| "Jingzhuiling Oral Liquor" is made on basis of the experimental prescription of HuBei Hospitol of Traditional Chinese Medicine, which is made of several Chinese herbs, including Radix Angelicae Sinensis, Caulis Spatholobi and so on,it possesses the effect of nurturing blood,extending the sinew and promoting the circulation of blood,it's also used to stretch the nerve and cure the diseases of cervical uertebral column which are caused by the infirmity in liver and kidney.It has the virtue of quick effect and convenient usage,so patients can easily accept it which is the perfect medicine of curing the diseases in the cervical verteboal column.In the researching process according to the rules for national new medicine,we researched this medcine in preparing technology,modeling technology, quality standard,tentative stability and pharmacodynamics systemically. All of these provided scientific proofs for its clinic effect.In the aspect of preparing technology,we studied the herbs for their water absorption rate at first. Weighed every kind of herbs in proportion and soaked them with corresponding volume of water.Every half hours,dissected one sample to check whether it was infiltrated,made sure of that the herbs are soaked on the whole after 1.5 hours,their water absorption rate is 146.24%;Then chose the proper comminuting level for the herbs which contain volatile oil,including Rhizoma chuanxiong, Rhizoma Atractylodis Macrocephalae,Fructus Psoraleae Herba Lycopi and Cortex Cinnamomi,water volume and extracting time are very important factors for extract too,the perfect extracting process is chosen by L9(34) orthogonal test which is as follow:smashing them into coarse powder,adding 6 times amount of water,extracting 7 hours,then mixing upthe herbs which have been extracted with proper volume of water,then blending the final extracting liquid and the filtrate of the herbs which have been extracted the volatile oil,then chose the best extracting technology by L9(34) orthogonal test which regarded water amount, boling time and boling times as the main affecting factors,the best extracting craft is as follow: 10 times amount of water boiling 2 times,every time for 1.5 hours;the extracting liquid is marinated with ethanol,chose the perfect depositing and purifing technology by L9(34) orthogonal test which regarded the relative density,concentrative degree and the depositing time as the main factors,it's generally examined by extracting rate for dry extraction and the content amount of paeoniflorin. In the best ethanol depositing craft,the filtrate's relative density should be concentrated to 1.04,the best ethanol proportion is 60% and depositing for 24 hours. In order to ensure the dosage's quality and stability, we added some additional materials.The best materials and its amount were determined as follow: tweens-80 which can increase the solubility of the effective element is 1.0% and sodium benzoate which is the perserative part is 0.2%,we studied it under different PH condition and discovered that PH degree was not needed to be adjusted,kept natural condition can maintain the content of effective element and the taste.When we studied the quality standard,we used the TLC to identify the Radix Angelicae Sinensis,Rhizoma chuanxiong,Radix Paeoniae Alba,Rhizoma Atractylodis Macrocephalae,Radix Glycyrrhizae and Flos Carthami respectively,the separation of the stains was apparent and the negative contrast was not disturbed.All of these proved that the method we used is specific.Chinese Angelica and chuanxiong have the same effective ingredient,so use identified them on the same board.We got theamount of paeoniflorin as the index ,used HPLC to determine the amount and found out the best method which was the basis to explore the tentative stability of Jingzhuiling.Then studied the affecting factors including indoor temperature,accelerating experiment(40 °C ,relative humidity is 75%),all of the results showed that the preparing technology is rational and the quality of this medicine is stable.Given the pharmacodynamical researc... |
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