Reverse engineering study of atomoxetine hydrochloride oral solution

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Author: Qian ZENG ¹ Xue-Ying WU ² Wei-Ting WANG ¹ Qi-Lin DUAN ²  Zhi-Jun HUANG ¹

Affiliation: 1. School of Chemistry, Chemical Engineering and Life Sciences, Wuhan University of Technology, Wuhan 430070, China 2. Jianmin Pharmaceutical Group Co.Ltd., Wuhan 430052, China

Keywords: Atomoxetine hydrochloride oral solution Reverse engineering Prescription study

DOI: 10.19960/j.issn.1005-0698.202305009

Reference: Qian ZENG, Xue-Ying WU, Wei-Ting WANG, Qi-Lin DUAN, Zhi-Jun HUANG.Reverse engineering study of atomoxetine hydrochloride oral solution[J].Yaowu Liuxingbingxue Zazhi,,2023, 32(5): 545-553.DOI: 10.19960/j.issn.1005-0698.202305009.[Article in Chinese]  Copied

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Abstract

Objective To determine the oral solution of atomoxetine hydrochloride prescription proportion by reverse engineering study.

Methods The contents of sodium benzoate, sorbitol and xy-litol in the reference preparation were determined by HPLC, the contents of sodium dihydrogen phos-phate and phosphoric acid were determined by spectrophotometry combined with pH detection. Other methods were used to determine the content of sucralose and the type and dosage of aromatics in the self-researched oral solution.

Results The 100 mL oral solution of atomoxetine hydrochloride contains 0.4 g of atomoxetine, 0.08 g of sodium benzoate, 3.3 g of sorbitol, 30.0 g of xylitol, 0.08 g of phosphoric acid, 1.3 g of sodium dihydrogen phosphate, 0.05 g of sucralose and 2.0 g of strawberry flavor. Conclu-sion Reverse engineering research can effectively analyze the prescription composition and consump-tion of atomoxetine hydrochloride oral solution. The quality of the prepared sample is basically the same as that of the reference preparation, and the quality is easy to control.

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1.杨俊,温美强,杨广雪,等.逆向工程在尼群地平片仿制中的应用[J].沈阳药科大学学报, 2022, 39(12): 1409-1420. [Yang J, Wen MQ, Yang GX, et al. Application of reverse engineering in the imitation of nitrendipine tablets[J]. Journal of Shenyang Pharmaceutical University, 2022, 39(12): 1409-1420.] DOI: 10.14066/j.cnki.cn21-1349/r.2021.0112.

2.范坤,丁珮,韩晓璐,等.基于逆向工程的复方咖啡因无水吞服颗粒的开发及研究[J].药学学报, 2022, 57(8): 2512-2519. [Fan K, Ding P, Han XL, et al. Development and research of compound caffeine waterless swallowed granules based on reverse engineering[J]. Acta Pharmaceutica Sinica, 2022, 57(8): 2512-2519.] DOI: 10.16438/j.0513-4870.2022-0117.

3.尚海巍.凝胶贴膏中挥发性成分的“逆向工程”分析[J]. 辽宁科技学院学报, 2022, 24(6): 37-40. [Shang HW. "Reverse Engineering" Analysis of Volatile Components in Gel Cataplasm[J]. Journal of Liaoning Insti-tute of Science and Technology, 2022, 24(6): 37-40.] DOI: 10.3969/j.issn.1008-3723.2022.06.010.

4.凌骅,余丽花,黄志军,等.呋塞米口服溶液的逆向工程研究[J].中国药师, 2021, 24(10): 1907-1910. [Ling H, Yu LH, Huang ZJ, et al. Reverse engineering of furosemide oral solution[J]. China Pharmacist, 2021, 24(10): 1907-1910.] DOI: 10.19962/j.cnki.issn1008-049X.2021.10.027.

5.谢凤,刘晓峰,林泓,等.注意缺陷/多动障碍儿童服用盐酸托莫西汀治疗的疗效与安全性观察[J].中南药学, 2020, 18(11): 1920-1927. [Xie F, Liu XF, Lin H, et al. Efficacy and safety of atomoxetine hydrochloride in children with attention deficit/hyperactivity disorder[J]. Central South Pharmacy, 2020, 18(11): 1920-1927.] DOI: 10.7539/j.issn.1672-2981.2020.11.030.

