Mac OS X 10.3.7 Quartz PDFContext - Word - 000494
Mac OS X 10.3.7 Quartz PDFContext - Word - 000494
Mac OS X 10.3.7 Quartz PDFContext - Word - 000494
OSTEOKING
Orally Administrated to Mice
Test Reporter:
Shu Ye
Professor of Pharmacology,
Kunming Medical College
Test Personnel:
Wang Youlan
Assistant Researcher of Medical Institute,
Kunming City
Manufacturer:
Yunnan Crystal Natural Drugs
Pharmaceutical Factory
Kunming China
1. Materials:
ICR mice were provided by the Animal Feeding Room, the Key Laboratory of
Pharmacology of Natural Drugs, Yunnan Province.
(Animal quality Certificate: No.: 0000265).
2. Methods:
Concentrated OSTEOKING was dispensed for experimental use at three times the
clinical concentration.
60 healthy mice (body weights: 18-22g) were selected and divided randomly into
three groups: 20 mice in each group, half of them male and half female.
3. Results:
2
4. Assay of maximum tolerated dosage (MTD)
20 qualified mice (described above), were selected for the assay, half male and
half female. Their stomachs were perfused with 50ml/kg of OSTEOKING
solution (equivalent to three times the clinical concentration) once after 12 hours
of fasting and then once every 8 hours (three times a day). The daily dosages were
150ml/kg (equivalent to 76.5g/kg of crude drug, according to surface area
conversion). This dosage was equivalent to 64.5 times the adult daily clinical
dosage. If converted according to body weight, the dosage would be 540 times the
adult daily clinical dosage. But even at this dosage, no animals died. We observed
the animals’ reaction every day, continuing for 14 days. All the animals survived
in good health. Their hair was smooth, and their diets and activities were normal.
We did not find any apparent toxic reactions. Therefore the MTD is greater than
150ml/kg (three times the clinical concentration).
5. Evaluation
We could not assay the half lethal dose in mice (LD50) even after perfusion into
the animals’ stomachs of three times the clinical concentration of OSTEOKING
and a dosage as high as 50ml/kg (equivalent to 25.5g/kg of crude drug). The test
of MTD showed that the daily dosage reached 150ml/kg (equivalent to 76.5g/kg
of crude drug). According to surface area conversion, it would be 64.5 times the
adult daily clinical dosage and 540 times the adult daily clinical dosage if
converted according to body weight. But even at this dosage, no animals died..
The results indicate that the MTD of OSTEOKING is greater than 150ml/kg,
(three times the clinical concentration). The clinical application dosage of
OSTEOKING is therefore safe.
(The original data of the test is kept in Pharmacology Teaching and Research
Section, Kunming Medical College).