WO2018059035A1 - Device for analyzing and managing pharmaceutical excipient - Google Patents

Device for analyzing and managing pharmaceutical excipient Download PDF

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Publication number
WO2018059035A1
WO2018059035A1 PCT/CN2017/090977 CN2017090977W WO2018059035A1 WO 2018059035 A1 WO2018059035 A1 WO 2018059035A1 CN 2017090977 W CN2017090977 W CN 2017090977W WO 2018059035 A1 WO2018059035 A1 WO 2018059035A1
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unit
information
window display
input
information processing
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PCT/CN2017/090977
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French (fr)
Chinese (zh)
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张泰�
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张泰�
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    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H40/00—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
    • G16H40/60—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
    • G16H40/67—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for remote operation
    • G06F19/3456—
    • G06F19/326—
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H20/00—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
    • G16H20/10—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H20/00—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
    • G16H20/10—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients
    • G16H20/17—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients delivered via infusion or injection
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H70/00—ICT specially adapted for the handling or processing of medical references
    • G16H70/40—ICT specially adapted for the handling or processing of medical references relating to drugs, e.g. their side effects or intended usage
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H20/00—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
    • G16H20/60—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to nutrition control, e.g. diets

Definitions

  • the invention belongs to the technical field of medical equipment, and particularly relates to a pharmaceutical excipient analysis and management device, which analyzes the safety of the medicine based on the characteristics of the pharmaceutical excipients, especially before the medication is used, the early adverse management of the potential adverse consequences, and the protection of the drug users Safe and reasonable medication.
  • Drugs refer to substances that are used by humans to prevent, treat, and diagnose human diseases, purposefully regulate human physiology, and specify indications or functional indications, usage, and dosage, including Chinese herbal medicines, Chinese herbal medicines, Chinese patent medicines, Chemical raw materials and their preparations, antibiotics, biochemical drugs, radioactive drugs, serum, vaccines, blood products and diagnostic drugs; the types of drugs are complex and diverse, and there are more than 20,000 species in the world; the approval number printed on the drug packaging “National Medicine Standard H (or ZSJBF) + 8 digits” means that it is a drug approved by the State Food and Drug Administration for production and marketing.
  • the H letter stands for chemical, Z proprietary Chinese medicine, S biological product, J imported drug domestic packaging, B has adjunctive therapeutic effects of drugs, F pharmaceutical excipients; pharmaceutical excipients refer to all the medicinal preparations other than the main drug in the formulation to solve the formability, effectiveness, stability and safety of the formulation during formulation design.
  • pharmaceutical excipients refer to all the medicinal preparations other than the main drug in the formulation to solve the formability, effectiveness, stability and safety of the formulation during formulation design.
  • Pharmaceutical excipients are the basic materials and important components of pharmaceutical preparations.
  • the material basis for ensuring the production and development of pharmaceutical preparations plays a key role in the formulation and production. It not only gives certain dosage forms of the medicine, but also has a great relationship with improving the efficacy of the medicine and reducing adverse reactions. Its quality reliability and variety Sex is the basis for ensuring the advanced nature of the dosage form and preparation.
  • pharmaceutical excipients in the preparation including solvents, propellants, solubilizers, cosolvents, emulsifiers, colorants, binders, disintegrators, fillers.
  • lubricants wetting agents, osmotic pressure regulators, stabilizers, glidants, flavoring agents, preservatives, suspending agents, coating materials, fragrances, anti-adhesives, integrators, penetration enhancers, pH Value modifier, buffer, plasticizer, surfactant, foaming agent, antifoaming agent, thickener, inclusion agent, moisturizer, suction Receptor, diluent, flocculant and deflocculant, filter aid and release retarder; the prior art drug analysis management is aimed at the main drug in the drug, only the pharmacological and toxicological properties of the active ingredient In the application of drug safety, in the application process of drugs, the auxiliary materials and main drugs in the drug work together in the human body, and participate in the process of pharmacokinetics.
  • Medicinal excipients not only have certain pharmacological and toxicological activities, but also affect the physical and chemical properties of the drug and the compatibility of various drugs, and can also affect the pharmacokinetic parameters and clinical test results of the drug.
