79 results about "In vitro dissolution" patented technology

The invention provides a medicine composition containing vinloxacin hydrochloride. The medicine composition comprises a quick-release pellet and a sustained-release pellet. The pharmaceutical composition provided by the invention has the advantages of good stability, capability of simultaneously meeting the specific requirement on in-vitro dissolution of the viloxin hydrochloride, small variety and dosage of auxiliary materials, higher safety and suitability for preparation of a preparation. And the protective layer is sprayed on the outer surface of the sustained-release layer, so that the advantages of weakening the electrostatic interaction of the pellets and preventing the particles from caking in the aging process are further achieved. In addition, the invention also provides a preparation method of the pharmaceutical composition, and the method has the advantages of high drug application rate, less fine powder, no filter bag and spray gun head blockage phenomenon, and suitableness for industrial production and application.

The invention relates to the technical field of pharmaceutical preparations, in particular to a brexpiprazole tablet and a preparation method thereof. The invention provides a brexpiprazole tablet. The brexpiprazole tablet comprises a tablet core and a coating layer, the tablet core is prepared from the following components in parts by weight: 0.25 to 10 parts of brexpiprazole, 20 to 90 parts of a filling agent, 0.5 to 10 parts of an adhesive, 5 to 20 parts of a disintegrating agent and 0.1 to 3 parts of a lubricating agent; wherein the particle size D90 of the brexpiprazole raw material is 20-51 [mu] m, the particle size D50 is 5-20 [mu] m, and the particle size D10 is less than 5 [mu] m; by controlling the particle size distribution of the brexpiprazole raw material, on one hand, the dissolution performance of the tablet is ensured, the consistency of in-vitro dissolution and a reference preparation is high, and when the brexpiprazole is prepared into the tablet, the brexpiprazole can be uniformly mixed even in a prescription with a small proportion; and on the other hand, the particle size range of the brexpiprazole raw material is wide, so that the step of further crushing the brexpiprazole with large particle size can be omitted.

The invention discloses a metformin empagliflozin tablet composition and a preparation method thereof. The metformin empagliflozin tablet composition is prepared from the following raw materials: metformin hydrochloride, empagliflozin, corn starch, copovidone, colloidal silicon dioxide, magnesium stearate and a gastric-soluble film coating premix. According to the metformin empagliflozin composition and the preparation method thereof, empagliflozin is dispersed in part of auxiliary materials, then mixing granulation is carried out through a wet granulator, empagliflozin and part of the auxiliary materials are premixed, and the particle size range of a metformin hydrochloride raw material is controlled, so that the problems of poor empagliflozin content uniformity and large inter-batch dissolution difference of the metformin empagliflozin composition prepared by a traditional process are solved; by controlling the mesh number of the wet granulation screen, the problems that materials adhere to the screen, discharging is difficult, and production efficiency is low in the wet granulation process are solved; compared with a fluidized bed production process, the equipment cost is low, the operation is simpler, and the production efficiency is higher; the pharmaceutical composition prepared by the preparation method disclosed by the invention is uniform in component mixing, simple to prepare, controllable in quality and consistent in in-vitro dissolution with an original preparation.

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 application provides a high-drug-loading porous breviscapine crystal and a preparation method thereof. The crystal is prepared by a solvent diffusion method, does not contain auxiliary materials, and has high drug purity. The crystal is a highly porous, spherical, round, particle-size-controllable, large-particle-size crystal particle, and is easy to implement in an industrial scale. The process is green, and the crystal is crystallized in an aqueous solution. The solvents used can be recycled and reused. The porous breviscapine crystal prepared by the application has rapid in-vitro dissolution, improved flowability and compressibility, and is beneficial to further preparation molding.

The invention discloses an in-vitro dissolution method of a posaconazole enteric-coated tablet, which is characterized in that a Tween-80 (TWEEN-80) surfactant is added into a dissolution medium, so that the solubility of the posaconazole enteric-coated tablet in a phosphate buffer solution is remarkably improved, the phenomenon that a solution in a dissolution cup is not uniform is solved, the jump point phenomenon of a dissolution curve is eliminated, and the dissolution rate of the posaconazole enteric-coated tablet is improved. When a phosphate buffer solution added with a certain amount of surfactant is used as a dissolution medium, the accumulated dissolution amount at each time point is stable, the dissolution curve is smooth, the detection result is accurate and reliable, the repeatability and predictability of the dissolution test are remarkably improved, and a more reliable detection method is provided for the initial stage of drug research and development and quality control.

