Epistaxis Hemostatic Gel Developed

Epistaxis hemostatic gel is the polysaccharide of Bletilla striata (Thunb. )Reichb.f.and the total alkaloid berberine of Coptis chinensis Franch. extracts are made into traditional Chinese medicine preparations, mainly used to treat nasal dryness, nose bleeding caused by inflammation. The issue in accordance with the "State Food and Drug Administration" issued by the Drug Registration in natural medicine, new drug research technology VI guidelines, use of modern pharmaceutical technology, the gel was part of pre-clinical pharmaceutical research, the specific includes the following sections:1 Extracts of herbs1.1 The extraction and separation of Bletilla striata (Thunb. )Reichb.f. technology and quality standardIn this study the extraction of water extraction and alcohol precipitation separation of Bletilla striata (Thunb. )Reichb.f. polysaccharides, the use of single-factor test first, dialogue and medicinal water absorption, extraction temperature and size of material to conduct a preliminary investigation, then the use of orthogonal test, the amount of water, extraction times and extraction time were optimized to determine the best white and polysaccharide extraction process: The water bath temperature is 90℃, the size of material of 10 mesh, plus 8 times the weight of water, extraction time is 1 hour, extracted for 3 times; purified by alcohol precipitation of white and polysaccharides, the results show that when the concentration of 70% ethanol precipitation, the precipitation in the highest content of white and polysaccharides; this study also looked at white and polysaccharide removal method of protein impurities, the results show that the hydrochloric acid to In addition to protein is better and suitable for industrial production.In accordance with "Chinese Pharmacopoeia" in 2005 edition of a herbal extract of the relevant inspection, the quality of dialogue and the polysaccharides were analyzed, including the character, identification, determination of other items. White and color reaction by polysaccharide in vitro qualitative identification by UV spectrophotometry white and polysaccharide content in the form of preparation in order to extract the feed, effectively overcome the natural product content of volatile active ingredients shortcomings, improve the safety of ingredients and effectiveness.1.2 The extraction and separation of the total alkaloids berberine of Coptis chinensis Franch. technology and quality standardIn this study the ethanol precipitation method of water extraction and separation of berberine alkaloids of Coptis chinensis Franch, the first use of single-factor test method, extraction solvent, extraction method and size of material to conduct a preliminary investigation; then orthogonal test method, solvent volume, extraction time and extraction times were optimized to determine the total alkaloid berberine optimum extraction: a simple reflux method using the size of material for the 10 orders, 70% ethanol extraction solvent, solvent volume was 6 times the weight of medicine, the extraction time is 1 hour, extract number is 3. Comprehensive use of water, precipitation and acid-base separation and purification of total alkaloids berberine, to determine process parameters: water content of berberine herbs Shen extract concentrate volume of 10 times the amount of milk of lime to adjust pH 9, adjusted by hydrochloric acid and pH value 1.In this study, according to "Chinese Pharmacopoeia" 2005 version of a medicinal extract of the relevant checks on the quality of berberine alkaloids were analyzed, including the character, identification, determination and so on, in which berberine hydrochloride was determined by TLC This method can be precise and accurate determination of content of the sample.2 Epistaxis hemostatic agents of the gelThe appearance of characters to gel in shape, painted ductility and viscosity for evaluation, first used gel matrix, pH regulating agents, moisturizing agents, absorption enhancers and preservatives such as excipients were screened initially to determine excipients concentration; followed by preparation of the gel to filter, will determine the process for the use of propylene glycol carbomer 934p sufficient wetting water swelling, adding extracts of various herbs and prescription of other accessories, then add Triethanolamine made of gel .Using Box-Behnken response surface design on the gel prescription absorption enhancers, moisturizing agents and to optimize the ratio of substrate concentration. The cumulative release of berberine hydrochloride for evaluation, using Design Expert 7.0 software for multiple linear regression of experimental data obtained multiple regression model, based on mathematical models describe the response surface map, the best prescription parameters: 2 methyl-β-cyclodextrin the amount of 1.2%, 10.8% in the amount of propylene glycol, carbomer 934p concentration of 0.74%.3 Cilia toxicity, allergic and irritant test of testThe topics to toad palate oral mucosa cilia transport rate and ciliary beat time for evaluation, on Epistaxis hemostatic gel cilia toxicity results showed that: the preparation of the mucous membranes and cilia no obvious toxicity. Epistaxis hemostatic gel were observed in guinea pig allergic skin reactions and on the rabbit nasal mucosa irritation produced by the situation. The results showed that: Epistaxis hemostatic gel after repeated administration smear, and positive drug 2,4 - dinitro chloro benzene, acetone as control, no cutaneous anaphylaxis in guinea pigs; to the rabbit nasal smear repeated epistaxis Hemostasis gel, no significant rabbit nasal mucosa irritation, compared with the control group no significant difference. In summary, the note Epistaxis hemostatic gel is safe and reliable.4 Initial StabilityTo traits (appearance, color, viscosity, with or without stratification, etc.), pH value, determination, etc. for evaluation, carried out on Epistaxis hemostatic gel to high temperature, low temperature, freezing, centrifugation and other factors test The results show that the gel light bleeding epistaxis instability, decreased viscosity, indicating need from light; in the dark under the packaging material, carried out on three batches of samples for 6 months of the initial stability of the results epistaxis bleeding gel is stable.Epistaxis bleeding through the gel on the part of the experimental pre-clinical pharmaceutical research, has been the formula was stable, without cilia toxic, allergic, irritant, quality control of epistaxis bleeding gel for further Pharmacodynamics and drug Science foundation; also nasal gel delivery system, the accumulation can learn from experience.