Study On The Preparation And Quality Standard Of Dispersible Tablets Of Zanthoxylum Nitidum

Objective:Zanthoxylum nitidum which first recorded in the"Shen Nong's Herbal Classic"belongs to rutaceae zanthoxylum。It is widely used for dredging collaterals,alliveating pain, reduction of swelling and detoxicate.Especially,it has significant treatment effect on reduction of swelling and relieve pain.There have only one fomulation LiangmianzhenZhentongPian as the general preparation on the market.This formulation that have emerged on the market appear a restricted use for the majority of patients.This thesis research the dispersible tablets of Zanthoxylum nitidum plan to use the Zanthoxylum nitidum for material basis to preparation of tablets with the modern pharmaceutical excipient and the modern rapid-release technology. These formulations could quickly collapse and release of drug by the immediate-release system to show a full pay to efficiency . And these features would show a improving to the bioavailiability and will become the basis of innovation in Traditional medicine finally.Methods:①Identification of Zanthoxylum nitidum herbs Selected 10 different origin herbs to test the content of related substances and to establish the fingerprint of these herbs,with which used as a reference to identify the medicinal species and as the quality control methods.②Extraction and refining the effective components of Zanthoxylum nitidum Try to extract the compositions by a certain concentration of ethanol and use the orthogonal experimental design method to select the key factors of extraction method.And use a silica-gel column chromatography to refining the first abstracting Zanthoxylum nitidum.③S tudy on preparation formula and production process Filter the best disintegrating type and the suitable ashesive,and use the multilevel orthogonal to investigate the amount of the various results of the multilevel orthogonal and to optimization the best formulation and preparation from the experimental results.④Study on the quality standards Including the Zanthoxylum nitidum extraction and the formulation of dispersible tablets of Zanthoxylum nitidum.Use the qualitative identification,quantitative identification to control the quality of Zanthoxylum nitidum extraction.And the inspection items such as the appearance of tables,characters,qualitative identification,quantitative identification,weight difference,in vitro disintregration time and dissolution,etc,are include in the tablet quality standards inside.Finally, to formulate the draft quality standards of dispersible tablets of Zanthoxylum nitidum.⑤Investigation on the initial stability Use the means of accelerated testing ande long-term stability testing to study the stability of our preparation.Results:①Identification of Zanthoxylum nitidum herbs The nitidinechloride content in is up to 0.13%,and the similarity of the fringerprint peaks during 10 different origins is to 90%.These could use as for the basis of the identification from the origin and the quality of the medicines.②Extraction and refining the effective components of Zanthoxylum nitidum To extract the Zanthoxylum nitidum herbs four times,each time 1.5 hours,with 8 times the amount of 70% ethanol.Make the extraction refined using silica-gel column chromatography after combining and concentrating the extracts.The nitidinechloride content is finnaly obtained refined extratct are to 17.3mg/g .③Study on preparation formula and production process The disintegrants in the optimization of the preparation prescription include MCC and PVPP. The final preparation prescription as follows: Zanthoxylum nitidum extration 100mg per film, SiO2 50mg per film, CaHPO4 163mg per film, MCC:PVPP (4:1)86mg per film,HPC26mg per film,Magnesium sterate 4mg per film. Use the wet granuation method to prepare the soft material.Finally,the prepared tablets have a smooth appearance and a good disintegration,and the average disintegration time is 20 second.④Study on the quality standards The results showed that the qualitive identification result of Zanthoxylum nitidum extraction was positive.The average distintegration time of dispersible tablets of Zanthoxylum nitidum is 20 second and the in vitro dissolution is to 70% within 40 minutes.The determination results showed that nitidinechloride content in dispersible tablets of Zanthoxylum nitidum is not less than 1.5mg per film.⑤Investigation on the initial stability The accelerate test and long-term stability test show that the tablets did not change significantly compared with 0 month.Conclusions:①The determination of nitidinechloride and fringerprint of Zanthoxylum nitidum herbs could be used as an identification of the herbal origin.Those detection methods show stable and reliable.②Successfully to identify the optimal extracting and refining technologies. And the finally obtained products have met the regulations and the preparation requirments.③Successfully to identify the best technology of the dispersible tablets'forming prescription. And this technology show stable and simple.④Successfully to create the draft quality standards of dispersible tablets of Zanthoxylum nitidum and the method is sensitive, accurate, reproducible and specific.⑤The preliminary stability tests show that the quality of dispersible tablets of Zanthoxylum nitidum is stable.The final conclusion is that the dispersible tablets of Zanthoxylum nitidum's period identified as 2-years.