The summary of SB anti-cancer injection

1. Acute toxicity test (Natural Products Research Institute of Seoul National University)

With mice and rats as test animals, acute toxicity after oral administration, hypodermic

injections, and intravenous injections were conducted, respectively. The results showed

that LD50 was 13.05ml/kg after intravenous injection, which implied the P sample had

relatively low toxicity.

2. Acute toxicity test with intravenous injection on a rat (Acute toxicity test at the

National Institute of Health and Safety Research)

After acute toxicity test with SB-31 through intravenous injections on SD rats, no

toxicity resulting from the test substance was found in clinical symptoms, weight

change, or autopsy. The LD50 (median lethal dose) for rat’s acute toxicity with

intravenous injection was more than 20ml/kg for both male and female rats.

3. Characteristics and stability tests (Busan Metropolitan City Institute of Health &

Environment)

After examining the SB-31 injection from the Hanbo Pharmaceutical Company, its

stability in all test categories was approved.

4. General pharmacological actions of SB-31 (Korea Research Institute of Chemical

Technology)

The general pharmacological actions test was conducted in order to evaluate the safety

of the SB-31 anti-cancer preparation. The results showed that there were virtually no

side effects on the central nervous system, the autonomous nervous system, the

digestive system, the amount of urine, and/or electrolytes. Based on the results, it is

considered that the medicine is very safe. 

5. Toxicity test of SB-31 (College of Veterinary Medicine, Chungbuk National

University)

1) Beagle dogs died after a single intravenous injection of 10ml/kg of SB-31 to test

acute toxicity. Bleeding and congestion were found in the lungs, kidneys, liver, and

stomach and mesentery, and the value of LD50 was 57.7ml/kg.

2) In the sub-acute toxicity test of the SB-31 on rats, 2.5ml/kg of SB-31 was applied to

the rats through intravenous injections for 4 consecutive weeks and 28 times in total. No

significant side effects or clinical symptoms were found, which implies it is a fairly safe

anti-cancer preparation.

3) In the sub-acute toxicity test of SB-31 on beagle dogs, 0.9ml/kg of SB-31 was

applied to the beagle dogs through intravenous injections for 4 consecutive weeks and

28 times in total. No significant side effects or clinical symptoms were found, which

implies it is a fairly safe anti-cancer preparation. The maximum innoxious dose was

0.9ml/kg or higher.

4) In the genetic toxicity test of SB-31, no carcinogenic substances or mutagenic

substances were found. SB-31 does not cause micronucleus formation in bone marrow

cells or chromosome aberration.

5) The antigen test of the SB-31 anti-cancer preparation was conducted on guinea pigs

in order to test anaphylaxis shock reaction. The pigs showed antigen positive in both

low and high doses. As for the beagle dogs, on the other hand, no positive reactions

were found during the 4 weeks in either low or high doses. From the results, it was

suspected that the antigen positive reaction was caused by vegetative heterogeneous

protein of the SB-31.

6) In the skin reaction test of SB-31 on rabbits, SB -31 was proved to be safe.

7) After the ocular irritation test of SB-31 on rabbits, it was found that SB-31 was safe

after contact with the eyes without any ocular irritation or lesions.

6. The anti-cancer effects of Sarcoma 180 (Natural Products Research Institute of Seoul

National University)

Cancer cells were injected under the skin of a mouse. After a week passed, a certain

portion of the sample was orally administered or injected under the skin of the mouse in

order to check the weight of the cancer after 30 days had passed. The cancer weight was

0.44g when the hypodermic injected dose was 0.3ml per 20g of weight, which was

equivalent to 16.1% of weight of the control group(2.71g). According to the criteria set

by the American Cancer Research Institute that considers the effect significant when the

value is under 42%, the P sample is considered to be very significant.

7. The anti-cancer effects of SB-31 on various cancer cell lines (Joint Research Institute

of Cancer of Chungnam National University)

After comparing the growth inhibition effects of SB-31 on various cancer cell lines such

as stomach cancer cell lines, lung cancer cell lines, liver cancer cell lines, womb cancer

cell lines, and breast cancer cell lines, with the control group on peripheral mononuclear

of normal people, the growth inhibition effect was more sensitive in cancer cells than in

normal mononuclear with a ratio of 3:1 or 5:1.

