original product (Mevalotin TM ; Daiichi Sankyo Co.,Ltd.) on clinical efficacy and safety.We targeted patients who were initially treated with the original product and then the generic product,and from electronic medical records,obtained their prescription data for 3 months before and after generic substitution.Next,we investigated clinical equivalence with regard to changes in total cholesterol (TC),HDL cholesterol (HDL),LDL cholesterol (LDL),and triglyceride (TG) levels as indices of clinical efficacy,as well as in ALT,AST,γ-GTP,and CPK levels as indices of safety.We examined the changes in each of these laboratory parameters between 3 months before substitution and 3 months after substitution.In 293 patients,no significant differences were observed in the indices of efficacy between before and after substitution.We also examined records for presence of diabetes mellitus and familial hypercholesterolemia and their influence on TC levels before and after substitution but no significant differences were observed in this regard.Accordingly,we concluded that the generic product investigated in this study was clinically as effective as the original product.

著者

相宮 光二 宮川 慶子 林 誠 長岡 宏一 阿部 康治 北 俊之

出版者

一般社団法人日本医療薬学会

雑誌

医療薬学 (ISSN:1346342X)

巻号頁・発行日

vol.36, no.7, pp.469-475, 2010 (Released:2012-03-10)

参考文献数

12

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Sulbactam sodium-ampicillin sodium (hereinafter referred to as SBT/ABPC) injections are widely used for the treatment of infection and in view of this,we conducted a study to examine the therapeutic equivalence of original and generic preparations of SBT/ABPC.In it,we compared efficacy and safety in patients diagnosed with pneumonia,acute bronchitis,or acute bronchiolitis who received the original or a generic SBT/ABPC injection at the National Organization Kanazawa Medical Center from May 2007 to March 2008.We analyzed the efficacy endpoints of body temperature,white blood cell count,and CRP level and the safety endpoints of AST (GOT),ALT (GPT),and BUN in 121 subjects receiving the original preparation and 112 receiving the generic one.Our results suggest therapeutic equivalence for both efficacy and safety,and we conclude that the generic version can definitely be used as an alternative to the original preparation.

著者

松浦 克彦 林 秀樹 杉山 正 片桐 義博

出版者

一般社団法人日本医療薬学会

雑誌

医療薬学 (ISSN:1346342X)

巻号頁・発行日

vol.32, no.4, pp.306-313, 2006-04-10 (Released:2007-11-09)

参考文献数

20

被引用文献数

5 5

---

A comparative study was carried out to evaluate the quality of one brand name tablet (A) and five generic tablets (B∼F) containing 5 mg of enalapril maleate (ENA). Tablet quality was evaluated based on such characteristics as content, impurities, dissolution profile, hygroscopic properties, and stability. In the purity test, we measured the quantities of degradation products such as diacid compound (DA) and diketopiperazine compound (DKP) and in the hygroscopicity test, the weight and hardness of the tablets without blister packaging was measured initially and after 2 weeks and 4 weeks of storage at 0%, 43%, 75% and 93% relative humidity (RH). To test stability, we measured the quantities of ENA, DA, and DKP in tablets stored without blister packaging at 40°C and 75% RH for 12 weeks.The ENA content in all preparations was approximately equal to the indicated content. Initially, DA was not detected in any of the preparations. About 0.3% DKP was detected in preparation B and C. The dissolution profiles of all generic tablets were similar to those of the brand name tablet. For preparations A, B, and D, a marked increase in tablet weight and decrease in tablet hardness was observed with increasing RH. In the stability test, the remaining ENA content in preparations A, B, and D after 12 weeks was significantly lower than the initial content. The DA content in preparations A and D had increased markedly after 12 weeks and so had the DKP content in preparation B.Our study showed that the quality of the generic tablets C, E, and F was comparable to that of brand name tablet A with respect to stability and resistance to humidity. We conclude that if generic manufacturers continue to produce such high quality drugs, this will lead to greater confidence in their effectiveness and an increase in their use in the clinical setting.

著者

尾鳥 勝也 田口 祐子 矢後 和夫

出版者

一般社団法人日本医療薬学会

雑誌

医療薬学 (ISSN:1346342X)

巻号頁・発行日

vol.31, no.9, pp.761-767, 2005-09-10 (Released:2011-03-04)

参考文献数

7

被引用文献数

5 6

---

We studied the quality and stability of generic sodium ozagrel solution products for injection. Through the use of inspection apparatus, we noted exfoliation of the surface layer of glass ampoules filled with sodium ozagrel solution drug products for injection. Also, foreign insoluble matter, such as oil droplets, which was assumed to be silicone that had been applied to the internal surface of syringe barrels, was observed in pre-filled syringe products. In a stability study performed under accelerated conditions (40°C/75% RH) the generic sodium ozagrel solutions yielded a degradation product that was not detected in the lyophilized original product. The degradation product content of some of the generic products was over 16 mg/mL of sodium ozagrel, exceeding the specification for the original lyophilized product. These results indicate that some of the generic products are inferior in quality and stability to the original lyophilized drug.

著者

大久保 正

出版者

一般社団法人日本医療薬学会

雑誌

医療薬学 (ISSN:1346342X)

巻号頁・発行日

vol.31, no.2, pp.121-124, 2005-02-10 (Released:2011-03-04)

参考文献数

10

被引用文献数

3 3

---

Using high performance liquid chromatography (HPLC), the author determined the content of nicardipine degradation product (L-1) in brand-name and generic-name nicardipine injection products. The mobile phase consisted of 0.25 % KH2PO4 (pH 6.5) -CH3OH (25 : 75, v/v) and the detection wavelength was set at 254 nmUV. A separate peak for L-1 was identified by using reference standard compounds. Several products of nicardipine injection on the Japanese market were analysed and the L-1 contents varied among them. Through this study, we found that there were differences in quality between the brand-name and generic nicardipine injection products, and that there were also differences in quality among the individual generic products.

