Pharmaceutical Reasearch On Huoxue Shujin Heji

There are a lot of orthopedics patients with sequelae, limbs traumatic patients joint function are limited after surgery and some bone disease patients, they either general soft tissue trauma or post-surgery rehabilitation process, or for other reasons, such as strain, degeneration and so on. Clinical treatment is very difficult, and the effect of rehabilitation treatment is not obvious or not lasting. The indications of surgical treatment for some cases are not clear, and the effect is not ideal, etc. Huoxue shujin Prescription is the superior prescription to treat such diseases in orthopedics. This topic under the guidance of TCM theory, based on the chemical composition and pharmacological effects of ingredients in prescription changed clinical medicinal broth into easy, carrying and storage of the misture. According to the relevant requirements of Drug registration management measures and Medical institution preparation registration management measures of CFDA, we proceed the pharmaceutical research of Huoxue shujin Heji, including literature research, preparation technology, quality standard, stability studies and preliminary efficacy studies.1.Literature researchExpound basis and significance of this topic. Summarized the curative effect in the clinical and mainly ingredients in the prescription of physical and chemical properties and pharmacological effects of Huoxue shujin Treatment.2.Study on preparation processIn order to maintain its material basis in treating diseases of the prescription, we used the traditional decoct method. With the index of the content of paeoniflorin and extract rate, according to the main factors like the use-levelof solvent, extracting time, extracting times affect extraction process, and based on L9(34) orthogonal experiments, we optimized the best extraction technology is herbs with 9 times the amount of water, reflux extraction twice, each 1.5 hours. Atmospheric concentration extract to relative density is about 1.25 after shaking.According to the daily medication, prescription can be made the Heji. The extract was concentrated to 0.75g crude drμg per mil, thenadd 0.2% steviosin,0.3% sodium benzoate, heated to boiling, refrigerated overnight (0～4 ℃), then filtration, potting and 100 ℃ sterilization for 30 minutes.3.Study on quality standardIn order to make the product quality controllable, we investigated the name, character, identification, inspection and content determination, thendrafed the quality standard. According to the result of content determination of the three batch samples, we suggested that content of paeoniflorin is not less than 0.70mg per milliliter temporarily.4. Study on stabilityIn order to investigate the stability of Huoxue shujin Heji and to define the period of validity, according to the guiding principles of stability study about traditional Chinese medicine and natural medicine, this subject tested the factor affecting experiment for the sample of the batch number for HX130105. We proceed the accelerated stability test for 6 months and long-term stability test for 18 months to three batchs of pilot samples. Studied on characters, identification and content determination of the products. The result showed that quality of Huoxue shujin Heji is stable.5. Explored the anti-osteoporosis activity and safetyApplication of zebrafish toxicity/efficacy evaluation method evaluated anti-osteoporosis activity and preliminary security of Huoxue shujin and Radix Rehmanniae Preparata. The results of the activity of anti-osteoporosis showed that bones stained area have very significant differences Compared with the model group in 200μg/mLof Huoxue shujin and 100μg/mL of Radix Rehmanniae Preparata, suggesting that there are anti-osteoporosis activity. The results of safety showed that both of LC50 are greater than 1500μg crude drug/mL, suggesting that Huoxue shujin Heji and water extract of Radix Rehmanniae Preparata safer within the effective dose range.Using HPLC chromatographic separation joint zebrafish model of toxicity evaluated the security of ingredients from Radix dipsacus, the result suggested that saponin compounds from Radix dipsacus are related with security risks for juveniles closely.Application of the zebrafish model evaluated security of three saponin compounds from Radix dipsacus (Asperosaponin Ⅵ,3-O-α-L-arabinopyranosyl-hederagenin and akebia saponin V) and found that there is a big difference of security to the healthy juveniles and osteoporotic juvenile.