24 results about "Bioequivalence" 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 utility model belongs to the technical field of bioequivalence tests, and particularly relates to a rectal administration device in a bioequivalence test, which comprises a mounting box and a medicine delivery component arranged on the outer side of the end part of the mounting box, the medicine feeding assembly comprises a mounting plate, a motor and a rotating disc, and the inner side of one end of the mounting box is fixedly connected with the mounting plate; the release position and depth of the medicine can be accurately controlled through the medicine feeding assembly, it is ensured that the medicine can reach a target area in the rectum, accurate control over the medicine dosage can be achieved through the device, the consistency of the dosage every time is ensured, and according to a traditional rectal administration mode, manual insertion and manual medicine injection are possibly needed; this may cause discomfort or pain of an injected person, while the drug delivery assembly can complete the drug delivery process instantly, thereby reducing the pain of organisms.

The present application relates to a kind of HPLC-MS / MS detection method of detecting in human plasma, desloratadine and 3-hydroxydesloratadine in human plasma, it includes the following steps: (1) human plasma sample pretreatment;(2) liquid chromatography-mass spectrometry detection, using mobile phase A and mobile phase B as mixed mobile phase is carried out gradient elution, wherein: mobile phase A is methanol-acetonitrile mixed solution, in mixed solution methanol and acetonitrile volume ratio is 4-6:6-4;Mobile phase B is 2-20mM ammonium formate aqueous solution;(3) the determination of the concentration of human plasma in lopatadine, desloratadine and 3-hydroxydesloratadine.The present application uses lopatadine-d4, desloratadine-d5, 3-hydroxydesloratadine-d4 as deuterium internal standard, using Agilent, ZORBAX Eclipse XDB-Phenyl is carried out gradient elution, deuterium internal standard and the measured substance has the same retention time, chemical property and matrix effect, the reproducibility, accuracy of determining the concentration of lopatadine, desloratadine and 3-hydroxydesloratadine in plasma are good.The method of the present application can be used to evaluate the bioequivalence of lopatadine.

The application discloses a complex long-acting preparation steady-state pharmacokinetics extrapolation equivalence prediction method, relates to the steady-state bioequivalence technical field, and comprises the following steps: collecting and unifying concentration-time, a drug administration scheme and a covariate, generating a standardized time, an event marker code and a covariate dictionary, setting a deletion weight and a population alignment weight; setting a candidate structure based on population pharmacokinetics, estimating a model and a covariate effect through a quality threshold determination with a weight; constructing a virtual population and performing multiple drug administration simulation to determine the reaching of stability according to the relative change of consecutive two trough concentrations, generating a peak-trough sampling time window; performing non-compartment analysis in the steady-state interval, calculating a dosing interval area, a steady-state peak value and a steady-state trough value, calculating a geometric mean ratio and a confidence interval of two preparations, carrying out efficacy-sample size linkage, and outputting a recommended design; the method can reduce the test burden, shorten the cycle and improve the decision transparency.

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 application discloses a drug interaction prediction and dose reference information generation method, system and device, and the method comprises the following steps: acquiring parameters of a Bruton's tyrosine kinase inhibitor as a target drug and an antiretroviral drug as an interaction drug; constructing and verifying a basic physiological pharmacokinetic model of each drug; integrating inhibition or induction parameters of the interaction drug on corresponding enzymes, constructing and verifying an interaction prediction model; running the verified model to simulate and calculate predicted exposure data of the target drug when the drugs are used in combination; and generating dose reference information meeting preset bioequivalence conditions by iteratively adjusting dose parameters of the target drug and re-simulating. The application realizes automatic, quantitative prediction and personalized dose scheme generation of specific drug combination interactions, and can provide key decision support for clinical combination drug use.

The present invention relates to a pharmaceutical combination preparation, which comprises all of ezetimibe, rosuvastatin and empagliflozin as active ingredients, and thus can be administered as a single drug, and not through co-administration, in the simultaneous treatment of dyslipidemia and diabetes, thereby increasing patient dosing convenience, minimally affecting dissolution between drugs, ensuring biological equivalence, and providing excellent stability of the active ingredients.