  • the combination and sequential application not only increase the chance of interaction between excipients and excipients and excipients and main drugs between different drugs, but also increase the possibility of adverse effects of drug incompatibility; there is no analysis and management of the effects of pharmaceutical excipients.
  • Patent or literature report on the safety of medication.
  • the object of the present invention is to overcome the shortcomings of the prior art, and to design a pharmaceutical excipient analysis and management device, and analyze the safety of the drug based on the existing characteristics of the pharmaceutical excipients, especially before the drug users use the drug.
  • the main structure of the pharmaceutical excipient analysis management device includes an information input unit, an information processing unit, a result feedback unit, and a window display unit; between the information input unit and the information processing unit, between the information processing unit and the result feedback unit, and The result feedback unit and the window display unit are electrically connected.
  • the input mode of the information input unit includes manual input, online input and scan code input, and the information processing unit records, stores, analyzes and manages information input by the information input unit, and the result feedback unit Sending the information processed by the information processing unit to the window display unit, the window display unit displays the result fed back by the result feedback unit; can be embedded in the server of the medical institution, and can also be used on the computer, the communication device, and the mobile data handheld terminal device.
  • the information on the adverse consequences due to the nature of the medicinal excipients, the contraindications between the medicinal excipients and the medicinal excipients and the main drug are input into the information input unit, and the information input unit sends the above information to the information processing unit.
  • the administrator regularly maintains, updates, modifies, supplements, and deletes the above information; when the physician uses the medicinal information and the medical prescription, the information input unit is input, and the information processing unit analyzes and manages the information after receiving the information.
  • the analysis result is sent to the window display unit through the result feedback unit, and the physician performs the prescription preparation or the prescription correction operation according to the analysis result displayed by the window display unit, and informs the prescription user of the precautions and dietary contraindications during the medication; when the pharmacist uses,
  • the prescription input information is input into the unit, the information processing unit receives the information, analyzes and manages the information, and sends the analysis result to the window display unit through the result feedback unit, and the pharmacist performs the prescription feedback to the physician according to the analysis result displayed by the window display unit or directly extracts Prescription operation, and Precautions and dietary contraindications inform the prescription drug taker; when the drug user uses, enter the drug name into the information input unit, the information processing unit receives the drug name, analyzes and manages the result, and sends the analysis result to the window display through the result feedback unit.
  • the drug user takes the medicine according to the analysis result displayed by the window display unit or abandons the medicine to consult with the medical institution and issues a new prescription, and takes the medicine according
  • the principle of the pharmaceutical excipient analysis and management device involved in the present invention is as follows: related medical research shows that the pharmaceutical excipients previously considered to be inactive have obvious pharmacological effects, and the existing part of the income is the Chinese Pharmacopoeia chemical drug catalogue.
  • Can be used as a drug pharmaceutical excipients are not inert components, and their pharmacological and physicochemical parameters include changes in pharmacokinetic parameters, trigger other diseases, lead to decreased reliability of diagnostic methods or test results, cause or enhance toxicity, cause Allergies, improvement of disease susceptibility, aggravation of the disease, and prognosis of the disease, in order to ensure the safety of medication, re-examination, analysis, management and early warning of pharmaceutical excipients.
  • the pharmaceutical excipient analysis and management device provides analysis, management and early warning services for drug use behavior from the perspective of the influence of the pharmaceutical excipients in the prevention, diagnosis, treatment and rehabilitation activities, and provides a new protection field for the safety and rationality of the drug use.
  • the reference opinion can also provide professional analysis and feedback for the staff of prevention, rehabilitation and social health examination institutions, which is conducive to improving the professional level and safety of medical services. Even ordinary users who do not have the knowledge base of drugs can also The analysis and management of drugs facilitates mobility and inaccessibility to medical institutions.
  • the present invention establishes a database, associates related websites, and updates data information in real time by collecting medical auxiliary materials and drug data information, and integrates research resources of pharmaceutical excipients into safe drug service, and inputs drug information. It can accurately and quickly obtain the results of drug analysis, with reliability and sustainable development.
