167 results about "Clinical safety" patented technology

The invention provides a vascular interventional surgery robot and a vascular interventional device. The suffered axial force and torque of a guide wire can be truly measured by a guide wire rotationand force feedback integrated module of the robot, and a hardware basis is laid for developing a human-computer interaction function. The robot is additionally provided with a detachable outer shell to meet the needs of surgical disinfection and ensure clinical safety and hygiene requirements. At the same time, the vascular interventional device is additionally provided with a four-degree-of-freedom mechanical arm structure on the basis of the vascular interventional robot, the height, position and stable support of the guide wire propulsion module are adjusted according to operation requirements, and wheels are arranged below a mechanical arm to facilitate the overall transportation and movement of the vascular interventional surgery robot. In addition, in the vascular interventional surgery robot and device, the size of the propulsion mechanism module is reduced as much as possible, the production materials are saved and the occupied space is saved.

The present invention provides a process for preparing cross-linked sodium hyaluronate microspheres capable of being adopted as an emboliaztion agent by adopting sodium hyaluronate as a raw material. The process comprises the following steps: preparing a sodium hyaluronate alkaline solution gel with a concentration of 10-30% g/ml; adding the sodium hyaluronate alkaline solution gel to an emulsifier-containing oil phase, and carrying out high speed emulsification through a shearing machine, wherein an emulsification speed is 500-2000 rpm, and a time is 10-20 min; adding a certain amount of a cross-linking agent, stirring for 4-6 h at a room temperature, carrying out a cross-linking reaction, and standing overnight after completing the reaction, wherein a mass percentage of the cross-linking agent in the oil phase is 0.2-2%; and adopting a water-soluble organic solvent to wash to remove the oil phase remained on the surface of the microspheres, and finally drying to obtain the cross-linked sodium hyaluronate microspheres. According to the present invention, the preparation process is simple; and the size of the obtained microspheres is suitable for routine blood vessel emboliaztion, and the obtained microspheres have characteristics of controllable particle size, good microsphere shape, easy screening, elasticity, expandibility, no toxic-side effect on human body, good biocompatibility, good biodegradability, and ensured clinical safety.

Computer systems and methods facilitate exploring results of drug candidate modeling. In one embodiment, the software is configured to receive raw data simulated by a probabilistic model of clinical safety, tolerability, and efficacy of a drug candidate. Index information is extracted from the raw data and then referenced to generate a metadata file, the structure of the metadata file explicitly reflecting a hierarchical structure of the model. The metadata file is in turn used to convert the raw data into a binary file, the metadata file explicitly identifying locations within the binary file, of treatment scenario information types and output performance information types. The metadata file is also referenced to generate an interface configured to receive inputs from a non-expert audience, and in turn present relevant subsets of the binary file in a limited number of plot and tabular formats. By standardizing presentation and manipulation of data from different models, software and methods in accordance with the present invention facilitate meaningful interaction between a non-expert audience, and the complex abstract mathematical models predicting drug behavior. The heightened audience-model interaction afforded by the present invention in turn promotes uniform and consistent evaluation of modeled data in the process of drug development.

The present invention relates to a system and method for electronic and algorithmic data mining of an individual physician's prescribing history to determine the approximate distribution of diseases within their practice population for optimizing pharmaceutical sales and marketing. Rapid and large-scale determination of specific clinical safety and efficacy attributes of a marketed drug which are most pertinent and relevant to a given physician, when compared to a competitor's drug, are defined and tabularized. Major clinical characteristics taken into account include a drug's safety, efficacy, cost, dosing convenience, formulary insurance coverage, side effect profiles, and FDA approval for the intended use. A symbolic representation of knowledge is employed in which the marketed drug and each competitor's drug are compared algorithmically against each other with a scoring system that is based upon machine analysis of each major clinical characteristic. The score is further refined according to the number and severity of safety interactions which are relevant to the comparison, and also based upon predicted prevalence of such interactions within a specific physician's practice.

