Preparation Of Sanzi Would Healing Sponge Dressing

Background:Medical dressing is referred to serve as a temporary skin substitute,cover on the wound bed and protect the wound from secondary damage, and meanwhile be able to create a damp, hypoxia or oxygen-free, slightly acidic microenvironment, so that it can promote wound healing quickly. It has gone through a slow development for hundreds of years. And until the1960s, the British animal physiologist Winter’s animal study had found that the epithelialization rate of pig wound covered by moisturizing airtight dressing was1times faster than exposure therapy. Also, both scholars Hinman and Maibach confirmed Winter’s view. Since then, the "moist healing" concept began to be widely accepted.(3) Mature stage:As people learn more about the pathophysiology of the wound healing process, the development of the new types of moisturizing dressing presents a diversified, functional trend. Ideal medical dressings should own good exudate absorption, moisture resistance and breathability. Besides, it is easy to use comfortably, to promote healing initiatively, and with low price, etc. Currently, the traditional gauze dressing, the new moisturizing airtight dressings and the traditional Chinese medicine dressings is common in clinic. Traditional gauze dressings have some obvious defects, such as prone to dry wound, adhering to wound bed, poor bacteria isolation, frequent dressing change, etc, which will gradually withdraw from the wound treatment in the future. Compared to the former, the new moisturizing dressings, which have a capability to manage wound bed environment, and to create a micro-environment for wounds, are playing a important role in wound treatment. However, due to its single function, lacking of initiative capabilities to promote healing, high prices, which will restrict its use in large scale. As to traditional Chinese medicine dressings, which own significant effects, safety, reliability and wide range of sources, are unique in the wound treatment. And it is suitable for all types of acute and chronic wound treatment. However, because of formulation disorder, lack of quality standards, inconvenient usage and other reasons, it results in a small range applications in clinical departments and need to be further developed and utilized. So far, there has been not a kind of dressing conforming to people’s expectation on the ideal dressing.Therefore, based on the current status of the development of medical dressings, this study aims to innovate a folk traumatology prescription and combine the characteristics of Chinese medicine dressing with the advantages of the new moisturizing dressings, so as to develop a kind of traditional Chinese medicine sponge dressing with initiatives to promote healing. For the sake of it, systematical study is needed in accordance with drug development process, which will provide experimental evidences for the latter industrial production.Objectives:The traditional folk prescription traumatology "Panax compound", is with efficacy of antibacterial property, hemostasis, analgesic and eliminating swelling, which served as the pharmacology basis for the proposed development of traditional Chinese medicine sponge dressings. Firstly, the sponge prepared by the medical polymer materials with excellent performance used as a drug carrier. Then add the active ingredients extracted from the compound into the carrier. Finally, developed a new type of airtight Chinese medicine sponge dressing by modern pharmaceutical technology. This dressing is intended for acute skin injuries, chronic infectious wounds, leg ulcers, diabetic foot wounds and other wounds. In order to promote sales of products listed, a series of research as extraction process, molding process, etc, should be conducted according to new drug development process, so as to provide experimental evidences for future industrial production.Methods:1. study of the extraction process of san zi wound healing sponge dressingAccording to traditional Chinese medicine "monarch" principle, the compound is consist of a series of herbs such as Panax notoginseng (Burk.) F. H. Chen, Callicarpa macrophylla Vahl, Bletilla striata(Thunb)Reichb.f., Acacia catechu (L.f.) Willd, Paederia scandense (Lour) Merrill, Zanthoxylum nitidum (Roxb.) DC, etc. In this study, based on extensive literature review, consulting traditional Chinese medicines expert and systematical analysis of each herbs in physical and chemical properties, we choosen ginsenosides Rg1, ginsenoside Rb1and extract yield as evaluation indexes of extraction efficiency of the compound, and HPLC method was used to measured liquid content of compound, and orthogonal design was adopted to optimize extraction technology by taking the amount and concentration of ethanol, extraction time as factors. Eventually the optimized the extraction process for traditional Chinese medicine sponge dressing was screened. Then under the optimized extraction process, we prepared the samples in triplicate for validation process, so as to evaluate the efficacy of the extraction process, and provide experimental evidences for future industrial production. 