The present invention relates to a stable pharmaceutical composition comprising amorphous form of dapagliflozin base presenting proper in vivo and in vitro dissolution profiles.

This invention belongs to the field of pharmaceutical formulation technology and discloses a baloxavir derivative tablet, its preparation method, and its application. The tablet comprises a surface-acidified passivated magnesium aluminum silicate carrier, baloxavir ester, poloxamer 188, microcrystalline cellulose, and magnesium stearate. During preparation, anhydrous citric acid is used to neutralize the basic active sites of pure magnesium aluminum silicate to construct micro-acidic channels. Subsequently, the carrier, baloxavir ester, and poloxamer 188 are mixed and heated, causing the polymer to melt, encapsulate the drug, and penetrate into the mesopores of the carrier. Finally, forced quenching treatment is performed to confine the drug in an amorphous or nanocrystalline state within the channels. This invention blocks the alkaline-catalyzed degradation pathway of baloxavir ester, maintains the high free energy state of the drug through physical spatial confinement, improves the in vitro dissolution rate, and enhances the flowability of the compressed powder.

The invention provides a method for preparing febuxostat tablets by dry granulation and tabletting, which not only avoids the adverse effects of moisture and high temperature on product quality in the traditional granulation and drying process, but also solves the problem of poor content uniformity caused by the adoption of a powder direct compression process due to poor powder flowability. The quality of the product is effectively ensured, the in-vitro dissolution is consistent with the reference, and the clinical bioequivalence test result is equivalent to the in-vivo bioequivalence test result.

The utility model discloses an automatic blending system for a dissolution medium. The device comprises a solvent transport vehicle, and a pH regulator bottle is arranged at the top of the solvent transport vehicle; the solvent barrel is arranged in the solvent transport vehicle, the solvent barrel is communicated with the pH regulator bottle, a water inlet is formed in the upper part of the solvent barrel, a water outlet is formed in the lower part of the solvent barrel, a stirring motor is arranged at the top of the solvent barrel, a stirring paddle is arranged at the bottom of the stirring motor, and the stirring paddle extends downwards into the solvent barrel; the heating and degassing device is arranged in the solvent transport vehicle, the heating and degassing device comprises a direct-current pump, a heating wire and a ventilation membrane, the solvent barrel is sequentially communicated with the direct-current pump, the heating wire and the ventilation membrane through a pipeline, and a flow meter is arranged on the pipeline. According to the utility model, the pH regulator bottle and the stirring paddle are arranged to carry out pH regulation on the mother liquor, and cyclic heating and degassing treatment are completed through the heating and degassing device, so that a preset temperature and an ideal degassing state are achieved.

A lacosamide pharmaceutical composition as well as a preparation method and application thereof are provided. According to the lacosamide pharmaceutical composition, lacosamide or a pharmaceutically acceptable salt thereof can be dissolved out at the same time, wherein the dissolution rate of the lacosamide pharmaceutical composition is not more than 40% within 1 hour, the dissolution rate of the lacosamide pharmaceutical composition is 20-70% within 6 hours, and the dissolution rate of the lacosamide pharmaceutical composition is not less than 65% within 24 hours. The lacosamide pharmaceutical composition has good slow release performance, the tablet size can be rapidly expanded in the in-vitro dissolution process, the expanded lacosamide pharmaceutical composition has good rigidity and elasticity and has a remarkable retention effect in the stomach, and the cumulative release rate within 24 hours can reach 80% or above.

