Surgery treatment for the proliferativ retinal detachment associated with macular hole in the morning glory syndrome

Surgery treatment for the proliferativ retinal detachment associated with macular hole in the morning glory syndrome

:-
 
Purpose: To evaluate the efficacy of vitrectomy with peripapillary photocoagulation and silicone oil tamponade for the proliferative retinal detachment associated with macular hole in children with morning glory syndrome.
Methods: Eight children with morning glory syndrome (mean age 8.0±2.8 years; range 5–13 years) were included; all patients had unilateral eye disease and were misdiagnosed as having bilateral squint or amblyopia for years, with best corrected visual acuity less than 0.1. Five patients could not cooperate with the fundus examination and one patient had lens opacities. B-ultrasound confirmed that all eight patients had retinal detachment and optic disc dysplasia. All patients underwent standard 3-port pars plana vitrectomy surgery (20G for three cases and 23G for five cases). At surgery, all patients were confirmed to have morning glory syndrome, macular hole, and proliferative retinal detachment; two cases had a funnel-shaped bulge. All the retinal detachment involved the macular area, and macular hole was detected in the abnormal expansion excavation of optic disc. The epiretinal membrane and subretinal membrane were completely peeled during the surgery. Combined photocoagulation in abnormal expansion excavation of optic disc and silicone oil tamponade were also performed.
Results: All eyes achieved anatomical resolution. After follow-ups ranging from eight months to four years, the visual function for all patients was improved by postoperative refractive correction associated with vision training. Best corrected visual acuity was 0.01 to 0.2 at the final follow-up, no retinal detachment recurred, and no silicone oil fluid flowed into the subretinal space. The silicone oil was successfully removed postoperatively after 1.5 years.
Conclusion: Vitrectomy with peripapillary photocoagulation and silicone oil tamponade is effective in treating the proliferative retinal detachment associated with macular hole in children with morning glory syndrome.
Purpose: To evaluate the efficacy of vitrectomy with peripapillary photocoagulation and silicone oil tamponade for the proliferative retinal detachment associated with macular hole in children with morning glory syndrome.
Methods: Eight children with morning glory syndrome (mean age 8.0±2.8 years; range 5–13 years) were included; all patients had unilateral eye disease and were misdiagnosed as having bilateral squint or amblyopia for years, with best corrected visual acuity less than 0.1. Five patients could not cooperate with the fundus examination and one patient had lens opacities. B-ultrasound confirmed that all eight patients had retinal detachment and optic disc dysplasia. All patients underwent standard 3-port pars plana vitrectomy surgery (20G for three cases and 23G for five cases). At surgery, all patients were confirmed to have morning glory syndrome, macular hole, and proliferative retinal detachment; two cases had a funnel-shaped bulge. All the retinal detachment involved the macular area, and macular hole was detected in the abnormal expansion excavation of optic disc. The epiretinal membrane and subretinal membrane were completely peeled during the surgery. Combined photocoagulation in abnormal expansion excavation of optic disc and silicone oil tamponade were also performed.
Results: All eyes achieved anatomical resolution. After follow-ups ranging from eight months to four years, the visual function for all patients was improved by postoperative refractive correction associated with vision training. Best corrected visual acuity was 0.01 to 0.2 at the final follow-up, no retinal detachment recurred, and no silicone oil fluid flowed into the subretinal space. The silicone oil was successfully removed postoperatively after 1.5 years.
Conclusion: Vitrectomy with peripapillary photocoagulation and silicone oil tamponade is effective in treating the proliferative retinal detachment associated with macular hole in children with morning glory syndrome.

