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Insulin Resistance Associated with Impaired Fasting Glycaemia in Anti-Retroviral Therapy Patients 胰岛素抵抗与抗逆转录病毒治疗患者空腹血糖受损相关
Pub Date : 2023-06-17 DOI: 10.32553/ijmbs.v7i6.2711
Karthik K, Arathi Pillai, Anurodh Gupta, Palaniswamy Ramaswamy, Leena Rawat, Sibin M K
Background: Insulin resistance was associated with type-2 diabetes mellitus regardless of HIV status. However, an association of insulin resistance in prediabetes with HIV-infected subjects undergoing anti-retroviral therapy (ART) has been reported in very few studies. Methods: Serum insulin and insulin resistance (HOMA-IR) were measured in ART patients with impaired fasting glycemia (IFG) and those with normal glucose tolerance (NGT) along with other biochemical parameters. Results: There was increased insulin resistance in the ART IFG group when compared to their ART NGT counterparts. There was a positive correlation of HOMA-IR with serum creatinine, triglycerides, and ALT levels. However, serum HDL showed a negative correlation with HOMA-IR. Conclusion: Present study showed that there is association of insulin resistance in IFG associated with HIV-infected subjects on ART. Hence, monitoring the insulin resistance in ART patients may help in early prevention of type 2 diabetes mellitus. Keywords: Human Immunodeficiency Virus, anti-retroviral therapy, impaired fasting glycemia, serum Insulin, HOMA-IR
背景:胰岛素抵抗与2型糖尿病相关,与HIV感染无关。然而,前驱糖尿病患者的胰岛素抵抗与接受抗逆转录病毒治疗(ART)的hiv感染者之间的关联在很少的研究中被报道。方法:测定空腹血糖受损(IFG)和糖耐量正常(NGT) ART患者血清胰岛素和胰岛素抵抗(HOMA-IR)及其他生化指标。结果:与ART NGT组相比,ART IFG组胰岛素抵抗增加。HOMA-IR与血清肌酐、甘油三酯和ALT水平呈正相关。血清HDL与HOMA-IR呈负相关。结论:目前的研究表明IFG中胰岛素抵抗与抗逆转录病毒治疗相关。因此,监测抗逆转录病毒治疗患者的胰岛素抵抗可能有助于2型糖尿病的早期预防。关键词:人类免疫缺陷病毒,抗逆转录病毒治疗,空腹血糖受损,血清胰岛素,HOMA-IR
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引用次数: 0
Process Validation of Paracetamol tablet as per ICH guidelines 根据ICH指南对扑热息痛片进行工艺验证
Pub Date : 2023-06-12 DOI: 10.32553/ijmbs.v7i6.2713
Ritika Bhatia, Rakesh Goyal, Dilip Agarwal
Process validation is an integral part of pharmaceutical manufacturing, ensuring that tablets are consistently produced with quality and efficacy in line with regulatory requirements. The International Council for Harmonization ICH) provides guidelines for the systematic validation of manufacturing processes. This research article presents a comprehensive study on process validation for Paracetamol tablets following the ICH guidelines. The article focuses on various aspects of the validation process, including process design, qualification, and continued process verification, with specific emphasis on Paracetamol tablet manufacturing. Experimental studies were conducted to characterize the critical process parameters and assess their impact on the tablet's quality attributes. The article also discusses the use of statistical analysis techniques for data evaluation and demonstrates the establishment of a robust validation protocol for Paracetamol tablet manufacturing. Through the application of the ICH guidelines, this research contributes to ensuring the consistency and reliability of Paracetamol tablets, enhancing patient safety and meeting regulatory expectations. Keywords: Process validation, ICH guidelines, Critical process parameters, Critical Process Attribution, Statistical analysis, and validation protocol;
工艺验证是药品生产的一个组成部分,确保片剂的质量和功效始终符合法规要求。国际协调理事会(ICH)为生产过程的系统验证提供指南。本文根据ICH指南对扑热息痛片的工艺验证进行了综合研究。本文重点介绍了验证过程的各个方面,包括工艺设计、确认和持续工艺验证,特别强调了扑热息痛片的生产。实验研究了关键工艺参数的特征,并评估了它们对片剂质量属性的影响。本文还讨论了数据评估的统计分析技术的使用,并演示了对乙酰氨基酚片剂生产的稳健验证方案的建立。通过应用ICH指南,本研究有助于确保扑热息痛片的一致性和可靠性,提高患者安全性并满足监管期望。 关键词:工艺验证,ICH指南,关键工艺参数,关键工艺归因,统计分析,验证方案;
