Articles Vol. 65 No. 1 18/01/2024

6. ESTABLISHMENT OF IN-HOUSE SPECIFICATIONS OF “NHAT GAN LINH” CAPSULES

Pham Xuan Phong1,2, Chu Van Men3,4, Chu Duc Thanh3,4, Tran Thi Tuyet Nhung1,2
1 Military Institute of Traditional Medicine
2 Viện Y học cổ truyền Quân đội
3 Vietnam Military Medical University
4 Học viện Quân y
Corresponding author: chuvanmen@gmail.com
DOI: 10.52163/yhc.v65i1.877
15 Views
21 Downloads
Keywords
Nhat gan linh, berberin, saikosaponin A, in-house specifications.
Abstract

Objectives: To establish the in-house specifications of “Nhat gan linh” capsules have been established.

Materials and Methods: Investigate the in-house specifications of Nhat gan linh capsules including criteria: appearance, loss on drying, disintegration test, dosage uniformity, identification, quantitative assay, heavy metals and microbial limits.

Results: Appearance: Hard capsules with brown color, bitter sweet; Loss on drying: no more than 6%; Test for disintegration: less than 15 minutes; Uniformity of dosage units: the average drug in capsules about 500mg ± 7.5%. Identification: qualitative assay of berberin and saikosaponin A in Nhat gan linh capsules using HPLC. Quantitative assay: the content of berberin and saikosaponin A each capsule not less than 40 and 2 mg/capsule, respectively. Heavy metals: not more than 10 ppm. Microbial limit: Satisfaction of Vietnamese Pharmacopoeia (Appendix 13.6- level 4).

Conclusions: The study has successfully developed the in-house specifications of Nhat gan linh capsules.

References
[1]
World Health Organization, Top 10 causes of Google Scholar
[2]
death in Viet Nam for both sexes aged all ages. Google Scholar
[3]
Cause-specific mortality, 2000 - 2019, 2019. Google Scholar
[4]
World Health Organization, World Hepatitis Google Scholar
[5]
Day: Increased knowledge key to prevention and Google Scholar
[6]
treatment of Hepatitis in Viet Nam, 2016. Google Scholar
[7]
Đỗ Tất Lợi, Cây thuốc và vị thuốc Việt Nam, Google Scholar
[8]
Nhà xuất bản Y học, 195, 1999. Google Scholar
[9]
Tarte PS, Shedharkar GR, Force Degradation Google Scholar
[10]
7. Độ nhiễm khuẩn47 Google Scholar
[11]
Study of Berberine Chloride by Using Stability Google Scholar
[12]
Indicating HPLC Method, International Journal Google Scholar
[13]
of PharmTech Research, 6(5), 2014,1490-500. Google Scholar
[14]
Nguyễn Minh Đức, Sắc ký lỏng hiệu năng cao và Google Scholar
[15]
một số ứng dụng vào nghiên cứu, kiểm nghiệm Google Scholar
[16]
dược phẩm, dược liệu và hợp chất tự nhiên; Nhà Google Scholar
[17]
xuất bản Y học thành phố Hồ Chí Minh, 138, Google Scholar
[18]
, 148-149. Google Scholar
[19]
Bộ Y tế, Dược Điển Việt Nam V, Nhà xuất bản Google Scholar
[20]
Y học, 2017. Google Scholar