  • the whole device is adaptable, and the carriers and terminals that carry it are diverse, adapt to the trend of social development, can be used alone, and can be integrated into existing
  • the drug management system or the server embedded in the medical institution is used in combination with the medical service system to avoid a lot of cumbersome manual monitoring work, improve work efficiency, reduce labor intensity, and maximize drug safety management; the structure is simple, the function is practical, and the operation Simple, safe, flexible, and application friendly.
  • 1 is a schematic view showing the principle of the main structure of the present invention.
  • the main structure of the pharmaceutical excipient analysis management device includes an information input unit 1, an information processing unit 2, a result feedback unit 3, and a window display unit 4; between the information input unit 1 and the information processing unit 2, and an information processing unit 2 and the result feedback unit 3 and the result feedback unit 3 and the window display unit 4 are electrically connected, the input mode of the information input unit 1 includes manual input, online input and scan code input, and the information processing unit 2 records, stores, The information input by the information input unit 1 is analyzed and managed, and the result feedback unit 3 transmits the information analyzed and processed by the information processing unit 2 to the window display unit 4, and the window display unit 4 displays the result fed back by the result feedback unit 3.
  • the pharmaceutical excipient analysis management device is embedded in the server of the medical institution and used in combination with other medical service systems, and the doctor will prematurely give birth to the information of the male child born 3.5 hours: the gestational age of the child is 26 weeks, and the birth weight is 0.83 kg.
  • the information processing unit 2 analyzes and manages the information, and detects that the blood sugar of the child is fluctuating.
  • the blood glucose monitoring system using the glucose dehydrogenase pyrroloquinoline quinone (GDH-PQQ) enzyme technology Since the hospital admission, the blood glucose monitoring system using the glucose dehydrogenase pyrroloquinoline quinone (GDH-PQQ) enzyme technology has been used. Regularly monitoring the blood glucose record, the information processing unit 2 finds that the human immunoglobulin contains the adjuvant maltose, and the information processing unit 2 analyzes and obtains the early warning information that the blood glucose may generate pseudo-hyperglycemia after the intravenous injection of the immunoglobulin, and the information processing unit 2 The warning information is sent to the window display unit 4 through the result feedback unit 3, and the physician analyzes the result according to the warning information displayed by the window display unit 4, and changes the medication order or the blood glucose monitoring system using different working mechanisms to avoid the influence of the medicinal auxiliary materials. Blood sugar value error, prescribing a wrong prescription.
  • the main structure of the pharmaceutical excipient analysis and management device according to the present embodiment is the same as that of the first embodiment.
  • the pharmaceutical excipient analysis and management device is embedded in a server of a medical institution and used in combination with other medical service systems.
  • the doctor will information about a 3 year old male patient: body weight 15kg, fever 2d, sore throat and severe dry cough 3d, body temperature 39.5 ° C, clinical diagnosis of community-acquired pneumonia, doctor's advice is once a day 5% glucose injection hydrogenation prednisone injection intravenously, twice a day 0.9% sodium chloride injection plus cefmetazole for injection Sodium instillation, 0.9 times daily sodium chloride injection plus injection erythromycin lactobion intravenous input into the information input unit 1, the information processing unit 2 receives the information for analysis and management, and the information processing unit 2 detects
  • the prednisolone injection in the doctor's order contains the medicinal adjuvant ethanol, and the information processing unit 2 analyzes the ethanol and cefmetazole sodium having a methylthiotetrazole group (MTT) and uses a disulfiram-like reaction.
  • the main structure of the pharmaceutical excipient analysis and management device according to the present embodiment is the same as that of the first embodiment.
  • the pharmaceutical excipient analysis management device is embedded in a server of a medical institution and used in combination with other medical service systems, and the physician will information on a 28-year-old female drug user:
  • the diagnosis result of luteal insufficiency and the prescription of the intramuscular injection of velvet stimulating hormone into the information input unit 1 the information processing unit 2 receives the information, analyzes and manages, and the information processing unit 2 detects that the chorionic gonadotropin contains dextran 40,
  • the information processing unit 2 analyzes that the dextran-containing 40 has a sensitizing property, and the allergic physique must first perform a skin test for safety.
