| Background:Since the aging population, the rapid development of transportation, the increased car accidents and other traumatic accident rates, making the skin wound that has increasingly become a very serious worldwide health problem and burden. People also made a lot of new treatment theories, methods and techniques on wound healing. In 1974, the world's first airtight dressing Opsite was born. since then, the"moist healing"concept began to be accepted widely. In recent 50 years, the basic research and clinical treatment of wounds confirmed that moist environment was conducive to wound healing. Therefore, new moisturizing dressing entered into the medical market. But the new moisturizing dressing had single function, costliness, slow market penetration and other shortcomings. Currently, new dressing had come mainly from Europe and the United States industry giants. Chinese medicine has unique features in the treatment of wounds, can take the initiative to promote wound healing and prevent scar formation, suitable for all types of acute and chronic wound treatment and care. What's more, it has the advantage of safty, side effects, sources of simple, which can reduce the cost of medical services, improving hospital efficiency. However, Chinese medicine dressing also can not maintain airtight dressing, moist micro-environment, inconvenient to use. Its security issue has attracted much attention.Medical dressing quality is directly related to patient safety. Developed country began to carry out safety monitoring of medical dressings from the 1960s. In 1976, the US Food and Drug Administration (FDA) began to manage medical dressings and established a series of biological and quality evaluation criteria. China began to study the biological evaluation of medical dressings from the late 1970s, even so, there were still some gaps compared with developed countries. The relevant provisions of Chinese medical device registration required to evaluate physical and chemical properties, biological evaluation, development of product quality standards after the completion of processing performance, beautiful design and other physical properties of the program. Due to the complexity of Chinese dressing ingredients and diversity of formulations, there was no unified Chinese medicine dressing evaluation criteria.Therefore, there were some deficiencieshe of Chinese medicine dressing, which needs further improvement. We developed the traditional folk prescription traumatology "Panax compound" through summarize Chinese herbal medicine and the folk widespread use, which based on the principles of traditional Chinese medicine formula. The compound is consist of a series of herbs such as Radix notoginseng, Callicarpa macrophylla Vahl, Bletilla striata, Acacia catechu, Paederia scandense, Zanthoxylum nitidum, Polygonum cuspidatum, etc. But the original dosage form was inconvenient to use, easy to contaminate wounds. We Combined the characteristics of the traditional Chinese Medicine with the advantages of the new type of moisturizing dressing, then developed a new type of airtight Chinese medicine sponge dressing which can absorb the drainage, promote the growth of granulation, reduce the infection, take the initiative to promote wound healing. Besides, the type of airtight Chinese medicine sponge dressing, is with efficacy of hemostasis, antibacterial property, analgesic and eliminating swelling. This dressing is intended for acute skin injuries, chronic infectious wounds, leg ulcers, diabetic foot wounds and other wounds. However, its safety and efficacy needs to be confirmed, and the quality needs to be evaluated. Therefore, a series of research as pharmacodynamics analysis, quality analysis, etc, should be conducted according to new drug development process, so as to provide experimental evidences for future industrial production.Objectives:I.To evaluate the validity and safety of the Sanzi wound healing sponge dressing, as well as its therapeutic mechanism.2. Evaluate the physical properties of Sanzi wound healing sponge dressing.3. To identify Radix Notogirmeng and Rhizoma Polygoni Guspidati.Methods:1. The effed on wound healing of Sanzi wound healing sponge dressingAcute trauma repair model includs tangent skin injury model, skin excision injury model, wound die or trauma cavity model, fault skin wound healing model chamber, burn (hot) injury model of wound healing. In this study, rat back small area skin defect was as wound model for the dressing assessment with a sword in rats back on both sides of the spine to open small full-thickness circular skin defect on the basis of extensive literature, expert consultation of clinical surgery, pharmacology. Rats were randomly divided into 3 groups,10 in negative control group,10 in positive control group,10 in experimental group. We put rats in prone position, cut off back hair, then made 2cm diameter circular full-thickness defect wound and disinfected the wound fully with chlorhexidine acetate solution after intraperitoneal injection of 3% sodium pentobarbital anesthesia. The experimental sample group was rapped with sponge dressing, while the positive control group was rapped with sponge matrix. The control group was rapped with petrolatum gauze. Changed the bandage daily for the first three days, every other day three days later, two days treatment after a week. We then observed the wound healing and wound pathology after 