2. Molding process of san zi wound healing sponge dressingIn this study, we screened out the medical polymer materials such as polyvinyl alcohol, chitosan and gelatin, with antibacterial property, hemostasis and initiative wound healing, as the dressing matrix recipe ingredient by preliminary experiments and literature review. Meanwhile, we determined the ratio of polyvinyl alcohol, gelatin and chitosan, the glutaraldehyde dosage and the glycerol dosage as sponge factors and drug dosage as fixed factors for the proposed sponge by extensive literature review. Then the forming procedure was investigated by orthogonal design with water absorption, moisture, and permeability as evaluation indexes. And these evaluation indexes, with highest degree of recognition, were screened out by simplified expert consultations, up to17experts, including traditional Chinese medicine preparation, pharmacology, burns and plastic, clinical surgery, nursing, nurse practitioners. Thus we optimized the molding process for the sponge dressing. Lastly, under the optimized molding process, 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.3. A preliminary study on the Sanzi wound healing sponge dressing on wound healing in ratsIn this study, completely random design was used as the pharmacology experiment research method, rat back small area skin defect was as wound model for the dressing assessment. After operation, the rats were randomly divided into gauze dressing group, sponge matrix group and Sanzi sponge dressing group. Then the3indexes, including wound morphological observation, the wound healing rate and wound histological observation, were collected and recorded in the model after3days,7days,14days respectively. 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.Results:l.The optimum extraction process of san zi wound healing sponge dressingExperimental results showed that the concentration of ethanol was with significant differences for the compound extract yield(P<0.05) among the factors. Extracted two times in a row, extract yield rate, ginsenosides Rgi rate and ginsenoside Rbi rate were93.51%,92.90%and91.58%respectively. Three extraction rate were exceled90.0%. So, Based on comprehensive consideration, the optimum process was as follows: extracted2times with8-fold the amount of70%ethanol,2hours per times, and repeat two times. Process validation results showed that under the optimum condition, the extract yeild was higher than nine orthogonal extraction process results, the two remaining extraction rate of ginsenosides Rbi, Rgi were close to the highest level, indicating that maximum extraction rate of the active ingredients of traditional chinese medicine could be obtained under the optimized extraction condition.2.The optimum molding process of san zi wound healing sponge dressingExperimental results showed that both the sponge’s water absorption and moisture retention were significantly affected by the ratio of the matrix and the amount of glutaraldehyde respectively (P<0.05). So, Based on comprehensive consideration, the optimum process was as follows:the matrix ratio was1:3:1, the dosage of glutaraldehyde was0.7mL, the dosage of glycerin was1.0mL. Process validation results showed that under optimum condition, water absorption of the sponge was higher than nine orthogonal molding process results, moisture and air permeability of the sponge were also close to the maximum level. The sponge preparation process were as follows:(1):Preparation of a concentrated solution of Chinese herbal compound concentrate:taking prescription medicine, extracted2 times with8-fold the amount of70%ethanol,2hours per time, and repeat two times. Then the filtrates were combined and filtered and then concentrated to50ml,1.9g crude drug/ml.(2) Preparation of sponge: matrix solution was mixed up to30mlâ†'Stir plentyâ†'Added1ml glycerinâ†'Stir plentyâ†'Add2ml concentrated liquid medicine (containing3.8g crude drug)â†'Stir plentyâ†'Add0.9ml glutaraldehydeâ†'Stir plentyâ†'Filmingâ†'Frozen24hours with-20℃freezerâ†'80℃vacuum freeze-dryingâ†'sealed packaging.3. A preliminary study on the Sanzi wound healing sponge dressing on wound healing in ratsThe experimental results showed that the healing condition of sponge matrix group and sponge dressing group were significantly better than the gauze dressing group after7days,14days in the model. However, there had no significant difference between the sponge matrix group and the sponge dressing group. It demonstrated that the polymeric sponge had healing effects, while traumatology recipe extract carried by the sponge had not play the desired effect.Conclusions:1. The established method was accurate and reproducible. The optimum extraction procedure was with the advantages of time-saving, labor-saving and high efficiency, which was stable, reasonable and practicable, will provide references for future industrial production2. The established molding procedure was stable and practicable. The prepared sponges have excellent water absorption, air permeability and moisture, which will provide references for future industrial production.3. The preliminary study on pharmacology of the sponge dressing has not obtained the ideal result. After full discussion and analysis with pharmacy experts, the possible factors were summarized as followed:(1) defects in the selection of animal model.(2) defects in the study design.(3)The problems on drug loading and drug release in the sponge dressing, which will provide ideas and directions for Future research.