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Design and optimization of purification process of sinomenine hydrochloride

Chinese Journal of Chemical Engineering 2023年第3期55卷 63-72页

作者： Dandan Ren Shanshan Xiang Yuwen Yan Ruiying Kong Xingchu Gong Pharmaceutical Informatics Institute College of Pharmaceutical SciencesZhejiang UniversityHangzhou 310058China Innovation Centerin Zhejiang University State Key Laboratory of Component-Based Chinese MedicineHangzhou 310058China Jinhua Institute of Zhejiang University Jinhua 321016China

sinomenine hydrochloride is generally produced from Caulis Sinomenii. At present, the purification process in industrial production suffers from large amount of solid waste, high solvent toxicity, and low sinomenine hydrochloride yield. In this study, a new purification process for sinomenine hydrochloride was proposed by using the extract obtained from acid extraction of Caulis Sinomenii as the starting *** process included the following steps: alkalization, extraction, water washing, acid–water stripping,drying, and crystallization. 1-Heptanol was used as the extractant. The distribution coefficients of sinomenine and sinomenine hydrochloride in 1-heptanol–water system were 27.4 and 0.0167, *** dissociation constants of sinomenine hydrochloride were 8.27 and 11.24, respectively. Process parameters of the new purification process were optimized with experimental design. The extractant1-heptanol and sinomenine hydrochloride in the crystallization mother solution can be recycled in the new process. The purity of the obtained sinomenine hydrochloride crystals exceeded 85%, and the yield was about 70%. Compared with current industrial processes, safer extractant, less solid waste, and higher sinomenine hydrochloride yield can be achieved using the new purification process of sinomenine hydrochloride provided in this study.

关键词： sinomenine hydrochloride Process optimization Extraction Crystallization 1-Heptanol

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Design and optimization of a greener sinomenine hydrochloride preparation process considering variations among different batches of the medicinal herb

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Chinese Journal of Chemical Engineering 2024年第7期71卷 77-90页

作者： Dandan Ren Jiale Xie Tianle Chen Haibin Qu Xingchu Gong Pharmaceutical Informatics Institute College of Pharmaceutical SciencesZhejiang UniversityHangzhou 310058China National Key Laboratory of Chinese Medicine Modernization Zhejiang UniversityHangzhou 310058China Jinhua Institute of Zhejiang University Jinhua 321016China

The current methods used to industrially produce sinomenine hydrochloride involve several issues,including high solvent toxicity,long process flow,and low atomic utilization efficiency,and the greenness scores of the processes are below 65 *** solve these problems,a new process using anisole as the extractant was *** exhibits high selectivity for sinomenine and can be connected to the subsequent water-washing *** alkalization of the medicinal material,heating extraction,water washing,and acidification crystallization were carried *** process was modeled and *** design space was *** recommended operating ranges for the critical process parameters were 3.0–4.0 h for alkalization time,60.0–80.0℃ for extraction temperature,2.0–3.0(volume ratio)for washing solution amount,and 2.0–2.4 mol·L^(-1) for hydrochloric acid *** new process shows good robustness because different batches of medicinal materials did not greatly impact crystal purity or sinomenine transfer *** sinomenine transfer rate was about 20%higher than that of industrial *** greenness score increased to 90 points since the novel process proposed in this research solves the problems of long process flow,high solvent toxicity,and poor atomic economy,better aligning with the concept of green chemistry.

关键词： sinomenine hydrochloride Process optimization Anisole

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The study on the release mechanism of sinomenine hydrochloride enteric osmotic pump capsule

The study on the release mechanism of sinomenine hydrochlori...

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2018年第十二届中国药物制剂大会

作者：陈轶凡 Rongfeng Hu Song Gao Anhui University of Chinese Medicine Key Laboratory of Xin'an Medicine Jointly Developed by Ministry of Education Anhui “115” Xin'an Pharmaceutical R&D Innovation Team Key Laboratory of Anhui Provincial Traditional Chinese Medicine Research and Development

