| BackgroundFracture is a kind of clinically frequently-occurring disease. Fracture healing is an extremely complex process of bone regeneration and repair, under the influence and regulation of a number of systemic and local factors. About 5% to 10% of fractures occur delayed union or disunion for various reasons, as seriously affects people's quality of life. How to accelerate fracture healing and how to improve the healing quality have been one of major topics that medical community are working together to focus on.External treatment with traditional Chinese medicine is a traditional medicine therapy that could use non-oral drugs stimulating meridians, acupoints, skin, mucosa, muscle, bones, etc. to achieve the purpose of preventing and curing diseases. External treatment with traditional Chinese medicine on fractures has a long history and significant effect. At present the main mechanism confirmed by researches includes the following aspects:improving blood circulation; promoting hematoma absorption and organization; increasing collagen synthesis; promoting calcium deposition; increasing the number of cells and promoting cell activity; regulating endocrine system; promoting callus formation and improving the quality of callus; interventing the effect of regulatory factors of bone formation; improving the content of trace elements, etc.Along with technology development, transdermal drug delivery has become the third largest route of administration. Traditional Chinese Medicine can be described as unique in this field. Advantages of external treatment with traditional Chinese medicine are that the effect of drug is direct and focused and able to direct the disease to make drug concentration within the local lesion significantly higher than blood drug level so that drugs play a full role and have a rapid effect and the dosage and side effects are much less than those of oral medicine. Transdermal therapeutic system of traditional Chinese medicine that conbines traditional external treatment with traditional Chinese medicine with modern transdermal technology will be the development trend of research on external treatment with traditional Chinese medicine in the future.At present dosage forms of external treatment with traditional Chinese medicine on fracture are mainly slurry, tincture and air pressure-canned nebula that are made by traditional Chinese medicine, as is reported in literatures. But they all have shortcomings and limitations. How to choose a valid prescription and use scientific and rational dosage forms for fracture hailing is the development trend of modernization of traditional Chinese medicine. The subject will conbine the most cutting-edge innovational outcome of modernization of traditional Chinese medicine——micron and nano medicine technology with restructuring technology of textile industry and create a new type of medical material——micron traditional Chinese medicine functional lining material, in order to conbine reposition, fixation with local application organically. Micron traditional Chinese medicine functional lining material is not only used as plaster bandage or inner liner when splintage, but also has the role of eliminating inflammation and analgesia and reducing trauma response and accelerating tissue repair and fracture healing and functional recovery.Micron-medicine is a new medicine whose particle size is micron level (average diameter≤15μm)combining modern technology with traditional processing techniques and preparation techniques, maintaining inherent material basis of pharmacodynamics of traditional Chinese medicine. It is the product of traditional Chinese medicine with micron-technology, not a new drug species. Micron-medicine can greatly improve drug activity and bioavailability and reduce dosage and side effects, which is closely related with the core of modernization of traditional Chinese medicine"safe, effective, controllable, and stability". First of all, not only micron-medicine particles made with ultrafine grinding technology can keep the active ingredients of traditional Chinese medicine not to be damaged, but aslo enhance the dissolution active ingredients of drug effectively and increase drug bioavailability because of increasing surface area of particles. Secondly, it can improve drug targeting to help control the distribution of drugs in vivo; This research product——micron traditional Chinese medicine functional lining material, is convenient for not only dose standardization but aslo standardization of manufacturing processes and quality control of the standard. This new type of medical function materials can be used as plaster bandage or inner liner when splintage and effectively promote fracture healing and functional recovery by conbining external fixation with local application organically. This experiment is to study the effects of micron traditional Chinese medicine functional lining material on the healing of fracture in rabbits from serum biochemical parameters, hemorheology, X ray and histomorphology aspects.ObjectiveTo study the effect of micron traditional Chinese medicine functional lining material on the healing of fracture in rabbits, so as to offer theoretical references for clinical applications and transformation.Methods1. Groups dividing and models establishment:24 male New Zealand white rabbits were randomly divided into 4 groups:micron group, traditional Chinese medicine control group,lining material control group and model control group. Each group consisted of 6 rabbits. With Chai Benfu's modeling method for the reference, all rabbits were made into fracture models with bone defect in the middle of the right radial2. Lining materials production:Micron traditional Chinese medicine functional lining material was made with micron-panax notoginseng powder made with high-energy ball milling with borneol and other medicines with reforming technology of textile industry.3.Treatment methods:All rabbits were modelled successfully. Rabbits in the micron group were treated with micron traditional Chinese medicine functional lining material plus plaster external fixation; those in the traditional Chinese medicine control group were treated with ordinary Chinese medicine functional material plus plaster external fixation; those in the lining material control group were treated with ordinary lining material added plaster external fixation; those in the natural healing control group had no special treatments. Lining