Study On The Pharmacy Of Wentong Ointment

ObjectWe studied the preparation process of Wentong Ointment and established its quality standard in order to go on further clinic research and register a new drug typed VI. We hope our study can gain great economic and social benefits.MethodIdentified the herb drug materials according to legal quality standard of Chinese pharmacopoeia. Optimized the SFE-CO₂ and ethanol processing craft of extraction by the orthogonal test. Established the final craft technology by mid-experiment. Identified Rhizoma Chuanxiong, Radix Notoginseng, Rhizoma Curcumae Longae and laurocapram in Wentong Ointment by TLC. Determined the content of camphor, isoborneol, borneol, cinnamaldehyde and eugenol in Wentong ointment by GC. Determined Wentong ointment by relevant rules of Ointment according to Chinese pharmacopoeia. Observed its stability during three months.Result1. The herb drug materialsRhizoma Chuanxiong, Radix Notoginseng Rhizoma, Rhizoma Curcumae Longae,Camphor,Borneolum Syntheticum, clove oil, cinnamon oil and etc were allpassed.2. The study of the SFE-CO₂ technologyUsed SFE-CO₂ to extract Rhizoma Chuanxiong, Rhizoma Curcumae Longae and other materials because they contain a great deal volatile components and optimized the SFE-CO₂ craft by the orthogonal test. Went on further determination of extractions by GC-MS. The result showed 9.8% extraction could be gotten and Turmerone, Zingiberene, Arturmerone and etc could be found.3. The study of the ethanol processing technologyAfter SFE-CO₂, we left the residue of SFE-CO₂ extraction and compounded othermaterials, then we used ethanol to further extraction. We also optimized the ethanol processing craft by the orthogonal test and determined the content of Rb₁, Rg₁ in Radix Notoginseng by TLCS. The result showed 91. 45% Rb₁, Rg₁ could be found.4. The study of the preparation technologywe studied on the PH value, and dosage of carbopl. The result showed PH value between 6. 0 to 6. 5 , temperature 50℃ and 2% carbopl were the best. We observed the stability of Wentong Ointment by cold> hot and centrifuged laboratory experiments. The result showed the Ointment was stable.5. The study of the mid-experiment200 fold of herb material of prescription were applied to process the mid-experiment of the SFE-CO₂ technology, the ethanol processing technology and the preparation technology. We experimented five batches of the mid-experiment of the SFE-CO₂ technology was amount to 48Kg. The result showed the amount of extraction was 4795g. The rate was 9. 9¹0. 2 %, similar to 9. 8%. The five batches of the mid-experiment of the ethanol processing technology was amount to 26Kg. The amount of extraction was 29. 7%. The relative density was 1. 20(50℃). The extraction rate of active components of Rb₁,Rg₁ in Radix Notoginseng was 90.2%, it had good repeatability. The five batches of the mid-experiment of the preparation technology showed that it had good repeatability too, and the Ointment was stable.6. The study of the quality standard of the Wentong OintmentIdentified Rhizoma Chuanxiong, Radix Notoginseng and laurocapram in Wentong Ointment by TLC. The result showed that the chromatogram of TLC was clear, and the resolution was well. Determined the content of camphor, isoborneol, borneol, cinnamaldehyde and eugenol in Wentong ointment by GC, and the recovery were 97.80%, 96.81%, 97.52%, 96.24%, 101.24% respectively and RSD were 1.05%, 1.34%, 1.28%, 1.89%, 1.49% respectively. The volume variation test and the limit microbe test complied with the general requirements for ointments (appendix 1.14). 7.The study of the stability of the Wentong OintmentThe description, identification, volume variation test and the limit microbe test and assay etc complied with the general requirements. Conclusions 1. The herb drug materialsAll the herb drug materials using in the experiment comply with the Chinese pharmacopoeia. 2.The study of the SFE-CO2 technologyThe best SFE-CO2 extraction condition is that the flow of CO2 is 21Kg/h, the pressure is 26MPa, the extraction time is 1h, and the extraction temperature is 45℃. The amount of extraction is markedly influenced by the extraction time and the pressure.3. The study of the ethanol processing technologyThe best ethanol extraction condition is that adding 80% ethanol to drug residue heats and refluxes three times for 1 hour each times ( the first time adds 6 times of 80% ethanol, the rests add 5 times of 80% ethanol), filter recovers ethanol from the filtrate, concentrates to the relative density of 1. 20 (50℃).4. The study of the preparation technologyThe PH value between 6.0 to 6.5, 50℃ and 2% carbopl are the best. The ointment is uniformity, exquisite, appropriate viscoidal, easy to spread on the skin and mucous membrane without thrill.5. The study of the mid-experimentThe best preparation processing is that: to coarse power of the herb drug material, Use SFE-CO2 to extract Rbizoma Chuanxiong, Rhizoma Curcumae Longae and other materials. The best SFE-CO2 extraction condition is that the flow of CO2 is 21Kg/h, the pressure is 26MPa, the extraction time is lh, and the extraction temperature is 45℃.The residue of SFE-CO2 extraction, Radix Notoginseng and etc add 80% ethanol , heat and reflux three times for 1 hour each times ( the first times add 6 times of 80% ethanol, the rest add 5 times of 80% ethanol), filter recover ethanol from the filtrate, concentrate to the relative density of 1.20(50℃). Adding the camphor, borneol, clove oil, cinnamon oil and adjuvant to SFE-CO2 extraction and ethanol extraction, heat , mix, fill, and packing up.6. The study of the quality standard of the Wentong OintmentTLC can identify the characteristic spots of the Rhizoma Chuanxiong, Rhizoma Curcumae Longae, Radix Notoginseng and laurocapram. According to nine batches sample determination result, the Wentong Ointment content limit interim stipulate that the content of camphor is 0.90-4. 10%, the content of borneol is no less then 0. 44%, the content of c innamaldehyde in Chinese cinnamon...