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引用次数: 0
Process Validation of Paracetamol Tablets: A Comprehensive Study Based on ICH Guidelines 对乙酰氨基酚片的工艺验证:基于ICH指南的综合研究
Pub Date : 2023-06-12 DOI: 10.32553/ijmbs.v7i6.2712
Ritika Bhatia, Mo. Firoj Tanwar, Rakesh Goyal, Dilip Agarwal
This research paper aims to provide a comprehensive understanding of the process validation of Paracetamol tablets according to the guidelines outlined by the International Council for Harmonisation of Technical Requirements forPharmaceuticals for Human Use (ICH). Paracetamol is a widely used analgesic and antipyretic drug, and ensuring the quality, safety, and efficacy of its dosage form is of utmost importance. This study encompasses the three stages of process validation, namely process design, process qualification, and continued process verification, with a focus oncritical parameters and attributes. The article also explores the role of regulatory guidelines, such as the ICH Q8 (R2), Q9,and Q10, in facilitating effective process validation. (1) Key words: Process Validation, ICH, CPP, CQA, SPC, Change Control, VMP;
本研究论文旨在根据国际人用药品技术要求协调委员会(ICH)概述的指南,提供对扑热息痛片工艺验证的全面理解。扑热息痛是一种应用广泛的镇痛解热药物,保证其剂型的质量、安全性和有效性至关重要。本研究包括工艺验证的三个阶段,即工艺设计、工艺确认和持续工艺验证,重点是关键参数和属性。本文还探讨了法规指南的作用,例如ICH Q8 (R2)、Q9和Q10,在促进有效的工艺验证方面。(1) & # x0D;关键词:过程验证,ICH, CPP, CQA, SPC,变更控制,VMP;
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引用次数: 0
To Assess the Maternal and Perinatal Outcome with Isolated Oligohydramnios in Third Trimester of Pregnancy 评估妊娠晚期孤立性羊水过少的孕产妇和围产期结局
Pub Date : 2023-05-19 DOI: 10.32553/ijmbs.v7i5.2708
Dr. Kamlesh Yadav, Dr. Ritu Choudhary, Dr. Preeti Kumari, Dr. Rakesh Kumar Serawat, Dr. Panki Kumari
Introduction: Oligohydramnios is described as a condition with decreased amniotic fluid volume relative to gestational age. Oligohydramnios is most commonly defined as an amniotic fluid index (AFI) ? 5 cm or the largest vertical pocket measuring ? 2 cm. Isolated oligohydramnios (IO) refers to the presence of oligohydramnios without fetal structural and chromosomal abnormalities, without fetal growth restriction, without intrauterine infection and in the absence of known maternal disease.Aim: To study was to analyse the maternal and fetal outcome in isolated oligohydramnios in third trimester of pregnancy.Method: This is prospective hospital based observational study which was carried out in department of obstetrics and gynaecology, S.P. Medical College, Bikaner for a period from June 2021 to May 2022. This study included 100 pregnant women, who fulfill inclusion and exclusion criteria, out of which 50 pregnant women with 28 completed weeks of gestation who had singleton pregnancy with cephalic presentation and Amniotic Fluid Index (AFI) < 5 cm enrolled as study cases while 50 pregnant women with AFI > 5 cm were in control group.Results: Majority of the patients were in 21-30 years of age in both groups. Majority of patients in both groups were illiterate, unbooked, belonged to rural area and were from lower middle socioeconomic status; hence both groups were comparable in this regards.  In our study in group A out of 50 patients, 33 (66%) had LSCS and 17 (34%) patients delivered by vaginal route and group B out of 50 patients, 43 (86%) patients delivered by vaginal route and only 7 (14%) patients had for LSCS.  NICU admission in group A was 14 (28%) and in group B 3(6%) respectively.Conclusion: C-Section rates were more common in group A compared to group B. NICU admission rate were more in group A (40%) compare to group B (14%). In Isolated oligohydramnios more babies had APGAR<7 at 1& 5min.
