Red yeast rice traditional Chinese medicine water infusion decoction piece
A technology of red yeast rice and traditional Chinese medicine, applied in the field of medicine, can solve the problems of difficult dissolution of active ingredients, complex chemical components, and different quality
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preparation example Construction
[0038] Preparation of reference substance solution Take an appropriate amount of lovastatin reference substance, accurately weigh it, add 75% acetone solution to make a solution containing 0.04mg per 1ml, and use it as lovastatin reference substance solution.
[0039] Preparation of the test solution Take this product, grind it finely, take about 0.78g, accurately weigh it, put it in a stoppered Erlenmeyer flask, add 25ml of 75% acetone solution accurately, weigh it, and make up the lost amount with 75% acetone solution. weight, shake well, filter, and take the filtrate, that is.
[0040] Determination method Precisely draw 5-10μl each of the above-mentioned lovastatin reference solution and the test solution, inject it into the liquid chromatograph, measure it, and obtain it.
[0041] The product is calculated as a dry product, and every 1g contains lovastatin (C 24 h 36 o 5 ), not less than 0.30mg.
[0042] Microbial limit inspection According to the microbial limit stan...
Embodiment 1
[0054] 160 kilograms of red yeast rice were divided into 3 experimental batches (60 kilograms per batch). According to the GMP standard of medicines, impurities were removed, dried, packaged (clean area), and sterilized to make small-package red yeast rice finished products.
[0055] (1) Comparison experiment of water decoction (100°C) and hot water (80-90°C) water immersion:
[0056] The product of the present invention is based on the comparison experiment of water decoction (100°C) and hot water (80-90°C) water immersion of red yeast rice, taking the total amount of lovastatin in the water extract as an index, comparing red yeast rice by electronic There may be differences in the indicators of water decoction and hot water brewing after beam irradiation sterilization.
[0057] Through the above experimental research (see Table 1-2, figure 1 ), the results of the present invention show that the total amount of lovastatin in the hot water (80-90°C) soaked extract of the "red...
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