materials were replaced weekly. All rabbits had been observed continuously for six weeks.4.Outcome measures:The size of notoginseng powder was compared before and after micron process in SEM. The serum concentration of AKP, Ca, Pand hemorheology indexes(ηB.200,ηB.30,ηB.1 andηp) were detected respectively before modeling settlement and after modeling for 2,4 and 6 weeks. All the animals of the fracture healing were observed under the X-ray and Scores of fracture callus and the fuzzy degree of the fracture line were assessed after modeling for 2,4 and 6 weeks. All the rabbits were killed 6 weeks after modeling. Those samples taken from the position to 0.5cm fracture fragments as the center were made HE staining after decalcified fixation, dehydration, paraffin imbedding and serial sections. The repair of fracture zone was observed under optical microscope.Statistical methodsThe statistical analysis was performed with SPSS 13.0 software package and the data were presented with the mean±standard deviation (x±s). Multiple comparison between the measured data were performed by using one-way ANOVA. Multiple comparisons of the serum concentration of AKP, Ca, P, hemorheology indexes(ηB.200,ηB.30,ηB.1 andηp) and scores of fracture callus and the fuzzy degree of the fracture line among different time spots in each group were analyzed by using repeated measures analysis of variance. Statistical significance was set at P <0.05.Result1. Detection of serum biochemical parameters:The results showed that the serum concentration of AKP, Ca and P at different time points of the fracture healing process were significantly different (F values were 3.147,3.427 and 6.452, P values were 0.048,0.037and 0.003). AKP in micron group reached a peak after 2 weeks of modeling, AKP in micron group, model control group and traditional Chinese medicine control group were significantly different (P values were 0.001,0.000); Ca in micron group, model control group and traditional Chinese medicine control group were significantly different (P values were 0.001,0.002); P in 4 groups were both dropped, P in micron group and the model group were significantly different (P= 0.042<0.05). After 4 weeks of modeling, Ca in every group began to decrease, which in micron group fell more. Ca in micron group, model control group and traditional Chinese medicine control group were significantly different (P= 0.000<0.05); P began to increase, which in micron group was apparent. P in micron group, model control group and traditional Chinese medicine control group were significantly different (P values were 0.002,0.048). After 6 weeks of modeling, AKP and P in micron group had been reduced to near normal. AKP and P in micron group, model control group and traditional Chinese medicine control group were significantly different (P<0.05).P in 4 groups remained at a high level. P in micron group, model control group and traditional Chinese medicine control group were significantly different (P values were 0.000,0.014). All serum biochemical indixes in lining material control group and model control group at the same time showed no significant difference (P> 0.05).2. Detection of hemorheology:All indixes of micron group were almost lower than other control groups. After 2 weeks of modeling,ηB.1,ηB.200 andηp in micron group and model control group were signific, antly different (P values were 0.000,0.017,0.000); After 4 weeks of modeling, four indixes in micron Group and model control group were significantly different (P= 0.000).ηB.1 andηp in micron group and traditional Chinese medicine control group were significantly different (P values were 0.000,0.001); After 6 weeks of modeling, four indixes in micron group and model control group were significantly different (P= 0.000).ηB.1 andηp in micron group and traditional Chinese medicine control group were significantly different (P values were 0.001,0.036).3. X-ray examination and external callus and fracture line blurring score:It showed that external callus were almost completely absorbed, cortical bone mineral density in the location of fracture closed to normal cortical bone and bone marrow cavity was completely recanalized after 6 weeks of modeling; It showed that fracture line disappeared, external callus began to absorb and bone marrow cavity remained unconnected in traditional Chinese medicine control group;There was a hardening and nonunion phenomenon of broken ends in model control group. External callus and fracture line blurring score showed that scores of lining material control group and model control group showed no significant difference (P= 0.819), scores of micron group and model control group were significantly different (P= 0.001) after 2 weeks of modeling; 4 weeks after modeling, scores of lining material control group and model control group showed no significant difference (P= 0.778). Scores of micron group and model control group were significantly different (P= 0.000). Scores of micron group and traditional Chinese medicine control group were significantly different (P= 0.010).6 weeks after modeling, scores of lining material control group and model control group showed no significant difference (P= 0.293), scores of micron group, model control group and traditional Chinese medicine control group were significantly different (P values were 0.000,0.027).4. Histomorphology:The first 6 weeks after modeling, vasculars between trabeculars in the location of fracture expanded and the number was larger; Endochondral bone was completed; A large number of osteoblasts were saw; Woven bone began shaping; The bone marrow cavity was recanalized in micron groups. Weaving bone, cartilage cells and endochondral bone were coexisted; In callus and external callus of stump were connected; Bone marrow cavity was not recanalized in traditional Chinese medicine group. While trabecular bone was smaller and blood vessels between trabeculars were less and in callus and external callus of stump were mainly unconnected and the bone marrow cavity was not recanalized.ConclusionMicron traditional Chinese medicine functional lining material can improve microcirculation, increase the activity of AKP, decrease the level of Ca, elevate the product of serum P and Ca, accelerate the proliferation of osteoblasts and promote callus formation and fracture healing.lt was stronger than ordinary traditional Chinese medicine functional lining material.
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