The Study Of Huayu Xiaozhong Spray Film

Huayu Xiaozhong spray film is from experienced prescription in folk,which is made up of distilled liquor dipping peach kemel, Cortex phellodendri,fructus gardeniae herbs, etc. It has the function of activating blood circulation to dissipate blood stasis, subduing swelling and alleviating pain, so it is applicable to soft tissue injury. Compared with the original dosage, the Huayu Xiaozhong spray film has the advantages of long action time, no local irritation, convenient carrying, easy control and stable quality.The main contents of this paper include:(1) By using single factor test, the main influence factors of Huayu Xiaozhong spray film in extraction process of medicinal materials were obtain; By orthogonal test,the optimal extraction process of Huayu Xiaozhong spray film was created;(2) Through the single factor and central composite design, the optimal forming prescription was created;(3) Respectively by TLC and HPLC method, we got the way of the determination of the qualitative identification and content of active ingredient preparation. Then we establish the quality standard of Huayu Xiaozhong spray film;(4) Study on the stability of Huayu Xiaozhong spray film;(5) By the modified Franz diffusion cell method and Huayu Xiaozhong spirit as control, the vitro transdermal test was performed.In this paper, firstly, by the single factor and orthogonal test, with the extraction rate of amygdalin as the index, the result was that the optimalextract processing was 12 times volume 60% ethanol with rude powder,after 24 hour of immersion with the percolate speed of 1.5ml/min. Then by CCD-RSM, With the film-forming time, spraying effect, thickness and maintain time of spray film as index, the optimal formula of Huayu Xiaozhong spray film was PVA17-88 5%, glycerol 4.5% and PVP-K30 5%.In order to identify quikly active ingredient of Huayu Xiaozhong spray film, method TLC was used to identify cortex phellodendri, Fructus Gardeniae, herba lycopi, rhizoma corydalis qualitatively. Method HPLC was used for the determination of the content of amygdalin. Through methodology validation, it prove that the determined method has good linear relationship among 235ng~3.76μg, and the recovery, precision and stability of the solution meet the requiremint.In order to control the quality of Huayu Xiaozhong spray film, we studied appearance properties, p H, formation time of film and maintenance time in this topic. By investigating the quality of the preparation, it is reddish brown to brown slightly sticky liquid, with the taste of alcohol. The average p H value of p H is 5.5~7.0, and the film formation time is no more than 10 min, and the membrane maintenance time is not less than 6 hours.We established the quality standards, in order to provide reference for the objective evaluation and effective control for the quality of Huayu Xiaozhong spray film.Due to the original preparation for wine, the efficacy will be affected because of the changing of the ethanol concentration at room temperature,so Huayu Xiaozhong spray film is improved. By the influencing factors test,accelerated test and long term stability test, the results indicate that the product is not stable under high temperature at 40℃, and should be kept in a cool place. Although accelerated test under the conditions of thecommercial package, 30℃±2℃, relative humidity 75%±5%, the contents and all kinds of inspection indexes are within the specified range. In the condition of the package of sale, sealed, cool place for 6 months, all kinds of inspection indexes are no obvious change. It shows that the prescription and technology has a certain reference value for the production research.In order to ensure the effect between Huayu Xiaozhong spray film and the original preparation, in this study, we have made studies in vitro percutaneous permeability. Result shows that there was no significant difference between the sampling points and the average cumulative infiltration. So there is no significant difference between Huayu Xiaozhong spray film and the original preparation in curative effect.