• Journal of Pharmacopuncture
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• v.12 no.4
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• pp.33-50
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• 2009

Objectives : This study was conducted to confirm validation and stability of concentration analysis method of pure melittin (Sweet Bee Venom-Sweet BV) extracted from the bee venom by utilizing protein isolation method of gel filtration. Methods : All experiments were conducted at Biotoxtech, a non-clinical studies authorized institution, under the regulations of Good Laboratory Practice (GLP). Standard solutions of melittin (SIGMA, USA) and test substances were dispensed and were analyzed with HPLC for Sweet BV to secure the validation of analysis. Results : 1. Measurement of system suitability of Sweet BV satisfied criterion of below 3%. 2. Confirming Linearity of Sweet BV in 10-200${\mu}g/m\ell$ solution yielded correlation coefficient (r) of 0.995 and accuracy of 85-115% which satisfy criterion. 3. Measurement of Specificity of Sweet BV didn't yield any substance affecting the peak of test substances, but detected at 21.22min verified as the test substance. 4. Confirming Intra-day of Sweet BV, accuracy and precision of 0.1, 100${\mu}g/m\ell$ were 105.70, 95.81 and 0.66, 0.73, respectively, satisfying both criteria of accuracy (85-115%) and precision (within 10%). 5. To measure Stability in autosampler, all samples used in Intra-day reproducibility sat in the autosampler for five hours and were re-analyzed. Both variability and precision satisfied the criteria. 6. Homogeneity of Sweet BV (0.1, 100${\mu}g/m\ell$) at upper, middle, and lower layers all satisfied the accuracy and precision criteria. 7. Stability of Sweet BV (0.1, 100${\mu}g/m\ell$) at room temperature for four hours and refrigerated for 7 days all satisfied the criterion. 8. For the measurement of Quality control, QC samples measured on the first and eighth day all satisfied accuracy and precision criteria. Conclusion : Above experiment data satisfies validation and stability of concentration analysis method of Sweet BV.

• Journal of Pharmacopuncture
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• v.14 no.3
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• pp.19-45
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• 2011

Objectives: This study was performed to analyse the effects of Sweet Bee Venom(Sweet BV-pure melittin, the major component of honey bee venom) on the central nervous system in rats. Methods: All experiments were conducted at Biotoxtech Company, a non-clinical studies authorized institution, under the regulations of Good Laboratory Practice (GLP). Male rats of 5 weeks old were chosen for this study and after confirming condition of rats was stable, Sweet BV was administered in thigh muscle of rats. And checked the effects of Sweet BV on the central nervous system using the functional observational battery (FOB), which is a neuro-toxicity screening assay composed of 30 descriptive, scalar, binary, and continuous endpoints. And home cage observations, home cage removal and handling, open field activity, sensorimotor reflex test/physiological measurements were conducted. Results: 1. In the home cage observation, there was not observed any abnormal signs in rats. 2. In the observation of open field activity, the reduction of number of unit areas crossed and rearing count was observed caused by Sweet BV treatment. 3. In the observation of handling reactivity, there was not observed any abnormal signs in rats. 4. In the observation of sensorimotor reflex tests/physiological measurements, there was not observed any neurotoxic signs in rats. 5. In the measurement of rectal temperature, treatment of Sweet BV did not showed great influences in the body temperature of rats. Conclusions: Above findings suggest that Sweet BV is relatively safe treatment in the central nervous system. But in the using of over dose, Sweet BV may the cause of local pain and disturbance of movement. Further studies on the subject should be conducted to yield more concrete evidences.

• Journal of Acupuncture Research
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• v.27 no.2
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• pp.79-87
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• 2010

Objectives : The aim of this study is to investigate the effect of Hominis Placenta pharmacopuncture therapy and sweet bee venom therapy on peripheral facial paralysis. Methods : Clinical studies were done 36 patients who were treated peripheral facial paralysis to Dept. of Acupuncture and Moxibusition, of Oriental Medicine Dong-Eui University from June 15, 2009 to January 5, 2010. Subjects were randomly divided into 2 groups. : Hominis Placenta Pharmacopuncture treated group (group A, n=18), sweet bee venom treated group (group B, n=18). In group A, we treated patients with dry needle acupuncture and Hominis Placenta pharmacopuncture therapy. In group B, we treated patients with dry needle acupuncture and sweet bee venom therapy. All process of treatment were performed by double blinding method. To investigate the effectiveness of treatment applied for two groups, we used Yanagihara's unweighed grading system at before treatment, after 1week, 2weeks, 3weeks and 4weeks of treatment. Results : The Yanagihara's scores of group B were higher than those of group A, but not statistically significant. The improvement indexs of group A and group B were different, but not statistically significant. Conclusions : There were no significant differences statistically between Hominis Placenta pharmacopuncture therapy and sweet bee venom therapy on peripheral facial paralysis.

