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 &
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
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
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
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
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
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
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
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)