| The research includes the extracting artwork and the preparing artwork by orthogonal design or uniformity design,the quality standard and the stability of "Xiangru cold soft-capsule" and "Xiangru cold drop-pill" which are gotten from the classic ancient prescription of "Elsholtziae seu Moslae Powder" .according to "the method of the new drug' s registration" and the claim of research of the sixth class of new Chinese drugs and natural drugs.The best extraction technology of the volatile oil of Mosla chinensis Maxim, is selected by orthogonal design, which is investigated by the yield of volatile oil .The best artwork is the soaking time for 2h, the extraction time for 10h, the dosage of water for 10 times;The supercritical fluid extraction technology of Magnoliae cortex and Artemisiae annuae is selected by single-factor-parallel experiment, which is investigated by the extraction yield of Magnolol, Honokiol and Artemisinine. The best artwork of Magnoliae cortex is the materials grain size for 40,the temperature fo 35-40℃, the pressure for 25Mpa, the time for 6h.The best artwork of Artemisiae annuae is the materials grain size for 40, the temperature for 40-45℃, the pressure for 20Mpa, the time for 6h;The extraction and purification technology is optimized by uniformity design, which is investigated by the yield of Baicalin. The best artwork of Scutellaria is the materials grain size for 40, the dosage of water for 10 times, the extraction times for 3,30min every times, the purification time of incubation is 1h,the standing time 12-24h.it is proved that these artwoks are practicable by trial and error.The praeparatum shaping technology of "Xiangru cold soft-capsule" and"Xiangru cold drop-pill" is optimized by orthogonal design, according tophysico-chemical property of raw material and the characteristic of softelastic capsule or drop pill. The best shaping artwork of soft capsule is thatto get arachis oil, add beeswax for 4% to it and heat, liquate, chilling, thenadd Scutellaria extractive for lOOmu and tween-80 for 0. 5% , finally be mingled with the extractive of others, mix fully and be made to soft capsules for 1000 pieces. The matching of capsule wall material is gelatinum: glycerine: distilled water =1. 0:0. 5:1. 0, the oloring agent is Tiehong for 0. 15%o. The best shaping artwork of dripping pills is that to mix base material (PE&ooo: PEG?* = 1: 5) with Scutellaria extractive for lOOmu, heat, liquate, chilling, then add other extractives and Sodium Tvlose for 4.8% to it, braid, incubate for 80°C, drop in methylsilicone oil (10~12°C) , finally be made to dripping pills for 1000 pieces.We research the quality control method of "Xiangru cold soft-capsule" and "Xiangru cold drop-pill" and draw up the quality standard of finished products. The primal active components of praeparatum, Thymol and Oxyzymol , are quantitated by GC., the content of Thymol and Oxyzymol in soft capsule s is above 8. 6mg one piece, and 0. 43mg one piece in dripping pills . It gives the reliable basis to the internal quality control of the preparation. Then we study the initial stability of six months of the finished products, it provides scientific foundation to formulate the expiration date of the praeparatums.By determing the LDM and studing the part pharmacology of "Xiangru cold soft-capsule" and "Xiangru cold drop-pill" , The pharmacological action of bacteriostasis, pyretolysis, anti-inflammatory, analgesia, checking emesis and diarrhea is distinguished, it is safe and effective in the treatment of summer hygrosis cold. |
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