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      Study on the Single Dose Toxicity of ShinEumHur Pharmacopuncture Injected into the Muscles of Rats

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          Abstract

          Objectives:

          This study was carried out to analyze the single dose toxicity of ShinEumHur (SEH) pharmacopuncture injected into the muscles of Sprague-Dawley rats.

          Methods:

          The SEH pharmacopuncture was made in a clean room at the Korean Pharmacopuncture Institute (K-GMP). After the mixing process with sterile distilled water had been completed, the pH was controlled to between 7.0 and 7.5. All experiments were conducted at Biotoxtech, an institution authorized to perform non-clinical studies under the Good Laboratory Practice (GLP) regulations. Sprague-Dawley rats were chosen for the pilot study. Doses of SEH pharmacopuncture, 0.25, 0.5 and 1.0 mL, were administered to the experimental groups, and a dose of normal saline solution, 1.0 mL, was administered to the control group. We examined the survival rate, weights, clinical signs, mean hematology parameters, mean clinical chemistry, necropsy and histopathological findings.

          This study was conducted under the approval of the Institutional Animal Ethics Committee.

          Results:

          No deaths or abnormalities occurred in any of the four groups. No significant changes in weight, hematological parameters or clinical chemistry between the control group and the experimental groups were observed. To check for abnormalities in organs and tissues, we used microscopy to examine representative histological sections of each specified organ; the results showed no significant differences in any of the organs or tissues.

          Conclusion:

          The above findings suggest that treatment with SEH pharmacopuncture is relatively safe. Further studies on this subject are needed to yield more concrete evidence.

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          Most cited references27

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          Liuwei Dihuang (LWDH), a Traditional Chinese Medicinal Formula, Protects against β-Amyloid Toxicity in Transgenic Caenorhabditis elegans

          Liuwei Dihuang (LWDH), a classic Chinese medicinal formula, has been used to improve or restore declined functions related to aging and geriatric diseases, such as impaired mobility, vision, hearing, cognition and memory. Here, we report on the effect and possible mechanisms of LWDH mediated protection of β-amyloid (Aβ) induced paralysis in Caenorhabditis elegans using ethanol extract (LWDH-EE) and water extract (LWDH-WE). Chemical profiling and quantitative analysis revealed the presence of different levels of bioactive components in these extracts. LWDH-WE was rich in polar components such as monosaccharide dimers and trimers, whereas LWDH-EE was enriched in terms of phenolic compounds such as gallic acid and paeonol. In vitro studies revealed higher DPPH radical scavenging activity for LWDH-EE as compared to that found for LWDH-WE. Neither LWDH-EE nor LWDH-WE were effective in inhibiting aggregation of Aβ in vitro. By contrast, LWDH-EE effectively delayed Aβ induced paralysis in the transgenic C. elegans (CL4176) model which expresses human Aβ1–42. Western blot revealed no treatment induced reduction in Aβ accumulation in CL4176 although a significant reduction was observed at an early stage with respect to β-amyloid deposition in C. elegans strain CL2006 which constitutively expresses human Aβ1–42. In addition, LWDH-EE reduced in vivo reactive oxygen species (ROS) in C. elegans (CL4176) that correlated with increased survival of LWDH-EE treated N2 worms under juglone-induced oxidative stress. Analysis with GFP reporter strain TJ375 revealed increased expression of hsp16.2::GFP after thermal stress whereas a minute induction was observed for sod3::GFP. Quantitative gene expression analysis revealed that LWDH-EE repressed the expression of amy1 in CL4176 while up-regulating hsp16.2 induced by elevating temperature. Taken together, these results suggest that LWDH extracts, particularly LWDH-EE, alleviated β-amyloid induced toxicity, in part, through up-regulation of heat shock protein, antioxidant activity and reduced ROS in C. elegans.
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            Inhibitory effect of Yukmijihwang-tang, a traditional herbal formula against testosterone-induced benign prostatic hyperplasia in rats