The present application relates to a kind of HPLC-MS / MS detection method of loxoprofen and its active metabolite trans-OH body in human plasma, it includes the following steps: (1) human plasma sample pretreatment;(2) liquid chromatography-mass spectrometry detection, using mobile phase A and mobile phase B as mixed mobile phase is carried out gradient elution, wherein, mobile phase A is acetonitrile, mobile phase B is 0.05% acetic acid aqueous solution;(3) the determination of loxoprofen and its active metabolite trans-OH body concentration in human plasma.The present application uses ACE, Excel 3SuperC18 as chromatographic column, in the process of gradient elution, the time of optimization elution and the proportion of mobile phase, linear range is all 0.200-40.0ng / mL, lower limit of quantification is low, sensitivity is high, reproducibility, accuracy is all better, can be used to evaluate loxoprofen and its active metabolite trans-OH body each dosage form bioequivalence.

The present invention relates to a pharmaceutical compound formulation that contains sacubitril-valsartan and an SGLT-2 inhibitor as active ingredients, thereby having a synergistic effect in the treatment of heart failure, while minimizing the effects of drug dissolution between each drug to ensure bioequivalence, suppressing the generation of related substances, and exhibiting excellent stability of the active ingredients.

The invention relates to a method for determining the content of auxiliary materials ethyl acetate and butyl acetate in an amorolfine hydrochloride liniment, the method has the advantages of high sensitivity, strong specificity, good accuracy and simple and rapid operation, can reduce the preparation development difficulty, reduce the workload of prescription development, shorten the research and development time and further improve the BE passing rate, and has practical significance.

The invention relates to a method for determining the content of an auxiliary material triethyl glyceride in an amorolfine hydrochloride liniment, which has the advantages of high sensitivity, strong specificity, good accuracy and simple and rapid operation, can reduce the preparation development difficulty, reduce the workload of prescription development, shorten the research and development time and further improve the BE passing rate, and has practical significance.

The invention discloses a macloxvir oral solution as well as a preparation method and application thereof, and belongs to the technical field of medical chemistry. The invention aims to solve the technical problems that the existing macloxvir preparation is inconvenient to take, slow in absorption, low in bioequivalence, tedious in preparation process and the like. The key point of the technical scheme is as follows: the oral solution of the macarovir comprises the following components: the macarovir, hydroxypropyl-beta-cyclodextrin, a flavoring agent, a pH regulator and water for injection, and the substitution degree of the hydroxypropyl-beta-cyclodextrin is 3.0-7.0.

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 discloses an automatic verification system for bioequivalence test data, and relates to the technical field of data services, the system comprises a data acquisition module, a knowledge graph construction module, a semantic reasoning verification module, an abnormity early warning module and a collaborative updating module; bE test data are respectively collected from the clinical data management unit, the detection instrument and the laboratory information management unit, a standardized data pool is formed through format standardization processing, and standard integration of the data is realized; core entities and corresponding attributes are defined, association relationships and mapping rules among the entities are determined, and by calculating association strength among different entities, reliable entity pairs are screened, incorporated into a knowledge graph and stored, and a traceable semantic association system among data is established; and extracting to-be-verified data, performing pop-up early warning by combining entity association strength, calculating an exception judgment index and generating a verification result early warning report, and meanwhile, pushing an exception early warning mail to a data administrator to ensure that data exception is identified and handled in time.

Described herein, in part, are single-unit dosage forms, comprising the compound of Formula (I) or a pharmaceutically acceptable salt thereof (e.g., the compound of Formula (II), e.g., PRAX-944 HCl), wherein the composition is bioequivalent to a reference composition of the same dosage strength administered as multiple small, round tablets. The present invention further comprises methods useful for treating a disease or condition relating to aberrant function or activity of a T-type calcium channel, such as tremor (e.g., essential tremor).

The invention discloses a complex long-acting preparation steady-state pharmacokinetic extrapolation equivalence prediction method, and relates to the technical field of steady-state bioequivalence, and the method comprises the steps: collecting and unifying concentration-time, administration schemes and covariables, generating standardized time, event identification codes and a covariable dictionary, and setting a deletion weight and a crowd alignment weight; setting a candidate structure based on group pharmacokinetics, and determining a model and a covariant effect through a weight estimation quality threshold; constructing a virtual crowd, carrying out multiple times of drug administration simulation, judging that the stability is achieved according to two continuous relative changes of valley concentrations, and generating a peak-valley sampling time window; carrying out non-atrioventricular analysis in the steady-state interval, calculating an administration interval area, a steady-state peak value and a steady-state valley value, calculating a geometric mean ratio and a confidence interval for the two preparations, carrying out efficacy-sample size linkage, and outputting a recommended design; the method can reduce the test burden, shorten the period and improve the decision transparency.

