中国药房
中國藥房
중국약방
CHINA PHARMACY
2001年
3期
171-172
,共2页
曾小耘%郑若纯%庄静波%罗丽娟%肖松
曾小耘%鄭若純%莊靜波%囉麗娟%肖鬆
증소운%정약순%장정파%라려연%초송
兰索拉唑%肠溶片%肠溶胶囊%溶出度
蘭索拉唑%腸溶片%腸溶膠囊%溶齣度
란색랍서%장용편%장용효낭%용출도
目的：探讨兰索拉唑肠溶片体外溶出度测定的方法， 并考察兰索拉唑肠溶片和肠溶胶囊溶出度的差异。方法：建 立兰索拉唑肠溶片溶出度的测定方法，测定并比较兰索拉唑两 种不同剂型的溶出度，提取溶出参数及方差分析。结果：（1 ）各肠溶片及肠胶囊在30min时累积溶出量均>80％；（2）A组间W eibull参数T50、Td和m值两两比较无显著性差异（P均>005），B组 亦然（P均>005）；（3）A组与B组比较T50、Td间差异极显著（ P均<0001），B组溶出50％及632％所需的时间明显短于A组，m 比较差异不显著（P>005），两组所拟合方程的斜率无显著性 差异。结论：本法作为兰索拉唑肠溶片的体外溶出度测定方法 简便、准确，重现性好，稳定可行；兰索拉唑肠溶片与肠溶 胶囊溶出度存在极显著差异。
目的：探討蘭索拉唑腸溶片體外溶齣度測定的方法， 併攷察蘭索拉唑腸溶片和腸溶膠囊溶齣度的差異。方法：建 立蘭索拉唑腸溶片溶齣度的測定方法，測定併比較蘭索拉唑兩 種不同劑型的溶齣度，提取溶齣參數及方差分析。結果：（1 ）各腸溶片及腸膠囊在30min時纍積溶齣量均>80％；（2）A組間W eibull參數T50、Td和m值兩兩比較無顯著性差異（P均>005），B組 亦然（P均>005）；（3）A組與B組比較T50、Td間差異極顯著（ P均<0001），B組溶齣50％及632％所需的時間明顯短于A組，m 比較差異不顯著（P>005），兩組所擬閤方程的斜率無顯著性 差異。結論：本法作為蘭索拉唑腸溶片的體外溶齣度測定方法 簡便、準確，重現性好，穩定可行；蘭索拉唑腸溶片與腸溶 膠囊溶齣度存在極顯著差異。
목적：탐토란색랍서장용편체외용출도측정적방법， 병고찰란색랍서장용편화장용효낭용출도적차이。방법：건 립란색랍서장용편용출도적측정방법，측정병비교란색랍서량 충불동제형적용출도，제취용출삼수급방차분석。결과：（1 ）각장용편급장효낭재30min시루적용출량균>80％；（2）A조간W eibull삼수T50、Td화m치량량비교무현저성차이（P균>005），B조 역연（P균>005）；（3）A조여B조비교T50、Td간차이겁현저（ P균<0001），B조용출50％급632％소수적시간명현단우A조，m 비교차이불현저（P>005），량조소의합방정적사솔무현저성 차이。결론：본법작위란색랍서장용편적체외용출도측정방법 간편、준학，중현성호，은정가행；란색랍서장용편여장용 효낭용출도존재겁현저차이。
OBJECTIVE： To study the method of measuring the in vitro dissolubility of lansoprazole enteric－ coated tablets and to find out the difference between the dissolubility of lansoprazole enteric－ coated tablets and that of lansoprazole enteric－ coated capsules.METHODS： To establish a measuring method of the dissolubility of lansoprazole enteric－ coated tablets and compare the dissolubility of lansoprazole enteric－ coated tablets with that of lansoprazole enteric－ coated capsules and to acquire the dissolving parameters for variance analysis.RESULTS： (1)The accumulative dissolving quantity of the both preparations exceeded 80％ in 30 minutes.(2)The comparison of Weibull parameters,T50,Td and m,between each other in group A showed no significant differences(P>0.05).It was the same for those of group B.(3)The parameters,T50 and Td,of group A,in comparison with those of group B,showed significant differences(P<0.001).The times needed for dissoiving 50％ and 63.2％
of quantity in group B were both shorter than those in group A.The m parameters in different groups had no significant differences(P>0.05).There was no significant difference in slope of equation between two groups.CONCLUSION： This measuring method of the in vitro dissolubility of lansoprazole enteric－ coated tablets is simple,convenient,accurate,stable,feasible and good in repetition.It is concluded that there is significant difference between the dissolubility of the two dosage forms of enteric－ coated preparation of lansoprazole.
