论文总字数：23217字

摘 要

目的：本论文建立了肾康颗粒中间产品的含量测定方法，主要利用高效液相色谱法进行肾康颗粒中间产品的含量测定。肾康颗粒由多味药材构成，本次实验我们以大黄丹参的含量测定为主。大黄的含量测定主要使用色谱柱Venµsil XBP C₁₈ (4.6×250mm，5µm), 流动相选择甲醇和0.1%磷酸溶液（82：18），1ml/min的流速以及检测波长是254nm，进样量是20µl等条件下进行含量测定。据结果显示大黄酸在0.52µg/ml到20.92µg/ml的范围内和峰面积有较好的线性关系，大黄素在0.50µg/ml到20.13µg/ml的范围内和峰面积有较好的线性关系，大黄酚在0.50µg/ml到20.10µg/ml的范围里和峰面积有较好的线性关系。丹参的含量测定主要使用了色谱柱Venµsil XBP C18 (4.6×250mm，5µm)，流动相选择乙腈和0.1%磷酸溶液（22：78），按1ml/min的流动速度以及检测波长是286nm，进样量是20µl等条件下进行含量测定。结果显示丹参在9.46µg/ml到472.85µg/ml这个浓度的范围里和其峰面积拥有较好的线性关系。肾康颗粒中间产品大黄酸，大黄素，大黄酚的标准品及供试品的稳定性良好，进样精密度良好，大黄酸，大黄素，大黄酚RSD分别为0.34%，0.30%，0.38%，大黄酸，大黄素，大黄酚的回收率良好，重复性良好，大黄酸，大黄素，大黄酚RSD分别为0.39%，0.18%，0.70%。肾康颗粒中间产品丹参的标准品及供试品溶液稳定性良好，进样精密度良好，RSD为0.36%；回收率良好,重复性良好，RSD为1.59%。故该方法简单高效，精准无误，适用于肾康颗粒中间产品的含量测定。

关键词: 高效液相色谱法 肾康颗粒中间产品 方法学研究 含量测定

Determination of the content of Shen Kang Granµles intermediate prodµcts

Abstract

Objective：In this paper, the content determination method of Shenkang granule intermediate product was established, and the content of Shenkang granule intermediate product was mainly determined by high performance liquid chromatography. Shenkang Granule is composed of multi-flavor medicinal materials. In this experiment, we mainly determined the content of Rhubarb and Salvia miltiorrhiza. The content of rhubarb was determined by using the column Vensil XBP C18 (4.6 x 250 mm, 5µm), mobile phase methanol and 0.1% phosphoric acid solution (82:18), flow rate and detection wavelength of 1 ml/min were 254nm, and injection volume was 20µL. The results showed that Rhein had a good linear relationship with peak area in the range of 0.52 µg/ml to 20.92 µg/ml, emodin had a good linear relationship with peak area in the range of 0.50µg/ml to 20.13 µg/ml, chrysophanol had a good linear relationship with peak area in the range of 0.50µg/ml to 20.10µg/ml. The content of Salvia miltiorrhiza was determined by using the chromatographic column Vensil XBP C18 (4.6 x 250mm, 5µm), the mobile phase was acetonitrile and 0.1% phosphoric acid solution (22:78), the flow rate and detection wavelength of 1ml/min were 286 nm, and the injection volume was 20µL. The results showed that Salvia miltiorrhiza had a good linear relationship with its peak area in the range of 9.46 g/ml to 472.85µg/ml. The standard products of rhein, emodin and chrysophanol of Shenkang granules and the samples were stable, with good precision. RSD of rhein, emodin and chrysophanol were 0.34%, 0.30%, 0.38%, respectively. RSD of rhein, emodin and chrysophanol were 0.39%, 0.18% and 0.70%, respectively. The standard and sample solution of Danshen, the intermediate product of Shenkang Granules, were stable, with good injection precision, RSD of 0.36%, good recovery, good repeatability, RSD of 1.59%. Therefore, the method is simple, efficient, accurate and suitable for the content determination of Shenkang granules intermediate products.

Key words : HPLC Shen Kang Granµles intermediate prodµcts

Methodology stµdy Content determination

目 录

摘 要 I

Abstract II

第一章 肾康颗粒中间产品的综述 1

1.1 肾康颗粒 1

1.1.1 肾康颗粒的基本信息 1

1.1.2 药理作用 1

1.1.3 临床应用 2

1.1.4 肾康颗粒的含量测定 3

1.2 研究依据与目的 3

第二章 肾康颗粒中间产品的含量测定 2

2.1 仪器与试剂 2

2.1.1 仪器 2

2.1.2 试剂 2

2.1.3 供试品与标准品 2

2.2 测定方法 3

2.2.1 溶液的配制 3

2.2.2 色谱条件 4

2.3 方法学研究 5

2.3.1 专属性实验 5

2.3.2 线性关系研究 6

2.3.3 进样精密度实验 9

2.3.4 重复性实验 12

2.3.5 回收率实验 15

2.3.6稳定性实验 20

2.4 含量测定 27

2.4.1大黄的含量测定 17

2.4.2 丹参的含量测定 19

2.5 讨论 19

2.6 小结 27

第三章 结论与展望 29

3.1 结论 29

3.2 展望 29

参考文献 30

致 谢 32

1. 肾康颗粒中间产品的综述

肾康颗粒

丹参是构成肾康颗粒的主药，与此同时还有其他七味副药，如大黄、茜草、忍冬藤、石菖蒲、石韦等，中医学认为肾康颗粒有化瘀解毒补养脾胃益于肾脏化解湿气降低气浊的功效。在日常生活中多用于脾脏肾气不足所致的水肿头晕，恶心呕吐。近几年的研究表示肾康颗粒可治疗临床上的慢性肾功能衰竭，肾脏功能显著被改善、免疫力能进一步被提高，目前主要用于治疗一般意义上的慢性肾炎。

1.1.1 肾康颗粒的基本信息

通用名：肾康颗粒 英文名：Shen Kang Granµles

中药成分复杂，故暂无明确的化学式。

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