  • the information processing unit 2 sends the warning information to the window display unit 4 through the result feedback unit 3, the physician According to the warning information displayed by the window display unit 4, after analyzing the result and asking the drug user, the prescription is suspended, the drug user is arranged to do the skin test, and the prescription drug selection is completed according to the skin test result.
  • the main structure of the pharmaceutical excipient analysis and management device according to the present embodiment is the same as that of the first embodiment.
  • the pharmacist inputs a group of anti-allergic prescriptions including vitamin C for injection and calcium gluconate injection into the information input unit 1, and the information processing unit 2 receives After the information is analyzed and managed, the information processing unit 2 detects that the vitamin C powder needle auxiliary contains anhydrous sodium carbonate, and the information processing unit 2 analyzes that the vitamin C powder needle auxiliary material contains anhydrous sodium carbonate, which may be produced with calcium gluconate injection.
  • the information processing unit 2 sends the warning information to the window display unit 4 through the result feedback unit 3, and the pharmacist analyzes the result according to the warning information displayed by the window display unit 4, and communicates with the doctor who prescribes the prescription in time to return the prescription.
  • the main structure of the pharmaceutical excipient analysis and management device according to the present embodiment is the same as that of the first embodiment.
  • the stand-alone version or the online version of the pharmaceutical excipient analysis management device is used by the user to input a set of drug names purchased by the user into the information input unit 1 when the user uses the information, and the information processing unit 2 receives the information.
  • the medicinal auxiliary material compatibility analysis and the administration information management, the information processing unit 2 detects the contraindications and the taking information and the dietary taboo management of the medicinal auxiliary materials, and the information processing unit 2 sends the warning information to the window display unit 4 through the result feedback unit 3, the medicinal user According to the analysis result of the warning information displayed by the window display unit 4, the patient or the medical institution is consulted in time.

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Abstract

A device for analyzing and managing a pharmaceutical excipient. A main structure comprises an information input unit (1), an information processing unit (2), a result return unit (3), and a window display unit (4). Electrical connections are established between the information input unit and the information processing unit, between the information processing unit and the result feedback unit, and between the result feedback unit and the window display unit. The information input unit has input modes comprising a manual input mode, an online input mode, and a code scanning input mode. The information processing unit records, stores, analyzes, and manages information inputted by the information input unit. The result return unit sends to the window display unit the information analyzed and processed by the information processing unit. The window display unit displays a result returned by the result return unit, and provides, on the basis of a characteristic of a pharmaceutical excipient, pre-warning management of potential side effects before pharmaceutical administration. The present invention has the features of having a simple structure and practical functions, being easy to use, and providing superior safety, flexibility during use, and a friendly application context.

Description

一种药用辅料分析管理装置Pharmaceutical excipient analysis management device 技术领域：Technical field:
本发明属于医疗设备技术领域，具体涉及一种药用辅料分析管理装置，基于药用辅料特性分析用药的安全性，尤其是在用药者用药前，对潜在的不良后果进行预警管理，保障用药者安全合理的用药。The invention belongs to the technical field of medical equipment, and particularly relates to a pharmaceutical excipient analysis and management device, which analyzes the safety of the medicine based on the characteristics of the pharmaceutical excipients, especially before the medication is used, the early adverse management of the potential adverse consequences, and the protection of the drug users Safe and reasonable medication.