Comparison of anterior segment optical coherence tomography and ultrasound biomicroscopy for iris parameter measurements in patients with primary angle closure glaucoma

Comparison of anterior segment optical coherence tomography and ultrasound biomicroscopy for iris parameter measurements in patients with primary angle closure glaucoma

:1-6
 
Purpose: To compare the repeatability and consistency of anterior segment optical coherence tomography (AS-OCT) and ultrasound biomicroscopy (UBM) in measuring iris parameters in patients with primary angle closure glaucoma.
Methods: Twenty-two patients (38 eyes) with primary angle closure glaucoma, including 5 eyes with acute angle closure glaucoma ,l0 fellow eyes of acute angle closure glaucoma, and 23 eyes with chronic angle closure glaucoma , were recruited consecutively in our hospital. All subjects underwent the anterior scanning by AS-OCT and UBM. peripheral iris thickness (pIT) and iris curvature (IC) in the anterior segment image obtained by AS-OCT and UBM were measured twice. The reproducibility of these two scans was evaluated by the intraclass correlation coefficient (ICC). A paired t-test was used to compare the difference between the two scans and the 95% limits of agreement (LoA) were calculated.
Results: UBM showed that the ICCs of pIT and IC were 0.892 and 0.936, and AS-OCT revealed 0.629 and 0.859, respectively. UBM had a higher reproducibility in both pIT and IC measurements as compared with AS-OCT. Differences in pIT measurement between AS-OCT and UBM (p=0.33l) were not statistically significant, with the 95% LoA (-0.l78 ~ 0.l56) mm as 36.l~4l.2% of the mean. The IC 0.053 mm smaller when measured by UBM than by AS-OCT  (p =0.0l7), with the 95% LoA(-0.l00~0.206) mm as 36.2~74.6% of the mean.
conclusionUBM had  a higher reproducibility in measuring iris parameters.The consistency between AS-OCT and UBM in measuring iris parameters was low in primary angle closure glaucoma patients.
PurposeTo compare the repeatability and consistency of anterior segment optical coherence tomography (AS-OCT) and ultrasound biomicroscopy (UBM) in measuring iris parameters in patients with primary angle closure glaucoma.
MethodsTwenty-two patients (38 eyes) with primary angle closure glaucoma, including 5 eyes with acute angle closure glaucoma ,l0 fellow eyes of acute angle closure glaucoma, and 23 eyes with chronic angle closure glaucoma , were recruited consecutively in our hospital. All subjects underwent the anterior scanning by AS-OCT and UBM. peripheral iris thickness (pIT) and iris curvature (IC) in the anterior segment image obtained by AS-OCT and UBM were measured twice. The reproducibility of these two scans was evaluated by the intraclass correlation coefficient (ICC). A paired t-test was used to compare the difference between the two scans and the 95% limits of agreement (LoA) were calculated.
ResultsUBM showed that the ICCs of pIT and IC were 0.892 and 0.936, and AS-OCT revealed 0.629 and 0.859, respectively. UBM had a higher reproducibility in both pIT and IC measurements as compared with AS-OCT. Differences in pIT measurement between AS-OCT and UBM (p=0.33l) were not statistically significant, with the 95% LoA (-0.l78 ~ 0.l56) mm as 36.l~4l.2% of the mean. The IC 0.053 mm smaller when measured by UBM than by AS-OCT  (p =0.0l7), with the 95% LoA(-0.l00~0.206) mm as 36.2~74.6% of the mean.
conclusionUBM had  a higher reproducibility in measuring iris parameters.The consistency between AS-OCT and UBM in measuring iris parameters was low in primary angle closure glaucoma patients.
Original Article

Relationship between Refractive Error and Ocular Biometrics in Twin children: the Guangzhou Twin Eye study

Relationship between Refractive Error and Ocular Biometrics in Twin children: the Guangzhou Twin Eye study

:129-133
 

Abstract

Purpose: A cross-sectional study was conducted to explore the relationship between refractive error and ocular biometrics in children from the Guangzhou twin eye study.

Methods: Twin participants aged 7-15 years were selected from Guangzhou Twin Eye study. Ocular examinations included visual acuity measurement, ocular motility evaluation, autorefraction under cycloplegia, and anterior segment, media, and fundus examination. Axial length (AL), anterior chamber depth (ACD), and corneal curvature radius were measured using partial coherence laser interferometry. A multivariate linear regression model was used for statistical analysis.

Results: Twin children from Guangzhou city showed a decreased spherical equivalent with age, whereas both AL and ACD were increased and corneal curvature radius remained unchanged. When adjusted by age and gender, the data from 77% of twins presenting with spherical equivalent changes indicated that these were caused by predictable variables (R2=0.77, P<0.001). Primary factors affecting children's refraction included axial length (β=-0.97, P<0.001), ACD (β=0.33, P<0.001), and curvature radius (β=2.10, P<0.001). Girls had a higher tendency for myopic status than did boys (β=-0.26, P<0.001). Age exerted no effect upon the changes in refraction (β=-0.01, P=0.25).

