新生儿退黄中药外洗液的临床开发研究  

Clinical Development and Research of Treating Jaundice for Newborn by Chinese Herbal Lotion(Tui Huang Xi Ye)

作　　者：吴曙粤[1] 王艳宁[1] 高桂娥[1] 钟慧[1] 黄仕孙[1] 王利民[1] 

机构地区：[1]广西南宁市第一人民医院,南宁市530022

出　　处：《广西医学》2009年第12期1755-1759,共5页Guangxi Medical Journal

基　　金：广西南宁市科学研究与技术开发计划项目(南科攻20040246C;南科攻2007011402C)

摘　　要：目的对国家发明专利新生儿退黄中药外洗液进行开发与临床研究,探讨新生儿退黄中药外洗液对新生儿黄疸的干预治疗效果、皮肤用药安全性、质量控制以及稳定性,进行临床观察和实验研究。方法(1)临床效果研究:选择足月正常新生儿120例,按随机数字表法分为两组,每组60例,对照组口服苯巴比妥+加味茵陈汤及日常护理,实验组60例用新生儿退黄中药外洗液药浴,均用药3d。比较两组黄疸出现时间、日均黄疸增值及退黄效果。(2)安全性研究:按照国家颁发的皮肤安全性试验研究,将新生儿退黄中药外洗液以29.6g和7.4g生药/kg(为临床剂量的40和10倍)分别进行急性毒性试验,皮肤刺激性试验,过敏性试验等,用药后分别观察受试动物外观特征,呼吸和中枢神经系统等情况,并作受药部位皮肤组织病理学检查。(3)质量控制:采用薄层色谱法对方中的大黄、薄荷进行薄层色谱鉴别,采用高效液相色谱法对制剂中栀子苷进行含量测定。(4)稳定性考察:对三个批次新生儿退黄中药外洗液进行初步和加速稳定性实验。结果(1)实验组黄疸出现时间相对推迟,经皮胆红素测定日增加值明显低于对照组,实验组血清总胆红素及间接胆红素明显低于对照组,高胆红素血症患病率明显减少,光疗率减少,差异均有统计学意义(P<0.05)。(2)新生儿退黄中药外洗液高、低剂量的安全性试验,动物的外观体征、行为活动、体重和皮肤组织病理学检查与对照组差异无统计学意义(P>0.05)。(3)薄层斑点清晰,分离度好、专属性强;栀子苷的进样量在5.46～81.9μg/ml内与峰面积积分值呈良好线性关系(r=0.9998),平均回收率为98.38%,RSD=1.53%(n=6)。(4)药液在室温、湿度60%～90%和正常光照条件下保存6个月,其性状、鉴别、检查、含量测定等考察项目均符合规定,初步稳定性试验和加速稳定性试验结果均提示本品两年内稳定。Objective To study clinical development and research on jaundice-abating Chinese herbal lotion（Tui Huang Xi Ye）, Chinese national invention patent, and explore the intervdntion effect, the drug security on skin, quality control and stability as adjunctive therapy on the neonatal jaundice. Methods （ 1 ） Research on clinical effects ： Selected 120 full-term normal newborns, which randomly divided into two groups, each group of 60 cases. Control group were treated with phenobarbitone, modified Yin-chen decoction and routine care, and jaundice-abating Chinese herbal lotion（ Tui Huang Xi Ye）to medicated bath were added to experimental group. Then compared the onset time of jaundice,average daily-added value and the effects of jaundice-abating between two groups. （2）Research on seeurity：Aecording to experimental study on skin safety issued by country,and put the lotion each of 29.6 g and 7.4 g crude drug/ml（as 40 times and 10 times of elinieal doses）into the aeute toxicity tests,skin irritation test,allergy test and so on. Then,observed the appearance eharaeteristies ,respiratory and central nervous system of the animal subject,etc ,and made parts of the skin to histopathologieal examination after use of the lotion. （3）Quality control ：Analyzed rhubarb and peppermint of the lotion by thin layer ehromatography （TLC） ,and assayed the contents of jasminoidin in the lotion by high performance liquid chromatography（HPLT） ;（4）Stability research ：the initial stability testing and the accelerated stability test with three batches of jaundiee-abating Chinese herbal lotion （Tui Huang Xi Ye ） respectively. Results （ 1 ） The onset time of jaundiee was later in the experimental group than that in control group, and the daily-added value of transcutaneous bilirubin measured was evidently lower in the experimental group than that in control group. Serum total biliruhin and indirect bilirubin after treatment were evidently lower in the intervention group than those in control group,

关 键 词：新生儿黄疸 新生儿退黄中药外洗液 皮肤用药安全性 质量控制 稳定性 

分 类 号：R287[医药卫生—中药学]