简介:羊水过少是指相对于胎龄羊水体积减少的一种情况。羊水过少最常见的定义是羊水指数(AFI)。5厘米或最大的垂直口袋测量?2厘米。孤立性羊水过少(IO)是指存在羊水过少,但没有胎儿结构和染色体异常,没有胎儿生长受限,没有宫内感染,没有已知的母体疾病。目的:分析妊娠晚期孤立性羊水过少的母胎结局。方法:这是一项前瞻性医院观察性研究,于2021年6月至2022年5月在比卡内尔S.P.医学院妇产科进行。本研究纳入100例符合纳入和排除标准的孕妇,其中50例妊娠完成28周、头位且羊水指数(羊水指数)< 5 cm的单胎妊娠作为研究病例,50例AFI > 5 cm的孕妇作为对照组。结果:两组患者年龄均以21 ~ 30岁为主。两组患者多为文盲、未预约、农村、中下社会经济阶层;因此,两组在这方面具有可比性。在我们的研究中,A组50例患者中,33例(66%)患者行LSCS, 17例(34%)患者经阴道分娩;B组50例患者中,43例(86%)患者经阴道分娩,只有7例(14%)患者行LSCS。A组14例(28%),B组3例(6%)。结论:A组剖腹产率高于B组。A组新生儿重症监护病房住院率(40%)高于B组(14%)。在孤立性羊水过少的婴儿中,更多的婴儿在1和5min时APGAR<7。
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引用次数: 0
Evaluation of Gynaecological Problems among Adolescent Girls attending Gynaecology out Patient Department at Tertiary Care Hospital in Western Rajasthan 在拉贾斯坦邦西部三级保健医院妇科门诊就诊的少女妇科问题的评估
Pub Date : 2023-05-19 DOI: 10.32553/ijmbs.v7i5.2709
Dr. Kamlesh Yadav, Dr. Panki Kumari, Dr. Ritu Choudhary, Dr Priti Kumari
BackgroundTo evaluated various gynaecological problems among adolescent girls attending gynaecology out patient department at tertiary care hospital in Western RajasthanMethodsHospital Based cross sectional study conducted on 138 adolescent girls.   Study population will consist of all unmarried Adolescent girl’s age 10-19 yrs. attending outpatient department of obstetrics and Gynaecology Sardar Patel medical college Bikaner.Inclusion criteriaAll the unmarried adolescent female with age 10-19 yrs. Who come to Gynae OPD with any gynaecological complaint and willing to participants?Exclusion criteriaThose not willing to participate and not given consent.Age less than <10 years and more than >19 years.
背景:评估在拉贾斯坦邦西部三级医院妇科门诊就诊的少女的各种妇科问题。方法:对138名少女进行基于医院的横断面研究。研究人群将包括所有10-19岁的未婚少女。比卡内尔萨达尔帕特尔医学院妇产科门诊主治医师。纳入标准:10-19岁未婚少女。谁来妇科门诊有妇科投诉,并愿意参加?排除标准:不愿参与且未经同意者。年龄不超过19岁。
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引用次数: 0
Canine Fossa Abscess-Induced Bullae Formation: A Case Report 犬窝脓肿致大疱形成1例报告
Pub Date : 2023-05-11 DOI: 10.32553/ijmbs.v7i5.2705
Puspita Rahardjo Putri, E. Lodra
Introduction: Canine fossa abscess is an odontogenic infection originating from the upper jaw teeth, specifically from the premolar or canine. This abscess needs to be treated properly because it can be life-threatening. Canine fossa abscess that induces the formation of bullae is rare.Case Report: A 55-year-old male complained of a lump under his eye that contain clear fluid after previously undergoing abscess drainage through intraoral access and teeth extraction that caused the canine fossa abscess. The lump was in the form of a ruptured bullae lesion and reappeared. The treatment performed was incision through extraoral access, postoperative bandage, and antibiotic medication. The result showed that the bullae disappeared. The prognosis, in this case, is ad bonam.Conclusion: Canine fossa abscess cases can be life-threatening. Complications that arise, such as bullae, are rare but it is important to know the causes, treatment, and management. It is crucial for dentists to be aware so that they can determine the treatment when such cases occur.Keywords: Fossa Canine Abscess, Drainage, Bullae
犬窝脓肿是一种起源于上颌牙齿的牙源性感染,特别是来自前磨牙或犬牙。这种脓肿需要适当治疗,因为它可能危及生命。犬窝脓肿导致大疱的形成是罕见的。病例报告:一名55岁男性主诉眼部肿块含有透明液体,此前曾通过口内通道进行脓肿引流和拔牙,导致犬窝脓肿。肿块以破裂的大泡病变的形式出现并再次出现。治疗方法为口外切开、术后包扎、抗生素治疗。结果显示大疱消失。在这种情况下,预后是良好的。结论:犬窝脓肿可危及生命。并发症的出现,如大疱,是罕见的,但重要的是要知道的原因,治疗和管理。对于牙医来说,意识到这一点是至关重要的,这样他们就可以在这种情况发生时决定治疗方法。关键词:犬窝脓肿,引流,大泡
