Research To The Quality Control Of Tongxuekang Capsule

A Tongxuekang capsule was a traditional Chinese medicine compound preparation which is researched into manufacture by Haitian pharmaceutical co.Ltd from the Fujian province. Each box contains12grains of Tongxuekang capsules and a subsidiary Baoxianzi capsule, the existing standards are contained in the seventeenth volumes of "New Drug to Formal National Standards" and the standard number is WS3-145(Z-135)-98(Z). Given the standard early, we can carry out many positive research works in order to make it meet the quality control specifications and ensure the safe and effective. This paper mainly conducts the research from the following aspects of its quality control.1. The determination of the Rhizoma Paridis polyphyllin I and polyphyllin Ⅱin Tongxuekang capsules.As one of the main ingredients-Rhizoma Paridis in Tongxuekang capsules, the work of relevant contents should be carried out in order to meet the quality control specification of traditional Chinese medicine. The Rhizoma Paridis polyphyllin Ⅰand polyphyllin Ⅱ in Tongxuekang capsules are two main active substance isolated from Rhizoma Paridis. This chapter established the method for the determination of Rhizoma Paridis polyphyllin I and polyphyllin II in Tongxuekang capsules, and provided the contents limits. The heat reflux extraction optimized through experiments was adopted to prepare the sample. The results showed that the developed method is accurate and reliable by measuring five batches of Tongxukang capsules, and this method can be used for the quality assessment and control of Tongxuekang capsules.2. The content limit method for the three kinds of double ester alkaloids in Tongxuekang capsules.Aconitine, hypaconitine and mesaconitine from the Aconitum as one of mainly herbs in Tongxuekang capsules have the functions of anti-inflammatory and analgesic effects; meanwhile, they have been proved to be highly toxic ingredients. In order to ensure the Aconitum concocted moderately and prevent poisoning before being added to medicines, it is necessary to establish the content limit method for the three kinds of double ester alkaloids. The analysis method validation showed that the measurement is sensitive, accurate and reliable, and this method can be accepted as a new effective approach for the quality control research of Tongxuekang capsules. The decrement of the content for the three kinds of double ester alkaloids showed that processing of Aconitum is an effective measurement to reduce the toxicity.3. The determination of strychnine in Tongxuekang Baoxianzi capsules.As one ingredient of Tongxuekang Baoxianzi capsules, Strychnos has the functions of blood circulation, bruises swelling and pain-relieved. Strychnine-one of mainly active substances from Strychnos is harmful to human when the dosage exceeds a certain limit. Consequently, it is necessary to establish the content range method for Strychnos in Tongxuekang Baoxianzi capsules. According to the results of the analysis validation and the testing for5batches samples, this means is stable, accurate and high reproducibly, and this method can provide a new approach for the quality control and evaluation of Tongxuekang capsules.4. The qualitative identification of Tongxuekang capsules by Near-infrared spectroscopy.As the state secret prescription, the specific prescription and the process parameters are banned to the public, therefore, the traditional thinking and analysis measurements for Tongxuekang capsules are limited. With the over dialectical idea, the identification model was developed through using the OPUS software processing the near infrared diffuse reflectance spectra of Tongxuekang capsules. According to the facts of the analysis validation and the completely correct identification for29batches samples (6batches are genuine and23batches are forged), this model is stable and accurate, and can be accepted to identify the authenticity of Tongxuekang capsules.5. The qualitative identification of Tongxuekang Baoxianzi capsules by Near-infrared spectroscopy.Similarly to the describes of the chapter Ⅳ, analysis measurements for Tongxuekang Baoxianzi capsules are limited. With the over dialectical idea, the identification model was developed through using the OPUS software processing the near infrared diffuse reflectance spectra of Tongxuekang Baoxianzi capsules. According to the facts of the analysis validation and the completely correct identification for20batches samples (6batches are genuine and14batches are forged), this model is stable and accurate, and can be used as a new powerful measurement for fighting against counterfeit goods and rural drug screening.