The invention discloses human body simulation fasting gastric juice and a preparation method thereof, and belongs to the technical field of in-vitro dissolution experiments of pharmaceutical preparations. The invention aims to solve the problems that in the prior art, simulated gastric juice has significant differences with real empty gastric juice of a human body in the aspects of surface tension, osmotic pressure and buffer capacity, so that an in-vitro evaluation result of a dissolution behavior of a pharmaceutical preparation is inaccurate, and scientificity and reliability of an in-vitro dissolution experiment of a drug are influenced. The human body simulated fasting gastric juice comprises the following components: 2 to 30 mg / mL of bovine serum albumin, 0 to 7.517 E-05 mol / L of glycocholic acid or glycocholate, 0 to 7.421 E-05 mol / L of glycochenodeoxycholic acid or glycochenodeoxycholate, 0 to 8.369 E-04 mol / L of taurocholic acid or taurocholate, 0 to 9.005 E-04 mol / L of taurochenodeoxycholic acid or taurochenodeoxycholate, 0.025 to 0.138 g / L of calcium chloride, 0.478 to 1.12 g / L of potassium chloride, 0.015 to 0.063 g / L of magnesium chloride, 2.05 to 5.26 g / L of sodium chloride, 0.037 to 0.411 g / L of sodium dihydrogen phosphate and a pH regulator. The method can be used for evaluating the dissolution behavior of the pharmaceutical preparation in vitro, and is suitable for the fields of drug development, quality control and the like.

The invention belongs to the field of medicine product manufacturing, relates to manufacturing and quality control of inhalation preparation medicine products, and provides a drug delivery particle collecting device used in inhalation preparation in-vitro research and evaluation. By optimizing the structure of the device, the provided drug delivery particle collecting device is not only suitable for collecting and measuring the traditional delivery dosage, but also especially suitable for applying the delivered drug particles to in-vitro dissolution evaluation; the medicine particles collected by the device provided by the invention can still keep extremely high dissolution curve similarity under different medicine deposition amounts (the similarity factor f2 of the optimal device can reach 90.6). On the basis, the influence of the medicine deposition amount on the dissolution rate can be avoided, and the product quality of the inhaled preparation medicine can be evaluated more objectively, so that the product research and development and quality control of the inhaled preparation new medicine or the imitated medicine can be smoothly promoted.

The invention discloses a combined package of an estradiol tablet and an estradiol didrogesterone tablet and a preparation method of the combined package. The package is composed of an estradiol tablet and an estradiol didrogesterone tablet. The combined package of the estradiol tablets and the estradiol digestrol tablets comprises the estradiol tablets and the estradiol digestrol tablets which are equal in tablet number, each of the estradiol tablets and the estradiol digestrol tablets comprises a tablet core and a coating layer, the tablet cores are prepared by a high-speed shearing granulation and tabletting process, and the prepared tablets are consistent with an originally developed agent Femoston in in-vitro release behavior, and have the advantages that the estradiol tablets and the estradiol digestrol tablets are combined, so that the estradiol and the estradiol digestrol tablets can be used for preparing the estradiol digestrol tablets; and in-vivo bioequivalence can be achieved. The high-speed shearing granulation mode is used for improving the particle mixing uniformity, so that the medicine content is more uniform, the in-vitro dissolution is stable, and the inter-batch difference is reduced. According to the invention, estradiol with a particle size of less than 20 [mu] m and didrogesterone with a particle size of less than 30 [mu] m are selected, high-speed shearing granulation is carried out by using a high stirring frequency, a special water adding device with a specific opening angle is selected, and the water adding amount, the water adding time and the stirring frequency are controlled at the same time, so that the tablets with rapid dissolution, uniform content and stable quality can be obtained.

1. The name of the product of this design: Dissolution Apparatus (14 cups). 2. Purpose of the product of this design: automatic drug dissolution instrument, in vitro dissolution test device. 3. The design key point of this appearance design product lies in the combination of shape and pattern. 4. The picture or photo that best illustrates the design points: three-dimensional picture.

The present invention relates to an oral solid dosage form comprising ticagrelor as pharmaceutically active ingredient and at least one excipient. In particular, the present invention relates to a process for producing an immediate release ticagrelor tablet composition which is wet granulated with croscarmellose sodium or sodium starch glycolate as a disintegrant in order to produce stable in vitro dissolution profile throughout the shelf-life.

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 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 provides a method for measuring the in-vitro dissolution rate of an acetaminophen and ibuprofen suspension medicine, belongs to the technical field of medicine analysis, and solves the problems that the in-batch difference of experimental results measured by a conventional dissolution instrument is large, and the single-point dissolution rate difference is large. By adopting a closed-loop flow cell mode, the in-vivo dissolution environment of the medicine can be more accurately simulated, the dissolution rate is effectively controlled, the in-batch difference is reduced, and the accuracy and the stability of dissolution rate measurement are improved. Through multi-step filtration and dilution treatment, the purity and accuracy of a dissolution solution sample are ensured, and the dissolution rate is accurately measured by using a high performance liquid chromatography (HPLC) technology, so that more reliable in-vitro dissolution rate data are obtained.

