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Acute Toxicity Test of
OSTEOKING
Orally Administrated to Mice
Kunming Medical College

Pharmacology Dept.
June 28, 1998
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:
1.1 Drug to be tested:
OSTEOKING, sepia solution, 1 ml of the solution equivalent to 0.17g of crude

drug, provided by Yunnan Crystal Natural Drug Pharmaceutical Factory ( Lot
NO: 98051)
1.2 Test animals:
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:
2.1 Tested drug:
Concentrated OSTEOKING was dispensed for experimental use at three times the
clinical concentration.
2.2 Division of test animals:
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.
2.2 Dosage design and drug administration:
The three groups were designated as a high-dosage group (50ml/kg of

OSTEOKING, equivalent to 25.5g/kg of crude drug), a medium-dosage group
(35ml/kg, equivalent to 17.9g/kg of crude drug) and a low-dosage group
(25ml/kg, equivalent to 12.8g/kg of crude drug), respectively. The animals fasted
for 12 hours before drug administration. The mice in each group were given the
drug at the dosages specified above, through one-time profusion into the animal’s
stomachs. The reaction of the animals was observed every day after drug
administration and continued for 7 days.
3. Results:
No toxic reactions or deaths occurred following one-time perfusion of

OSTEOKING into the animal’s stomachs All of the tested animals’ conditions
were fine, their activities were normal and their hair looked smooth. Therefore,
even when the dosage of OSTEOKING solution reached 50ml/kg, equivalent to
25.5g of crude drug at 1 time (converted accordingly to surface area), equivalent
to 21.5 times the adult daily clinical dosage and 180 times the dosage calculated
according to body weight, we could not assay the half lethal dose. The following
is the assay of the maximum tolerated dosage.
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).

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Acute Toxicity Test of

Kunming Medical College

1.1 Drug to be tested:

OSTEOKING, sepia solution, 1 ml of the solution equivalent to 0.17g of crude

1.2 Test animals:

2.1 Tested drug:

2.2 Division of test animals:

2.2 Dosage design and drug administration:

The three groups were designated as a high-dosage group (50ml/kg of

No toxic reactions or deaths occurred following one-time perfusion of

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