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引用次数: 0
To Compare the Rescue Analgesia used in Post-Operative Period of Dexmedetomidine and Clonidine as an Adjuvant to Intrathecal Bupivacaine in Patients Undergoing Total Abdominal Hysterectomy 目的:比较右美托咪定与克拉定在全腹子宫切除术患者鞘内布比卡因辅助下术后的镇痛效果
Pub Date : 2023-05-06 DOI: 10.32553/ijmbs.v7i5.2706
Dr. Rupesh Choudhary, Dr. Rahul Sharma, Dr. Ankita Jamwal, Dr. Divya Drishti
Background: Spinal block is the first choice for lower abdominal surgeries. Bupivacaine is the most common local anaesthetic used but has a shorter duration of action. Many adjuvants have been used to improve the quality of analgesia till postoperative period. In this study, we used ?2-agonists. Methods: A prospective randomized single blind study was conducted in the Department of Anaesthesia IGMC SHIMLA at Kamla Nehru state hospital. Results: Injection PCM 1gm was used as rescue analgesic if VAS ?4 was achieved in any patient. In Group C 10 patients received Inj PCM as compared to 8 patients in Group D. One patient in each group received 1 dose, 5 in Group C and 2 in Group D received 2 doses and 4 in Group C and 5 in Group D received 3 doses of Inj PCM in 24 hrs postoperative period. (p=0.693). Conclusion: We concluded that the rescue Analgesia used in post operative period.
背景:脊柱阻滞是下腹部手术的首选。布比卡因是最常用的局部麻醉剂,但作用时间较短。许多辅助药物被用于改善术后镇痛质量。在这项研究中,我们使用了2-受体激动剂。方法:在Kamla Nehru国立医院IGMC SHIMLA麻醉科进行前瞻性随机单盲研究。结果:凡达到VAS ?4级的患者均采用注射PCM 1gm作为抢救镇痛药。术后24小时内,C组10例患者注射PCM, D组8例,C组5例,D组2例,C组4例,D组5例,注射PCM 3次。(p = 0.693)。结论:术后应采用抢救性镇痛。
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引用次数: 0
To Compare the Side Effect of Dexmedetomidine and Clonidine as an Adjuvant to Intrathecal Bupivacaine in Patients Undergoing Total Abdominal Hysterectomy 目的比较右美托咪定与克拉定在全腹子宫切除术患者鞘内辅助布比卡因的副作用
Pub Date : 2023-05-06 DOI: 10.32553/ijmbs.v7i5.2707
Dr. Rupesh Choudhary, Dr. Rahul Sharma, Dr. Ankita Jamwal, Dr. Divya Drishti
Background: Addition of adjuvants to routinely used intrathecal drugs is cornerstone in safe and effective prolongation of single shot spinal block for gynecological surgery. In resource deficient countries, where epidural anaesthesia is usually not used because of cost factor, adjuvants are routinely used to prolong the effect of regional anaesthesia. Alpha 2 agonists are considered best drugs as adjuvants, but there is inconclusive data in literature about the block characteristic, dose at which to be used and side effect after use of these drugs. Methods: A prospective randomized single blind study was conducted in the Department of Anaesthesia IGMC SHIMLA at Kamla Nehru state hospital. Results: Hypotension was seen in 5 patients of Group C and 4 patients of Group D. Three patients in both the groups required 2 doses of Inj mephenteramine and 2 patients in Group C and 1 in Group D required single dose of Vasopressor (Inj mephentermine). (p=0.83). Five patients had bradycardia, 3 Nausea and 3 had shivering in Group C, while only 2 patients had side effects in Group D i.e one patient had bradycardia and another nausea, vomiting. (p= 0.657) Conclusion: We observed hypotension, bradycardia, nausea vomiting and post operative shivering in our patients during the study period but there was no statistical significance achieved amongst the groups. (p>0.05). 
