Studies On The Preparation Technology And Quality Standard Of Callicar Nudiflora Powder

Callicarpa nudiflora is a dicotyledonous plant of the family Verbenaceae.In China,it is mainly distributed in Jiangxi,Fujian,Guangdong,Guangxi,Hainan and other provinces to the south of the Yangtze River Basin.In recent years,there is a large area of planting in Wuzhishan,Baisha and other Li areas in Hainan Province.The chemical constituents of callicarpa nudiflora are terpenoids,flavonoids,etc.It has the functions of anti inflammation,detoxification,astringency and hemostasis.And it is used for suppurative inflammation,burns and bleeding.There are tablets,granules and other dosage forms in the market,most of which are internal preparations,while the external dosage forms are blank.In the face of the current situation that it is difficult to obtain the approval of new traditional Chinese medicine,the preparation process of callicarpa nudiflora powder for external use is studied in this paper.In addition,the quality standards of medicinal materials,extracts and powder were studied,aim to lay a foundation for further toxicological evaluation of the preparation and declaration of hospital or antitypesetting preparations.In order to expand the current market sales varieties of naked flower Purple Pearl medicine and enhance the added value of the medicine planting.The hemostasis experiment of water extract of callicarpa nudiflora was carried out by using hemostasis model of femoral vein in rats.The results showed that the water extract group could significantly shorten the bleeding time of femoral vein and reduce the amount of bleeding.Compared with the starch control group,the difference was statistically significant(P<0.05),and there was no significant difference between the water extract group and Yunnan Baiyao Group(P>0.05).It is suggested that the water extract of callicarpa nudiflora has the effect of hemostasis.The results of bacteriostasis experiment in vitro showed that,when the concentration of callicarpa nudiflora powder extract was 0.25 g/ml and 0.50 g/ml,it was sensitive to Staphylococcus aureus,has good bacteriostatic effect.And it has no or weak bacteriostatic effect on E.coli.Combined with the physical properties of the extract and the characteristics of the external powder,the preparation technology of the powder was studied on the basis of the hemostatic effect experiment.In this paper,the selection,drying method,drying time and the ratio of the excipients were investigated.The results show that the best forming process of the powder is:starch and talcum powder are used as auxiliary materials,and dry extract quantity:auxiliary material quantity=1:2:3.5,dry in oven at 70?for 3h.The powder was determined by single sieving method,100%passing No.6 sieve;the color is uniform without pattern or stain when observed in the bright place;moisture content<9.0%;the average content is 4.9914g<5.0g±7%;all in accordance with Pharmacopoeia standards.By using modern analytical methods,the quality standards of callicarpa nudiflora,its extract and powder were studied as follows:1)A TLC method was established for the identification of two main components in callicarpa nudiflora,extract and powder;The results of methodological study showed that the fluorescent spots were clear,the separation of the two main components was good Rf=0.23~0.38,and the specificity,reproducibility and durability were good.2)A method for the determination of five heavy metals and harmful elements in callicarpa nudiflora,extract and powder was established by flame atomic absorption spectrometry and hydride atomic fluorescence spectrometry;The results showed that the linear correlation coefficient of five elements was 0.9964~0.9998,close to 1,the precision was less than 3.0%,and the recovery was 91.7%~104.1%;And the contents of five elements in 7batches of callicarpa nudiflora,dry extracts and 3 batches of powder were determined.The results are in line with the national standard.3)A HPLC method was established for the determination of the content of active components in callicarpa nudiflora powder;The results showed that the linear equations for the determination of luteolin-7-O-glucoside and acteoside were y=2667108x-36343,R~2=1,y=1520790x-16266,R~2=0.9999,the precision,stability and repeatability were not more than 3%,and the recovery was 94.23%~101.74%.The content of three batches of callicarpa nudiflora powder was determined,and the results were all in accordance with the requirements.In summary,on the basis of the extraction of callicarpa nudiflora,the hemostasis experiment of the water extract of callicarpa nudiflora in vitro was carried out.And research on the preparation of callicarpa nudiflora hemostatic powder(including its molding process and dosage form inspection)was completed.The antibacterial activity of the powder was also studied in vitro.The quality standard of medicinal material,extract and powder of callicarpa nudiflora was studied.TLC,heavy metal and harmful elements inspection and content determination were established.In order to control the effectiveness and safety of the developed products.