• Journal of Acupuncture Research
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• v.26 no.6
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• pp.241-249
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• 2009

Objectives : The purpose of this study is to report the patients with compressive neuropathy of the radial nerve(Saturday Night Palsy), who was improved by acupuncture and Sweet Bee Venom(SBV) treatment. Methods & Results : The patients were hospitalized or outpatient in Dept. of Acupuncture & Moxibustion, traditional korean medical hospital, Sangji University from 1st, Dec. 2008 to 30th June 2009, and treated with acupuncture, SBV, electrical stimulation therapy and herbal medication therapy. To evaluate the wrist drop and numbness of fingers, coding result(Arbitrary values used to evaluate result) and digital infrared thermal image, which was well defined diagnostic tool estimating skin surface temperature difference, were used. As a result, patient symptoms were improved remarkably. Conclusions : Patients were treated during 6 weeks in average. 2 cases were excellent and 1 case was evaluated good result by the acupuncture, Sweet Bee Venom, electrical stimulation therapy.

• Journal of Pharmacopuncture
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• v.12 no.2
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• pp.85-90
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• 2009

Objectives : Sweet bee venom(SBV) is pure melittin, the main component of bee venom, made by removing another components through gel filtration chromatography and propionic acid/urea polyacrylamide gel electrophoresis. In the using SBV, 2 patients were experienced anaphylaxis by SBV. So, we reported the process of anaphylaxis and consider these situation. Methods : We observed 2 patients suffered from anaphylaxis after treated with SBV in the Korean Medical Hospital, Sangji University. Results : Though SBV was removed allergen from bee venom, it is not possible to complete prevention of anaphylactic shock in the clinics. So, Korean medical doctor using BV or SBV must be prepare the system consider a countermeasure by anaphylaxis.

• The Journal of Internal Korean Medicine
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• v.38 no.5
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• pp.698-708
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• 2017

Objectives: The aim of this study was to report the clinical effects of a combination of Gamiguibi-tang and sweet bee venom on a patient with Raynaud's disease. Methods: The patient with Raynaud's disease was treated with Gamiguibi-tang three times a day for 43 days and with sweet bee venom daily. The effects on Raynaud's disease were measured on both hands using a cold stress test and an infrared thermometer and by digital infrared thermographic imaging and a NRS (Numeric Rating Scale). We conducted the cold stress test at 6-8 day intervals from 2016.04.27 to 2016.06.08. Results: After treatment, the symptoms of pain were decreased in both hands and digital infrared thermographic imaging (DITI) confirmed a rise in the temperature of the fingers. The fingertip temperature increased from 29.6 to 30.4 degrees and the cooling/rewarming ratio (CRR) increased steadily. No adverse events were found at discharge. Conclusions: Gamiguibi-tang combined sweet bee venom may improve symptoms in patients with Raynaud's disease.

• Journal of Acupuncture Research
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• v.30 no.5
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• pp.211-217
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• 2013

Objectives : The purpose of this study was to prove the clinical safety of Sweet Bee Venom(BV) and observe the physical reaction(percentage of localized itching & pain) after Sweet BV treatment. Methods : This study was carried out on 130 patients who had been injected with Sweet BV in Koran Medicine Hospital of Woosuk University from March 20, 2012 to June 30, 2013. Patients were treated with Sweet BV daily and we checked the physical reaction. After that, we analyzed those according to treatment times and body parts of injection. Results : 37 patients(28.46 %) complained localized itching and 41 patients(31.54 %) complained localized pain after Sweet BV injection. In 37 patients who complained localized itching, 8 patients were experienced itching in the first treatment. And 27 patients were experienced itching in the 1st~5th treatment. Wrist, ankle and toe were the highest percentage of localized itching. Finger was the highest percentage of localized pain. Knee showed a relatively higher percentage of itching, pain, itching & pain than other body parts. Conclusions : This study suggested that Sweet BV treatment was relatively safe treatment and doctors should explain the physical reaction before treating patients. Further studies are needed to propose a guideline for safety and treatment.

