• Clinical and Experimental Reproductive Medicine
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• v.21 no.1
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• pp.21-29
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• 1994

Subzonal insemination(SUZI) has been proposed for patients with severe male factor and previous fertilization failure. However, very low fertilization rates still persisted. The aims of this study were firstly, to examine the relationships between the fertilization rate and sperm parmeters, sperm incubation media and time, secondly, to evaluate the outcome of 119 cycles of SUZI applied the modified sperm preparation method. The fertilization rates were influenced more sensitively by sperm preincubation media and time than by sperm parameters. According to preincubation media and time, the fertilization rates were 43.3% in 50% follicular fluid (HFF), 36.6% in 10% fetal cord serum(FCS), and with the time, increased in FCS, but decreased in HFF. In regrd with sperm parameters, the fertilization rates were 42.9% in normal and 37.6% in subnormal group. The best results were obtained from SUZI by the spermatozoa incubated in 50% HFF for 6-8 hours. So we tried 119 cycles of SUZI(normal; 39 cycles, subnormal; 80 cycles) using the preparation method of 6-8 hour incubation in 50% HFF. There were no signigicant differences in the fertilization rates between normal(125/269, 46.4%) and subnormal sperm(264/635, 41.6%). Contrary to the fertilization rates, pregnancy outcomes were different between both groups. Better results obtained from the subnormal group than the normal in the number of transferred embryos, that of good embryos, and developmental rate of the fertilized eggs. The pregnancy rates per transfer were totally 13.3%(13/98),20.0%(13/65) in subnormal group. In the normal group, 2 patients showed ${\beta}$-hCG positive, but resulted in chemical pregnancy. Of 13 clinical pregnancies, two aborted, 6 on-going, and 5 delivered. In conclusion, SUZI is an effective technique to overcome fertilization failure for male factor and unexplained. The fertilization rate is influenced by sperm parameters, sperm incubation media and time. Also the quality of oocytes might be important for pregnancy as same as that of sperm.

• The Journal of Internal Korean Medicine
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• v.33 no.1
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• pp.62-68
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• 2012

Objectives : This study aimed to evaluate the single oral dose toxicity of Seonpyejeongcheon-tang (SJT) in male and female Sprague-Dawley rats. Methods : In this single oral toxicity study, rats were orally administrated in a single dose of 0 or 5,000 mg/kg SJT. There were 7 rats in each group. After single administration, mortality, clinical signs, body weight changes and gross pathological findings were observed for 14 days. Organ weight, clinical chemistry and hematology were tested after 14 days. Results : There was no mortality or other clinical signs for 14 days. There were also no significant differences in body weight, organ weights, hematological and serum chemical parameters between the SJT and control groups. Conclusions : The results obtained in this study suggest that the 50% lethal dose of SJT is over 5,000 mg/kg, so this finding can be expected to provide scientific evidence for the safety of SJT.

• CELLMED
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• v.11 no.1
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• pp.2.1-2.8
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• 2021

The clinical condition Amnesia causes difficulty in learning new information and the inability to recall past events. It is primarily concerned with recent memory loss. Majoon-e-Nisyan (MJN) is a polyherbal Unani formulation, present in a semi-solid form. It is widely used potent drug of the Unani System of Medicine (USM) for treating Nisyan (amnesia). In the present study polyherbal Unani formulation, MJN has been studied for its quality control and acute toxicity. Standardization (quality control) of drugs deals with drug identity, drug quality and purity determination. Standardization of MJN had been done as per the Unani pharmacopoeial parameters approved by World Health Organization (WHO) - Pharmacognostical parameters, Physico-chemical parameters, high-performance thin-layer chromatography (HPTLC), microbial load, aflatoxin, and heavy metals. Solvents and chemicals used in the study were of analytical grade and used instrument were calibrated. By conducting an acute oral toxicity study in rats, the safety of MJN was assessed. The limit test method of OECD guideline 425 was followed in the study. Results of standardization and standard operating procedures (SOPs) for preparation of MJN may serve as the standard reference in the future. The data generated in the study for the quality control of MJN proved the quality of formulation and shows that MJN is not toxic in rats following acute dosing up to 2000 mg/kg bw. The data obtained in the paper for MJN may be used as a standard guideline for preparation of the formulation which can save time, cost, and resources for future research endeavours.

