Objective  To study the rheological properties of terbinafine hydrochloride cream, and provide a research basis for the consistency of this product.

Methods  The Kinexus rheometer was used to determine the dynamic and steady rheological parameters of terbinafine hydrochloride cream. Comparative studies on the rheological curves, yield stress, viscosity measurement, linear viscoelasticity and creep recovery of original and generic terbinafine hydrochloride cream were carried out.

Results  The original and generic terbinafine hydrochloride cream were both non-Newtonian fluid with shear thinning. The yield stress of three generic were similar to the original. The linear viscoelastic region of three generic were similar to the original, and the ranges of linear viscoelastic were both 0.01%-1%, the elastic moduli were all greater than the viscosity moduli and were viscoelastic materials. It could be seen from the creep recovery curve that the creep behavior of three generic were basically the same with the original.

Conclusion  Among the six terbinafine hydrochloride creams measured experimentally, the rheological properties of most generic drugs are basically the same as the original.

1.邓红, 张蜀, 林华庆, 等. 2种盐酸特比萘芬乳膏体外透皮扩散试验研究[J]. 中国药房, 2011, 22(29): 2723-2725. [Deng H, Zhang S, Lin HQ, et al. Study of transdermal diffusion experiment of 2 kinds of terbinafine hydrochloride cream in vitro[J]. China Pharmacy, 2011, 22(29): 2723-2725.] DOI: CNKI:SUN:ZGYA.0.2011-29-018.

2.刘智豪, 衡伟利, 钱帅, 等. 皮肤外用制剂的流变学研究进展[J]. 中国药科大学学报, 2022, 53(1): 105-112. [Liu ZH, Heng WL, Qian S, et al. Advances in rheological study of topical preparations for skin[J]. Journal of China Pharmaceutical University, 2022, 53(1): 105-112.] DOI: 10.11665/j.issn.1000-5048.20220116.

3.陈倩倩, 刘杰, 徐鑫, 等. 卡波姆980与卡波姆981不同加入比例对双唑泰凝胶流变学性质的影响[J]. 中国药师, 2019, 22(1): 57-60. [Chen QQ, Liu J, Xu X, et al. Effect of carbomer 980 and carbomer 981 with different addition proportions on the rheological property of metronidazole, clotrimazole and chiorhexidine acetate gel[J]. China Pharmacist, 2019, 22(1): 57-60.] DOI: 10.3969/j.issn.1008-049X.2019.01.014.

4.Simões A, Miranda M, Cardoso C, et al. Rheology by design: a regulatory tutorial for analytical method validation[J]. Pharmaceutics, 2020, 12(9): 820. DOI: 10.3390/pharmaceutics12090820.

5.黄乐乐, 马晋隆, 王嘉明, 等. 流变学评价在皮肤局部外用半固体制剂处方开发中的应用进展[J]. 中国医药工业杂志, 2022, 53(5): 611-620. [Huang LL, Ma JL, Wang JM, et al. Progress in application of rheological evaluation in formulation development of semisolid preparations for topical skin use[J]. Chinese Journal of Pharmaceuticals, 2022, 53(5): 611-620.] DOI: 10.16522/j.cnki.cjph.2022.05.003.

6.高旋, 刘超逸, 王林波, 等. 夫西地酸乳膏流变学性质的一致性评价研究[J]. 药品评价, 2023, 20(2): 135-138. [Gao X, Lin CY, Wang LB, et al. Research on consistency evaluation of fusidic acid cream's rheological property[J]. Drug Evaluation, 2023, 20(2): 135-138.] DOI: 10.19939/j.cnki.1672-2809.2023.02.02.

7.吴晓鸾, 马建芳, 范宵宇, 等. 四类眼用制剂流变学性质的研究[J]. 药学学报, 2017, 52(1): 146-152. [Wu XL, Ma JF, Fan XY, et al. Research in rheological properties of four types of ophthalmic preparations[J]. Acta Pharmaceutica Sinica, 2017, 52(1): 146-152.] DOI: 10.16438/j.0513-4870.2016-0986.

8.王林波, 刘蔚, 陈祝康. 维生素A棕榈酸酯凝胶动力黏度测定方法的研究[J]. 药物分析杂志, 2009, 29(11): 1808-1811. [Wang LB, Liu W, chen ZK. Research on m ethod for m easurem entofthe dynam-ic viscosity of vitam in A palm itate gel[J]. Chinese Journal of Pharmaceutical Analysis, 2009, 29(11): 1808-1811.] DOI: CNKI:SUN:YWFX.0.2009-11-009.