• Journal of Acupuncture Research
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• v.37 no.3
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• pp.173-176
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• 2020

Sweet bee venom (SBV) causes less hypersensitivity reactions compared with whole bee venom. To determine the appropriate SBV initial dose for pharmacopuncture treatment of lower back pain, the initial dose, and the dose which caused hypersensitivity were retrospectively reviewed between January 1^st, 2017 and December 31^st, 2019. There were 523 first-visit patients who received SBV pharmacopuncture for lower back pain and 41 showed hypersensitivity. No systemic reactions were observed and localized reactions were not severe. Hypersensitivity was observed during the first (7 cases), and fifth treatments (8 cases). An initial SBV (10%) volume of 0.1 mL was used in 2 cases, 0.2 mL in 6 cases, 0.6 mL in 41 cases, and 1.2 mL in 474 cases. The hypersensitivity rate during the first and fifth treatment was 1.34% and 1.53%, respectively. As a result, 1.2 mL of SBV was considered the acceptable initial dose. However, for safer treatment, we recommend limiting the initial dose of SBV to 0.5 mL.

• Journal of Pharmacopuncture
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• v.12 no.4
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• pp.5-32
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• 2009

Objectives: This study was performed to analyse single dose toxicity of pure melittin(Sweet Bee Venom-Sweet BV) extracted from the bee venom by utilizing protein isolation method of gel filtration. Methods: All experiments were conducted at Biotoxtech, a non-clinical studies authorized institution, under the regulations of Good Laboratory Practice (GLP). Six weeks old female Sprague-Dawley rats were chosen for the pilot study and determined 30㎎/㎏ which is 4285 times higher than the clinical application dosage as the high dosage, followed by 15 and 7.5㎎/㎏ as mid and lose dosage, respectively. Equal amount of excipient to the Sweet BV experiment groups was administered as the control group. Results: 1. No mortality was witnessed in all of the experiment groups. 2. Hyperemia and movement disorder were observed around the area of administration in all groups, and higher occurrence in the higher dosage groups. Hyperemia and movement disorder diminished with elapsed time. 3. For the weight measurement, male groups showed larger reduction in weight in accordance with higher dosage. Female groups didn't s how significant changes. 4. To verify abnormalities of organs and tissues, cerebellum, cerebrum, liver, lung, kidney, and spinal nerves were removed and conducted histological observation with H-E staining. No abnormalities were detected in any of organs and tissues. 5. One female rat in the 30㎎/㎏ group had amputated toe near the administered area and histopathological finding was hemorrhage with inflammation. This is presumed as a secondary infection after the administration of Sweet BV. Conclusion: Above findings suggest Sweet BV is relatively s safe treatment medium. Further studies on the subject should be conducted to yield more concrete evidences.

• Journal of Pharmacopuncture
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• v.11 no.4
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• pp.15-24
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• 2008

Objective The aim of this study is to investigate if Sweet Bee Venom(SBV) Therapy has the equal effect in comparison with Bee Venom (BV) Therapy on Chronic Lower Back Pain. Methods Clinical studies were conducted to 39 patients who were treated Chronic Lower Back Pain in Dept. of Acupuncture and Moxibustion, Dongeui University from March 1 to June 30, 2008. Subjects were randomly devided into 2 groups : BV treated group(Group A, n=19), SBV treated group(Group B, n=20) In BV treated group(Group A), we treated patients with dry needle acupuncture and BV Therapy. In SBV treated group(Group B), we treated patients with dry needle acupuncture and SBV Therapy. All process of treatment were performed by double blinding method. 1. To estimate the efficacy of venom in controlling pain, we have checked Visual Analog Scale(VAS). 2. For evaluating functional changes of patients, we have checked Oswestry Lower Back Disability Questionnaire(ODI). 3. To estimate Itching which is the most prominent symptom of allergic reaction, we have checked Visual Analog Scale(VAS). Results 1. In controlling pain, the results of BV treated group(Group A) is more effective than that of SBV treated group(Group B). 2. In promoting function, the results of BV treated group (Group A) is more effective than that of SBV treated group(Group B). 3. In controlling itching, the results of SBV treated group(Group B) is more effective than that of BV treated group(Group A). Conclusions According to the study, SBV Therapy shows more effective result than BV Therapy in controlling itching. But BV Therapy is more effective than SBV Therapy in controlling pain and promoting function.