The invention relates to a preparation method of an orally disintegrating tablet. The orally disintegrating tablet contains active ingredients, a water-insoluble film-forming material accounting for 0.1%-4% of the total weight of the tablet and other pharmaceutically acceptable additives, and is prepared through a wet granulation process. The orally disintegrating tablet prepared according to the method disclosed by the invention can control the release rate of the active ingredients and is favorable for ensuring the bioequiavailability, clinical safety and efficacy of a product. Furthermore, the method disclosed by the invention has the advantages of simple process flow and easiness in realization of industrial production.

The invention belongs to the field of biomedicine, and in particular discloses a method for extracting mesenchymal stem cells from trace human fatty tissues and massively culturing. The method for extracting mesenchymal stem cells from trace human fatty tissues comprises the steps of: locally narcotizing in small area by injecting lidocaine, extracting trace fatty tissues of a patient by using a micro draining needle; then soaking with a phosphate buffer, centrifugally washing and obtaining fatty tissues in a sterile state; and digesting with collagenase, centrifuging with gradient and filtering and then culturing in an in-vitro culturing system. The invention effectively reduces the pain of the patient, eliminates the barrier that the thin patient can not obtain the fatty tissues, avoids using animal products in the whole cell culturing system, especially serum-free products, and meets the demands on future clinical safety application.

The invention discloses a patient self-control sedative target control infusion system based on the anesthesia depth monitoring. The infusion system comprises the four modules of a central processor control module, a BIS sedation depth and vital sign monitoring feedback module, an output request module, and an output execution module. According to the infusion system, the target controlled infusion is used as the mode of the self-controlled dosing for a patient, the target controlled infusion is a therapeutic scheme calculated based on the group drug generation-medicine efficacy power theory by a computer, and blood plasma/effect compartment medicine concentration is used as the target control objective, the target controlled infusion can be rapidly achieved or modulated, the stability and a certain degree of safety of the sedative level can be guaranteed, and the BIS sedation depth monitoring system is used to monitor the sedation depth of the patient, when combined with the vital sign indicator, the clinical safety is increased to a greater extent.

The invention relates to a method for preparing a gelatin microballoon embolization agent, which comprises the following steps of dissolving gelatin or mixture of gelatin and medicine at 30-70 DEG C, filtering to obtain gelatin solution with 15%-60% of solid content, adding gelatin solution into oil phase liquid paraffin with mass ratio of 1%-2% of stabilizer Span 80, wherein the volume ratio of water and oil is 1/1-1/10, stirring for 15 minutes by 200-800r/min, adding cross-linking agent aldehyde compound with mass percent of 2%-50% at low temperature of 0-10 DEG C, solidifying for 1-2 hours, washing or drying the cross-linking agent to obtain the microballoon embolization agent after freeze drying or dehydration. The method has the beneficial effects that the gelatin microballoon embolization agent has certain elasticity and expansibility, the surface is smooth, the sphere is obvious, the size and the shape of the sphere is uniform, the grain size is controllable, clinical embolization effect can be improved, and side effect can be lowered, the clinical controllability is strong, antitumor drug can be added into the microballoon in manufacture process, so that double therapeutical effect of medicine treatment and embolization can be realized. The gelatin has good biocompatibility and biodegradablity, and clinical safety can be guaranteed.

A serum-free cryoprotectant includes: 8-15 v/v% of DMSO, 85-92 v/v% of a DMEM basic culture medium, and a nutritional additive. The nutritional additive includes: fibroblast growth factors, insulin, growth hormone, transferrin, bone morphogenetic protein 4, glutamine, sodium pyruvate, beta-mercaptoethanol, human epidermal growth factor, sodium selenite, and various amino acids and vitamins. The cryoprotectant is free of animal sourced serum and avoids pollution and risk of allergen, and has better clinical safety. The serum-free cryoprotectant is suitable for cryopreservation of human placenta sourced, umbilical cord sourced and cord blood sourced mesenchymal stem cells; compared with common serum cryoprotectants, perinatal mesenchymal stem cells preserved in the cryoprotectant have high cell survival rate after resuscitation, have excellent adherence growth status and maintain biological characters well.

