荊芥連翹湯 抽出物의 SD Rats에서 28일 經口 반복투여 독성시험 (28days Repeat Oral Dose Toxicity Test of “Hyeonggaeyeongyotang” extract in SD Rats)

서지정보

· 발행기관 : 대한한의학방제학회
· 수록지 정보 : 대한한의학 방제학회지 / 16권 / 1호 / 147 ~ 168페이지
· 저자명 : 안현주, 김상찬, 지선영, 황순이, 이종록

초록

Objectives : HYTE (Hyeonggaeyeongyotang Extract), a polyherbal formula has been used as folk medicine, 28days repeat oral dose toxicity was tested in SD rats according to KFDA Guideline[2005-60].
Methods : In this study, mortality, clinical signs, body weight and gains, food and water consumption, ophthalmologic observation, urinalysis, hematology, serum biochemistry, gross findings, organ weight and histopathological observations were conducted during 28days of dosing periods.
Results :
1. No HYTE treatment-related mortalities and clinical signs were detected in all dosing levels
tested in male and female rats during the whole experimental periods.
2. No HYTE treatment-related changes on body weight, gains and food consumption were detected in all dosing levels tested in male and female rats during the whole experimental periods except for 2000㎎/㎏-dosing female groups in which significantly increase of body weight, gains, food and water consumption were detected compared to that of vehicle control in some points.
3. No HYTE treatment-related changes on ophthalmologic examination were detected in all dosing levels tested in male and female rats.
4. No HYTE treatment-related changes on urinalysis were detected in all dosing levels tested in male and female rats except for 2000㎎/㎏-dosing female groups in which, significantly increase of urine volume and related decrease on the urine specific gravity were detected as secondary effects of increase on the water consumptions not HYTE treatment-related toxicological signs.
5. No HYTE treatment-related changes on hematology were detected in all dosing levels tested in male and female rats except for increases in the total WBC count and lymphocytes of 2000㎎/㎏-dosing male and female groups with decrease of large unstained cells as pharmacological effects of immune enhancements not HYTE treatment-related toxicological signs.
6. No HYTE treatment-related changes on serum biochemistry were detected in all dosing levels tested in male and female rats.
7. No HYTE treatment-related changes on gross findings, organ weight and histopathology were detected in all dosing levels tested in male and female rats except for 2000㎎/㎏-dosing male and female groups in which, spleen and thymus organ weights, hypertrophy at gross observation and hyperpalsia of lymphoid cells and follicles at histopathological observation in spleen and thymus were detected as pharmacological effects of immune enhancements not HYTE treatment-related toxicological signs.
Conclusions : Based on these results, the NOAEL and MTD of HYTE in SD rats were considered as over 2000㎎/㎏, respectively at 28days repeat oral dose toxicity test because most of these findings were considered as results of pharmacological effects of immune enhancements not HYTE treatment-related toxicological signs or secondary effects.

영어초록

Objectives : HYTE (Hyeonggaeyeongyotang Extract), a polyherbal formula has been used as folk medicine, 28days repeat oral dose toxicity was tested in SD rats according to KFDA Guideline[2005-60].
Methods : In this study, mortality, clinical signs, body weight and gains, food and water consumption, ophthalmologic observation, urinalysis, hematology, serum biochemistry, gross findings, organ weight and histopathological observations were conducted during 28days of dosing periods.
Results :
1. No HYTE treatment-related mortalities and clinical signs were detected in all dosing levels
tested in male and female rats during the whole experimental periods.
2. No HYTE treatment-related changes on body weight, gains and food consumption were detected in all dosing levels tested in male and female rats during the whole experimental periods except for 2000㎎/㎏-dosing female groups in which significantly increase of body weight, gains, food and water consumption were detected compared to that of vehicle control in some points.
3. No HYTE treatment-related changes on ophthalmologic examination were detected in all dosing levels tested in male and female rats.
4. No HYTE treatment-related changes on urinalysis were detected in all dosing levels tested in male and female rats except for 2000㎎/㎏-dosing female groups in which, significantly increase of urine volume and related decrease on the urine specific gravity were detected as secondary effects of increase on the water consumptions not HYTE treatment-related toxicological signs.
5. No HYTE treatment-related changes on hematology were detected in all dosing levels tested in male and female rats except for increases in the total WBC count and lymphocytes of 2000㎎/㎏-dosing male and female groups with decrease of large unstained cells as pharmacological effects of immune enhancements not HYTE treatment-related toxicological signs.
6. No HYTE treatment-related changes on serum biochemistry were detected in all dosing levels tested in male and female rats.
7. No HYTE treatment-related changes on gross findings, organ weight and histopathology were detected in all dosing levels tested in male and female rats except for 2000㎎/㎏-dosing male and female groups in which, spleen and thymus organ weights, hypertrophy at gross observation and hyperpalsia of lymphoid cells and follicles at histopathological observation in spleen and thymus were detected as pharmacological effects of immune enhancements not HYTE treatment-related toxicological signs.
Conclusions : Based on these results, the NOAEL and MTD of HYTE in SD rats were considered as over 2000㎎/㎏, respectively at 28days repeat oral dose toxicity test because most of these findings were considered as results of pharmacological effects of immune enhancements not HYTE treatment-related toxicological signs or secondary effects.

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