Conclusion: Refraction is correlated with ocular biometrics. Refractive status is largely determined by axial length as the major factor. 


Abstract

Purpose: A cross-sectional study was conducted to explore the relationship between refractive error and ocular biometrics in children from the Guangzhou twin eye study.

Methods: Twin participants aged 7-15 years were selected from Guangzhou Twin Eye study. Ocular examinations included visual acuity measurement, ocular motility evaluation, autorefraction under cycloplegia, and anterior segment, media, and fundus examination. Axial length (AL), anterior chamber depth (ACD), and corneal curvature radius were measured using partial coherence laser interferometry. A multivariate linear regression model was used for statistical analysis.

Results: Twin children from Guangzhou city showed a decreased spherical equivalent with age, whereas both AL and ACD were increased and corneal curvature radius remained unchanged. When adjusted by age and gender, the data from 77% of twins presenting with spherical equivalent changes indicated that these were caused by predictable variables (R2=0.77, P<0.001). Primary factors affecting children's refraction included axial length (β=-0.97, P<0.001), ACD (β=0.33, P<0.001), and curvature radius (β=2.10, P<0.001). Girls had a higher tendency for myopic status than did boys (β=-0.26, P<0.001). Age exerted no effect upon the changes in refraction (β=-0.01, P=0.25).

Conclusion: Refraction is correlated with ocular biometrics. Refractive status is largely determined by axial length as the major factor. 
Original Article

Ten-year Follow-up of Familial Nanophthalmos in Three siblings

Ten-year Follow-up of Familial Nanophthalmos in Three siblings

:113-118
 

Abstract

Purpose: Nanophthalmos is a rare congenital disorder associated with a high incidence of angle-closure glaucoma. We followed the clinical manifestations of three siblings to evaluate their responses to various treatments.
Methods:  Three sisters with nanophthalmos were followed from 2000 to 2013. Glaucoma and cataract treatments were performed whenever indicated.
Results: The oldest sister had chronic elevation of intraocular pressure(IOP) and underwent laser peripheral iridotomy (LPI) on both eyes, followed by uneventful phacoemulsification with intraocular lens (IOL) implantation on the left eye and phacotrabeculectomy with IOL implantation on the right eye. The middle sister had acute elevation of IOP and initially underwent phacoemulsification combined with implantation of two IOLs on her left eye and LPI on her right eye. Severe uveal effusion occurred when phacoemulsification was performed on her right eye 6 years later, but ultimately was com pletely resolved. In both sisters, stable IOP and visual results were achieved after lensectomy. The youngest sister, who had suspected angleclosure, achieved a stable IOP and visual results with prophylactic LPI alone.
Conclusion: In nanophthalmic eyes, the severity of the disease may foreshadow the severity of surgical complications and responses to therapy. (Eye science 2013 ; 28:113-118)

Abstract
Purpose: Nanophthalmos is a rare congenital disorder associated with a high incidence of angle-closure glaucoma. We followed the clinical manifestations of three siblings to evaluate their responses to various treatments.
Methods: Three sisters with nanophthalmos  were followed from 2000 to 2013. Glaucoma and cataract  treatments  were performed whenever indicated.
Results: The oldest sister had chronic elevation of intraocular pressure(IOP) and underwent laser peripheral iridotomy (LPI) on both eyes, followed by uneventful phacoemulsification with intraocular lens (IOL) implantation on the left eye and phacotrabeculectomy with IOL implantation on the right eye. The middle sister had acute elevation of IOP and initially underwent phacoemulsification combined with implantation of two IOLs on her left eye and LPI on her right eye. Severe uveal effusion occurred when phacoemulsification was performed on her right eye 6 years later , but ultimately was com pletely resolved. In both sisters, stable IOP and visual results were achieved after lensectomy. The youngest sister, who had suspected angle-closure, achieved a stable IOP and visual results with prophylactic LPI alone.
Conclusion: In nanophthalmic eyes, the severity of the disease may foreshadow the severity of surgical complications and responses to therapy. (Eye science 2013 ; 28:113-118)

A Rat Model of Autologous Oral Mucosal Epithelial Transplantation for corneal Limbal stem cell Failure

A Rat Model of Autologous Oral Mucosal Epithelial Transplantation for corneal Limbal stem cell Failure

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Purpose: To establish an animal model of autologous oral mucosa grafting for limbal stem cell deficiency.