• Toxicological Research
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• v.16 no.4
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• pp.302-309
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• 2000

The purpose of this study is to investigate toxic effects of iso-butylalcohol (iBA) in Sprague-Dawley (SD) rats under the exposure of 6 hours a day, 5 days a week for 13 weeks by inhalation, and to evaluate the occupational safety of iBA in comparison with the permissible exposure level (PEL) stipulated by the Occupational Safety and Health Administration (OSHA). iBA did not induce any abnormal changes from the aspects of clinical signs, feed consumption, ophthalmic test, urinalysis, hematology and blood chemistry during and at the terminal of the inhalation toxicity tests. We did not find any abnormal findings in the gross and microscopic observations due to the inhalation of iBA. There was no alteration in relative organ weights by the inhalation of iBA. No observed adverse effect level (NOAEL) of iBA was considered to be more than 3,000 ppm in rats under the inhalation of 6 hours a day, 5 days a week for 13 weeks. Fifty ppm of iBA, the PEL regulated by OSHA, is too conservative for working places. As iBA showed no abnormal observations in all the experimental parameters at any concentration under this experimental condition, we suggest that 150 ppm is safe enough for the PEL of iBA in the working areas, even taking into onsideration that OSHA lowered the PEL to 50 ppm for fear of the probable risk of its skin irritation.

• Biotechnology and Bioprocess Engineering:BBE
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• v.8 no.5
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• pp.279-285
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• 2003

Lidocaine and galactose loading tests were performed on a bioartificial liver (BAL), an extracorporeal medical device incorporating living hepatocytes in a cartridge without a transport barrier across the membranes. The concentration changes were analyzed using pharmacokinetic equations to evaluate the efficacy and limitation of the proposed method. Lidocaine and galactose were found to be suitable drugs for a quantitative evaluation of the BAL functions, as they did not interact with the plasma proteins or blood vessels, making their concentrations easy to determine. The drug concentration changes after drug loading were easily analyzed using pharmacokinetic equations, and the BAL functions quantitatively expressed by pharmacokinetic parameters, such as the clearance (CL) and galactose elimination capacity (GEC). In addition, these two drugs have already been used in clinical tests to evaluate human liver functions over long periods, and lidocaine CL values and GEC values reported for a normal human liver. Thus, a comparison of the CL and GEC values for the BAL and a natural liver revealed what proportion of normal liver functions could be replaced by the BAL.

• YAKHAK HOEJI
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• v.33 no.4
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• pp.229-236
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• 1989

Even though two different preparations are chemically equivalent, the variance of bioavailability differenciates the clinical effect of preparations, so that the preparations need to be evaluated by comparing bioavailability in vivo as well as chemical equivalence. In this study, bioequivalence tests of commercially available isoniazid tablets A, B, C and D (standard) were performed to give some guidelines to bioequivalence test. The bioavailability parameters obtained by drug administeration were statistically analyzed. Statistical evaluation of the data involved an analysis of variance for a cross over design. Cross over design was employed with 8 healthy volunteers. The results were within 20% difference of mean value in the AUC, Cmax, Tmax and amount of urinary excretion (Au) between standard and isoniazid tablets. The results of ANOVA showed no significant differences for 'group or sequence', but almost not for 'between subjects'. The tablet. A, B and D were within 20 min, but tablet C was within 50 min. Tablet A was biologically equivalent in the Au. tablet B biologically equivalent in the Au and AUC. Tablet C was biologically equivalent in the Au. The relationship between the dissolution rate and Au was significant.

• Journal of Microbiology and Biotechnology
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• v.23 no.5
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• pp.587-601
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• 2013

During the last few decades, it has become evident that the compatibility of the yeast biochemical environment with the ability to process and translate the RNA transcript, along with its capacity to modify a translated protein, are relevant requirements for selecting this host cell for protein expression in several pharmaceutical and clinical applications. In particular, Pichia pastoris is used as an industrial host for recombinant protein and metabolite production, showing a powerful capacity to meet required biomolecular target production levels in high-throughput assays for functional genomics and drug screening. In addition, there is a great advantage to using P. pastoris for protein secretion, even at high molecular weights, since the recovery and purification steps are simplified owing to relatively low levels of endogenous proteins in the extracellular medium. Clearly, no single microexpression system can provide all of the desired properties for human protein production. Moreover, chemical and physical bioprocess parameters, including culture medium formulation, temperature, pH, agitation, aeration rates, induction, and feeding strategies, can highly influence product yield and quality. In order to benefit from the currently available wide range of biosynthesis strategies using P. pastoris, this mini review focuses on the developments and technological fermentation achievements, providing both a comparative and an overall integration analysis. The main aim is to highlight the relevance and versatility of the P. pastoris biosystem to the design of more cost-effective microfactories to meet the increasing demands for recombinant membrane proteins and clinical antibodies for several therapeutic applications.