背景:在常规鞘内药物的基础上添加辅助剂是安全有效延长妇科手术单针脊髓阻滞的基础。在资源缺乏的国家,由于成本因素通常不使用硬膜外麻醉,通常使用辅助剂来延长区域麻醉的效果。α - 2激动剂被认为是最好的佐剂,但文献中关于阻滞特性、使用剂量和使用后副作用的数据尚无定论。方法:在Kamla Nehru国立医院IGMC SHIMLA麻醉科进行前瞻性随机单盲研究。结果:C组5例、D组4例患者出现低血压,两组均有3例患者需要2剂量注射甲非那明,C组2例、D组1例患者需要单剂量注射甲非那明。(p = 0.83)。C组有5例心动过缓,3例恶心,3例寒战,而D组只有2例出现副作用,即1例心动过缓,1例恶心,呕吐。(p= 0.657)结论:研究期间患者出现低血压、心动过缓、恶心呕吐、术后寒战,但组间差异无统计学意义。(p > 0.05)。
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引用次数: 0
A Comparative Study to Assess the Safety and Efficacy between Intravenous Iron Sucrose and Ferric Carboxymaltose in the Treatment of Iron Deficiency Anemia in Pregnancy – A Single Center Prospective Observational Study from a Tertiary Care Center. 静脉注射蔗糖铁和羧麦芽糖铁治疗妊娠期缺铁性贫血的安全性和有效性的比较研究——一项来自三级保健中心的单中心前瞻性观察研究。
Pub Date : 2023-05-05 DOI: 10.32553/ijmbs.v7i4.2699
Dhruvi Joshi, Dhruvi Joshi, Dr. Moolchand Khichad, Dr.Abhishek Mittal, D. Joshi
AbstractObjective: To Compare the safety and efficacy between intravenous iron sucrose and ferric carboxy maltose in the treatment of iron deficiency anemia in pregnancy.Methodology: A Prospective study was conducted on 100 antenatal women with iron deficiency anemia in department of Obstetrics and Gynecology of a tertiary care center in northern India from June 2021 to May 2022.Results: The mean age in group A (Iron Sucrose group) was 25+ 2.83 years and in group B (FCM group) was 24.08+4.45 years. In group A (IS group) the average increase in Hb level was about 1.24 ± 0.29 gm/dl at 3 weeks and 2.62 ± 0.2 gm/dl at 6 weeks. In group B (FCM group) the average increase was about 1.74 ± 0.42 gm/dl at 3 weeks and 4.15 ± 1.94 gm/dl at 6 weeks. In IS group the average increase in ferritin was about 18.83 ± 18.18 ng/dl at 3 weeks and 43.54 ± 31.71 ng/dl at 6 weeks. In FCM group the average increase was about 34 ± 19.83 ng/dl at 3 weeks and 96.62 ± 50.7 ng/dl at 6 weeks. P value at both time periods was 0.0001, which is highly significant. 43 patients (86%) in Group B as compared to 19 patients (38%) in group A showed improvement in anaemia in PBS findings over 3 week and 6 week period, which was statistically significant with a P value of 0.024. In Group A (IS group ) only two patients complained of diarrhoea, two complained of headache, 1 patient complained of nausea ,vomiting, one complained of nausea only, In Group B (FCM group) total 3 patients (6%) complained of minor reactions like nausea, vomiting and itching. There were mild side effects only in both the groups.Conclusion: Intravenous FCM is more efficient and better alternative than iron sucrose in the treatment of iron deficiency anaemia in pregnancy.Key Words: IDA, FCM, IS, Ferritin, Haemoglobin.