Methods: The study was carried from August to october 2012. Fourteen SD rats were randomly and evenly allocated to study group A and control group B. Limbal stem cell deficiency was established by alkali burn in the right eye of each rat in both groups. Rats in group A received autologous oral mucosa strip transplantation following the chemical burn. Rats in group B did not receive surgery after the chemical burn. Topical antibiotics and dexamethasone were used in all rats. Corneal clarity, corneal fluorescein staining, oral mucosal graft survival, and complications at postoperative days 1, 3, 7, 14 were observed.
Results: The oral mucosa strip graft was detached in one rat in group A. Reepithelialization was observed starting from the graft position and was completed within 14 days in the remaining 6 eyes in group A. However, persistent corneal epithelium defect was observed in all eyes in group B,  among which corneal melting and perforation was observed in 2 eyes and corneal opacification with neovascularization was observed in the remaining 5 eyes.
Conclusion: Autologous oral mucosa strip grafting for limbal stem cell deficiency can be achieved by a rat model following chemical burn. The fate of the transplanted oral mucosal epithelial cells warrants further study. 


Purpose: To establish an animal model of autologous oral mucosa grafting for limbal stem cell deficiency.

Methods: The study was carried from August to october 2012. Fourteen SD rats were randomly and evenly allocated to study group A and control group B. Limbal stem cell deficiency was established by alkali burn in the right eye of each rat in both groups. Rats in group A received autologous oral mucosa strip transplantation following the chemical burn. Rats in group B did not receive surgery after the chemical burn. Topical antibiotics and dexamethasone were used in all rats. Corneal clarity, corneal fluorescein staining, oral mucosal graft survival, and complications at postoperative days 1, 3, 7, 14 were observed.

Results: The oral mucosa strip graft was detached in one rat in group A. Reepithelialization was observed starting from the graft position and was completed within 14 days in the remaining 6 eyes in group A. However, persistent corneal epithelium defect was observed in all eyes in group B,  among which corneal melting and perforation was observed in 2 eyes and corneal opacification with neovascularization was observed in the remaining 5 eyes.

Conclusion: Autologous oral mucosa strip grafting for limbal stem cell deficiency can be achieved by a rat model following chemical burn. The fate of the transplanted oral mucosal epithelial cells warrants further study. 

常见角膜病变基因治疗的进展

Development of Gene Therapy on common corneal Diseases

:1-3
 

角膜是基因治疗的理想靶器官。角膜碱烧伤、角膜新生血管、角膜移植术后排斥反应因其病理机制复杂,所牵涉的致病因素众多而治疗困难,疗效不佳。本文就基因治疗在上述疾病中的应用加以综述,以了解基因治疗应用于角膜病变的新进展 。

Abstract: cornea is an ideal target organ for gene therapy. corneal alkali burn , corneal neovascularization and corneal graft rejection tend to be with poor treatment efficacy due to its complex pathogenesis. This article aims to update the recent progress of gene therapy on corneal diseases.

经验交流

眼科研究型医院专职研究护士管理实践

Management practices of dedicated research nurses in an ophthalmic research hospital

