37 results about "Generic drug" patented technology

A method for detecting a generic drug pretended to be an reference listed drug comprises the following steps: step 1, obtaining reference listed drug standard spectral data and to-be-measured sample spectral data; step 2, choosing reference listed drug characteristic peaks and to-be-measured sample characteristic peaks; step three, screening matched characteristic peaks in the to-be-measured sample characteristic peaks conforming to matching conditions, and calculating the number of the matched characteristic peaks; and step four, comparing a difference value between the number of the reference listed drug characteristic peaks and the number of the matched characteristic peaks with a predetermined standard threshold t, when the difference value is less than or equal to t, judging a to-be-measured sample to be a real drug, and when the difference value is greater than t, judging the to-be-measured sample to be a fake drug, wherein t is an arbitrary integer value of 1-10. According to the method provided by the invention, the difference between the generic drug and the reference listed drug can be intuitively and comprehensively displayed, and a drug system with relatively low API content and with the other components in the drug and with relatively large interference on API characteristic peaks also can be effectively detected.

This invention provides methods for determining liposome bioequivalence between a generic drug product and a reference brand-name product. Specific methods for determining bioequivalence between doxorubicin hydrochloric acid (HCl) liposome injection product (Doxil®) and a generic pegylated liposome doxorubicin product are disclosed herein.

The invention discloses irbesartan capsules and a preparation method thereof, and application in consistence evaluation on generic drugs. The preparation method comprises the following steps: uniformly mixing irbesartan, a filler, a disintegrant, a hydrogel matrix material, an acidifier and a surfactant according to a certain ratio, dissolving an adhesive into purified water, spraying into a fluidized bed pelletizing coating machine, carrying out primary pelletizing, drying, uniformly mixing a flow aid and a lubricant, and filling common gelatin capsules with the mixture, thereby obtaining theirbesartan capsules. In the acceleration testing and long-term testing and stability investigation process, properties, dissolution rates, related substances and the like of the irbesartan capsules produced by using the preparation process disclosed by the invention are not remarkably changed, and the irbesartan capsules have effects equivalent to those of a conventional product (the product nameis irbesartan tablet, the trade name is irbesartan, the specification is 0.15g, the producer is Sanofi Winthrop Industrie) on in-vivo organisms.

The invention discloses a PEGylated asparaginase as well as applications thereof to medicament preparation and clinic treatment. One molecule of asparaginase in the asparaginase modified by PEG is coupled to 13-45 molecules of PEG, and the PEG is straight-chain PEG whose average molecular weight is 2-20KDa. The PEGylated asparaginase is modified by PEG. The PEGylated asparaginase has the advantages of reduced immunogenicity, obviously prolonged half life, etc.; PEG and asparaginase are coupled more stable. Compared with branded drugs and generic drugs of commercially available PEGylated asparaginase, the PEGylated asparaginase has the advantages of more stable structure, firm combination of PEG, uneasy falling, higher homogeneity, and higher activity.

The invention relates to the technical field of detection methods for drug quality, in particular to a detection method for the generic drug quality. The method comprises the steps that when two or more fitting parameters of a generic drug are out of a confidence interval of a brand-name drug, the quality of the generic drug is not similar to the quality of the brand-name drug; when three or more fitting parameters of the generic drug are within the confidence interval of the fitting parameters of the brand-name drug, the quality of the generic drug is similar to the quality of the brand-name drug. According to the detection method for the generic drug quality, the accuracy and sensitivity of a quality detection result can be improved, and therefore the quality of the generic drug can be detected; in addition, the detection method for the generic drug quality is applicable to quality detection of different drugs and drugs of different dosage forms, and therefore the application range of the detection method for the generic drug quality is enlarged.

The invention discloses an itopride hydrochloride micro-tablet, a preparation method thereof and application thereof in consistency evaluation of generic drugs. According to the itopride hydrochloridemicro-tablet, the preparation method thereof and the application thereof in the consistency evaluation of the generic drugs, itopride hydrochloride and various ingredients are mixed, pelletized and dried, and then evenly mixed with an extra disintegrant and a lubricant, and the mixture is pressed into the micro-tablet of which the diameter is no more than 3MM. A capsule can be filled with the micro-tablet, multiple dissolution curves of a prepared itopride hydrochloride capsule in vitro are consistent with an original product (product name: itopride hydrochloride tablet; trade name: Weilisu;specification: 0.05g; certificate holding merchant: ABBOTT LABORATORIES (M) SDN. BHD), in the process of accelerated test and long-term test stability investigation, related substances have no significant change, and the micro-tablet has a bioequivalence trend with the original product after the meal.