The application discloses a nanometer preparation of bufonin for treating colon cancer, which has a core-shell structure, wherein the inner core is a nanocrystal composed of bufonin and a stabilizer, and the outer shell is a pH-responsive material and a pore-forming agent; the nanometer preparation of bufonin for treating colon cancer is prepared by using the stabilizer, the bufonin and the pH-responsive material; the in-vitro dissolution characteristics of the poorly soluble drug bufonin are improved by nanometerization treatment, and the dissolution characteristics are obviously improved compared with the raw drug; the pH responsiveness of the Eudragit L-100 protects the bufadienolides in the bufonin from being destroyed by the strong acidic condition of gastric juice, thereby improving the stability and effectiveness of the drug, reducing the initial release of bufalin, cinobufagin and resibufogenin in the stomach, making the drug target the intestinal site, making the three kinds of bufonin components achieve effective and rapid synergistic release in the intestinal site, increasing the utilization rate of the drug in the intestinal tract, and being beneficial to the treatment of colon cancer.

The invention discloses a dapagliflozin-propylene glycol monohydrate pharmaceutical composition and a preparation method thereof, and relates to the technical field of medicine preparation, the pharmaceutical composition is composed of dapagliflozin-propylene glycol monohydrate, microcrystalline cellulose, lactose anhydrous, polyvinylpolypyrrolidone, silica, magnesium stearate and a coating agent; in the preparation process, firstly, the raw material medicines are sieved by a 120-mesh sieve, so that the in-vitro dissolution capacity is fully improved, and then granulation and coating are performed; the dapagliflozin propylene glycol monohydrate has the advantages that the coating rate of the prepared dapagliflozin propylene glycol monohydrate is high and reaches 95% or above through the unique ingredient proportion of the auxiliary materials and the coating agent, the disintegration time is short under various pH medium conditions, the dapagliflozin propylene glycol monohydrate can be completely disintegrated within 30 seconds, and the dissolution rate in 15 minutes reaches 85% or above. The sample content is uniform and reaches 100%; the prepared dapagliflozin and propylene glycol monohydrate composition has better stability under the conditions of high temperature, high humidity and illumination, and meanwhile, the tablet surface is smooth, so that the compliance of a patient can be improved.

The invention belongs to the technical field of medicines, and particularly relates to an icaritin tablet and a preparation method thereof. According to the tablet prescription, the problem of in-vitro dissolution of an indissolvable drug icaritin is solved, and compared with commercially available icaritin soft capsules, the tablet has greater advantages in manufacturing cost and production efficiency compared with a soft capsule dosage form. The tablet process is easy to implement and suitable for industrial production.

The invention discloses a determination method of a dissolution curve of a fenerenone tablet, a similarity evaluation method and application thereof, the dissolution rates of the fenerenone tablet at different time points are determined by adopting a closed-loop or open-loop system of a flow cell under different conditions, the dissolution curve is drawn, and then the similarity of the dissolution curve is evaluated through a similarity factor f2. According to the invention, a loading mode of the fenerenone tablet is constructed, so that the fenerenone tablet can be uniformly released, efficient dissolution can be favorably maintained, and the dissolution behavior of a medicine in a body can be better simulated. The dissolution curve of the fenerenone tablet measured through the flow cell method is high in distinguishing capacity, the difference between the imitated preparation and the reference preparation can be effectively distinguished, and consistency evaluation on the imitated preparation and the reference preparation is achieved.

The application relates to the technical field of pharmaceutical preparations, in particular to a loratadine immediate-release tablet based on a co-micronization technology and a preparation method thereof; a pharmaceutical composition comprises a co-micronization compound, the co-micronization compound comprises loratadine and a co-micronization carrier; the application discloses a loratadine immediate-release tablet based on a co-micronization technology and a preparation method thereof, the dissolution rate and stability of the loratadine are improved by adopting the co-micronization technology and a new type of excipient combination; meanwhile, the prepared loratadine immediate-release tablet also has good in-vitro dissolution performance; the loratadine immediate-release tablet prepared by the application reduces impurity growth in the production and storage processes and obviously improves the stability of the drug; the loratadine immediate-release tablet disclosed by the application does not contain lactose in the prescription, so that the side reaction of lactose intolerance can be effectively avoided.