This application discloses a method for determining the dissolution profile and in vivo bioequivalence of a tablet. The tablet comprises, by weight, 180-220 parts indobufen, 200-250 parts lactose, 40-60 parts microcrystalline cellulose, 10-20 parts povidone, 20-40 parts sodium carboxymethyl starch, 1-10 parts sodium dodecyl sulfate, and 1-10 parts magnesium stearate. The median particle size of the lactose in this invention is 38-60 μm, and the bulk density is 0.55-0.68 g / ml. Basket dissolution is employed, with controlled conditions including: a temperature of 37±1℃, a pH of 4.5-7.6 in the dissolution medium, purified water, and a rotation speed of 75-100 rpm. This invention, combined with an optimized dissolution detection method, can ensure that the dissolution profiles of the self-made sample and the reference formulation are similar in multiple media, and guarantees consistency with the in vivo efficacy of the reference formulation.

The invention belongs to the technical field of pharmaceutical preparations, and particularly relates to an MR (magnetic resonance) antagonist medicine and a preparation method thereof as well as an MR antagonist tablet and a preparation method thereof. By controlling the particle size of the fenerenone, tablets of different specifications are all dissolved out in vitro and are well fit with a reference preparation in dissolution, and in-vivo bioequivalence is better facilitated; the suspension is prepared from the raw material medicines and at least one of the adhesive and the surfactant, and a fluidized bed process and a liquid spraying adding mode are adopted, so that the flowability of the materials is improved, the mixing uniformity and the content uniformity can meet the requirements, and the content uniformity can be ensured to meet the requirements. And dissolution fitting and in-vivo bioequivalence of preparations with different specifications and an original reference preparation can be realized under various medium conditions.

The invention relates to the technical field of bioequivalence evaluation, in particular to an ethyl eicosapentaenoate soft capsule bioequivalence analysis method which comprises the following steps: S1, acquiring PK parameter information which is obtained by performing a PK test; s2, constructing a mixed effect model, and analyzing and calculating the PK parameters subjected to logarithmic transformation; s3, bioequivalence judgment is conducted, and a judgment result is output. According to the method, bioequivalence analysis on the ethyl eicosapentaenoate soft capsule is achieved.

The invention relates to the technical field of pharmaceutical preparations, and particularly discloses an entacapone and didopa compound tablet and a preparation method thereof. The entacapone and didopa compound tablet is prepared from the following raw materials in parts by mass: 200 parts of entacapone, 90 to 110 parts of levodopa, 22 to 28 parts of carbidopa, 110 to 130 parts of mannitol, 150 to 170 parts of disintegrating diluent, 25 to 30 parts of disintegrating agent, 0.5 to 1.5 parts of stabilizer and 13 to 17 parts of lubricant. The stabilizer comprises citric acid and succinic acid. The specific stabilizer can adjust the pH value of the microenvironment so as to stabilize the main drug, enhance the antioxidant effect of the main drug and improve the disintegration performance at the same time. By screening and designing the raw materials, the entacapone and didopa compound tablet is similar to an original product in dissolution rate, equivalent to an original product in bioequivalence, good in friability, not easy to stick and excellent in stability.

The present invention relates to a pharmaceutical combination preparation which has a synergistic effect in the treatment of heart failure by including sacubitril-valsartan and an SGLT-2 inhibitor together as active ingredients, while ensuring bioequivalence between drugs because the influence of one drug on the elution of another drug is minimized. In addition, the generation of impurities in the pharmaceutical combination preparation is inhibited, and thus the stability of the active ingredient is also very excellent.

Described herein, in part, are single-dose dosage forms comprising a compound of Formula (I) or a pharmaceutically acceptable salt thereof (e.g., a compound of Formula (II), e.g., PRAX-944 HCl), which compositions are bioequivalent to an identical dose of a reference composition administered as multiple small, round tablets. The invention further includes methods useful for treating diseases or conditions associated with abnormal function or activity of T-type calcium channels, such as tremor (e.g., essential tremor).

The invention relates to the technical field of pharmaceutical analysis, in particular to a dissolution detection method and a quality control method of a palmitate oral solid preparation. According to the method, the test sample solution is determined by adopting specific high-speed line chromatography detection conditions, the dissolution rate of the test sample at different sampling time points can be effectively and rapidly detected, and the method has the characteristics of strong specificity, rapidness, accuracy, good reproducibility and high sensitivity, can be widely applied to quality monitoring of preparations, and has wide application prospects. Reliable reference basis can be provided for development of a prescription process of a preparation, and is closely related to the in-vivo bioavailability, so that the research risk of the in-vivo bioavailability and bioequivalence can be greatly reduced.