The Studies On Fingerprint Of Radix Puerariae And Quality Control Of Several Chemical Drugs

Radix Puerariae is one of Traditional Chinese Medicine with extensive application on clinic. Puerarin, daidzein and daidzin are three active components of Radix Puerariae. The research specified on HPLC fingerprints and quality evaluation methods of Radix Puerariae. And it has great significance in modern quality control of Traditional Chinese Medicine. In addition, the quality control methods of compound pramoxine hydrochloride cream, rosuvastatin calcium tablet, voriconazole for injection and secnidazole capsule were studied.There are three sections.I Review1. The current research works about Radix Puerariae on its utilization of resource, chemical components, effective components extraction and separation, analytical methods of its quality control were summarized in this part.2. The research and development of clinical application, pharmacology function and preparation of pramoxine hydrochloride, rosuvastatin calcium, voriconazole and secnidazole were summarized in this part.II Studies on HPLC fingerprints of Radix Puerariae1. The optimized extraction condition is: 30% methanol aqueous, 30 minutes, 40°C, 70Hz ultrasonic and extracting solution ratio 125:1. This is a simple, fast, effective and stable method.2. The effect of mobile phase, elution process, column temperature, flow rate and detection wavelength to the fingerprints of Radix Puerariae were studied. The separation condition is, mobile phase: methanol+acetonitrile(70:30)[B]-water[A], the elution began with 20% and rise to 55%(0→50mintues), column temperature: 35°C, detection wavelength: 268nm. The method is simple, fast, repetitive and stable.3. The HPLC fingerprints analysis method of Radix Puerariae were established by series of experiments. The content of puerarin and daidzein in different Radix Puerariae samples were determined by this method. And, the quality evaluation of different Radix Puerariae samples from various producing areas was made by similarity analysis and PCA analysis.III Studies on quality control of several chemical drugs1. To establish an HPLC method for the determination of compound pramoxine hydrochloride cream. The CLC-ODS C₁₈ column (150mmx4.6mm,5μm) and acetonitrile -phosphate buffer solution(55:45) as the mobile phase(adjusted to pH 7.5) were used for the determination with the detection wavelength of 224nm and the column temperature of 40°C. The linear relationship was obtained with the range of 0.2120—0.9035mg/mL (r=0.9999). The average recovery was 99.63% (RSD=0.53%).2. To establish an HPLC method for the determination of rosuvastatin calcium tablet. A CLC-ODS C₁₈ column(250mm×4.6mm,5μm) and water-methanol-acetonitrile(45:20:35) as the mobile phase(adjusted to pH 3.5) were used for the determination with the detection wavelength of 242nm and the column temperature of 25°C. A linear relationship was obtained with the range of 20.0～500.0μg/mL (r=0.9999).The average recovery was 99.87% (RSD=0.60%).3. To develop an HPLC method for the determination of voriconazole for injection. A VP-ODS C₁₈ column (150mm×4.6mm,5μm) and acetonitrile-water(40:60) as the mobile phase were used for the determination with the detection wavelength of 255nm and the column temperature of 30°C. A linear relationship was obtained with the range of 0.1010⁰.9605mg/mL (r=0.9995).The average recovery was 99.80% (RSD=0.27%).4. To establish an HPLC method for the determination of secnidazole capsule. A VP-ODS C₁₀ column (150mm×4.6mm,5μm) and methanol-20mmol phosphate buffer solution(20:80) as the mobile phase were used for the determination with the detection wavelength of 319nm and the column temperature of 30°C. The linear relationship was obtained with the range of 20.0--250.0μg/mL(r=0.9999). The average recovery was 99.58% (RSD=0.32%).These above methods are simple, sensitive, accurate and suitable for the quality control of several chemical drugs.