The effects of exposure at room temperature to pharmacopuncture within a syringe: an investigation of changes in microbiological safety

Article information

Acupunct. 2015;32(4):37-45
1Department of Acupuncture and Moxibustion Medicine, Gang-Nam Jaseng Oriental Medicine Hospital
2Jaseng Spine and Joint Research Institute, Jaseng Medical Foundation
3Department of Rehabilitation Medicine of Korean Medicine, Gang-Nam Jaseng Oriental Medicine Hospital
*Corresponding author: Jaseng Spine and Joint Research Institute, Jaseng Medical Foundation, 3F, 858, Eonju-ro, Gangnam-gu, Seoul, 135-896, Republic of Korea, Tel: +82-2-3218-2251, E-mail: lkomvje@jaseng.co.kr

This study was supportd by Korea Promotion Institute for Traditional Medicine Industry(KOTMIN) service task. Thanks for funding.

Received 2015 November 19; Revised 2015 December 01; Accepted 2015 December 02.

Abstract

Objectives:

The main aim of this study is to evaluate changes in the microbiological safety of pharmacopuncture exposed to room temperature for an elapsed period of time.

Methods:

The four most frequently used pharmacopuncture products were stored in syringes at room temperature at three different hospitals for 24 hours and 48 hours respectively and they were compared with pharmacopuncture products stored in vials through a sterility and microbial limited test.

Results:

Storage forms and duration of exposure to room temperature did not show significant difference in bacterial or fungal contamination which was confirmed by the sterility and microbial limited test.

Conclusions:

Pharmacopuncture products stored in syringes at room temperature for 24 hours and 48 hours demonstrated their safety in terms of lack of microbiological contamination.