背景技术：Background technique:
药品是指以人为使用对象，预防、治疗、诊断人的疾病，有目的地调节人的生理机能并规定有适应症或者功能主治、用法和用量的物质，包括中药材、中药饮片、中成药、化学原料药及其制剂、抗生素、生化药品、放射性药品、血清、疫苗、血液制品和诊断药品；药品的种类复杂，品种繁多，全世界大约有20000余种；药品包装上印制的批准文号“国药准字H(或Z.S.J.B.F)+8位数字”表示其是国家药监局批准生产和上市销售的药品，H字母代表化学药品、Z中成药、S生物制品、J进口药品国内分包装、B具有辅助治疗作用的药品、F药用辅料；药用辅料是指在制剂处方设计时，为解决制剂的成型性、有效性、稳定性、安全性加入处方中除主药以外的一切药用物料的统称，包括生产药品和调配处方时使用的赋形剂和附加剂，药用辅料除了赋形、充当载体、提高稳定性外，还具有增溶、助溶和缓控释的重要功能，是可能会影响到药品的质量、安全性和有效性的重要成分；药用辅料是药物制剂的基础材料和重要组成部分，是保证药物制剂生产和发展的物质基础，在制剂剂型和生产中起着关键的作用，不仅赋予药物一定剂型，而且与提高药物的疗效和降低不良反应有很大的关系，其质量可靠性和多样性是保证剂型和制剂先进性的基础，药用辅料在制剂中作用分类有66种，包括溶剂、抛射剂、增溶剂、助溶剂、乳化剂、着色剂、黏合剂、崩解剂、填充剂、润滑剂、润湿剂、渗透压调节剂、稳定剂、助流剂、矫味剂、防腐剂、助悬剂、包衣材料、芳香剂、抗黏合剂、整合剂、渗透促进剂、pH值调节剂、缓冲剂、增塑剂、表面活性剂、发泡剂、消泡剂、增稠剂、包合剂、保湿剂、吸 收剂、稀释剂、絮凝剂与反絮凝剂、助滤剂和释放阻滞剂等；现有技术中的用药分析管理针对的都是药品中的主药，只对有效成分的药理毒理性质在用药安全方面作出预测，药品应用过程中，药品中的辅料和主药是共同作用于人体的，全程参与药品代谢动力学过程的，多种药品辅料基于自身特性对用药结果会发生重要影响，药用辅料不但具有一定的药理和毒理活性，也能影响药品理化性质及多种药物并用时的相容性，还能影响药品的代谢动力学参数和临床检验结果，当前临床常见的多药合用和序贯应用，不但增加了不同药品之间辅料与辅料和辅料与主药相互作用的机会，也提高了药品配伍禁忌产生不良后果的可能性；目前尚未有分析和管理药用辅料特性影响用药的安全性的专利或文献报道。因此，研发一种药用辅料分析管理装置，基于药用辅料特性分析用药的安全性，尤其是在用药者用药前，对潜在的不良后果进行预警管理，保障用药者及预防疫苗接种人群等用药的安全合理性，很有市场推广前景和应用价值。Drugs refer to substances that are used by humans to prevent, treat, and diagnose human diseases, purposefully regulate human physiology, and specify indications or functional indications, usage, and dosage, including Chinese herbal medicines, Chinese herbal medicines, Chinese patent medicines, Chemical raw materials and their preparations, antibiotics, biochemical drugs, radioactive drugs, serum, vaccines, blood products and diagnostic drugs; the types of drugs are complex and diverse, and there are more than 20,000 species in the world; the approval number printed on the drug packaging “National Medicine Standard H (or ZSJBF) + 8 digits” means that it is a drug approved by the State Food and Drug Administration for production and marketing. The H letter stands for chemical, Z proprietary Chinese medicine, S biological product, J imported drug domestic packaging, B has adjunctive therapeutic effects of drugs, F pharmaceutical excipients; pharmaceutical excipients refer to all the medicinal preparations other than the main drug in the formulation to solve the formability, effectiveness, stability and safety of the formulation during formulation design. The general term for materials, including the excipients and additives used in the production of pharmaceuticals and formulating prescriptions, in addition to shaping, serving as a carrier, improving stability In addition, it also has important functions of solubilization, solubilization and controlled release, and is an important component that may affect the quality, safety and effectiveness of pharmaceuticals. Pharmaceutical excipients are the basic materials and important components of pharmaceutical preparations. The material basis for ensuring the production and development of pharmaceutical preparations plays a key role in the formulation and production. It not only gives certain dosage forms of the medicine, but also has a great relationship with improving the efficacy of the medicine and reducing adverse reactions. Its quality reliability and variety Sex is the basis for ensuring the advanced nature of the dosage form and preparation. There are 66 kinds of pharmaceutical excipients in the preparation, including solvents, propellants, solubilizers, cosolvents, emulsifiers, colorants, binders, disintegrators, fillers. , lubricants, wetting agents, osmotic pressure regulators, stabilizers, glidants, flavoring agents, preservatives, suspending agents, coating materials, fragrances, anti-adhesives, integrators, penetration enhancers, pH Value modifier, buffer, plasticizer, surfactant, foaming agent, antifoaming agent, thickener, inclusion agent, moisturizer, suction