48 results about "In vitro dissolution" 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 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.

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.

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 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.

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 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 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 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 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.

The present invention provides a method of treating IgA nephropathy, the method comprising: (i) identifying a pharmaceutically acceptable composition intended for treating IgA nephropathy comprising budesonide and one or more pharmaceutically acceptable excipients providing modulated release of the budesonide following administration to the gastrointestinal tract, the composition comprising budesonide and one or more pharmaceutically acceptable excipients in a standard in vitro dissolution test, the one or more excipients comprising budesonide and one or more pharmaceutically acceptable excipients comprising budesonide and one or more pharmaceutically acceptable excipients comprising budesonide and one or more pharmaceutically acceptable excipients comprising budesonide and one or more pharmaceutically acceptable excipients comprising budesonide; the following requirements are met; (a) when the dissolution medium is aqueous and has a pH of about 1.2, no more than about 10% of the budesonide is released into the dissolution medium within about 120 minutes; (b) a requirement for no more than about 10% of the budesonide to release into the dissolution medium within about 30 minutes when the dissolution medium is aqueous and has a pH of about 6.8; and (c) a requirement for release of at least about 70% of the budesonide into the dissolution medium within about 120 minutes when the dissolution medium is aqueous and has a pH of about 6.8; (ii) a step of administering said composition to a patient suffering from IgA nephropathy in need of said treatment.

The invention relates to the technical field of food additive preparation, in particular to a novel curcumin self-micellization solid dispersion and a preparation method thereof.The method comprises the steps that F127 and TPGS serve as composite carriers, the composite carriers and curcumin raw material medicine are dissolved in absolute ethyl alcohol, a solvent is removed through rotary evaporation, freeze drying, grinding and sieving are conducted, and the self-micellization solid dispersion is prepared. According to the process, the solubility and the stability of the curcumin are remarkably improved, the prepared solid dispersion has the characteristics of high drug loading capacity, good physical stability and rapid in-vitro dissolution, and in a simulated digestion experiment, the release rates of the curcumin in the oral cavity and gastric juice reach 9.9% and 4.6% respectively and are far superior to those of free curcumin, so that the curcumin solid dispersion can be applied to the oral cavity and the gastric juice of the oral cavity and the gastric juice of the oral cavity and the gastric juice of the oral cavity. Through the synergistic effect of micelle wrapping and the surfactant, drug aggregation is effectively reduced, gastrointestinal adsorption and permeation are enhanced, bioavailability is greatly improved, the curcumin dispersible tablet is suitable for development of various efficient preparations such as oral administration, inhalation and percutaneous absorption, and the key problems that curcumin is poor in dissolubility and low in bioavailability are solved.

The invention discloses a piribedil sustained-release tablet and a preparation method thereof, the sustained-release tablet comprises piribedil or pharmaceutically acceptable salt, a filler, an adhesive and a lubricant, the filler is talcum powder, the adhesive is povidone, the lubricant is magnesium stearate, the lubricant is internally and externally added, and the filler is magnesium stearate. The piribedil sustained-release tablet provided by the invention is stable in quality, has consistent in-vitro dissolution with an original piribedil sustained-release tablet (an original research manufacturer: French Schwia, the trade name: Tesudoda), is simple and convenient to operate, and is beneficial to industrial production.

This invention relates to the field of pharmaceutical formulation technology, specifically disclosing an olopatadine orally rapidly disintegrating tablet composition and its preparation method. The composition comprises olopatadine, mannitol, a taste masking agent, a disintegrant, a flavoring agent, colloidal silica, and magnesium stearate. By weight percentage, the amounts of olopatadine, mannitol, colloidal silica, and magnesium stearate are 1.0-10.0%, mannitol, colloidal silica, and magnesium stearate, respectively. The composition prepared using this formulation improves drug stability, exhibits an in vitro dissolution profile consistent with the reference formulation, and has a pleasant taste, increasing palatability during administration.

