| A systematic study on the preparing technology and quality standard of Langchuang Kangfu Wan (concentrated) had been finished under the guidance of the Traditional Chinese Medicine theory and with the help of the modern pharmaceutical technology.Langchuang Kangfu Wan(concentrated) is a preparation which consists of Huangqi(Radix Astragali), Zhiheshouwu(Radix Polygoni Multiflori Preparata)and other herbs. It possesses the function of calming Heart and strengthening Spleen, nourishing Liver and Kidney, clearing away Heat-toxin, activating Blood circulation and relieving Bi-syndrome. It has a definitive effect on Systemic Lupus Erythematosus & Lupus Nephritis because of disharmony of Heart and Spleen, Yin deficiency of both Liver and Kidney as well as Qi stagnation and Blood stasis.Based on the clinic demand, the dosage form is chosen as condensed pill. According to the action and indication as well as the character of ingredients contained in th-e herbs, the optimum extract conditions about water-extract are selected by using orthogonal design which use quite a few assessing norms to evaluate them omprehensively. The optimum extract conditions are all herbs made by decocted twice for 2 hours each time after adding to 10 portions water. The water-extract is separated by high speed c-entrifugal filter. Then water-extract filtrate is covered under reduced pressure and concentrated to the thick extract with a relative density of 1.35～1.40 (60℃), drying by microwave vacuum in low temperature. At last, some adjuvants are added to the powder to make condensed pill.Meanwhile, the quality standard of the product for clinical trial is draw out, studing the ingredients such as Huangqi(Radix Astragali), Zhiheshouwu(Radix Polygoni Multiflori Preparata), Qinjiao(Radix Gentianae Macrophyllae) and Gancao(Radix Glycytthizae) respectively by using TLC. At the same time, the content of Astragaloside I is determined by means of HPLC-ELSD , accomplishing the systematic methodology.Regarding the stability, the preliminary research lasts for 3 months, indicating that Langchuang Kangfu Wan is stable and the packing is suitable.All the above experiments prove that the preparation process is reasonable and practicable, the standard is controllable, the quality of the sample is steady on the whole as well. |
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