16 results about "Generic drug" patented technology

The invention belongs to the field of medicines, and relates to a perindopril amlodipine solid preparation as well as a preparation method and application thereof. In the prior art, when an in-vitro dissolution behavior of an imitated medicine of perindopril and amlodipine tablets is investigated, it is found that the release behaviors of the perindopril and amlodipine tablets are difficult to keep consistent with those of an original developed preparation at the same time, so that the safety and effectiveness of the imitated medicine are not guaranteed. A large number of experiments find that the particle size distribution and the water content of the microcrystalline cellulose are controlled, so that the in-vitro dissolution curve of the perindopril amlodipine solid preparation is similar to that of an imported original development agent produced by an original research company, the possibility of bioequivalence with the original development agent is improved, and the drug consistency evaluation requirement is met.

The invention discloses a determination method for a dissolution curve of a citrus flavone tablet, and belongs to the technical field of pharmaceutical analysis. The method comprises the following steps: setting dissolution conditions, and preparing a dissolution medium which is a strong alkali solution with the mass volume ratio of 0.1-0.6% or a strong alkali and weak acid salt solution with the mass volume ratio of 1-2% and a Tween 80 solution with the mass volume ratio of 1-2%; the method comprises the following steps: setting liquid chromatography detection conditions, and adopting a Phenomenex Gemini chromatographic column; preparing a test solution and a reference solution; and finally, detecting the contents of diosmin and hesperidin in each solution according to a liquid chromatography to obtain dissolution rates at different time, and establishing a dissolution curve according to the dissolution rates and the dissolution time. The method has the advantages of scientificity, durability and reproducibility, the measured dissolution curve has distinguishing power, the in-vitro release behavior of the dissolution curve can be evaluated, guarantee is provided for quality consistency between batches of drugs, the method can also be used for quality consistency evaluation work of imitated drugs and originally developed preparations, and the medication curative effect is guaranteed.

The present invention discloses a PEGylated asparaginase and its application in drug preparation and clinical treatment. In the PEG-modified asparaginase of the present invention, one molecule of asparaginase is coupled with 13-45 molecules of polyethylene glycol, wherein the polyethylene glycol is a linear polyethylene glycol with an average molecular weight of 2-20 kDa. The asparaginase after PEG modification prepared by the present invention. The PEGylated asparaginase provided by the present invention has the advantages of reducing immunogenicity and significantly extending half-life, and the coupling of polyethylene glycol and asparaginase is more stable. Compared with the original research drug and generic drug products of the PEGylated asparaginase sold on the market, the PEGylated asparaginase provided by the present invention has a more stable structure, a firm PEG bond, is not easy to fall off, and has higher homogeneity and activity.

The present application relates to a drug protein binding rate prediction method; first, the influence of drug protein binding on protein structure change is characterized by two-dimensional near-infrared correlation spectroscopy, and then a quantitative model is established for predicting the drug protein binding rate by using the characteristic spectrum area related to the drug protein binding. The two-dimensional correlation spectroscopy and machine learning are organically combined to establish a prediction model for the drug protein binding rate in the simulated physiological environment from the aspects of structure characterization signal extraction, separation and quantitative analysis; in actual operation, the sample processing method is simple, the time consumption is less, the cost is low, and the technology is suitable for various related scientific research activities, which can not only realize the protein binding rate prediction of one kind of drug (including acid / alkali type, salt type), but also can distinguish the protein binding rate difference of different products of the same drug, and has important significance for drug in vitro evaluation, generic drug consistency evaluation, pharmacodynamics research and the like.

The utility model discloses a medicine dissolving device for imitated medicine analysis, and relates to the technical field of medicine dissolving, in particular to the medicine dissolving device for imitated medicine analysis, which comprises a barrel body and a processing mechanism arranged behind the barrel body and used for fixing the barrel body, the vertical frame is arranged behind the barrel body, the base is fixed at the bottom of the vertical frame, and the shaft brackets are fixed on two sides of the top of the base; the side frame is rotationally installed at the upper end of a shaft frame through a shaft rod, the guide frame is fixed to the rear end of the shaft rod, and the guide groove is formed in the guide frame. The movable frame is arranged on the vertical frame, the driving frames are fixed to the two sides of the bottom of the movable frame, and the rolling wheels are rotationally installed on the rear surfaces of the lower ends of the driving frames and located in the guide grooves; the stirring paddle can be controlled to enter or be separated from the barrel body through lifting of the movable frame, and the execution assembly is controlled to fix or unfix the barrel body.

