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Sore anti-inflammatory ointment is made of natural medicine by Lithospermum extract and rhubarb extract topical preparations, mainly for skin epidermal damage caused erosion of wounds, fungal infections, chronic skin ulcers, and other symptoms. In accordance with the guiding principles of Chinese medicine, natural medicine, \includes the following sections. 1 herbs extract 1.1 Lithospermum naphthoquinone extraction and separation processes and quality standards of the extract to study the test to a comparative study of the traditional solvent extraction and new technologies CO 2 supercritical fluid extraction, CO 2 supercritical fluid extraction method to extract high purity extraction effect, and the extract is no organic solvent residue, etc., can improve the efficacy of this preparation, while sore face irritating , in line with the preparation of the treatment of the disease needs. Naphthoquinone ingredients Lithospermum total thermal instability, its content was significantly decreased when the temperature exceeds 60 ° C, CO 2 supercritical fluid extraction has a low operating temperature, composition is not destruction advantages. In sum, the final to determine CO 2 Supercritical Fluid Extraction separation Lithospermum active ingredients naphthoquinone. Orthogonal experiment method preferred extraction temperature, extraction pressure and extraction time, the active ingredient in the total naphthoquinone β, β'-dimethyl acryloyl A Kaning as index, measured by high performance liquid chromatography extraction the content of the material, to determine the optimum extraction technology of of Lithospermum total naphthoquinone: extraction temperature of 40 ° C, extraction pressure 30MPa, extraction time of 120 minutes. A pharmacopoeia of Chinese herbal medicines with reference to the 2010 edition of the Pharmacopoeia of the People's Republic of China to extract the relevant check items, a of Lithospermum total naphthoquinone quality standard, including traits, loss on drying, residue on ignition, heavy metals and other items through the thin layer chromatography of its qualitative analysis by high performance liquid chromatography its quantitative analysis, and develop the limits of the inspection. The results show that this process extracts high purity and less impurities, and has the advantages of low temperature, non-toxic, energy saving and environmental protection, suitable for promotion and enlarge production. 1.2 rhubarb anthraquinone extraction process of studying the test and extract quality standards using high concentrations of ethanol extraction, total rhubarb anthraquinones acid separation, and then macroporous resin purification, the first use of a single-factor test method preliminary investigation on the the herbs particle size, extraction methods and extraction solvents; orthogonal experiment method, the preferred amount of solvent extraction times and extraction time, to determine the best extraction process of Rhubarb: simple reflux method, herbs particle size is too 60 mesh sieve, the extraction solvent is 70% ethanol, a single solvent amount was 8 times herbs weight, the extraction time was 1 hour, extracted for 3 times. Integrated use of macroporous Resin and acid-base separation and purification of rhubarb in total anthraquinone ingredients, determine the process parameters: elution with 75% ethanol solution, adding hydrochloric acid adjusted to pH 1.0. To extract check items a pharmacopoeia of Chinese herbal medicines with reference to the 2010 edition of the Pharmacopoeia of the People's Republic of China, establish quality standards Rhubarb, including traits, loss on drying, total ash and other items, by thin-layer chromatography its qualitative analysis by UV spectrophotometry its quantitative analysis and the development of the limits of the inspection. The results showed that the extraction rate of this process the extract purity suitable for industrial production. 2 Sores anti-inflammatory ointment preparation of filters commonly used ointment base, propylene glycol, emulsifiers, liquid paraffin, lanolin, and preservatives and other excipients, ointment Appearance spreadability and consistency as index through transdermal absorb the cumulative permeation amount Filter absorption promoting agent and its amount, initially identified kind of excipients, the dosage range. Box-Behnken response surface design ointment prescription stearate, optimize the ratio of the amount of propylene glycol and Azone. Cumulative permeation amount of active ingredient beta the Lithospermum total naphthoquinone β'-dimethyl propenoyl A Kaning, 8 hours transdermal absorption as index multiple regression fit to the experimental data using the Design Expert 7.1.6 software, to draw multiple regression model, based on a mathematical model depicting response surface, and the optimum prescription process parameters: the amount of stearic acid was 29.03%, and 6.88% of the amount of propylene glycol, Azone amount of 2.73%. Considering the feasibility of industrial production, and therefore determine the stearic acid in an amount of 29%, propylene glycol in an amount of 7%, an amount of 3% Azone. Finalize the preparation process: stearic acid, lanolin, liquid paraffin as the oil phase, 50 ℃ water bath heated to dissolve; propylene glycol, Azone, triethanolamine, Ethylparaben dissolved in water as the aqueous phase, a water bath heated to the same temperature, the mixture of the two and stir until condensation that was packing. 3 allergic and hemolysis test of this experimental observation rabbit skin allergic reaction to erythema as the marker of the severity of the edema, anaphylactic Experimental Study of a sore anti-inflammatory ointment, the results show that the: Sores anti-inflammatory ointment repeated smear administration, to do with the positive drug 2,4 - dinitrochlorobenzene acetone control rabbits no skin allergy, no apparent allergic reaction to the preparation. The use of observation and ultraviolet spectrophotometry monitoring sore anti-inflammatory ointment hemolysis of red blood cells in the blood of rabbits, distilled water was used as a positive control, hemolysis rate calculated preparation. The results show that: the preparation hemolysis rate of less than 5%, no significant hemolysis, indicating that the preparation is safe, laid the foundation for further study. 4 preparations quality standards of sore anti-inflammatory ointment quality standards established under the premise of stable pharmaceutical formulations, preparation process, including the character, identification, inspection (particle size, quantity of contents, pH value, sterile, microbial limit), assay . To reflect and control the quality of the preparations. Through the sore anti-inflammatory ointment preclinical pharmaceutical part of the test, the preparation process is stable, allergic and hemolytic and quality controlled sore anti-inflammatory ointment, laid the foundation for further pharmacodynamic and clinical studies.
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