The present invention discloses a preparation method and application of gefitinib-hesperetin nano-cocrystals, belonging to the field of pharmaceutical technology. The gefitinib-hesperetin co-crystals and a stabilizer are placed in a grinding jar, ultrapure water is added, and ultrasound is applied until the gefitinib-hesperetin co-crystals and the stabilizer are evenly dispersed. Grinding beads are added, the rotation speed is adjusted, and the gefitinib-hesperetin nano-cocrystals are obtained after grinding. The present invention takes gefitinib as the research object and hesperetin as the co-crystal former, and successfully obtains gefitinib-hesperetin nano-cocrystals by combining crystal engineering and nanotechnology. The structure and physicochemical properties of the gefitinib-hesperetin co-crystals are characterized by a series of solid characterization techniques, and its in vitro dissolution, in vitro anti-tumor activity, and in vivo bioavailability in rats are systematically evaluated. It is shown that the gefitinib-hesperetin nano-cocrystals not only effectively improve the solubility and bioavailability of gefitinib, but also enhance the anti-tumor activity of the drug.

The application discloses a kind of fumarate vinorelbine tablet compositions and preparation method thereof, fumarate vinorelbine raw drug, excipient, first part low molecular weight low substitution hydroxypropyl cellulose and stabilizer are mixed into premix substrate;Granulation is sprayed in wet granulator second part low molecular weight low substitution hydroxypropyl cellulose aqueous solution;Pre-drying is passed through 20 mesh sieve, again drying is passed through 24 mesh sieve;Add disintegrating agent and lubricant mixture;Tabletting;Finally coating.The method is by internal and external addition method and three-step granulation process, ensure that in vitro dissolution property is equivalent to original research drug, use lipid plasticizer instead of polyethylene glycol, can reduce coating temperature, reduce drug thermal degradation.Fluidized bed one-step granulation is split into two independent steps of high-speed shearing granulation and fluidized bed drying, greatly simplify the production process process parameter control difficulty, more easily to scale-up production, make production process control more accurate, product quality is more stable, production cost is significantly reduced.

The invention belongs to the technical field of pharmaceutical preparations, and discloses melogabalin besylate tablets and a preparation method thereof. The melogabalin besylate tablet comprises a medicine tablet core and a coating layer, the medicine tablet core is prepared from the following raw materials in parts by weight: 4 to 10 parts of melogabalin besylate, 60 to 120 parts of a filling agent, 10 to 20 parts of a disintegrating agent, 0.5 to 1.0 part of an adsorbent and 1.0 to 2.0 parts of a lubricating agent. According to the invention, no antioxidant is added, the process adopts a direct powder tabletting technology, and the raw material medicines and the mannitol are mixed step by step in a gradient manner and assisted by a forced sieving treatment manner, so that the good mixing uniformity of the preparation is ensured; meanwhile, the risk that the preparation is unstable possibly caused by a conventional granulation process is avoided, the preparation process is simplified, and the stable quality of the tablet is also ensured. The prepared melogabalin besylate tablet has good in-vitro dissolution similarity and in-vivo bioequivalence with a reference preparation.

The present invention relates to a pharmaceutical composition in the form of a sterile and injectable dosage form comprising a controlled release dosage form comprising colchicine for use in the treatment of arthropathy, such as osteoarthritis, aggressive hand osteoarthritis and any other type of chondropathy, by intraarticular injection of said pharmaceutical composition into the joint, such as osteoarthritis, aggressive hand osteoarthritis, and any other type of chondropathy. The present invention relates to colchicine, in particular colchicine, and / or for the treatment of pain-related arthropathy, and / or for the protection of joints, bones and / or cartilages, in which 80% by weight of colchicine is released for more than one month, and in which colchicine is present in a concentration of 1 to 27.5 mg per mL of sterile and injectable dosage, and / or for the treatment of pain-related arthropathy, and / or for the protection of joints, bones and / or cartilages. The invention also relates to a sterile and injectable pharmaceutical composition comprising a controlled release dosage form containing colchicine, which has a suitable in vitro dissolution characteristic. The invention also relates to a formulation in powder form and to a pharmaceutical composition in sterile and injectable dosage form form suitable for intra-articular injection comprising colchicine, in particulate form comprising a polymer matrix, and to a related kit or article of manufacture.