The present application relates to the technical field of pet medicine, in particular to a dissolution method of a pharmaceutical composition containing flucloronide and application thereof. The dissolution method is as follows: when the temperature of the dissolution medium is 37 DEG C + / - 0.5 DEG C, the pharmaceutical composition containing flucloronide is added, stirring is started at a speed of 80 revolutions / minute-150 revolutions / minute and timing, sampling is carried out in 1 hour-24 hours, and the dissolution medium includes 0.1-0.5 mol / L strong base and 2% w / v-4% w / v SDS. The dissolution method can be used to evaluate the in-vitro dissolution behavior of the pharmaceutical composition containing flucloronide, investigate the influence of different prescription compositions, different preparation processes and differences of raw and auxiliary materials on in-vitro dissolution, evaluate the consistency of batch quality, guide the development of generic drugs and accelerate the research and development progress of generic drugs.

The invention discloses a method for detecting glucosamine sulfate by using a liquid chromatography-mass spectrometry technology. The method comprises the following steps: adopting an octadecyl silane bonded silica gel column as a chromatographic column; an acidic aqueous solution is used as a mobile phase A; and carrying out gradient elution by using an organic solution as a mobile phase B. The detection method has the advantages of high sensitivity, strong specificity, high precision, strong accuracy and simple and rapid operation, and can greatly shorten the experiment time and realize rapid detection of the dissolution curves of the glucosamine sulfate capsule imitation medicine and the reference preparation.

The invention relates to an empagliflozin tablet and a preparation method thereof. The empagliflozin tablet comprises an empagliflozin tablet and a coating layer, the coating layer contains any one or a combination of at least two pigments selected from amaranth, sunset yellow, lemon yellow, new red, allura red or carmine. The pigment is used for replacing titanium dioxide and / or iron oxide yellow in the gastric-soluble film coating of the empagliflozin tablet, so that the safety and the quality of the gastric-soluble film coating are improved. The empagliflozin tablet prepared by the method has a relatively good dissolution behavior, meets the requirement of consistency of imitated medicines, has excellent stability, and is safer and more reliable.

The invention belongs to the technical field of pharmaceutical preparation analysis and detection, and particularly relates to a determination method of a dissolution curve of diclofenac sodium sustained release tablets. According to the method, a sample dissolution method is optimized, and a reciprocating cylinder method is used for dissolving out the sample, so that the determination method is not influenced by the release speed of the diclofenac sodium sustained release tablet in an acid medium and the degradation degree of the released raw material medicine, the in-vivo release environment of the medicine is better simulated, the accuracy is high, the reliability and the repeatability are good, and the method is suitable for industrial production. The method can be used for judging whether a self-made preparation of a BE test is equivalent to a reference or not, and the method for determining the dissolution curve established by the invention can provide guidance for the process research of a preparation prescription required by the declaration of a generic drug.

The invention relates to a drug protein binding rate prediction method. The method comprises the following steps: firstly, characterizing the influence of the drug protein binding effect on the protein structure change by using a two-dimensional near-infrared correlation spectroscopy, and then establishing a quantitative model by using a characteristic spectrum region related to the drug protein binding effect to predict the drug protein binding rate. A two-dimensional correlation spectrum and machine learning are organically combined, and a prediction model for simulating the drug protein binding rate in the physiological environment is established from three aspects of structural characterization signal extraction, separation and quantitative analysis; in actual operation, the technology is simple in sample treatment method, less in consumed time, lower in cost and suitable for various related scientific research activities, not only can predict the protein binding rate of one type of drugs (including acid / alkali type and salt type), but also can distinguish the difference of the protein binding rates of different products of the same drug, and has a good application prospect. The method is of great significance to in-vitro evaluation of drugs, consistency evaluation of imitated drugs, pharmacodynamic research and the like.

The application belongs to the technical field of pharmaceutical analysis, and particularly discloses a method for determining acid resistance of lansoprazole enteric-coated capsules and application thereof.The method for determining acid resistance of lansoprazole enteric-coated capsules first adopts a reciprocating cylinder method to perform acid dissolution on the content of lansoprazole enteric-coated capsules, and then adopts a high performance liquid chromatography method to determine the residual content of lansoprazole in the content after acid resistance; the acid-dissolved acid-resistant medium is an acetate buffer solution containing an anionic surfactant, and the pH value of the acetate buffer solution is 4.5.The acid resistance determination method has strong in-vitro and in-vivo correlation, and can effectively improve the success rate of in-vitro evaluation of bioequivalence of generic drugs and reference preparations.