The invention relates to the field of stem cells, discloses a frozen stock solution of stem cells, and in particular discloses a human adipose tissue-derived stromal cell frozen stock solution which consists of human plasma and dimaethyl sulfoxide. Compared with an ordinary cell frozen stock solution, the human adipose tissue-derived stromal cell frozen stock solution disclosed by the invention is relatively high in clinical security as no non-human source serum or protein is provided and the risk that contamination or allergen is introduced is avoided. The experience shows that compared with the ordinary cell frozen stock solution, the human adipose tissue-derived stromal cell frozen stock solution disclosed by the invention is relatively high in motility rate of cells in frozen stock, good stem cell characteristics are maintained, and human fat stem cells can be preserved and applied for a long time.

The invention provides a pharmaceutical composition of lysine and vitamin containing chiral isocompounds, the pharmaceutical composition is mainly used for preventing or treating growth retardation of mammals and human, malnutrition, inappetence, cerebral ischemia, brain trauma, anemia, hair growth, hair loss, fatty liver, hepatitis, atherosclerosis, hyperlipidaemia or oxiunt radical scavenger and the like, the composition can better adapt to patients with metabolic acidosis and hyperchloremia, and the pharmaceutical composition can adapt to new applicable people on clinic use or can have better pertinence or better clinical safety.

The invention relates to the technical field of medicine, in particular to a quinazolinone derivative, a preparation method and application thereof. The invention discloses quinazolinone compounds as structural general formula (I) or pharmaceutically acceptable salt thereof. Most of the compounds have stronger PDE5 inhibition activity than that of Sildenafil, and have higher selectivity than thatof PDE 6 distributed on a retina. Therefore, the compounds are expected to show better clinical safety and effectiveness, and have wide clinical application prospect.

The present invention provides a combined pharmaceutical composition of paclitaxel and CDKS kinase inhibitors, comprising active ingredients and pharmaceutically acceptable excipients, characterized in that: the active ingredients are composed of paclitaxel and CDK4/6 kinase represented by formula I Inhibitors or pharmaceutically acceptable salts thereof, the mass ratio of paclitaxel and CDK4/6 kinase inhibitors or pharmaceutically acceptable salts thereof in the active ingredient is (2‑8):1. The pharmaceutical composition has good anticancer curative effect and low toxic and side effects; due to the sensitivity of CDK4/6 kinase inhibitors to paclitaxel, the combination of the two produces a synergistic effect, thereby reducing the clinical dosage of capecitabine and reducing the large dosage Toxic and side effects produced by using capecitabine can improve the safety index of clinical treatment and have good clinical application prospects.

The invention discloses a serum-free culture medium suitable for immune cell large-scale culture, and belongs to the field of cell biology and medical immunology. The serum-free culture medium takes an RPMI1640 culture medium as a basis, additive components are further contained and include HEPES, phenol red sodium salt, L-glutamate and sodium bicarbonate. Insulin, transferrin, selenium, human albumin and interleukin-2 can be further added. Components contained in the culture medium are chemical defined components, no animal serum components are contained, and the serum-free culture medium is suitable for large-scale culture of immunity cells and is high in clinical safety and good in proliferation effect.

The invention belongs to the field of biomedicine, and particularly relates to an aluminum hydroxide gel-polysaccharide composite immunologic adjuvant and a preparation method and application thereof. The invention aims to provide a new immunologic adjuvant with good performance. The technical scheme is to provide a composite immunologic adjuvant. The composite immunologic adjuvant mainly contains aluminum hydroxide gel and polysaccharide serving as bacteria source. The aluminum hydroxide gel-polysaccharide composite immunologic adjuvant provided by the invention has the advantages of strong immunocompetence, high clinical safety and the like, and is an excellent composite immunologic adjuvant aiming at various antigens. The hepatitis vaccine and tumor vaccine prepared by taking the aluminum hydroxide gel-polysaccharide composite provided by the invention as adjuvant has stronger immune effect and anti-cancer effect, and thus new selection is provided for the development and application of vaccine.