Receptor, diluent, flocculant and deflocculant, filter aid and release retarder; the prior art drug analysis management is aimed at the main drug in the drug, only the pharmacological and toxicological properties of the active ingredient In the application of drug safety, in the application process of drugs, the auxiliary materials and main drugs in the drug work together in the human body, and participate in the process of pharmacokinetics. The various drug accessories will have an important impact on the drug results based on their own characteristics. Medicinal excipients not only have certain pharmacological and toxicological activities, but also affect the physical and chemical properties of the drug and the compatibility of various drugs, and can also affect the pharmacokinetic parameters and clinical test results of the drug. The combination and sequential application not only increase the chance of interaction between excipients and excipients and excipients and main drugs between different drugs, but also increase the possibility of adverse effects of drug incompatibility; there is no analysis and management of the effects of pharmaceutical excipients. Patent or literature report on the safety of medication. Therefore, the development of a pharmaceutical excipient analysis management device, based on the characteristics of pharmaceutical excipients to analyze the safety of drugs, especially before the drug users, early warning management of potential adverse consequences, to ensure that drug users and preventive vaccination population, etc. The safety and rationality of the market is very promising and application value.
发明内容：Summary of the invention:
本发明的目的在于克服现有技术存在的缺点，设计一种药用辅料分析管理装置，在现有药用辅料特性研究的基础上分析用药的安全性，尤其是在用药者用药前，对潜在的不良后果进行预警管理，保障用药者用药的安全合理性。The object of the present invention is to overcome the shortcomings of the prior art, and to design a pharmaceutical excipient analysis and management device, and analyze the safety of the drug based on the existing characteristics of the pharmaceutical excipients, especially before the drug users use the drug. The adverse consequences of early warning management to ensure the safety and rationality of drug users.
本发明涉及的药用辅料分析管理装置的主体结构包括信息输入单元、信息处理单元、结果反馈单元和窗口显示单元；信息输入单元与信息处理单元之间、信息处理单元与结果反馈单元之间和结果反馈单元与窗口显示单元之间均电连接，信息输入单元的输入方式包括手动输入、联机输入和扫码输入，信息处理单元记录、存储、分析和管理信息输入单元输入的信息，结果反馈单元将信息处理单元分析处理后的信息发送给窗口显示单元，窗口显示单元将结果反馈单元反馈的结果显示；能够嵌入医疗机构的服务器中使用，也能够在计算机、通讯设备和移动数据手持终端设备上联机或单机使用；管理者使用时，将药品和药用辅料的综述资料、药学研究资料、药用辅料的饮食禁忌、 因药用辅料自身性质而出现的不良后果信息、药用辅料之间以及药用辅料与药品主药之间的配伍禁忌信息输入到信息输入单元中，信息输入单元将上述信息发送给信息处理单元进行记录和存储，管理者定期维护、更新、修改、补充和删减上述信息；医师使用时，将用药者信息和医嘱处方输入信息输入单元中，信息处理单元收到信息后进行分析和管理并将分析结果通过结果反馈单元发送至窗口显示单元，医师根据窗口显示单元显示的分析结果进行处方开具或处方更正的操作，并将用药期间的注意事项和饮食禁忌告知处方使用者；药师使用时，将处方输入信息输入单元中，信息处理单元收到信息后进行分析和管理并将分析结果通过结果反馈单元发送至窗口显示单元，药师根据窗口显示单元显示的分析结果进行处方反馈至医师或直接提取处方的操作，并将注意事项和饮食禁忌告知处方药品拿取者；用药者使用时，将药品名称输入信息输入单元中，信息处理单元收到药品名称后进行分析和管理并将分析结果通过结果反馈单元发送至窗口显示单元，用药者根据窗口显示单元显示的分析结果进行用药或者放弃用药前往医疗机构咨询并开具新的处方，用药时根据窗口显示单元显示的注意事项和饮食禁忌提示信息服用药品。The main structure of the pharmaceutical excipient analysis management device according to the present invention includes an information input unit, an information processing unit, a result feedback unit, and a window display unit; between the information input unit and the information processing unit, between the information processing unit and the result feedback unit, and The result feedback unit and the window display unit are electrically connected. The input mode of the information input unit includes manual input, online input and scan code input, and the information processing unit records, stores, analyzes and manages information input by the information input unit, and the result feedback unit Sending the information processed by the information processing unit