Article(id=1236335232341823829, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236335227262529633, articleNumber=null, orderNo=null, doi=null, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=null, receivedDateStr=null, revisedDate=null, revisedDateStr=null, acceptedDate=1688313600000, acceptedDateStr=2023-07-03, onlineDate=1772694889388, onlineDateStr=2026-03-05, pubDate=1696003200000, pubDateStr=2023-09-30, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1772694889388, onlineIssueDateStr=2026-03-05, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1772694889388, creator=13701087609, updateTime=1772694889388, updator=13701087609, issue=Issue{id=1236335227262529633, tenantId=1146029695717560320, journalId=1235980733773295621, year='2023', volume='32', issue='18', pageStart='1801', pageEnd='1904', issueExtLink='null', onlineDate='null', pubDate='null', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1772694888176, creator=13701087609, updateTime=1772694973637, updator=13701087609, preIssue=null, nextIssue=null, ext={EN=IssueExt(id=1236335585770656362, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236335227262529633, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1236335585770656363, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236335227262529633, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null}, startPage=1893, endPage=1898, ext={EN=ArticleExt(id=1236335232568316256, articleId=1236335232341823829, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Study on stability and bioactivity of hepatocyte growth factor for injection in various solvents, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=

Objective: To study the stability of hepatocyte growth-promoting factor for injection (HGFI) and its compatibility with different material infusion sets by physical and chemical testing and cell experiment. Methods: HGFI was dissolved with different solvents. Then the solution was sampled at 0 h and 24 h with or without infusion tube made of polyvinylchloride (PVC), thermoplastic elastomer (TPE), of thermoplastic polyurethanes (TPU) to determine the pH value, protein, clarity, visible foreign bodies, insoluble particles, osmolarity, content and macromolecular substances. HGFI was dissolved with 5% glucose injection or normal saline for 0 h and 24 h, and then diluted with complete medium and co-incubated with rat liver cells (BRL) for 48 h. The cell viability was detected by CCK-8 method. Results: The pH value, protein, degree of clarification, visible foreign bodies, insoluble particles, osmotic molar concentration, content determination, and macromolecular substances of HGFI dissolved with 5% glucose, normal saline, 5% glucose and normal saline and sampled via/not via infusion tube of different materials (PVC, TPE, TPU) at 0 h and 24 h all met the requirements of 2020 edition of Chinese Pharmacopoeia. Compared with the normal control group, HGFI solutions at 0 h and 24 h not only had no toxic effects on BRL cells, but also significantly increased the viability of BRL cells. Conclusion: HGFI is stable within 24 h with different solvents and has good compatibility with infusion sets of different materials. Moreover, it keeps wonderful bioactivity within 24 h.

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目的：通过理化实验和细胞实验研究注射用促肝细胞生长素（hepatocyte growth-promoting factor for injection, HGFI）的溶媒稳定性以及与不同材质输液管的相容性，为其临床使用提供科学依据。方法：理化实验：HGFI分别用不同注射液复溶，于0和24 h经/不经聚氯乙烯（polyvinylchloride, PVC）、热塑性橡胶（thermoplastic elastomer, TPE）、热塑性聚氨酯橡胶（thermoplastic polyurethanes, TPU）输液管取样，测定其pH值、蛋白质、澄清度、可见异物、不溶性微粒、摩尔渗透压浓度、含量和高分子物质。细胞实验：HGFI用5%葡萄糖注射液和0.9%氯化钠注射液复溶，于0与24 h取溶液与完全培养基配制成不同浓度的药液，与大鼠肝细胞（BRL）共孵育48 h，CCK-8法检测细胞活力。结果：理化实验：HGFI用5%葡萄糖注射液、0.9%氯化钠注射液、5%葡萄糖氯化钠注射液复溶，室温（26 ℃）不避光放置0和24 h，经/不经PVC，TPE，TPU材质输液管取样，其pH值、蛋白质、澄清度、可见异物、不溶性微粒、渗透压摩尔浓度、含量测定、高分子量物质均符合《中华人民共和国药典》2020年版的质量标准。细胞实验：正常对照组与HGFI 0 h比较活性相当，与HGFI 24 h比较，放置24 h的HGFI配制药液能观察到BRL细胞活力显著提高，HGFI配制药液对BRL细胞无不良毒性作用。结论：HGFI用5%葡萄糖注射液、0.9%氯化钠注射液、5%葡萄糖氯化钠注射液复溶在24 h内稳定，与PVC，TPE，TPU输液管的相容性良好且与正常对照组比较仍保持良好的生物活性。

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林柳青，女，主管技师，主要从事中药药理研究。联系电话：(020)36591225，E-mail: 451893302@qq.com。

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林柳青，女，主管技师，主要从事中药药理研究。联系电话：(020)36591225，E-mail: 451893302@qq.com。

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