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      實驗研究

      磷酸川芎嗪滴丸溶出度測定方法的研究

      孟薇

      [文章下載]

      【摘要】  【摘要】目的 探究磷酸川芎嗪滴丸溶出度測定方式。方法 選擇6批磷酸川芎嗪滴丸,分析對比使用水、磷酸鹽緩沖液(pH=6.8)、醋酸鹽緩沖液(pH=4.5)、鹽酸溶液(pH=1.2)的溶出曲線,之后制定檢驗溶出度方式:以80%的標示量為限度、HPLC測定、取樣20分鐘、500 mL的水為溶出介質、轉速為每分鐘50轉。

      【關鍵字】  磷酸川芎嗪滴丸,溶出度,測定,溶出曲線

      中圖分類號:文獻標識碼:文章編號:

      [Abstract] Objective To explore the dissolution determination method of ligustrazine phosphate dropping pills. Methods Six batches of ligustrazine phosphate dropping pills were selected and the dissolution curves of water, phosphate buffer (pH=6.8), acetate buffer (pH=4.5) and hydrochloric acid solution (pH=1.2) were analyzed and compared. The dissolution test methods were formulated as follows: 80% of the labeling amount was limited, determination by HPLC, sampling 20 minutes, 500 mL of water as dissolution medium, and speed was 50 revolutions per minute. Results There was no significant difference in the dissolution curves of 6 batches of ligustrazine phosphate dropping pills in four dissolution media: water, phosphate buffer (pH=6.8), acetate buffer (pH=4.5) and hydrochloric acid solution (pH=1.2). All the six batches of ligustrazine phosphate dropping pills could be dissolved in 15 minutes. Conclusion The dissolution rate of 6 batches of ligustrazine phosphate dropping pills determined by four dissolution media is reliable and accurate, which is helpful to control the quality of drugs and provide reference data for drug dissolution.

      磷酸川芎嗪屬于鈣離子拮抗劑的一種,存于川芎根莖內,屬于川芎嗪的磷酸鹽,存在抑制血小板集聚、活血化瘀、動脈擴張以及調節微循環等功效[1]。此種藥物在臨床中缺血性腦血管疾病治療中使用率較高,例如高血壓、冠心病、腦栓塞誘發腦梗死、腦血栓、腦供血不足等[2]。此種藥物屬于處方藥,通常有膠囊劑、注射劑和片劑,而近幾年新研究出一種劑型為磷酸川芎嗪滴丸,主要是利用固體分散技術所制[3]。此種劑型存有生物利用率高、吸收迅速、易等優勢。而藥物的生物利用率和質量與溶出度密切相關?,F階段國內磷酸川芎嗪滴丸的溶出方法主要包括籃法和槳法,檢測方式主要包括UV吸收系數法和UV對照品比較法,均有一定的差異性[4-5]。因此本次針對磷酸川芎嗪滴丸溶出度測定方式進行了研究,同時分析了6批藥物在不同溶出介質的溶出曲線。詳情報道如下。 1 試藥和儀器 1.1 試藥:磷酸川芎嗪對照品(中國藥品生物制品檢定所,批號:100845-201002)100 mg;磷酸川芎嗪滴丸(批號:140638、140628、160104、151123、150804、160332);陰性樣品。 1.2 儀器:①電子天平(BP-210S)。②針頭式微孔濾膜過濾器:津騰0.45 μm孔徑、13 mm直徑。③高效液相色譜柱:迪馬Cl8(5μ,250 mm×4.6 mm)。④高效液相色譜儀:島津高效液相色譜儀(LC-2030檢測器)。⑤溶出度儀:。 1.3 試劑:甲醇為色譜純、其它試劑為分析純。

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