In order to examine the changes in the effects of the medicine that contains glycoprotein

when kept at room temperature, a stability test was conducted in the same method as

above. As a result of dissolving the medicine and storing it at room temperature, no

changes were observed in the initial 4 days, but the LD50 value started to go up after 6

days had passed.

8. Selective effects on various solid cancer cell lines (Journal of American Cancer

Association, April 1994, Journal of Korean Cancer Association)

Professor Kim, Sang-yong at the Joint Research Institute of Cancer of Chungnam

National University studied this anti-cancer preparation and published a paper in the

American Cancer Association and the Journal of Korean Cancer Association in April

and December of 1994, respectively, and reported that it has selective effects on solid

cancer cell lines with the ratio at 4:1.

9. Study of mechanism (Joint Research Institute of Cancer of Chungnam National

University)

SB-31 has the pharmacological action of apoptosis that destroys cancer cells only . The

study was published for the International Seminar for the Researchers of Crude Drugs

held in Beijing, China in October of 1995 and in the Journal of The Korean Association

of Internal Medicine.

10. Anti-cancer effects of SB-31 in vivo and in vitro (Research Institute of

Biotechnology)

In order to examine the validity of SB-31’s anti-cancer effects, lung cancer cell lines

and large intestine cell lines were transplanted into a nude mouse, and SB-31 was

injected for comparison analysis. The test was conducted at the Research Institute of

Biotechnology. The results showed that SB-31 showed more significant anti-cancer

effects than Adriamycin in lung cancer and intestine cancer.

11. The pharmacokinetics of SB-31 with an indicator of Glycyrrhizin (Pharmaceutical

College of Chungnam University, August 1998)

SB-31, which is made from the root of Pulsatilla Koreana, ginseng, and licorice, was

hypodermically injected into rats and rabbits. Then, the distribution and excretion

conditions were studied with Glycyrrhizin as the indicator. Published in Journal No.

8302 of the Clinical Study Association.

12. Separation of the index component (SB312) by using the root of Pulsatilla Koreana

(Pharmaceutical College of Chungnam University)

The index component was separated by using powdered root of Pulsatilla Koreana,

which was provided by the SB Pharmaceutical Company, as the solvent. Then, the dose

of the root of Pulsatilla Koreana was obtained from the SB injection that was provided

by Hanbo Pharmaceutical Company and it also determined the dose of SB312.

13. Other immunity toxicity tests of SB injections into the spleen cell of a rat; a 13-

week repetitive toxicity test through intravenous injection)

According to the immunity toxicity test using a male SD rat that had received SB

injections for 13 weeks through intravenous injections, no changes occurred in cellmediated

immunity or humoral immunity. According to the repetitive toxicity test

through intravenous injections of SB injections for 13 weeks to both male and female

SD rats, no significant changes occurred in the maximum dose of 0.8ml/kg, of which it

was considered that the innoxious dose was 0.8ml/kg or higher.

14. Test of reproductive toxicity on fertility and early embryo development and test of

toxicity that may occur before and after giving birth and on the maternal body function

(Veterinary Research Institute of Chungbuk National University)

In this study, in order to examine the possible reproductive toxicity on fertility and early

embryo development when applying SB injections and the toxicity that may occur

before and after birth and on the maternal body function, we conducted a search

according to “the standard of pharmaceutical toxicity tests” under Notice 1999-61 by

the KFDA (enacted on December 22, 1999). No symptoms attributable to the sample

were observed over the test period in either the experimental group that received SB

injection or in the control groups.

15. A 13-week repetitive toxicity test of SB injections through intravenous injections on

beagle dogs and a 4-week recovery test (Veterinary Research Institute of Chungbuk

National University)

After conducting repetitive toxicity tests of SB injections through intravenous injections

into male and female beagle dogs, there was on influence on weight gain of 10% or less,

as well as on death when the dose of 1ml/kg was injected during the consecutive 13-

week test period. This indicates that the SB injection is safe and the maximum tolerant

dose is 1ml/kg or higher.

16. Phase 1 clinical tests of SB injections

The phase 1 clinical tests conducted in order to examine the safety of SB injections on

cancer patients, the maximum tolerant dose (MTD), and validity

(Clinical Test Institute: Medical Center of Youngnam University)

17. Phase 2 clinical tests conducted in order to examine the safety and

validity of SB injections into progressive or metastatic lung cancer patients.

(Clinical Test Institute: Medical Center of Kyungbuk National University, Dongsan

Medical Center of Keimyung University, and SAM Hospital)