:499-506
 
眼科研究型医院是推动医学创新与成果转化的核心平台。其中,专职临床研究护士(clinical research nurse,CRN)在提升临床研究的规范性及整体质量方面发挥着不可或缺的作用。然而,当前国内尚缺乏针对眼科领域CRN管理模式的系统总结和实践指导,制约了该群体专业价值的充分发挥和制度化建设的推进。本研究以中山大学中山眼科中心(三级甲等眼科研究型医院)2013—2024年间的CRN管理实践为样本,系统梳理其管理体系的构建路径与实施成效。研究发现,通过构建“准入-培训-双轨管理”体系和实践模式,能够显著提升CRN队伍的专业能力和研究项目的整体质量。机构质控数据显示,配备CRN后的研究项目质量评分由(67.5±17.2)分显著提升至(99.3±1.0)分(P<0.001),证实了该体系的有效性和可行性。研究结果还为我国眼科临床研究护理专业化发展提供了可复制的实践模板,还进一步分析提炼出CRN的三项核心职能:一是项目管理中的流程优化,保障研究环节高效协同;二是参与者管理,强化对参与者权益的保护;三是数据质量控制,确保研究数据的准确性与完整性。在此基础上,针对当前CRN发展中普遍存在的职责不清、培训缺失、政策滞后等问题,本文还提出推动“层级化培训常态化”“政策规范细则化”等优化建议,助力我国眼科临床研究由“经验驱动”向“体系驱动”转型,为临床研究护理专业化提供实践模板和决策参考。
Ophthalmic research hospitals serve as critical platforms for advancing medical innovation and translating research outcomes into practice. Dedicated Clinical Research Nurses (CRNs) play a pivotal role in enhancing the quality, compliance, and integrity of clinical research conducted within these settings. However, in China, there remains a lack of systematic models and practical guidance for CRN management specific to the field of ophthalmology, which has hindered the full realization of their professional value and the advancement of institutionalized development. This study examined CRN management practices at Zhongshan Ophthalmic Center, Sun Yat-sen University, a Grade A tertiary ophthalmic research hospital, between 2013 and 2024 as a case example to systematically examine the development pathway and outcomes of its CRN management system. The findings demonstrate that the implementation of a standardized system encompassing entry qualifications, tiered training, and structured practice models significantly enhanced both the professional competency of CRNs and the overall quality of clinical research projects. According to institutional quality control data, the quality score of clinical research projects increased significantly from 67.5±17.2 to 99.3±1.0 (P<0.001) following the integration of CRNs. Moreover, the study identifies three core functional domains of CRNs: (1) optimizing research processes to improve project coordination and efficiency; (2) managing research participants to safeguard ethical compliance and rights protection; and (3) ensuring data quality and integrity through rigorous oversight. In response to persistent challenges such as unclear role definitions, insufficient training systems, and lagging policy support, the study proposes actionable strategies, including the institutionalization of hierarchical and continuous training as well as the refinement of policy frameworks. These findings provide a scalable and evidence-based reference for promoting the professionalization and systemic development of ophthalmic clinical research nursing in China.
综述

眼表的微环境及其调节机制

The ocular surface microenvironment and its regulatory mechanisms

:491-498
 
眼表是一个复杂且精细的系统,包括角膜、泪膜和结膜等多个结构。作为眼部直接与外界接触的部分,眼表不仅负责起着保护眼睛的作用,还在视觉功能中扮演着至关重要的角色。眼表微环境(ocular surface microenvironment,OSM)的平衡对眼睛的健康至关重要,任何微环境的失衡都可能引发多种眼表疾病,如干眼症、角膜炎等。随着现代人群生活方式的改变,视屏终端综合征(Visual Display Terminal,VDT)发生率急剧上升,破坏了OSM的平衡,导致眼表疾病的发病率大大升高,特别是干眼症的发病率显著增加,严重影响了患者的生活质量,因此,深入研究维持OSM稳态的调节机制以及探索有效的治疗策略显得尤为紧迫。近年来,研究突破了传统的解剖学框架,揭示了OSM的多系统协同调控机制,为维持眼表微环境稳态提供了新的思路。神经、淋巴、免疫系统之间相互调节,不仅有助于深入挖掘眼表疾病的关键分子和信号通路,还为发现新的生物标志物以及潜在治疗靶点提供了新的方向。因此,本文章系统综述了近年来OSM调节机制的最新进展,重点讨论神经、淋巴和免疫调节在维持OSM稳态中的作用,并分析三者之间的相互影响,以期为眼表疾病的预防及诊疗提供新的思路。
The ocular surface is a complex and sensitive system composed of includes various structures including the cornea, tear film and conjunctiva. As the part of the eye directly exposed to the external environment, the ocular surface not only protects the eye, but also plays a vital role in vision. The balance of the ocular surface(OSM) is essential for eye health, and any disruption can lead to ocular surface diseases, such as dry eye and keratitis. With the evolving lifestyle of the modern population, the incidence of Visual Display Terminal (VDT) syndrome has significantly increased, disturbing the OSM balance and leading to a rise in ocular surface diseases, particularly dry eye disease, which severely impacts patients' quality of life. Therefore, it is crucial to conduct comprehensive research into the regulatory mechanisms that maintain OSM homeostasis and explore effective therapeutic strategies. Recent studies have moved beyond traditional anatomical frameworks, uncovering the multi-system coordinated regulatory mechanisms of OSM, providing new insights into maintaining ocular surface homeostasis. The interplay between the nervous, lymphatic, and immune systems not only helps identify key molecules and signaling pathways involved in ocular surface diseases but also offers new opportunities for discovering novel biomarkers and potential therapeutic targets. This article presents a systematic review of the latest advancements in OSM regulatory mechanisms, focusing on the roles of nervous, lymphatic, and immune regulation in maintaining OSM homeostasis and analyzing the interactions among these systems, with the goal of offering new insights for the prevention and treatment of ocular surface diseases.
论著