The invention relates to a method for detecting the dissolution curve of a simvastatin tablet. The method comprises the following steps: (1) preparing a dissolution medium: preparing the dissolution medium at a dissolution temperature of 40 DEG C or less by using Tween-80 as a medium; 2) taking a simvastatin reference substance, and preparing a reference substance solution; (3) preparing a samplesolution by using a dissolvability detection technology; (4) detecting the dissolution quantity by high performance liquid chromatography, wherein the sample introduction temperature of a sample chamber is 4-5 DEG C; (5) repeating step (3) and step (4) twice or more; and (6) evaluating: calculating a similarity factor f2 by using a similarity factor technology, and comparing the similarity betweenthe dissolution curve of a generic preparation and the dissolution curve of a reference preparation by using the similarity factor f2. The method is scientific, durable and reproducible, can be usedfor evaluating the quality consistency evaluation of a generic drug and an original drug, and also can provide a guarantee for the consistency of the inter-batch quality of the drug.

The invention relates to the field of analytical chemistry, in particular to a method for determining a dissolution curve of lanthanum carbonate chewable tablets. An oar method is adopted, wherein a dissolution medium is 0.25 N hydrochloric acid solution, and the rotating speed is 50-75 revolutions per minute. The method for determining the dissolution curve of the lanthanum carbonate chewable tablets has the characteristics of science, durability, reproducibility and the like, the influence of different prescriptions and process variables on the in vitro release of the lanthanum carbonate chewable tablets can be effectively distinguished, the method for determining the dissolution curve of the lanthanum carbonate chewable tablets can be used for quality consistency evaluation of generic drugs and original research drugs, guarantee can be provided for consistency of quality between batches of drugs, the quality of the drugs is further ensured, and consistency of quality and curative effect is achieved.

The invention discloses an itopride hydrochloride tablet, a preparation method of the tablet, and application in consistency evaluation of generic drugs. The raw material medicine of itopride hydrochloride has the characteristics of easily absorbing moisture, becoming sticky in water and crystallization, so that the materials become sticky and has poor granulation. Therefore, wet granulation is not suitable for preparing itopride hydrochloride tablets. In the present invention, itopride hydrochloride and various auxiliary materials are mixed uniformly, and then tablets with a diameter of about7 mm, a thickness of about 3 mm and a weight of about 130 mg, are obtained by directly pressing the above mixture. According to the itopride tablets produced by directly pressing powder, not only thedifficulty of granulation can be solved, but also the production process is simple, and the manufacturing cost is low. The multiple dissolution curves of the tablets in vitro are consistent with thedissolution curves of the original research product, related substances have no obvious change in the process of an accelerated test and long-term test stability investigation, and the tablets are bioequivalent with the original research product after meal.

The invention provides an early-stage information monitoring method and device for generic drugs, electronic equipment and a storage medium. The method comprises the following steps: acquiring customs import and export information, government department public information and medicine information; based on the customs import and export information, the government department public information and the medicine information, obtaining medicine import related information; and pushing information to a user based on the existence state of the drug import related information. According to the method, the device, the electronic equipment and the storage medium provided by the invention, a user can be helped to obtain early-stage enterprise generic drug project approval information, high manpower, capital and time investment is saved, and the enterprises are guided to reasonably approve projects.

The invention relates to the technical field of medicine quality control, in particular to a determination method for a dissolution curve of an ulipristal acetate solid preparation. The method comprises the following steps: by taking a solvent containing Tween 80 as a dissolution medium, detecting the accumulated dissolution rates of an ulipristal acetate solid preparation in the dissolution medium at different dissolution time points by adopting a paddle method in a stirring state, and then drawing a dissolution curve, wherein the volume percentage concentration of the Tween 80 in the dissolution medium is 0.1-2%. According to the method, the surfactant Tween 80 is added into the dissolution medium to evaluate the dissolution curve of the ulipristal acetate tablet, so that the quality of the ulipristal acetate tablet is scientifically and objectively evaluated, the method can be used for evaluating the quality consistency (similarity) of a generic drug and an original drug, and the quality consistency between batches of drugs can be guaranteed.

The invention provides a metronidazole tablet composition with stable quality. A preparation method comprises the following steps: (1) preparation of raw materials and auxiliary materials; (2) mixingto prepare a soft material; (3) granulating; (4) drying; (5) size stabilization; (6) total mixing; and (7) tableting. The metronidazole tablet composition disclosed by the invention is definite in curative effect and stable in quality, and is consistent with reference listed drugs in quality and curative effects, and generic drugs can well replace the reference listed drugs; and the production process is simple, and the process tolerance is good.