Objective: To compare the differences in identification tests of vacant gelatin capsules and enterosoluble vacant gelatin capsules in the four national pharmacopoeias, optimize the identification test methods and improve the specificity of identification results. Methods: The biuret method was used to identify vacant gelatin capsules and enterosoluble vacant gelatin capsules, and an appropriate amount of adsorbed activated carbon was added to eliminate the masking effect of pigments in capsules. Results: The identification method was optimized, the pigment in the capsule solution was adsorbed by activated carbon, and the capsule solution showed a clarified colorless solution, which could produce a distinct violet after the color development by biuret reaction. Conclusion: This method can significantly improve the specificity of vacant gelatin capsules and enterosoluble vacant gelatin capsules identification compared with domestic and foreign pharmacopoeia methods. It can provide scientific and reasonable revision suggestions for the optimization and improvement of the identification test of vacant gelatin capsules and enterosoluble vacant gelatin capsules in the Chinese Pharmacopoeia.
GUO Wen-xu, WANG Dan-dan, ZHOU Tao, ZHANG Ai-jing, CHEN Yue
. Improvement study on the identification test of vacant gelatin capsules and enterosoluble vacant gelatin capsules*[J]. Chinese Journal of Pharmaceutical Analysis, 2024
, 44(2)
: 368
-372
.
DOI: 10.16155/j.0254-1793.2024.02.21
[1] GULLAPALLI RP, MAZZITELLI CL. Gelatin and non-gelatin capsule dosage forms[J]. J Pharm Sci, 2017, 106(6):1453
[2] GÓMEZ-GUILLÉN MC, GIMÉNEZ B, LÓPEZ-CABALLERO ME, et al. Functional and bioactive properties of collagen and gelatin from alternative sources: a review[J]. Food Hydrocolloids, 2011, 25(8): 1813
[3] 朱琳娇,陈运动,吴永江. 电感耦合等离子体质谱法检测明胶空心胶囊中10种元素的含量[J]. 中国现代应用药学, 2013,30(11):1228
ZHU LJ, CHEN YD, WU YJ. Determination of 10 elements in vacant gelatin capsules by ICP-MS [J]. Chin J Mod Appl Pharm, 2013, 30(11): 1228
[4] 王丹丹,金立,陈越,等.水浸洗法测定明胶空心胶囊中六种焦油色素含量及结果分析[J]. 海峡药学,2016,28(6):51
WANG DD, JIN L, CHEN Y, et al. Determination of six tar colorants in vacant capsules by water immersing and results analysis[J]. Strait Pharm J, 2016, 28(6): 51
[5] 王翀,杜明荦,仲平.UPLC法检测明胶空心胶囊中9种合成着色剂[J]. 药物分析杂志,2016,36(10):1857
WANG C, DU ML, ZHONG P. Simultaneous detection of 9 synthetic pigments in vacant gelatin capsules by UPLC[J]. Chin J Pharm Anal, 2016,36(10):1857
[6] 苏铭晖.明胶应用领域的概述[J]. 明胶科学与技术,2018,38(2):61
SU MH. Overview of gelatin and its fields of application [J]. Sci Technol Gelatin, 2018, 38(2): 61
[7] 中华人民共和国药典 2020 年版. 四部[S]. 2020: 687,671,720,796
ChP 2020.Vol Ⅳ[S]. 2020: 687,671,720,796
[8] 王丹丹,俞辉.《中国药典》2020年版中胶囊用明胶标准注释[J]. 中国药品标准,2022,23(4):347
WANG DD, YU H. Notes on gelatin for capsule in Chinese Pharmacopoeia 2020[J]. Drug Stand China, 2022, 23(4): 347
[9] JP ⅩⅧ. [S]. 2021: Official Monographs 1060
[10] EP 11.1 Vol Ⅰ [S]. 2023: Monographs 0330
[11] USP-PF 48[S]. 2022: C315397
[12] 胡立立, 王蕾.HPLC法同时测定胶囊囊壳中9种合成色素的含量[J]. 辽宁医学院学报, 2017, 38(4):15
HU LL, WANG L.The simultaneous determination of nine kinds of synthetic pigments in capsule shells by high performance liquid chromatography[J]. Liaoning Med Univ, 2017,38(4):15
[13] 孙健,胡青,冯睿,等.色素在药品中使用的监管及检测方法[J]. 医药导报,2022, 41(3):377
SUN J, HU Q, FENG R, et al. Supervision and detection methods of colorants in drugs[J]. Herb Med, 2022, 41(3):377
[14] 赵海云,李玉杰,张冬梅,等. LC-MS/MS定量分析药用明胶空心胶囊中合成色素的含量[J]. 药物分析杂志,2017,37(7):1329
ZHAO HY, LI YJ, ZHANG DM, et al. Quantitative determination for 22 synthetic pigments in medical gelatin capsule shells by liquid chromatography-MS/MS[J]. Chin J Pharm Anal, 2017,37(7):1329
[15] 董宇.活性炭的吸附性能及表征方法[J]. 中国资源综合利用, 2020, 38(7): 64
DONG Y. The adsorption performance and characterization method of activated carbon[J]. China Res Compr Utiliz, 2020,38(7): 64