眼解剖整合课程在眼科住院医师规范化培训教学中的应用

The application of the integrated course on ocular anatomy in the standardized training teaching of ophthalmology residents

:483-490
 
目的:探索和评价“线上教学-理论小课-Wetlab实操”眼解剖整合课程在眼科住院医师规范化培训(住培)教学中的应用和效果。方法:纳入中山大学中山眼科中心2023年新入培的住培学员93名,在岗前培训时进行眼解剖整合课程教学。在课程前后分别进行测试,评价课程教学效果,并在课程结束后采用匿名线下测试考核和满意度问卷调查的形式对课程的满意度进行调查。结果:培训前(T1)和培训后(T2)总分中位数分别是60分和70分,T1最低分、25%、75%和最高分分别是10、40、62.5和90,T2最低分、25%、75%和最高分分别是30、60、80和100,T2得分显著高于T1得分,差异具有统计学意义(P<0.000 1);T1和T2的自信度平均值分别为26.53±5.08、31.83±4.02,差异有统计学意义(P<0.001)。学员普遍表示对整合课程满意。结论:学员们接受整合课程培训后,对眼解剖学知识的掌握程度有明显提高,对整合课程满意度高。眼解剖整合课程有效性显著,是具有推广意义的教学改革。
Objective: To explore and evaluate the application and effect of an integrated   ocular anatomy course comprising three main components: ‘online preview,’ ‘lecture,’ and ‘Wetlab dissection training’in the standardized training teaching of ophthalmology residents (hereinafter referred to as "resident training"). Methods: A total of 93 new resident trainees from Zhongshan Ophthalmic Center of Sun Yat-sen University in 2023 were included in the integrated course on ocular anatomy during pre-job training. Tests were carried out before and after the course to evaluate the teaching effect of the course, and questionnaires were issued after the course to investigate the satisfaction of the course. It adopts the form of anonymous offline test and satisfaction questionnaire. Results: The median total scores before (T1) and after (T2) training were 60 and 70, respectively; the lowest scores, 25%, 75% and highest scores of T1 were 10, 40, 62.5 and 90, respectively; the lowest scores, 25%, 75% and highest scores of T2 were 30, 60, 80 and 100, respectively, and the scores of T2 were significantly higher than those of T1. The difference was statistically significant (P<0.000 1). The mean confidence of T1 and T2 were 26.53±5.08 and 31.83±4.02, respectively, and the difference was statistically significant (P<0.001). Participants generally expressed satisfaction with the integrated programme. Conclusions: After receiving the training of the integrated course, the students' mastery of the knowledge of ocular anatomy has been significantly improved, and the satisfaction of the integrated course is high. The integrated course on ocular anatomy is effective, and it is a teaching reform with popularization significance.
论著

高效液相色谱法测定曲伏噻吗滴眼液中曲伏前列素有关物质

Determination of related substances of travoprost in travoprost and timolol maleate eye drops by HPLC