3,7,14 days re-spectivcly in different groups. The wound area of each wound was measured on the 3rd,7th,14th day after operation, thereafter, as well as the scores of inflammation response in the wound tissues measured on the 3rd,7th day after operation. And statistical analysis of the data were performed to evaluate the effect of Sanzi sponge dressing, which will provide experimental evidence for later clinical trial.2. The study on quality standard of the Sanzi wound healing sponge dressingIn this study, based on extensive literature review, consulting traditional Chinese medicines experts and nursing experts, we choosen physical and chemical method, thin layer chromatography to test quality. Distinguish the ginsenoside Rbi, ginsenoside Rg1 and Polydatin. Put the reference solution, the test solution and the negative solution points on the same TLC plate, then made the separation of the sample solution contained in the component. The resulting chromatograms were compared for identification of the formulation. After that, the forming procedure was investigated by orthogonal design with permeability, water absorption, moisture, the tear strength, heat resistance, cold resistance, weight differences. The samples in triplicate were prepared for validation process, so as to evaluate the efficacy of the molding process, and provide experimental evidences for future industrial production. Thin layer chromatography method was condutced to identify knotweed glycosides.Results:1. Diet and activity of ratsAwake after anesthesia, the rats were poor spirit, without any active movement and diet; The first 3 days after treatment, mental state, diet and active motion of rats in the experimental group and the positive control group were near normal, nevertheless, the negative control group had a small amount of activities and diets, mental state improved. After treatment for 7days,14days, mental state, active motion and diet were normal, so there was no significant difference between the two groups. Each group of experimental rats were no deaths.2. Wound healing of ratsThe first three days after treatment, the wound healing rate of experimental group (40.22±0.05)%, positive control group (38.33±0.1)%, were higher than the negative control group (22.02±0.03)%, and there was a significant difference(P<0.0 5); the first seven days after treatment, the experimental group wound healing rate was (71.32±0.08)%, higher than the positive control group (60.66±0.09)% and the negative control group rate (50.01±0.10)%, so there was a significant difference(P<0. 05); after fourteen days of treatment, the wound healing rate in experimental group was (90.44±0.07)%, higher than the positive control group (81.03±0.04)% and the negative control group (71.65±0.10)%, and there was a significant difference (P< 0.05).Compared with the control group, after 3 days of treatment, the experimental group appeared earlier in the capillaries, fibroblasts proliferation; after treatment for 7 days, collagen fibers of the experiment group was significantly greater than the control group; after treatment for 14 days, there was no obvious change compared with the postoperative 7 days.The first three days after treatment, the wound inflammation score of the experimental group was(3.20±0.42), lower than the positive control group (4.18±0.60) and the negative control group (5.67±0.50), and there was a significant difference (P<0.05); after treatment for seven days, the experimental group wound inflammation score was(1.70±0.48), lower than the positive control group (2.55±0.52) and the negative control group (3.89±0.33), so there was a significant difference (P<0.05). Sanzi wound healing sponge dressing could reduce the excessive secretion of exudate.3. The preliminary stability of the Sanzi wound healing sponge dressingExperimental results showed that the Sanzi wound healing sponge dressing has good ventilation rate, water absorption, moisture resistance, heat resistance, cold-resistant. Besides, the tear strength and the difference of weight were reasonable. The results were as follows:average permeability rate(80.86%), average moisturizing effect (38.11%), average absorbent(11.15 times), tear strength(140g/cm3), the most large weight difference (3.5%), the minimum weight difference (3.4%). There was no oil leakage phenomenon after placed in heat preservation oven and no obvious stratification after storage in a freezer. The characteristic of identification by TLC was distinct, and the corresponding position had the same color spots.Conclusions:1. The Sanzi wound healing sponge dressing can quickly stop bleeding and promote the recovery of diet and activity through the study on the main pharmacodynamics.It has the effect of bacteriostasis, anti-inflammation, promoting blood circulation and removing blood stasis, which can absorb wound exudate, prevent infection, promote wound angiogenesis, accelerate wound healing, reduce scar,complications and mortality. Therefore, it was safe for application of wound healing.2. The Sanzi wound healing sponge dressing has good ventilation rate, water absorption, moisture resistance, heat resistance, cold-resistant. Besides, the tear strength was high, the weight difference was within 5%. The quality controlled of the Sanzi wound healing sponge dressing was feasible. TLC identification was simple, accurate and reproducible. |
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