著者

鳴戸 郁江 岡本 佳菜美 西方 真弓 松山 賢治

出版者

一般社団法人日本医療薬学会

雑誌

医療薬学 (ISSN:1346342X)

巻号頁・発行日

vol.32, no.6, pp.523-530, 2006-06-10 (Released:2007-11-09)

参考文献数

9

被引用文献数

6 6

---

In order to evaluate generic versions of famotidine, 11 kinds of famotidine tablets and 7 kinds of famotidine injection (both tablets and injection included the branded product, respectively) were subjected to dissolution testing and HPLC analysis.In the case of tablets, both the branded drug (Gaster®) and the 10 generics satisfied the standard dissolution test requirement that more than 70% of tablets should dissolve within 60 min, though there were significant differences in the time taken to achieve more than 70% dissolution. In this respect, some of the generics were quite different from the branded drug.As for the famotidine injection-formulations, both the branded drug, (Gaster® injection) and the 6 generics satisfied the standard for the content test in JP XIV. However, HPLC analysis showed that generic formulations contained a variety of impurities while the branded injection (Gaster® for injection 20 mg) contained very few impurities. In three of the generic injection-formulations-Famostagine® for injection 20 mg, Progogue® for injection 20 mg and Gasport® for injection 20 mg —the contents of impurities were significantly different from that of Gaster® for injection 20 mg.The present study showed that there were appreciable quality differences between the branded and generic versions of famotidine irrespective of formulation.

著者

矢野 良一 中村 敏明 谷 大輔 西里 洋平 後藤 伸之 脇屋 義文 政田 幹夫

出版者

一般社団法人日本医療薬学会

雑誌

医療薬学 (ISSN:1346342X)

巻号頁・発行日

vol.33, no.12, pp.998-1002, 2007 (Released:2009-09-04)

参考文献数

9

被引用文献数

3 5

---

The purpose of this study was to evaluate the quality of the original and 3 generic formulations of Iopamidol injection.To do this,the free iodine concentration and osmotic pressure were measured.In addition,impurities were tested for using high performance liquid chromatography-tandem mass spectrometry.There were no major differences between the original and generic formulations as regards free iodine concentration and osmotic pressure measurements,though one lot of the original formulation failed the free iodine concentration test.However,in the HPLC analysis,some substances not present in the original product were detected in the generic formulations.One of them was identified as DM 1/2,a substance related structurally to Iopamidol.

著者

木村 康浩 大浜 修 土井 穂波 柴田 ゆうか 木平 健治

出版者

一般社団法人日本医療薬学会

雑誌

医療薬学 (ISSN:1346342X)

巻号頁・発行日

vol.34, no.6, pp.573-577, 2008 (Released:2009-09-04)

参考文献数

6

被引用文献数

5 4

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Very little information is available on the quality of generic products and it has recently been reported that anaphylaxy shock occurred when a generic formulation of an injectable cefazolin sodium product was used in a patient before surgery.This suggests that the generic product contained impurities that caused such an adverse reaction.It is therefore important to determine the constituents of generic products and compare them with those of the original products.We analyzed the original cefazolin sodium product and 4 generics of it by means of high performance liquid chromatography in order to determine differences in quality between them.Three impurities were found in the original product and 4 in the generic products,respectively.However,the impurity content of all of the generic products was significantly higher than that of the original product and on analyzing synthetic samples of impurities which could possibly be contained in the cefazolin sodium products,the chromatographic peaks of three of them overlapped with the peaks observed in the chromatograms of the original and generic products.These results suggest that there can be great differences in quality between the original and generic products,and that the impurities might be cefazolin-related substances.We must therefore select generics based on an appraisal of the quality information available for them in order to minimize unexpected adverse reactions and achieve more cost effective and safe therapy.

著者

吉田 阿希 舘 知也 兼松 勇汰 杉田 郁人 野口 義紘 大澤 友裕 安田 昌宏 水井 貴詞 後藤 千寿 寺町 ひとみ

出版者

一般社団法人日本医療薬学会

雑誌

医療薬学 (ISSN:1346342X)

巻号頁・発行日

vol.44, no.1, pp.49-53, 2018-01-10 (Released:2019-01-10)

参考文献数

19

被引用文献数

1

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Recently, the use of complementary alternative medicine (CAM) has been increasing in Japan. There are few reports on the use of CAM such as health foods and supplements in cancer patients despite the high interest in it. In this study, we performed a retrospective research to elucidate factors influencing the use of health foods and supplements in cancer patients. The objectives were inpatients diagnosed with cancer at Gifu Municipal Hospital between October 1, 2014 and March 31, 2015. Survey items were age, gender, information on cancer, history of chemotherapy and operation, prescription drugs, and health foods and supplements at admission. A multiple logistic regression analysis was conducted to evaluate the influence of survey items on the use of health foods and supplements. Statistical significance was set at P < 0.05. Patients using health foods and supplements were 5.8% (59/1,012). The use rate of health foods and supplements is significantly high in recurrent patients [odds ratio (OR), 4.83; 95% confidence interval (CI), 2.55-9.15; P < 0.001] and is significantly low in patients receiving operation [OR, 0.363; 95% CI, 0.197-0.667; P = 0.001]. In this study, it was clarified that recurrent cancer patients more frequently use health foods and supplements, and that cancer patients undergoing surgery use them less frequently.