7 results about "Nicergoline" patented technology

The invention provides a method for detecting trace dimethyl sulfate in nicergoline, which comprises the following steps of: carrying out derivatization reaction on an azacyclo-compound serving as a derivatization agent and dimethyl sulfate in nicergoline to generate a derivatization product, and determining the amount of the derivatization product by using a high performance liquid chromatograph-mass spectrometer, therefore, the content of dimethyl sulfate in nicergoline is obtained. Compared with the prior art, the detection method provided by the invention has the characteristics of good specificity, high sensitivity, good reproducibility and the like, and makes up the vacancy of how to detect trace dimethyl sulfate in nicergoline in the prior art.

The invention discloses an HPLC (High Performance Liquid Chromatography) analysis method for an impurity I in nicergoline tablets. The HPLC analysis method comprises the following steps: 1) preparing a diluent, a test solution, a reference solution and a blank auxiliary solution; (2) testing by using chromatography, wherein a mobile phase is a buffer solution (1 ml of triethylamine, 1000 ml of water, uniformly mixing, and adjusting the pH value to 2.4 by using phosphoric acid)-acetonitrile (70: 30); the column temperature is 30 DEG C, the flow rate is 1.0 ml / min, the detection wavelength is 228 nm, the sample injection volume is 10 [mu] l, and the operation time is 35 min. According to the method, the impurity I in the nicergoline tablet can be independently analyzed, the detection problem of the impurity I in the nicergoline tablet production process is solved, the content of the impurity I in the nicergoline tablet is accurately detected, a producer can compare with the quality of an original research medicine in the consistency evaluation process, and the quality of the product is improved. The method is of great significance in improving the product quality of tablets and improving the medication safety of patients.

The present application relates to a sublingual tablet of nicergoline and a preparation method thereof, the sublingual tablet of nicergoline comprising nicergoline and pharmaceutically acceptable excipients; the pharmaceutically acceptable excipients comprise organic acid, diluent, disintegrant and lubricant. In the sublingual tablet of nicergoline, the organic acid as a cosolvent and the combination with nicergoline can increase the cumulative dissolution rate and dissolution rate of nicergoline, and improve the bioavailability and pharmacodynamic persistence of nicergoline. At the same time, the sublingual tablet of nicergoline can avoid liver first-pass effect, and has the advantages of convenient use and no need of water for administration.

The utility model discloses a dissolving device for purifying nicergoline impurity E. The dissolving device relates to the technical field of pharmaceutical instruments and comprises a base, a pressure spring, a workbench and a vibration motor, the workbench comprises a bottom plate, a top plate and a vertical supporting plate. An electrically-driven heating sheet is arranged in the round hole of the top plate, and the outer edge of the heating sheet is fixedly connected with the top plate; the top plate is provided with an inserting hole, and a holding arm is rotationally connected into the inserting hole. And the top end of the holding arm can press and limit a rotary bottle with a spherical middle lower part and arranged in the heating sheet. According to the utility model, the heating sheet is of the hemispherical shell-shaped structure, so that the heating sheet is used for accommodating the spherical part at the middle lower part of the rotary bottle, and the outer wall of the bottom of the rotary bottle can be matched and attached with the inner wall of the heating sheet, so that the rotary bottle is stably placed and is prevented from toppling over; the embracing arms can rotate so as to realize buckling and opening; in the buckling state, the attaching part tightly presses the rotary bottle, so that the rotary bottle is prevented from bouncing out of the heating piece when the workbench vibrates, and the stability of the rotary bottle is improved.

Provided are a nicergoline sublingual tablet and a preparation method therefor. The nicergoline sublingual tablet comprises nicergoline and a pharmaceutically acceptable auxiliary material; the pharmaceutically acceptable auxiliary material comprises an organic acid, a diluent, a disintegrant and a lubricant. In the nicergoline sublingual tablet, the organic acid is used as a co-solvent, and the compounding of same with nicergoline can increase the cumulative dissolution rate and dissolution speed of nicergoline, thereby improving the bioavailability and efficacy durability of nicergoline. The nicergoline sublingual tablet can avoid the hepatic first-pass effect, and has the advantages of convenient use and no need to be taken with water.

The invention discloses a method for detecting nicergoline related substances. The method comprises the following steps: preparing a test solution; preparing a contrast solution; and respectively injecting the test solution and the contrast solution into a high performance liquid chromatograph, and simultaneously detecting various related substances of nicergoline under the same chromatographic condition by using a mixed-mode chromatographic column through a gradient elution procedure. By adopting the strong cation exchange and reversed-phase C18 mixed filler chromatographic column and combining with an optimized ion pair reagent buffer system and a gradient elution procedure, all key impurities in nicergoline can be detected at one time by adopting a set of liquid chromatography system, so that the detection efficiency is improved by about 50%, the operation process is greatly simplified, and the detection cost is reduced. Solvent consumption and personal errors are reduced; the separation degree of each impurity peak and the main peak is greater than 2.0, the peak shape is symmetrical, the system adaptability is good, the method reproducibility is excellent, and a more efficient, comprehensive and reliable analysis means is provided for the quality control of nicergoline.

The invention discloses a nicergoline intermediate and a preparation method of nicergoline, and in the preparation process, 1-methyl ergoline and methanol are subjected to a photoreaction in the presence of sulfuric acid and mercaptan at the same time to generate the nicergoline intermediate, namely 1-methyl-10alpha-methoxyl light ergoline; according to the method, the mercaptan is added in the photoreaction process, so that the reaction time is greatly shortened, the kilogram power consumption of the photoreaction is reduced, and meanwhile, the mercaptan is low in price, so that the production cost is reduced on the whole; and the original photochemical reaction equipment does not need to be changed, so that the productivity is greatly improved. In addition, the yield is ideal on the premise of high purity, and the method can be suitable for industrial preparation of nicergoline.