The invention belongs to the technical field of pharmaceutical preparations, and particularly relates to a bepiridic acid quick-release preparation and a preparation method thereof. Compared with the prior art, the preparation method strictly controls the particle size of the bepiridic acid, greatly reduces the types of used auxiliary materials, does not need to add an organic solvent in the preparation process, and is safe and pollution-free; the preparation process belongs to a continuous process and has fewer process steps, so that the production time is shortened, continuous operation is realized, and the production cost is reduced; according to the present invention, with the preparation method, the particles can be uniformly dispersed, the extrudate content uniformity is good, the good in vitro dissolution uniformity is provided, the compressibility of the effective component is not required, the medication safety of the patient is substantially improved, the dissolution rate is improved, and the high bioavailability is provided.

The application belongs to the technical field of veterinary drug preparation, and particularly relates to a water-soluble florfenicol powder and a preparation method thereof. The water-soluble florfenicol powder is prepared from the following components by weight: florfenicol 20-25 parts, folium isatidis flavones 3-8 parts, a composite dispersion carrier 30-35 parts, hydroxypropyl-beta-cyclodextrin 10-15 parts, a surfactant 6-8 parts, and lactitol 3-5 parts. The water-soluble florfenicol powder prepared by adopting florfenicol and folium isatidis flavones as the effective components and cooperating with specific excipients has high in-vitro dissolution rate, can effectively improve the bioavailability and treatment effect, and has excellent storage stability, and can maintain the drug efficacy and chemical integrity even under long-time storage or specific conditions, and is not prone to degradation or deterioration.

This invention belongs to the fields of biomedicine, beauty, and personal care health technology, and specifically relates to an amorphous assembly of capryloylglycine and tranexamic acid, its preparation method, and its application. The method involves adding capryloylglycine and tranexamic acid to an alcoholic solution, rotary evaporating, and drying to obtain a co-amorphous compound; mixing a cyclodextrin compound solution with the co-amorphous compound, heating to react, and drying to obtain the product. This assembly achieves high drug loading, significantly improves apparent solubility and in vitro dissolution rate, and overcomes application bottlenecks without altering the structure and properties of the active ingredients. This invention achieves multi-pathway targeted oil control and whitening through the synergistic encapsulation of capryloylglycine and tranexamic acid, with effects superior to single components. The cyclodextrin inclusion imparts excellent stability to the system, inhibits recrystallization, and provides both solubilization and controlled release effects; the components are safe and mild, with a near-neutral pH and strong formulation compatibility; its preparation process is mild, simple to operate, has high yield, is environmentally friendly, and easily industrialized.

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 invention discloses a dronedarone liposome preparation for injection and a preparation method of the dronedarone liposome preparation, and belongs to the field of preparation of pharmaceutical preparations. The dronedarone liposome preparation for injection comprises an active component and a pharmaceutical adjuvant, the active component is dronedarone or a pharmaceutically acceptable salt thereof; the pharmaceutic adjuvants comprise a phospholipid material, a stabilizer and an emulsifier; the dronedarone liposome preparation comprises the following components in percentage by weight: 10%-30% of an active component, 50%-80% of a phospholipid material, 2%-15% of a stabilizer and 0.5%-5% of an emulsifier, wherein the emulsifier is selected from cholate. The dronedarone lipidosome for injection is prepared by adopting a lipidosome process, the problems of low solubility and slow in-vitro dissolution rate of dronedarone are solved, the prepared dronedarone lipidosome preparation for injection is high in encapsulation efficiency, good in stability and high in bioavailability, the maximum concentration after redissolution can reach 50 mg / ml, and meanwhile, the liver first-pass effect of oral administration is avoided.

The invention provides a compound phosphate particle composition and a preparation method thereof. The compound phosphate granules prepared by the prescription process can effectively ensure the crystal form stability of the raw material medicines, obtain a good in-vitro dissolution effect, and meanwhile, are more favorable for preventing the aggregation phenomenon of the granules.