Fig. 1

Sterility test result of Shinbaro pharmacopuncture

Fig. 2

Sterility test result of Hwangryun-Hae-Dok-tang pharmacopuncture

Fig. 3

Sterility test result of Jungsongouhyul pharmacopuncture

Fig. 4

Sterility test result of Bee venom pharmacopuncture

Fig. 5

Limited test(Bacteria) result of Shinbaro pharmacopuncture

Fig. 6

Limited test(Fungi) result of Shinbaro pharmacopuncture

Fig. 7

Limited test(Bacteria) result of Hwangryun-Hae-Dok-tang pharmacopuncture

Fig. 8

Limited test(Fungi) result of Hwangryun-Hae-Dok-tang pharmacopuncture

Fig. 9

Limited test(Bacteria) result of Jung-songouhyul pharmacopuncture

Fig. 10

Limited test(Fungi) result of Jungsongouhyul pharmacopuncture

Fig. 11

Limited test(Bacteria) result of Bee venom pharmacopuncture

Fig. 12

Limited test(Fungi) result of Bee venom pharmacopuncture

Strain and Criteria for Media Probability Test

Strain and Criteria for Validation Test

Test Result

References

1. Korean Acupuncture & Moxibustion Society Textbook Compilation Committee. Acupuncture and Moxibustion Gyeonggi: Jipmoondang; 2008. p. 408.
2. Nam SC. 經絡 Seoul: Sinilmunhwasa; 1967. p. 7–31.
3. Baik SI, Ahn JC, Kim YJ, Kim HS, Kwon KR. Type Analysis of Pharmacopuncture Paper Published in the Journal of Korean Acupuncture and Moxibustion Society. The Acupuncture 2006;23(6):19–27.
4. Park JM. Pharmacopuncture in Korea A Systematic Review of Randomized Controlled Trials [dissertation] Seoul: Kyung Hee University; 2013. Korean.
5. Lee JH, Kim MJ, Lee JW, Kim MR, Lee IH, Kim EJ. A Study on Standardization of Shinbaro Pharmacopuncture Using Herbal Medicines Identification Test and HPLC-DAD. The Acupuncture 2015;32(2):1–9.
6. Lee JH, Chung HJ, Lee IH, Lee JW, Kim EJ, Kim MJ. Study on Single-dose Intramuscular Toxicity of Shinbaro Pharmacopuncture in Sprague-Dawley (SD) Rats and Beagle Dogs. JKRM 2015;25(3):1–9.
7. Kang MS, Byun IJ, Lee SN, Kim KH. A study on the Stability of Diluted Bee Venom Solution. Jounal of Pharmacopuncture 2003;6(2):105–11.
8. Baek SH, Lee IH, Kim MJ, et al. Component Analysis and Toxicity StudyofCombined Cultivated Wild Ginseng Pharmacopuncture. Korean J Orient Int Med 2015;36(2):189–99.
9. Byun BH, Seo BI. Safety studyonGenetic Toxicity of Cervi Pantotrichum Cornu Herbal acupuncture Solution(CPCHA). Kor J Herbology 2005;20(2):1–6.
10. Kim HK, Ma JY, Cheon WK, et al. Studies on effect and Safety of various Aqua-acupunctures from Scutellariae Radix. Korean journal of oriental medicine 1997;3(1):183–97.
11. MINISTRY OF FOOD AND DRUG SAFETY. Dae Han Yak Jeon Available from: URL: http://www.mfds.go.kr/index.do?mid=686&pageNo=40&seq=6049&cmd=v.
12. Lee SH, Choi SM, Yang EJ. Bee Venom Acupuncture Augments Anti-Inflammation in the Peripheral Organs of hSOD1G93A Transgenic Mice. Toxins(Basel) 2015;7(8):2835–44.
13. Kim JM, Jeon HJ, Kim HJ, Cho CK, Yoo HS. Bee Venom Pharmacopuncture: An Effective Treatment for Complex Regional Pain Syndrome. Jounal of Pharmacopuncture 2014;17(4):66–9.
14. Kang I, Moon JY, Lim MJ, Cho JH, Lee HE. The Comparison Study between Different Interventions for Treating Acute Ankle Sprain. The Acupuncture 2008;25(5):89–95.
15. Cho JY, Kim YJ, Kim EJ, Lee SD, Kim KS. The EffectsofHwangryunhaedok-tang Pharmacopuncturebythe Anti-inflammatory Action of Suppression of iNOS Production on Mice with Allergic Rhinitis. The Acupuncture 2012;29(1):89–101.
16. Lee CW, Park IB, Kim SW, et al. The Clinical Study on Chronic Conjunctivitis or Xerophthalmia treated with The Hwangryunhae-dock-tang Herbal Acupuncture Therapy. Korean J Acupunct 2003;20(4):77–84.
17. Jeong MJ, Kwon OG, Woo CH, An HD. Dose dependent effects of Jungsongouhyul Pharmacopuncture on Low Back Pain. Journal of pharmacopuncture 2011;14(2):45–52.
18. Choi EH, Chun HS, Ryu HS, Lee JH, Yang DS, Hong S. Case Report of Radial Nerve Palsy Patients Treated with Additional Jungsongouhyul Pharmacopuncture. Journal of pharmacopuncture 2011;14(4):63–9.
19. Jung MJ, Lee JH, Yeom SR, et al. Effects of Dokwal-tang and Jungsongouhyul Pharmacopuncture on pain control and nerve regeneration after crush injury in rat sciatic nerve. JKRM 2009;19(2):51–72.
20. Porco TC, JAragón T, Fernyak SE, et al. Risk of infection from needle reuse at a phlebotomy center. Am J Public Health 2001;91(4):636–8.
21. Rapiti E, Prüss ÜA, Hutin Y. Sharps injuries: assessing the burden of disease from sharps injuries to health-care workers at national and local levels Geneva: WHO Environmental Burden of Disease Series; 2005. p. 11.
22. WHO Guidelines Approved by the Guidelines Review Committee. WHO Guideline on the Use of Safety-Engineered Syringes for Intramuscular, Intradermal and Subcutaneous Injections in Health-Care Settings Geneva: World Health Organization; 2015. Available from: http://www.who.int/injection_safety/global-campaign/injection-safety_guidline.pdf.
23. Hutin Y, Hauri A, Chiarello L, et al. Best infection control practices for intradermal, subcutaneous, and intramuscular needle injections. Bull World Health Organ 2003;81(7):491–500.
24. Kerddonfak S, Manuyakorn W, Kamchaisatian W, Sasisakulporn C, Teawsomboonkit W, Benjaponpitak S. The stability and sterility of epinephrine prefilled syringe. Asian Pac J Allergy Immunol 2010;28(1):53–7.

Article information Continued

Fig. 1

Sterility test result of Shinbaro pharmacopuncture

Fig. 2

Sterility test result of Hwangryun-Hae-Dok-tang pharmacopuncture

Fig. 3

Sterility test result of Jungsongouhyul pharmacopuncture

Fig. 4

Sterility test result of Bee venom pharmacopuncture

Fig. 5

Limited test(Bacteria) result of Shinbaro pharmacopuncture

Fig. 6

Limited test(Fungi) result of Shinbaro pharmacopuncture

Fig. 7

Limited test(Bacteria) result of Hwangryun-Hae-Dok-tang pharmacopuncture

Fig. 8

Limited test(Fungi) result of Hwangryun-Hae-Dok-tang pharmacopuncture

Fig. 9

Limited test(Bacteria) result of Jung-songouhyul pharmacopuncture

Fig. 10

Limited test(Fungi) result of Jungsongouhyul pharmacopuncture

Fig. 11

Limited test(Bacteria) result of Bee venom pharmacopuncture

Fig. 12

Limited test(Fungi) result of Bee venom pharmacopuncture

Table 1

Strain and Criteria for Media Probability Test

Strain used medium Criteria
Clostridium sporogenes
Pseudomonas aeruginosa
Staphylococcus aureus
Thioglycollate medium Certain Growth of Strain
Aspergillus brasiliensis
Bacillus subtilis
Candida albicans
Tryptic soy agar

Table 2

Strain and Criteria for Validation Test

Strain used medium Criteria
Clostridium sporogenes
Pseudomonas aeruginosa
Staphylococcus aureus
Thioglycollate medium Same Growth between Control group
Aspergillus brasiliensis
Bacillus subtilis
Candida albicans
Tryptic soy agar

Table 3

Test Result

Sterility test Limited test
0 h 24 h 48 h 0 h 24 h 48 h
Dae jeon SBO
HR
JS
BV
Bu cheon SBO
HR
JS
BV
Hae un dae SBO
HR
JS
BV