The invention relates to chitosan microspheres. The microspheres are solid spheres which have smooth surface and uniform granularity and are formed by crosslinking of chitosan and a crosslinking agent, wherein the grain diameter of each microsphere is 50-1200 mu m, preferably 50-600mu m, and further preferably 150-300mu m; and the grain diameter difference is not more than 20 percent, and preferably not more than 10 percent. The microspheres provided by the invention have the characteristics of small grain diameters and high uniformity, and are capable of improving the safety effectiveness of embolism in interventional therapy, reinforcing the clinical operability, reducing the clinical safety accident rate and reducing the production cost.

The invention relates to the field of cells, in particular to a cell cryoprotectant and a cryopreservation method. The cell cryoprotectant is prepared from DMSO, human albumin and a serum-free medium. The cryprotectant does not contain animal serum, the risks of introducing contamination and allergens are avoided, and the higher clinical safety is achieved compared with a conventional cell cryoprotectant. Meanwhile, the GMSCs cryoprotectant can well keep the activity of cryopreserved cells.

The invention relates to a construction method and application of a humanized mouse model, in particular to a construction method and application of a transgenic mouse model of a human Nbs1<c.657del5> gene. The method includes: constructing a 5bp deletion mutation-containing BAC carrier in the human Nbs1 gene, conducting pronuclei microinjection, and performing screening to obtain 3 stable transgenic lines for high expression and low expression of the human Nbs1 gene. The transgenic mouse involved in the invention has the phenotypes of delayed puberty, uniform shortening of body length and bone dysplasia at certain proportion in one of the lines, and a new mouse model is established for Nijmegen breakage syndrome diseases. At the same time, as the Nbs1 gene function impairment is closely related to cancers, the transgenic model can be applied to short-term carcinogenic tests in drug pre-clinical safety evaluation, thus providing a potential substitution model for traditional biennium carcinogenic tests and also providing an effective tool for research of carcinogenesis mechanisms.

A remotely controlled slow-releasing electronic capsule able to be partially degradated for releasing medicine, food or making substance in digestive tract is composed of casing, remotely controlled driver, slow-releasing channel of medicine and a medicine tablet core with a conic or cylindrical boss at its one end. Under the drive of said driver, said boss on medicine tablet can move forward to open the medicine releasing channel for slowly releasing the medicine. Said casing consists of the scaffold able to be degradated and a coated layer.

The invention relates to the technical field of stem cell cryopreservation, in particular to a parodontium stem cell cryoprotectant and a cryopreservation method thereof. The parodontium stem cell cryoprotectant is prepared from, 500-2000 mg/L of trehalose, 5-20vt% of acetamide, 5-15vt% of DMSO and the balance a basal culture medium. Compared with a conventional cell cryoprotectant, the parodontium stem cell cryoprotectant and the cryopreservation method thereof have the advantages that the cryoprotectant has a less damage effect on cells during cell cryopreservation, the cell viability is higher, the cryopreservation effect of the cryoprotectant is obviously superior to that of the conventional cell cryoprotectant; on one hand, the cost of the cell cryopreservation can be reduced to a certain degree, on the other hand, the introduction of heterologous matter can be avoided, and the clinical safety is higher.

The invention discloses an ornidazole injection and a preparation method thereof. Mixed liquid of absolute ethyl alcohol and polyethylene glycol-15-hydroxystearate serves as a solvent of the ornidazole injection, wherein the polyethylene glycol-15-hydroxystearate accounts for 6-14% in terms of the mass percentage of the injection. The use of a propylene glycol solvent can be prevented, and the preparation (the injection) is good in stability and good in clinical safety. The invention also discloses a preparation method of the injection; and the preparation process (the preparation method) is simple and easy to implement.