:471-482
 
目的:建立高效液相色谱法(high-performance liquid chromatography,HPLC)测定曲伏噻吗滴眼液中曲伏前列素有关物质。方法:采用Agilent SB-C18色谱柱(50 mm×2.1 mm,2.7 μm);以磷酸溶液(取磷酸2.0 mL,加水稀释并定容至1 000 mL,用氢氧化钠溶液调节pH至3.0)为流动相A,乙腈为流动相B,洗脱梯度;流速为每分钟3.0 mL;柱温为30 ℃;检测波长为220 nm;进样体积100 μL。结果:在该色谱条件下,曲伏前列素与各杂质均可良好分离;在酸、碱、氧化、高温和强光破坏条件下,曲伏前列素峰纯度合格,物料守恒。曲伏前列素、5,6-反式曲伏前列素和15-酮曲伏前列素分别在0.041~3.245 μg/mL(r=1.000 0)、0.040~3.229 μg/mL(r=1.000 0)、0.039~3.088 μg/mL(r=0.999 9)范围内线性关系良好,其最低检测限分别为0.020、0.020和0.020 μg/mL;6份样品中5,6-反式曲伏前列素的含量相对标准偏差(relative standard deviatio,RSD)为0.2% (n=6),15-酮曲伏前列素的含量RSD为0.3% (n=6),重复性良好;对照品溶液和供试品溶液在室温条件下放置100h稳定,5,6-反式曲伏前列素的平均回收率为95.2%,相对标准偏差RSD为0.5% (n=9),15-酮曲伏前列素的平均回收率为92.7%,RSD为1.2% (n=9)该方法重现性好。结论:本方法简便、快速、准确。适用于检测曲伏噻吗滴眼液中的曲伏前列素有关物质。
Objective: To develop a high-performance liquid chromatography (HPLC) method for the determination of related substances in Travoprost and Timolol Maleate Eye Drops, sepcifically focusing on Travoprost and its impurities. Methods: The analytic column used was an Agilent SB-C18 (50 mm × 2.1 mm,2.7 μm) . A phosphoric acid solution (prepared by diluting 2.0 mL of phosphoric acid with water tto final volume of 1,000 mL and adjust the pH to 3.0 with sodium hydroxide solution) was used as mobile phase A, while acetonitrile served as mobile phase B. The elution was performed using a gradient program at a flow rate of 3.0 mL/min. The detection wavelength was set at 220 nm, and the column temperature was maintained at 30 ℃. The injection volume is 100 μL. Results: Under the described chromatographic condition, Travoprost and its various impurities were well separated. The purity of the Travoprost peak was qualified, and the material remained stable under conditions of acid, alkali, oxidation, high temperature, and strong light exposure. The linear ranges for Travoprost, 5,6-trans-Travoprost, and 15-keto-Travoprost were determined to be 0.041~3.245 μg/mL(r=1.0000), 0.040~3.229 μg/mL(r=1.0000), 0.039~3.088 μg/mL(r=0.9999), respectively. The lowest detection limits for these compounds were all 0.020 μg/mL, The relative standard deviation (RSD) for the content of 5,6-trans-travoprost and 15 keto trovopros in six samples were 0.2% (n=6) and 0.3% (n=6), respectively, indicating good reproducibility. Both the reference solution and the test solution remained stable at room temperature for 100 hours,The average recovery rates for 5,6-trans-Travoprost and 15-keto-Travoprost were 95.2% (RSD 0.5%,n=9) and 92.7% (RSD 1.2%, n=9) respectively, further confirming the high reproducibility of the method. Conclusions: The developed HPLC method is simple, rapid, and accurate, making it suitable for the determination of related substances in Travoprost and Timolol Maleate Eye Drops.
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  • 眼科学报

    主管:中华人民共和国教育部
    主办:中山大学
    承办:中山大学中山眼科中心
    主编:林浩添
    主管:中华人民共和国教育部
    主办:中山大学
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  • Eye Science

    主管:中华人民共和国教育部
    主办:中山大学
    承办:中山大学中山眼科中心
    主编:林浩添
    主管:中华人民共和国教育部
    主办:中山大学
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