發(fā)布時間：2018-11-17 09:33

【摘要】：杜仲降壓片由杜仲、益母草、夏枯草、黃芩、鉤藤5味中藥組成,最早收載于《中國藥典》1977年版一部,為糖衣片,檢測項(xiàng)目只有鉤藤的顯微鑒別和理化鑒別,無含量測定項(xiàng)。1992年收載于《衛(wèi)生部藥品標(biāo)準(zhǔn)》中藥成方制劑第6冊,標(biāo)準(zhǔn)編號為WS3-B-1185-92,名稱改為復(fù)方杜仲片(杜仲降壓片),為糖衣片,處方與《中國藥典》1977年版相同,但對制法做了修改,檢測項(xiàng)目只有鉤藤的顯微鑒別和理化鑒別,無含量測定項(xiàng)。2014年廣州市香雪制藥股份有限公司對復(fù)方杜仲片(杜仲降壓片)修改了規(guī)格,標(biāo)準(zhǔn)為國家藥品標(biāo)準(zhǔn)YBZ28882005(WS3-B-1185-92-1),為薄膜衣片,檢測項(xiàng)目只有鉤藤的顯微鑒別和理化鑒別,無含量測定項(xiàng)。2015年康普藥業(yè)股份有限公司對復(fù)方杜仲片的標(biāo)準(zhǔn)進(jìn)行了提高,質(zhì)量標(biāo)準(zhǔn)為國家食品藥品監(jiān)督管理局國家藥品標(biāo)準(zhǔn)YBZ07792004(WS3-B-1185-92-2),檢驗(yàn)項(xiàng)目新增了鹽酸水蘇堿、熊果酸的薄層色譜鑒別和用高效液相色譜法測定黃芩苷含量。杜仲降壓片具有補(bǔ)腎、平肝、清熱之功效,用于腎虛肝旺之高血壓癥。目前關(guān)于杜仲降壓片質(zhì)量控制方法的研究較少,因此建立對其的質(zhì)量控制方法至關(guān)重要。杜仲補(bǔ)肝腎、強(qiáng)筋骨、安胎等功效。益母草活血調(diào)經(jīng),利尿消腫清熱解毒。夏枯草清肝瀉火,明目,散結(jié)消腫。黃芩清熱燥濕,瀉火解毒,止血,安胎。鉤藤息風(fēng)定驚,清熱平肝。本研究建立了杜仲降壓片中杜仲、益母草、鉤藤的薄層色譜鑒別方法,夏枯草中迷迭香酸、黃芩中黃芩苷及黃芩素的高效液相色譜含量測定方法及杜仲降壓片中杜仲、益母草、夏枯草、黃芩、鉤藤5味中藥材的特征圖譜研究方法。目的:建立杜仲降壓片的質(zhì)量控制方法。方法:薄層色譜法鑒別杜仲降壓片中的杜仲、益母草、鉤藤;高效液相色譜法測定夏枯草中迷迭香酸及黃芩中黃芩苷和黃芩素的含量,并對杜仲降壓片特征圖譜進(jìn)行了研究,色譜柱為Thermo(賽默飛)(4.6×250mm;5μm),乙腈-0.1%磷酸溶液梯度洗脫,流速為1.0 mL·min-1,檢測波長為330 nm,柱長250mm,柱溫為30℃。結(jié)果:薄層色譜中,在與杜仲對照藥材、鹽酸水蘇堿對照品、鉤藤對照藥材相應(yīng)的位置上,顯相同顏色的斑點(diǎn)。建立了杜仲降壓片中杜仲、益母草、夏枯草、黃芩、鉤藤5味中藥材的特征圖譜,共有8個特征峰,以峰6為S峰,各特征峰的相對保留時間分別為0.37、0.48、0.51、0.59、0.95、1.00、1.40、1.46。迷迭香酸在49.9~898.6μg范圍內(nèi),線性關(guān)系良好,回歸方程為Y=3086.1x+2607.1,R2=1,黃芩苷在355.2~6776.0μg范圍內(nèi),線性關(guān)系良好,回歸方程為Y=1656.8 x-145198,R2=0.9996,黃芩素在83.5~453.6μg范圍內(nèi),線性關(guān)系良好,回歸方程為Y=2827.8x-24929,R2=0.9998。方法重復(fù)性、精密度、穩(wěn)定性、耐用性良好,回收率分別為101.7%、98.1%、97.6%,RSD2%。結(jié)論:本研究中建立的方法快捷高效,專屬性良好,能較好地控制杜仲降壓片的質(zhì)量。
[Abstract]:Kuzhong Jiangya tablet is composed of five kinds of Chinese medicine, Eucommia ulmoides, Leonurus, Prunella subtilis, Scutellaria baicalensis, Uncaria, which was first collected in 1977 edition of the Chinese Pharmacopoeia. It is a sugar-coated tablet. No content determination item. 1992 in the "Ministry of Health Drug Standards" Chinese medicine prescription, Volume 6, the standard number for WS3-B-1185-92, changed to compound Eucommia tablets (Duzhong Jiangya tablets), as a sugar coating tablets, The prescription was the same as the 1977 edition of Chinese Pharmacopoeia, but the preparation method was modified. In 2014, Guangzhou Xiangxue Pharmaceutical Co., Ltd. revised the specification of compound Eucommia ulmoides tablets (Duzhong Jiangya tablets), the national drug standard YBZ28882005 (WS3-B-1185-92-1), the film clothing tablets, In 2015, Kangpu Pharmaceutical Co., Ltd. improved the standard of compound Eucommia tablets. The quality standard is YBZ07792004 (WS3-B-1185-92-2), the national drug standard of the State Food and Drug Administration. The TLC identification of stachydrine hydrochloride and ursolic acid and the determination of baicalin by high performance liquid chromatography (HPLC) have been added to the test item. Duzhong Jiangya tablet has the effect of tonifying kidney, calming the liver and clearing heat. There are few researches on the quality control methods of Eucommia ulmoides hypotensive tablets at present, so it is very important to establish the quality control methods for Eucommia ulmoides. Eucommia tonify liver and kidney, strengthen muscles and bones, and so on. Motherwort grass blood-activating regulation, diuretic swelling-clearing-heat detoxification. Prunus vulgaris clear the liver, clear the fire, eyes, scattered knot detumescence. Scutellaria clear heat and dampness, diarrhea fire detoxification, hemostasis, Anti-fetus. Hookwood wind calm alarm, clearing heat and calming the liver. In this study, a TLC method for identification of Eucommia ulmoides, Leonurus and Uncaria in Kuzhong Jiangya tablets, determination of rosemary acid in Prunella vulgaris, baicalin and baicalin in Scutellaria baicalensis, and Eucommia ulmoides and Leonurus in Jiangya tablets of Eucommia ulmoides were established. Study on characteristic Atlas of five Chinese Medicinal herbs, Prunella subtilis L., Scutellaria baicalensis and Rhizoma Uncaria. Objective: to establish a quality control method for Eucommia uzhong Jiangya tablets. Methods: TLC was used to identify Eucommia ulmoides, Leonurus and Uncaria in Jiangya tablets of Eucommia ulmoides. The content of rosemary acid, baicalin and baicalin in Scutellaria baicalensis was determined by HPLC. The characteristic chromatogram of Eucommia ulmoides Jiangya tablets was studied. The chromatographic column was Thermo (4.6 脳 250mm). The gradient elution of 5 渭 m), acetonitrile-0.1% phosphoric acid solution was carried out at a flow rate of 1.0 mL min-1,. The detection wavelength was 250 mm at 330 nm, and the column temperature was 30 鈩，

本文編號：2337303