            Background Yukmijihwang-tang, a traditional herbal formula, has been used for treating disorder, diabetic mellitus and neurosis in China (Liu-wei-di-huang-tang in Chinese), Japan (Lokumijio-to in Japanese) and Korea for many years. In this study, we investigated the effects of Yukmijihwang-tang water extract (YJT) on the development of benign prostatic hyperplasia (BPH) using a rat model of testosterone propionate (TP)-induced BPH. Methods A total of 30 rats were divided into five groups. One group was used as a control and the other groups received subcutaneous injections of TP for 4 weeks to induce BPH. YJT (200 or 400 mg/kg) was administered daily for 4 weeks to two groups by oral gavage concurrently with the TP. The animals were euthanized, the prostate and body weights were recorded, and tissues were subjected to hormone assays and histomorphology. In addition, we investigated proliferating cell nuclear antigen (PCNA) expression in the prostate using immunoblotting. Results Animals with BPH showed significantly increased absolute and relative prostate weights, increased dihydrotestosterone levels in the serum or prostate and increased PCNA expression in the prostate; however, YJT-treated animals showed significant reductions compared with the animals with TP-induced BPH. Histomorphology also showed that YJT inhibited TP-induced prostatic hyperplasia. Conclusions These findings indicate that YJT effectively inhibited the development of BPH and might be a useful drug clinically.
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              Construction of a traditional Chinese medicine syndrome-specific outcome measure: the Kidney Deficiency Syndrome questionnaire (KDSQ)

              Background Development of Traditional Chinese Medicine (TCM) syndrome-specific outcome measures is needed for the evaluation of TCM syndrome-specific therapies. We constructed a Kidney Deficiency Syndrome Questionnaire (KDSQ) for the evaluation of the common TCM syndromes Kidney-Yin Deficiency Syndrome (KDS-Yin) and Kidney-Yang Deficiency Syndrome (KDS-Yang) in middle-aged women with menopausal symptoms. Methods KDS-Yin and KDS-Yang were traditionally defined by expert opinion were validated by exploratory factor analysis (EFA) and structural equation modeling (SEM). Content validity was tested by EFA on a sample of 236 women from a seminar and SEM on another sample of 321 women from a postal survey. Other psychometric properties were tested on 292 women from the seminar at baseline and two systematically selected sub-samples: 54 who reported no changes in discomforts 11–12 days after the baseline and 31 who reported changes in discomforts 67–74 days after the baseline. All participants completed the KDSQ, the Greene Climacteric Scale and the standard 12-item Short Form Health Survey. Results The EFA and SEM established the measurement models of KDS-Yin and KDS-Yang supporting content validity of the KDSQ. Internal consistency was good (Cronbach’s Alpha >0.70). Construct validity was supported by theoretically-derived levels of correlation with the established external measures. Test–retest reliability was strong (ICCagreement: KDS-Yin, 0.94; KDS-Yang, 0.93). The KDSQ was responsive to changes over time as tested by effect size and longitudinal validity. Conclusions The KDSQ was a valid and reliable measure for KDS-Yin and KDS-Yang in Hong Kong Chinese middle-aged women with menopausal symptoms.
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                Author and article information

                Contributors
                kscndl@hanmail.net
                Journal
                J Pharmacopuncture
                J Pharmacopuncture
                J Pharmacopunct
                10.3831
                Journal of Pharmacopuncture
                KOREAN PHARMACOPUNCTURE INSTITUTE
                2093-6966
                2234-6856
                December 2016
                : 19
                : 4
                : 350-358
                Affiliations
                [1 ]Department of Korean Medicine, Shinangun Geriatric Hospital, Korea
                [2 ]Department of Acupuncture & Moxibustion Medicine, Wonkwang University Gwangju Korean Medical Hospital, Gwangju, Korea
                [3 ]Nervous & Muscular System Disease Clinical Research Center of Wonkwang University Gwangju Korean Medical Hospital, Gwangju, Korea
                [4 ]Department of Internal Medicine, Oriental Medical Hospital, Wonkwang University Gwangju Korean Medical Hospital, Gwangju, Korea
                [5 ]Department of Oriental Internal Medicine, Oriental Medical Hospital, Wonkwang University Gwangju Korean Medical Hospital, Gwangju, Korea
                [6 ]Department of Radiology, Wonkwang University Gwangju Korean Medical Hospital, Gwangju, Korea
                Author notes
                * Corresponding Author *Corresponding Author Sungchul Kim. Department of Acupuncture & Moxibustion Medicine, Wonkwang University Gwangju Korean Medical Hospital, 543-8 Juweol 1-dong, Nam-gu, Gwangju 503-310, Korea. Tel: +82-62-670-6441 Fax: +82-62-670-6767 E-mail: kscndl@hanmail.net
                Article
                10.3831/KPI.2016.19.037
                5234355
                22a34689-8f78-4657-acac-2523cbc6f992
                Copyright ©2016, KOREAN PHARMACOPUNCTURE INSTITUTE

                This is an Open-Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License ( http://creativecommons.org/licenses/by-nc/3.0/) which permits unrestricted noncommercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                : 14 November 2015
                : 22 September 2016
                Categories
                Original Article

                intramuscular injection, pharmacopuncture, shineum-hur (seh), toxicity test

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