9.杨美成, 陆明, 陈桂良, 等. 聚丙烯酸树脂Ⅳ动力黏度测定方法的研究[J]. 中国药事, 2013, 27(10): 1084-1087. [Yang MC, Lu M, Chen GL, et al. Method development for measuring the dynamic viscosity of polyacrylic resin Ⅳ[J]. Chinese Pharmaceutical Affairs, 2013, 27(10): 1084-1087.] DOI: 10.3969/j.issn.1002-7777.2013.10.020.

10.郑英, 付再林, 陶蓉, 等. 纳米银温敏原位凝胶的制备及流变学考察[J]. 中国药房, 2013, 24(21): 1983-1985. [Zheng Y, Fu ZL, Tao L, et al. Preparation and rheological study of silver nanoparticles thermosensitive situ gel[J]. China Pharmacy, 2013, 24(21): 1983-1985.] DOI: CNKI:SUN:ZGYA.0.2013-21-027.

11.Yazdanpanah G, Jiang Y, Rabiee B, et al. Fabrication, rheological, and compositional characterization of thermoresponsive hydrogel from corne[J]. Tissue Eng Part C Methods, 2021, 27(5): 307. DOI: 10.1089/ten.tec.2021.0011.

12.Mendichi R, Schieroni AG, piovani D, et al. Comparative study of che-mical composition, molecular and rheological properties of silicone oil medical devices[J]. Transl Vis Sci Technol, 2019, 8(5): 9. DOI: 10.1167/tvst.8.5.9.

13.杨锐, 许凯, 李盼盼, 等. 药用辅料白蜂蜡流变学构效关系研究[J]. 药物分析杂志, 2021, 41(10): 1775-1781. [Yang R, Xu K, Li PP, et al. Study on structure-rheological activity relationship of pharmaceutical excipients white beeswax[J]. Chinese Journal of Pharmaceutical Analysisl, 2021, 41(10): 1775-1781.] DOI: 10.16155/j.0254-1793.2021.10.15.

14.Jens C, Annick L. Optimisation of carbomer viscous eye drops: an in vitro exper-imental design approach using rheological techniques[J]. Eur J Pharm Biopharm, 2002, 54: 41-50. DOI: 10.1016/S0939-6411(02)00036-X.

15.刘茜. 流变学研究对超分子凝胶领域发展的意义[J]. 当代化工, 2021, 50(3): 716-719. [Liu Q. Significance of rheological research on the development of supramolecular gels[J]. Contemporary Chemical Industry, 2021, 50(3): 716-719.] DOI: 10.3969/j.issn.1671-0460.2021.03.050.

16.罗海英, 郭敬. 卡波凝胶的流变学性质研究[J]. 广州化工, 2022, 50 (10): 48 -50. [Luo HY, Guo J. Study on Rheological Properties of Carbomer[J]. Guangzhou Chemical Industry, 2022, 50(10): 48-50.] DOI: 10.3969/j.issn.1001-9677.2022.10.014.

17.王祺玥, 沈雁, 徐家生. 可注射更昔洛韦温敏型原位凝胶剂的研究[J]. 药学进展, 2014, 38(8): 754-760. [Wang QY, Shen Y, Xu JS. Study on injectable thermosensitive in-situ hydrogel as ganciclovir delivery system, 2014, 38(8): 754-760. ] DOI: CNKI: SUN:YXJZ.0.2014-10-009.

18.敦洁宁, 冉勇, 何晓明, 等. 秦皮温敏眼用即型凝胶的制备与体内外研究[J]. 中国药学杂志, 2016, 51(19): 1671-1677. [Dun JN, Ran Y, He XM,et al. Preparation, in vitro and in vivo studies of fraxini cortex thermosensitive in-situ-forming eye gel[J]. Chinese Pharmaceutical Journal, 2016, 51(19): 1671-1677.] DOI: CNKI:SUN:ZGYX.0.2016-19-008.

19.陈燕平, 王林波, 邵泓,等. 甲基纤维素动力黏度测定方法的研究[J]. 中国药学杂志, 2013, 48(5): 385-387. [Chen YP, Wang LB, Shao H, et al. Determination method of dynamic viscosity of methylcellulose[J]. Chinese Pharmaceutical Journal, 2013, 48(5): 385-387.] DOI: 10.11669/cpj.2013.05.013.