The present invention provides a method of treating IgA nephropathy, the method comprising: (i) identifying a pharmaceutically acceptable composition intended for treating IgA nephropathy comprising budesonide and one or more pharmaceutically acceptable excipients providing modulated release of the budesonide following administration to the gastrointestinal tract, the composition comprising budesonide and one or more pharmaceutically acceptable excipients in a standard in vitro dissolution test, the one or more excipients comprising budesonide and one or more pharmaceutically acceptable excipients comprising budesonide and one or more pharmaceutically acceptable excipients comprising budesonide and one or more pharmaceutically acceptable excipients comprising budesonide and one or more pharmaceutically acceptable excipients comprising budesonide; the following requirements are met; (a) when the dissolution medium is aqueous and has a pH of about 1.2, no more than about 10% of the budesonide is released into the dissolution medium within about 120 minutes; (b) a requirement for no more than about 10% of the budesonide to release into the dissolution medium within about 30 minutes when the dissolution medium is aqueous and has a pH of about 6.8; and (c) a requirement for release of at least about 70% of the budesonide into the dissolution medium within about 120 minutes when the dissolution medium is aqueous and has a pH of about 6.8; (ii) a step of administering said composition to a patient suffering from IgA nephropathy in need of said treatment.

The present invention provides for a method of treatment of IgA nephropathy, which method comprises:(i) identifying a pharmaceutically acceptable composition intended to treat IgA nephropathy comprising budesonide and one or more pharmaceutically-acceptable excipients that provide for a modified release of said budesonide after administration to the gastrointestinal tract, which composition fulfils the following requirements in a standard in vitro USP<711> / Ph.Eur. 2.9.3 dissolution test using a dissolution apparatus according to Apparatus 2 (Paddle Apparatus) of said test;(a) the composition fulfils the requirement that no more than about 10% of the budesonide is released into the dissolution medium within about 120 minutes, when the dissolution medium is aqueous and has a pH of about 1.2;(b) the composition fulfils the requirement that no more than about 10% of the budesonide is released into a pharmaceutically-relevant dissolution medium within about 30 minutes; and(c) the composition fulfils the requirement that at least about 70% of the budesonide is released into the pharmaceutically-relevant dissolution medium within about 120 minutes;(ii) wherein the method comprises the step of administering said composition to a patient with IgA nephropathy in need of said treatment.

The invention discloses a mometasone furoate nasal spray in-vitro dissolution detection sample as well as a pretreatment method and an in-vitro dissolution detection method thereof, and belongs to the technical field of pharmaceutical analysis. The pretreatment method of the in-vitro dissolution detection sample comprises the following steps: adding a mometasone furoate nasal spray into cellulase for enzymolysis, dispersing a mixture after enzymolysis on a microfiltration membrane, and drying to obtain the in-vitro dissolution detection sample. The invention discloses a mometasone furoate nasal spray in-vitro dissolution detection sample prepared by the pretreatment method, and an in-vitro dissolution detection method adopting the detection sample. Cellulase is added into the mometasone furoate nasal spray for enzymolysis, proper enzymolysis conditions are screened, and API particles are released from a cross-linked structure formed by the auxiliary materials, so that interference of the auxiliary materials on preparation dissolution detection is eliminated.

This invention introduces a stable oral tablet dosage form comprising palbociclib or its pharmaceutically acceptable salts, along with at least one excipient. By adjusting the amount of excipients, the formulation enhances the flow and granulation properties, ensuring uniform die filling and precise weight control during tablet production. Specifically, it involves a process for producing without flow and adhesive problems that can be dry granulated powder comprising palbociclib, to prepare storage-stable tablets having an acceptable in-vitro dissolution profile.