4 results about "Bulk drug" patented technology

The invention provides a method for detecting polymer impurities in a cefadroxil bulk drug or a preparation thereof, which is based on reversed-phase high-performance liquid chromatography. The method comprises the following steps that chromatographic conditions are established, and a polymer impurity positioning control solution is prepared, wherein the chromatographic conditions are as follows, a stationary phase is octadecyl silane bonded silica gel, a mobile phase is 0.02 mol/L monopotassium phosphate solution with the pH value of 4.8-5.2 as a mobile phase A, methanol is taken as a mobile phase B, and gradient elution is performed; the flow rate is 0.9 to 1.1 ml/min; the column temperature is 28-32 DEG C; the detection wavelength is 220nm. According to the method for detecting the polymer impurities in the cefadroxil bulk drug or the preparation of the cefadroxil bulk drug, multiple polymer impurities can be detected at the same time, the separation degree of all the polymer impurities is good, and the method can eliminate interference of small molecule impurities in the cefadroxil bulk drug or the preparation of the cefadroxil bulk drug.

The invention provides a preparation method of rocuronium bromide. The preparation method comprises the following steps: step 1, reacting a raw material compound I with acetyl chloride to obtain a compound II; 2, dropwise adding a hydrochloric acid solution into the compound II obtained in the step 1 to carry out a hydrolysis reaction, performing standing for layering, removing part of an organiclayer, adjusting the pH value of the residual reaction solution to 7-9 by using a sodium carbonate aqueous solution, separating out an organic phase, and treating to obtain a compound III; 3, adding dichloromethane, anhydrous magnesium sulfate and alkaline aluminum oxide into the compound III and allyl bromide, carrying out a quaternization reaction under the nitrogen flow, filtering under the protection of nitrogen after the reaction is completed, concentrating a filtrate to obtain a concentrate, pulping the concentrate by using a dichloromethane-methyl tert-butyl ether-ethyl acetate system,separating out solids, and carrying out freeze drying to obtain a rocuronium bromide pure product. The purity of the prepared bulk drug product is greater than or equal to 99.8% (according to a USP40correction result), the maximum impurity content is less than or equal to 0.1% (according to the USP40 correction result), and the solvent residue sum is less than or equal to 0.5%.

The invention discloses a height increasing traditional Chinese medicine pellet, and belongs to the technical field of traditional Chinese medicine, bulk drugs comprise the following traditional Chinese medicine components: ginseng, American ginseng, dogwood, cornu cervi pantotrichum, schisandra chinensis, eucommia ulmoides, achyranthes bidentata, ophiopogon root, rhizoma drynariae, codonopsis pilosula, astragalus membranaceus, prepared rehmannia root and the like, and pharmaceutic adjuvants comprise starch, lactose and chitosan-benzoic acid-polyaspartic acid cross-linked polymer. According to the height-increasing traditional Chinese medicine pellet disclosed by the invention, active ingredients of the radix achyranthis bidentatae and the human placenta are extracted and then are directly mixed with other crushed active ingredients to prepare the pellet, so that the pellet is convenient to take, children do not generate rejection psychology when taking the pellet, and the problem that the existing traditional Chinese medicine decoction is poor in taste is solved; the height-increasing traditional Chinese medicine pellet adopts medicinal and edible traditional Chinese medicinal materials, contains various nutrient substances, such as protein, amino acid, vitamins and various trace elements, required by height increase of a human body, can provide nutrient substances for the body, promote metabolism of the body, regulate various physiological functions of a physiological system and enhance immunity, and can improve physique after being taken persistently. The body development and the skeleton growth are promoted.