14 results about "Reference preparation" patented technology

The application discloses a method for detecting the dissolution curve of ezetimibe and rosuvastatin calcium tablets, and belongs to the technical field of drug detection. The method uses an aqueous solution containing 0.1-0.3 wt% polysorbate 80 as a dissolution medium, and performs dissolution according to a dissolution instrument basket method, wherein the rotating speed of the rotating basket is 50-100 revolutions per minute, and the mesh number of the rotating basket is 10 meshes. The method provided by the application has good dissolution for both ezetimibe and rosuvastatin calcium, and has the characteristics of strong specificity, high sensitivity, high accuracy, good durability and the like, can effectively distinguish the difference between self-prepared preparations and reference preparations, and is more universal and practical, and is more simple and efficient in operation.

The present application relates to the field of pharmaceutical excipient detection, in particular to a method for quantitatively detecting calcium stearate and magnesium stearate in preparations by ion chromatography. The present application draws the standard curves of calcium / magnesium ions and excipients calcium stearate / magnesium stearate respectively, obtains the slope ratio of the two, obtains the conversion coefficient of the content of calcium / magnesium ions in calcium stearate / magnesium stearate, so as to accurately detect the content of calcium stearate or magnesium stearate in preparations. The detection method has high sensitivity, strong specificity, high precision, strong accuracy, simple and fast operation, wide applicability, low detection cost, realizes the quantitative detection of common excipients calcium stearate / magnesium stearate in preparations, thereby effectively guiding the self-prepared preparations to be consistent with the reference preparation prescription.

The invention relates to a furosemide tablet and a preparation method thereof.The furosemide tablet is prepared from, by weight, 25.00% of furosemide, 40%-45% of filler, 27%-33% of adhesive, 0.5%-1.5% of lubricant, 1.0%-2.0% of anti-sticking agent and 0.5%-1.5% of flow agent.The furosemide tablet is prepared by adopting the technology that purified water is directly added without preparing the adhesive; a wet granulation process is adopted, the controllability of process parameters in the production process is high, the human influence of operation of multiple process steps is reduced, the quality stability of the medicine is effectively improved, the quality of the medicine is equivalent to that of a commercially available reference preparation, and multiple dissolution curves are similar to that of the reference preparation; the in-vitro dissolution behavior similar to that of a reference preparation is shown, the quality is stable, and the dissolution behaviors among batches are consistent.

The application provides a pharmaceutical composition of finerenone and a preparation method and use thereof. The pharmaceutical composition of the application has good dissolution in various media, and has good uniformity, tolerance and particle size after being prepared into a preparation, and is consistent with the in-vitro release effect of a reference preparation.

The invention belongs to the technical field of pharmaceutical preparations, and particularly relates to a citrus flavone tablet and a preparation method thereof. Tablet cores of the citrus flavone tablets comprise 450-550 parts by weight of citrus flavone, 50-74 parts by weight of microcrystalline cellulose, 20-34 parts by weight of carboxymethyl starch sodium, 20-40 parts by weight of gelatin, 4-8 parts by weight of talcum powder and 2-6 parts by weight of magnesium stearate, the citrus flavone tablets are prepared through a one-step granulation process, a wetting process is specially added before one-step granulation, adhesion of raw material medicines in the initial stage of granulation is avoided, and the content of the raw material medicines is increased. Meanwhile, low content caused by loss of raw material medicines due to single use of a one-step granulation process is avoided. According to the present invention, the particles similar to the reference preparation are obtained by using the specific components, the specific wet granulation wetting and the one-step granulation process, the in vitro dissolution of the obtained citrus flavone tablet is similar to the reference preparation, the disintegrated particles are similar to the reference preparation, and the treatment effect is further ensured.

The present application belongs to the field of polymer detection, and particularly relates to a method for determining the content of carbomer in a preparation by high performance liquid chromatography-evaporative light scattering, comprising the steps of chromatographic conditions, drawing a standard curve of the logarithm of the carbomer concentration versus the logarithm of the peak area, preparing a blank sample solution, preparing and detecting a test sample solution, and the like. The present method utilizes the linear relationship between the logarithm of the concentration of carbomer in an evaporative light scattering detector and the logarithm of the response value, and through a certain sample pretreatment method, the carbomer is quantitatively dissolved and uniformly dispersed in a solvent, and then enters the HPLC-ELSD chromatographic system, so as to achieve the purpose of quantitative detection. The detection method realizes the quantitative detection of the commonly used auxiliary material carbomer in an external semi-solid preparation, thereby effectively guiding the self-made preparation to be consistent with the prescription of the reference preparation.