6.单艳红,陈一心.盐酸托莫西汀治疗注意缺陷多动障碍患儿的疗效及安全性[J].临床精神医学杂志, 2020, 30(5): 345-348. [Shan YH, Chen YX. The efficacy and safety of atomoxetine in the treatment of children with attention deficit hyperactivity disorder[J]. Journal of Clinical Psychiatry, 2020, 30(5): 345-348.] DOI: 10.3969/j.issn.1005-3220.2020.05.017.

7.李长秀,詹英杰,黄妙巧.盐酸托莫西汀治疗儿童注意缺陷多动障碍的效果探讨[J].中国实用医药, 2020, 15(13): 145-147. [Li CX, Zhan YJ, Huang MQ. Effect of Atomoxetine Hydrochloride on Attention Deficit Hyper-activity Disorder in Children[J]. China Practical Medicine, 2020, 15(13): 145-147.] DOI: 10.14163/j.cnki.11-5547/r.2020.13.064.

8.饶斯清, 陈楚雄, 杨梦心, 等. 盐酸托莫西汀胶囊在健康人体的药动学研究[J]. 广东药学院学报, 2010, 26(2): 115-118. [Rao SQ, Chen CX, Yang MX, et al. Pharmacokinetics of atomoxetine hydrochloride capsules in healthy volunteers[J]. Journal of Guangdong Pharmaceutical University, 2010, 26(2): 115-118.] DOI: 10.3969/j.issn.1006-8783.2010.02.002.

9.国家药品监督管理局.仿制药参比制剂目录（第二十六批）[EB/OL]. (2020-04-17) [2022-09-05]. https://www.nmpa.gov.cn/xxgk/ggtg/qtggtg/20200417163201362.htmL.

10.于风平,贺敦伟,闫敏,等.口服固体制剂中淀粉类辅料含量的"逆向工程"分析[J].中国药事, 2018, 32(3): 348-353. [Yu FP, He DW, Yan M, et al. "Reverse Engineering" analysis of starch excipient in oral solid preparations[J]. Chinese Pharmaceutical Affairs, 2018, 32(3): 348-353.] DOI: 10.16153/j.1002-7777.2018.03.010.

11.向俊, 王芳斌, 荆辉华, 等. 基于不同检测器高效液相色谱法测定食品中糖醇的研究[J]. 食品与机械, 2018, 34(9): 92-95. [Xiang J, Wang FB, Jing HH, et al. Analysis and assessment of two kinds of high performance liquid chromatography methods to detect xylitol, sorbitol and maltitol in foods[J]. Food and Machin-ery, 2018, 34(9): 92-95.] DOI: 10.13652/j.issn.1003-5788.2018.09.019.

12.PMDA.ストラテラ内用液0.4%[EB/OL]. (2020-07) [2022-09-05]. https://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/530471_1179050S1022_1_09.

13.礼来公司. Strattera 4mg/mL oral solution[EB/OL]. (2021-02-08) [2022-09-05]. https://www.medicines.org.uk/emc/product/6827/smpc#EXCIPIENTS.

14.M.S墨梅, A.K罗伊. 阿托莫西汀溶液: 中国专利, CN105705135A[P]. 2016-06-22.

15.田甜, 柳艳云, 江燕. 高效液相色谱法测定软胶囊囊壳中山梨醇的含量[J].中国检验检测, 2021, 29(2): 34-36. [Tian T, Liu YY, Jiang Y. Determination of sorbitol in soft capsule shell by HPLC[J]. China Inspection Body & Laboratory, 2021, 29(2): 34-36.] DOI: 10.16428/j.cnki.cn10-1469/tb.2021.02.011.

16.王洋洋, 刘庆旺, 范振忠, 等. 磷酸根离子检测的研究方法[J]. 化学工程师, 2021, 35(12): 57-60. [Wang YY, Liu QW, Fan ZZ, et al. Research progress of phosphate ion detection[J]. Chemical Engineer, 2021, 35(12): 57-60.] DOI: 10.16247/j.cnki.23-1171/tq.20211257.

17.江丽芳. 磷钼蓝分光光度法测定高纯H2O2中微量磷酸根[J].化学工程与装备, 2009, (6): 118-122. [Jiang LF. Spec-trophotometry determination of trace phosphorus in H2O2 by phospho- molybdenum blue[J]. Chemi-cal Engineering & Equipment, 2009, (6): 118-122.] DOI: 10.3969/j.issn.1003-0735.2009.06.046.