to the window display unit, the window display unit displays the result fed back by the result feedback unit; can be embedded in the server of the medical institution, and can also be used on the computer, the communication device, and the mobile data handheld terminal device. On-line or stand-alone use; when using the manager, review the information on pharmaceuticals and pharmaceutical excipients, pharmaceutical research materials, dietary taboos for pharmaceutical excipients, The information on the adverse consequences due to the nature of the medicinal excipients, the contraindications between the medicinal excipients and the medicinal excipients and the main drug are input into the information input unit, and the information input unit sends the above information to the information processing unit. For recording and storage, the administrator regularly maintains, updates, modifies, supplements, and deletes the above information; when the physician uses the medicinal information and the medical prescription, the information input unit is input, and the information processing unit analyzes and manages the information after receiving the information. The analysis result is sent to the window display unit through the result feedback unit, and the physician performs the prescription preparation or the prescription correction operation according to the analysis result displayed by the window display unit, and informs the prescription user of the precautions and dietary contraindications during the medication; when the pharmacist uses, The prescription input information is input into the unit, the information processing unit receives the information, analyzes and manages the information, and sends the analysis result to the window display unit through the result feedback unit, and the pharmacist performs the prescription feedback to the physician according to the analysis result displayed by the window display unit or directly extracts Prescription operation, and Precautions and dietary contraindications inform the prescription drug taker; when the drug user uses, enter the drug name into the information input unit, the information processing unit receives the drug name, analyzes and manages the result, and sends the analysis result to the window display through the result feedback unit. In the unit, the drug user takes the medicine according to the analysis result displayed by the window display unit or abandons the medicine to consult with the medical institution and issues a new prescription, and takes the medicine according to the cautions displayed by the window display unit and the dietary taboo information.
本发明涉及的药用辅料分析管理装置的原理是：相关医学研究表明，以前视为无活性的药用辅料其实存在明显的药理作用，现有部分收入《中国药典》化学药品目录药用辅料本身能够作为药物，药用辅料不是惰性组分，其包括的药理作用和理化参数特性会改变药物代谢动力学参数、引发其他疾病、导致诊断方法或检验结果可靠性下降、引起或增强毒性反应、引起变态反应、提高疾病易感性、加重病情、以及预后转归，为保证用药安全，必须对药用辅料重新审视、分析、管理和预警。The principle of the pharmaceutical excipient analysis and management device involved in the present invention is as follows: related medical research shows that the pharmaceutical excipients previously considered to be inactive have obvious pharmacological effects, and the existing part of the income is the Chinese Pharmacopoeia chemical drug catalogue. Can be used as a drug, pharmaceutical excipients are not inert components, and their pharmacological and physicochemical parameters include changes in pharmacokinetic parameters, trigger other diseases, lead to decreased reliability of diagnostic methods or test results, cause or enhance toxicity, cause Allergies, improvement of disease susceptibility, aggravation of the disease, and prognosis of the disease, in order to ensure the safety of medication, re-examination, analysis, management and early warning of pharmaceutical excipients.