The application discloses a kind of sodium zirconium cyclosilicate A crystal form and preparation method thereof, it is related to pharmaceutical technical field.The X-ray powder diffraction pattern of the crystal form has characteristic diffraction peaks at 2θ angle 10.63±0.2°, 12.24±0.2°, 13.89±0.2°, 14.62±0.2°, 15.24±0.2°, 15.55±0.2°, 17.86±0.2°, 21.48±0.2°, 21.93±0.2°, 25.55±0.2°, 26.18±0.2°, 28.88±0.2°, 29.52±0.2°, 30.19±0.2°, 36.19±0.2°.The sodium zirconium cyclosilicate A crystal form of the application has similar physicochemical properties with reference preparation (ZS-9 crystal form), and the preparation method does not require special process conditions such as high temperature and high pressure, does not require special reaction equipment, is low in cost and easy to scale up.

The invention discloses a dienogest-containing oral solid preparation and a preparation method thereof, the dienogest-containing oral solid preparation is prepared from dienogest and pharmaceutically acceptable auxiliary materials, and the particle size D50 of a dienogest bulk drug is controlled to be 200-300nm. Surprisingly, it is found that the dissolution rate of the dienogest can be increased by controlling the particle size of the dienogest raw material medicine to be 200-300 nm, meanwhile, the in-vivo bioavailability (BE) condition of the prepared dienogest oral solid preparation is similar to that of a reference preparation, and in-vivo bioequivalence of the prepared dienogest oral solid preparation and the reference preparation is achieved.

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 invention relates to an empagliflozin pharmaceutical composition and a preparation method thereof. According to the invention, through the specific proportion of the filling agent and the particle size of the raw material medicines, and the direct tabletting process, the commercial complex process is avoided, the reproducibility and stability of the product process are ensured under the condition of safe and efficient production, the quality meets the requirement in a long-term stability test, and better stability is achieved; and in an in-vivo bioequivalence test, clinical equivalence with a reference preparation is shown.

The invention relates to the technical field of medicine analysis, in particular to a dissolution medium for detecting the dissolution rate of coenzyme Q10 tablets and a detection method for the dissolution rate of the coenzyme Q10 tablets, the dissolution medium for detecting the dissolution rate of the coenzyme Q10 tablets comprises a surfactant, the surfactant is triton, the concentration of the surfactant is 0.7 wt%-1.0 wt%, and the pH value of the dissolution medium is 5.8-6.8. By controlling the concentration of triton in the dissolution medium and the pH value of the dissolution medium, the dissolution medium has high dissolution rate on the coenzyme Q10 tablet, and particularly, the addition amount of triton is controlled to be 0.7-1.0 wt%, so that the quality evaluation accuracy of the coenzyme Q10 tablet is increased to the maximum extent, and the intrinsic quality of a self-made preparation and the intrinsic quality of a reference preparation can be effectively distinguished.

The application provides a pharmaceutical composition of finerenone and a preparation method and use thereof. The pharmaceutical preparation prepared by the method of the application has good stability and is consistent with the release effect of a reference preparation.

The invention discloses a method for optimizing a dissolution curve and in-vivo bioequivalence of a tablet. The tablet comprises the following components in percentage by mass: 1-5% of amlodipine besylate (based on amlodipine), 55-65% of microcrystalline cellulose, 25-35% of anhydrous calcium hydrogen phosphate, 1-3% of carboxymethyl starch sodium and 0-2% of magnesium stearate. According to the invention, microcrystalline cellulose with an average particle size of 90-140 [mu] m, bulk density of 0.26-0.37 g / cm < 3 > and drying weight loss of not more than 1.5% is selected, and an optimized dissolution detection method is combined, so that dissolution curves of a self-made sample and a reference preparation in a plurality of media are similar, and in-vivo curative effects of the self-made sample and the reference preparation are ensured to be consistent.

The invention provides an olopatadine hydrochloride granule and a preparation method thereof, the olopatadine hydrochloride granule is only composed of 0.4-0.7 part by weight of an olopatadine hydrochloride active pharmaceutical ingredient, 58-61 parts by weight of lactose and 38-41 parts by weight of cane sugar, the raw materials are subjected to wet granulation and drying granulation to obtain the olopatadine hydrochloride granule, and the cane sugar is crushed and sieved by a 80-mesh sieve. And sieving wet granules obtained by granulation through a 18-20-mesh sieve, drying, sieving the granules through a 16-20-mesh sieve, and finishing the granules. The olopatadine hydrochloride granules are simple in component and good in palatability, and can be quickly dissolved out like a reference preparation in different media, the dissolution curve is similar to that of the reference preparation, and the dissolution behavior is the same as that of the reference preparation.