摘要目的:比较静脉注射蔗糖铁与羧化麦芽糖铁治疗妊娠期缺铁性贫血的安全性和有效性。方法:前瞻性研究于2021年6月至2022年5月在印度北部一家三级保健中心的妇产科对100名缺铁性贫血的产前妇女进行了研究。结果:A组(蔗糖铁组)平均年龄25+ 2.83岁,B组(FCM组)平均年龄24.08+4.45岁。A组(IS组)Hb水平3周平均升高1.24±0.29 gm/dl, 6周平均升高2.62±0.2 gm/dl。B组(FCM组)3周时平均升高1.74±0.42 gm/dl, 6周时平均升高4.15±1.94 gm/dl。IS组铁蛋白3周平均升高18.83±18.18 ng/dl, 6周平均升高43.54±31.71 ng/dl。FCM组3周平均升高34±19.83 ng/dl, 6周平均升高96.62±50.7 ng/dl。两个时间段的P值均为0.0001,具有高度显著性。B组43例(86%)与A组19例(38%)的PBS检查结果在3周和6周期间有所改善,P值为0.024,差异有统计学意义。A组(IS组)仅有2例患者主诉腹泻,2例患者主诉头痛,1例患者主诉恶心、呕吐,1例患者仅主诉恶心,B组(FCM组)共有3例(6%)患者主诉恶心、呕吐、瘙痒等轻微反应。只有两组都有轻微的副作用。结论:静脉FCM治疗妊娠期缺铁性贫血比蔗糖铁治疗效果更好。关键词:IDA,流式细胞仪,IS,铁蛋白,血红蛋白。
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引用次数: 0
Fabrication and Evaluation of Rimantadine Loaded Niosomes 金刚乙胺负载牛小体的制备与评价
Pub Date : 2023-05-02 DOI: 10.32553/ijmbs.v7i4.2698
S. P, Alagarsamy V, Subhash Chandra Bose P., S. V, Saritha D
Influenza virus is a highly contagious zoonotic respiratory disease that causes seasonal outbreaks each year and unpredictable pandemics occasionally with high morbidity and mortality rates, posing a great threat to public health worldwide. Besides the limited effect of vaccines, the problem is exacerbated by the lack of drugs with strong antiviral activity against all flu strains. Rimantadine is one of the effective anti-viral drugs that is used in treating influenza virus. In present study niosomes of Rimantadine were developed by ether injection method. Total 6 formulations were prepared by altering ratios of span 60 and cholesterol. The prepared formulations were evaluated for different parameters. In vitro drug release studies were carried out for all the formulations and among five formulations F5 was found to have highest drug release. Prepared niosomes were incorporated in gel and evaluation studies like pH, homogenicity, viscosity and spreadability were carried out. All the parameters were found satisfactory. It was compared with marketed gel. The former has shown drug release till 12 h whereas the latter has shown only till 6 h. Thus, sustained release of drug loaded niosomes was proved.
流感病毒是一种高度传染性的人畜共患呼吸道疾病,每年都会引起季节性疫情,偶尔会出现不可预测的大流行,发病率和死亡率都很高,对全世界的公共卫生构成巨大威胁。除了疫苗的作用有限之外,缺乏对所有流感病毒株都具有强抗病毒活性的药物使问题更加严重。金刚乙胺是一种有效的抗病毒药物,用于治疗流感病毒。本研究采用乙醚注射法制备了金刚乙胺小体。通过改变span - 60与胆固醇的比例,共制得6种配方。对制备的配方进行了不同参数的评价。对所有制剂进行体外释药研究,发现5种制剂中F5释药最高。将制备好的乳质体掺入凝胶中,并进行pH、均质性、粘度和铺展性等评价研究。所有参数均令人满意。并与市售凝胶进行了比较。前者的药物释放时间为12小时,而后者仅为6小时。因此,证明了载药小体的缓释作用。
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引用次数: 0
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International Journal of Medical and Biomedical Studies
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