• Preventive Nutrition and Food Science
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• v.11 no.2
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• pp.115-119
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• 2006

The object of this study was to examine whether the germanium fortified yeast administered to SD rat is accumulated in the liver and kidney. The administration doses were within 2,000 mg/kg which is the level of NOAEL (no observed adverse effect level) proved through the previous study of single/consecutive oral toxicity test. There were no significant clinical symptoms and mortality following the administration of organic germanium-fortified yeast (0, 500, 1,000, 2,000 mg/kg) during the whole test period, and also no difference in the consumed amount of feed and water for each group. No significant abnormalities of hematology and blood chemistry parameters were found in all groups of organic germanium-fortified yeast (0, 500, 1,000, 2,000 mg/kg). The amount of germanium accumulated in liver and kidney was 0 g/kg by ICP-AES method in the group of organic germanium-fortified yeast. In the positive control group of $GeO_2$ (150 mg/kg), the amount of accumulation was shown to 3135.0 and 4277.2 g/kg in each female and male kidney and 1044.3 and 2135.8 g/kg in each female and male liver, respectively. Organic germanium-fortified yeast, a biosynthetic product resulting from putting germanium into yeast, did not show any clinical symptoms, blood chemical significance, and residues in kidney and liver. It could be inferred that the non-toxic amount of organic germanium-fortified yeast was up to 2,000 mg/kg.

• Journal of Korean Medicine Rehabilitation
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• v.28 no.2
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• pp.61-72
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• 2018

Objectives The purpose of this experiment is to evaluate 4 weeks DRF (Dose Rate Finding) and single oral dose toxicity of ChondroT in rats. Methods In 4-week DRF, male and female Sprague-Dawely rats were treated with ChondroT at oral dose of 0, 500, 1000, and 2000 mg/kg. clinical signs, body weight, food consumption, necropsy findings, organ weight, hematological and blood-chemical parameters, and histological findings were monitored for 4 weeks. Also, after single oral administration of ChondroT, mortality, clinical signs, body weight, and necropsy findings were minitored for 2 weeks. Results In 4-week DRF and single dose oral toxicity study of ChondroT in sprague-Dawley rats, ChondroT did not exhibit any toxicity under the study conditions employed. Conclusions The results suggested a no-observed adverse effects level (NOAEL) was over 2,000 mg/kg/day in SD rats after oral administration, this study could be used as basic study of the repeated dose 13-week oral toxicity study of ChondroT.

• Clinical and Experimental Reproductive Medicine
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• v.38 no.2
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• pp.75-81
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• 2011

Objective: Bisphenol A (BPA) is a chemical used extensively to manufacture plastics and epoxy resin liners for food and beverage cans. BPA, with properties similar to estrogen, has endocrine-disrupting effects. In the present study, we examined the effects of early prepubertal BPA exposure on the onset of puberty and reproductive parameters such as estrous cycle and reproductive organ weights in female mice. Methods: Female mice were injected subcutaneously at postnatal day (PND) 8 with BPA (0.1, 1, 10, 100 mg/kg) in sesame oil or with sesame oil alone. Body weight was measured from PND 10 to 70. Vaginal opening and estrous cycle were monitored from PND 20 to 29. Animals were sacrificed at PND 25, 30, and 70, and the ovary and uterus weights were measured. Results: Early prepubertal exposure to BPA (10 and 100 mg/kg) significantly decreased body weight from PND 18 to 30. BPA treated mice at testing dose levels showed early opening of the vagina compared to the control group. The number of estrous cycle and days of estrus were significantly decreased in high dose (100 mg/kg) BPA treated mice. The ovary weight at PND 25 and 30 was significantly decreased in all BPA treatment groups. Conclusion: Early prepubertal exposure to BPA accelerated the onset of puberty but decreased reproductive parameters in female mice.