The application discloses a bio-drug structure consistency evaluation method and system based on high-field nuclear magnetic resonance, and belongs to the technical field of nuclear magnetic resonance testing materials. Firstly, the high-field nuclear magnetic resonance 2D 1 H- 1 H TOCSY spectrum and 2D 1 H- 1 H NOESY spectrum of a generic drug and an original research drug are collected, signals with differences are marked, data such as chemical shift difference and spatial distance difference are calculated, then new two-dimensional spectrum diagrams are reconstructed and dimension reduction processing is performed; Pearson fitting of one-dimensional signal peaks is further performed; and the chemical shift difference, the spatial distance difference and the Pearson fitting result are used for consistency evaluation of covalent structure and spatial structure of the bio-drug. The application can be calculated with high efficiency and high accuracy through software, can comprehensively evaluate the consistency of the higher structure which has a greater influence on drug activity, and can evaluate the consistency of the overall structure of the generic drug and the original research drug.

The utility model discloses a contrast test tube device for liquid imitation drug analysis, and relates to the technical field of flange processing. Comprising a base, and a mounting frame is fixed to the top of the base; the mounting frame is composed of a plurality of vertical plates and a bottom plate which are distributed at equal intervals, and the upper ends of every two adjacent vertical plates are connected through a connecting block; an inserting groove is formed in the middle of the connecting block, a test tube is inserted into the inserting groove, and a sealing assembly is arranged at the top of the test tube. According to the comparison test tube device for analyzing the liquid imitation medicine, the mounting frame is arranged on the base, and a plurality of vertical plates on the mounting frame are matched with the connecting blocks and the bottom plate to form a plurality of test tube slots, so that the device can load a plurality of different test tubes at the same time for analyzing and comparing the medicine, and meanwhile, a sealing assembly is arranged at the top of each test tube; a connecting plate on the sealing assembly is matched with a sealing gasket to seal a test tube opening, and liquid in the test tube is prevented from making contact with the external environment.

The utility model relates to the technical field of medicine management, in particular to an imitated medicine classification management device which comprises a shell, a base and a waterproof pad, the base is fixedly installed at the lower end of the shell, the waterproof pad is fixedly connected to the lower end of the base, and a sealed structure facilitating medicine taking is arranged at the front end of the shell. One side of the shell is provided with a structure facilitating medicine taking and placing at a high position, and the inner side of the shell is provided with an air exhaust and dehumidification structure. According to the classified management device for the imitation medicine, the sealing frame adopts a plurality of holes formed in the outer side of the shell, the overturning cover can rotate upwards to be opened on the inner side of the sealing frame, the plugging ring is also made of a rubber material, and after the overturning cover and the sealing frame are attached together, the attaching tightness of the plugging ring and the sealing frame can be enhanced; the turnover cover and the shell can be connected by tightening the bolt, so that the flow step of taking the imitation medicine is simpler and saves time, and the working efficiency of the classification management device for the imitation medicine is improved.

The invention belongs to the technical field of pharmaceutical analysis, and particularly relates to a method for detecting the content of povidone K30 in compound alpha-keto acid tablets. According to the detection method disclosed by the invention, the content of povidone K30 in the compound alpha-keto acid tablet is detected by using a high performance liquid chromatography. The detection method comprises the following steps: preparing a test solution; a preparation method of the test solution comprises the following steps: (1) mixing the compound alpha-keto acid tablet with acetonitrile to dissolve povidone K30; performing solid-liquid separation to obtain a stock solution; and (2) diluting the stock solution with water to obtain a test solution. By improving the preparation method of the test solution, the problems of multiple components, high polarity, weak absorption and easy interference of the compound alpha-keto acid tablet are solved, the method is high in specificity and high in accuracy, and supportive data are provided for research on imitation medicine development, consistency evaluation, bioequivalence and the like.

The invention belongs to the technical field of medicines, and particularly relates to a method for determining the dissolution rate of an ibuprofen suspension based on a flow cell and application. According to the method, key parameters are screened, optimal parameters are adopted, and the flow cell determination method for external dissolution of the ibuprofen suspension is provided. The method has good specificity, low detection limit and quantitation limit and high accuracy. The method is applied to determination of in-vitro dissolution conditions of ibuprofen suspension preparations of different production enterprises, and has good distinguishing ability. According to the method, similar dissolution curves of the original research medicine and the generic medicine passing the consistency evaluation are shown, and dissimilar dissolution curves of the generic medicine not passing the consistency evaluation are shown. Compared with a paddle method, the method provided by the invention has better discrimination, provides reference for quality control of the ibuprofen suspension preparation, especially for dissolution rate inspection, is beneficial to smooth development of consistency evaluation work, and provides a basis for effective research of the suspension preparation.