Objective: The aim of this study was to establish a method for measuring the release rate of sinomenine hydrochloride enteric osmotic pump capsule and to investigate its drug release mechanism. Methods: The drug release behavior of enteric osmotic pump capsules were evaluated by similar factor method, and the effect of diffusion mechanism on drug release were studied by investigating the drug release of perforated and non-perforated capsules. The dyeing method was used to observe whether the capsule release was regulated by osmotic mechanism. And the release rate was conducted to investigate whether drug release was affected by osmotic mechanism and swelling mechanism. Results: The release of enteric osmotic pump capsule accords with the zero order release equation. The results of the release rate showed that the method had high sensitivity and good stability. The drug release in elementary enteric osmotic pump capsule was mainly affected by the osmotic pressure difference between two sides of the capsule. However, the drug release in the push-pull enteric osmotic pump capsule was inversely proportional to the osmotic difference across capsule and the content of PEO in the booster layer. Conclusion: The established method met the requirements of the determination of sinomenine hydrochloride in vitro. The release of the elementary enteric osmotic pump capsule was mainly regulated by the osmotic mechanism, while the release of the push-pull enteric osmotic pump capsule was controlled by the mechanism of osmotic and swelling.

关键词： sinomenine hydrochloride enteric osmotic pump capsule release mechanism

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In vivo evaluation of a novel enteric positioning osmotic pump capsule of sinomenine hydrochloride

In vivo evaluation of a novel enteric positioning osmotic pu...

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2018年第十二届中国药物制剂大会

作者：孙玉莲 Rongfeng Hu Anhui University of Chinese Medicine Key Laboratory of Xin'an Medicine Jointly Developed by Ministry of Education Anhui “115” Xin'an Pharmaceutical R&D Innovation Team Key Laboratory of Anhui Provincial Traditional Chinese Medicine Research and Development

Objective: The aim of this study was to evaluate the pharmacokinetics of the sinomenine hydrochloride loaded enteric targeting osmotic pump capsules in vivo. Methods: The in vivo test was performed in beagle dogs. A two-period crossover experimental design was adopted to evaluate the pharmacokinetics of the enteric positioning osmotic pump capsule of sinomenine hydrochloride versus commercial enteric-coated tablets. Determination of sinomenine hydrochloride in plasma was carried out by HPLC method. The DAS 2.0 pharmacokinetics software was used to calculate pharmacokinetics parameters. Results: Compared with commercially enteric-coated tablets, the relative bioavailability of enteric osmotic pump capsules was 140.33%, yet with a prolonged retention time. The AUC0→∞ of enteric osmotic pump capsules was more stable, Cmax were lower and Tmax was prolonged. Conclusion: The results indicated that the novel enteric osmotic pump capsule successfully controlled the release of sinomenine hydrochloride. The enteric positioning osmotic pump capsule utilizing both osmotic principle and enteric targeting would be a promising strategy for certain drugs to improve efficacy by enhancing oral bioavailability, minimizing the frequency of administration and reducing the fluctuation of plasma concentration.

关键词： sinomenine hydrochloride Osmotic pump capsule enteric positioning In vivo

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Preparation and evaluation of sinomenine hydrochloride patch

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Journal of Chinese Pharmaceutical Sciences 2010年第2期19卷 110-114页

作者：李馨儒黄燕清李晓燕周艳霞刘艳国明祝清芬谢元超范治云北京大学医学部药学院药剂学系北京100191 北京大学医学部药学院药学教学实验中心北京100191 山东省药检所山东济南250012

The sinomenine hydrochloride （SH） patch, a topical drug delivery system, was prepared and characterized. The in vitro release was studied according to the paddle-over-disk method in the appendix of Chinese Pharmacopeia （appendix XD, 2005）. Stability of SH patch was evaluated at accelerated testing conditions （40 ℃, 75% RH）. Pharmacological and pharmacokinetics study were also performed. It was found that the release of SH from patches depended on pH value of the release medium. There were no significant differences between SH patches stored for 6 mon and those stored for 0 mon in the drug content, initial adhesion, lasting stickiness, peeling strength and in vitro release. SH patches exhibited better anti-inflammatory activity as well as analgesic efficacy. More importantly, primary pharmacokinetic parameters of SH patch, such as Cmax and AUC, were much lower than those of SH solution dosed orally. In conclusion, the patch might be a promising delivery system for SH, which bypassed the gastrointestinal tract and was a convenient, efficacious, safe and non-invasive delivery method.

关键词： sinomenine hydrochloride Patch Stability Pharmacokinetics Release Pharmacodynamics

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