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Preparation And Quality Of Ganoderma Lucidum Spore Powder Chewable Tablets

Posted on:2014-12-25Degree:MasterType:Thesis
Country:ChinaCandidate:J J WangFull Text:PDF
GTID:2174330482983197Subject:Microbial and Biochemical Pharmacy
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Ganoderma lucidum Spore powder is a powdered solid obtained by grinding the spores of the Ganoderma lucidum. It was first included in the "Shen Nong’s Herbal Classic", and it also can help to support and strengthen the functions of spleen and stomach, tranquilize mind by nourishing the heart, etc. It is used in the adjuvant therapy for patients with heart-spleen deficiency, debility after long illness and tumor. Polysaccharides, triterpenic acids, adenosine are the main components of Ganoderma lucidum, their percentage content is an important criterion for its quality identification. Clinical trial shows that Ganoderma lucidum has an effect on the treatment of multiple incurable diseases, such as neurasthenia, insomnia, chronic hepatitis, bronchitis, asthma, arthritis, gastric ulcer, nephritis and etc. Thus it has a broad market and application prospects. In order to meet the market need and provide the convenience for patients taking, we have developed the Ganoderma lucidum Spore Powder Chewable Tablet and studied its prescription, production process, quality control and stability.Ganoderma lucidum Spore Powder Chewable Tablets’ prescription and production process:Comparing with different prescriptions, take certain amount of calcium hydrogen phosphate and sucrose, thoroughly mix them with the primary drug, sift, add an appropriate amount of 40% syrup evenly mix until soft, sift again, granulate, pelletize after drying, and then blend with certain amount of magnesium stearate, test the content and tabletting, By taking an influence factor inspection tests of the prescription (illumination tests and high temperature tests), the production process of Ganoderma lucidum Spore Powder Chewable Tablets is optimized, it is easy to operate, mature and stable.Ganoderma lucidum Spore Powder Chewable Tablets’ quality controls: According to the Chinese Pharmacopeia (2010 edition), we did some quality studies on this product including content limitation, physical and chemical characteristics, content identification test, weight difference examination, high performance liquid chromatography (HPLC) method and UV spectrophotometry, The study method is quick, easy, and fit for relevant standards.Ganoderma lucidum Spore Powder Chewable Tablets’ stability study:According to the relevant requirements of the appendix in two parts of Chinese Pharmacopeia (2010 edition). We did some stability test on this product, The results show that removing the outer packing, this product has no significant changes in the conditions of strong light and high temperature, The simulation listed packing sample of this product has been observed by being palced under the condition of 40℃±2℃, RH 75% ±5% for 6 months and 25℃±2℃, RH 60%±10% for 9 months, the results shows no significant change in various parameters neither. Reffering to the stability study results, it is recommend storing this product sealed in shade.
Keywords/Search Tags:Ganoderma lucidum Spore Chewable Tablets, production process, prescription, quality control, stability
PDF Full Text Request
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