本发明涉及的药用辅料分析管理装置从药品中的药用辅料影响预防、诊疗和康复活动的角度为用药行为提供分析、管理和预警服务，为用药的安全合理性提供新的保障领域，能够为药物分析和管理医务人员提供参考和帮助，能够为护理、临床检验和影像学医务人员提供 参考意见，也能够为预防、康复和社会健康查体机构的工作人员提供专业的分析反馈意见，有利于提高医疗服务的专业水准和安全性，甚至不具备药品知识基础的普通用户也能够就具体药品进行分析和管理，为行动不便和远离医疗机构的用药者带来方便。The pharmaceutical excipient analysis and management device according to the present invention provides analysis, management and early warning services for drug use behavior from the perspective of the influence of the pharmaceutical excipients in the prevention, diagnosis, treatment and rehabilitation activities, and provides a new protection field for the safety and rationality of the drug use. Provides reference and assistance for drug analysis and management of medical staff, and can provide care, clinical laboratory and imaging medical staff The reference opinion can also provide professional analysis and feedback for the staff of prevention, rehabilitation and social health examination institutions, which is conducive to improving the professional level and safety of medical services. Even ordinary users who do not have the knowledge base of drugs can also The analysis and management of drugs facilitates mobility and inaccessibility to medical institutions.
本发明与现有技术相比，通过收集药用辅料和药品数据信息建立数据库、关联相关网站并实时对数据信息进行更新，整合药用辅料的研究资源用于安全用药服务中，输入用药信息后能够准确快速得到用药分析结果，具有可靠性和可持续发展性，整个装置的适应性强，承载其的载体和终端形式多样，适应社会发展潮流，能够单独使用，也能够将其整合入现有用药管理系统或嵌入医疗机构的服务器中结合医疗服务系统共同使用，避免大量繁琐的人工监测工作，提高工作效率，减轻劳动强度，最大程度上实现用药安全性管理；其结构简单，功能实用，操作简便，安全性能好，使用方式灵活，应用环境友好。Compared with the prior art, the present invention establishes a database, associates related websites, and updates data information in real time by collecting medical auxiliary materials and drug data information, and integrates research resources of pharmaceutical excipients into safe drug service, and inputs drug information. It can accurately and quickly obtain the results of drug analysis, with reliability and sustainable development. The whole device is adaptable, and the carriers and terminals that carry it are diverse, adapt to the trend of social development, can be used alone, and can be integrated into existing The drug management system or the server embedded in the medical institution is used in combination with the medical service system to avoid a lot of cumbersome manual monitoring work, improve work efficiency, reduce labor intensity, and maximize drug safety management; the structure is simple, the function is practical, and the operation Simple, safe, flexible, and application friendly.
附图说明：BRIEF DESCRIPTION OF THE DRAWINGS:
图1是本发明的主体结构原理示意图。1 is a schematic view showing the principle of the main structure of the present invention.
具体实施方式：detailed description:
下面结合附图通过实施例对本发明做进一步描述。The invention will be further described by way of examples with reference to the accompanying drawings.
实施例1：Example 1:
本实施例涉及的药用辅料分析管理装置的主体结构包括信息输入单元1、信息处理单元2、结果反馈单元3和窗口显示单元4；信息输入单元1与信息处理单元2之间、信息处理单元2与结果反馈单元3之间和结果反馈单元3与窗口显示单元4之间均电连接，信息输入单元1的输入方式包括手动输入、联机输入和扫码输入，信息处理单元2记录、存储、分析和管理信息输入单元1输入的信息，结果反馈单元3将信息处理单元2分析处理后得信息发送给窗口显示单元4，窗口显示单元4将结果反馈单元3反馈的结果显示。The main structure of the pharmaceutical excipient analysis management device according to the embodiment includes an information input unit 1, an information processing unit 2, a result feedback unit 3, and a window display unit 4; between the information input unit 1 and the information processing unit 2, and an information processing unit 2 and the result feedback unit 3 and the result feedback unit 3 and the window display unit 4 are electrically connected, the input mode of the information input unit 1 includes manual input, online input and scan code input, and the information processing unit 2 records, stores, The information input by the information input unit 1 is analyzed and managed, and the result feedback unit 3 transmits the information analyzed and processed by the information processing unit 2 to the window display unit 4, and the window display unit 4 displays the result fed back by the result feedback unit 3.
本实施例涉及的药用辅料分析管理装置嵌入医疗机构的服务器中与其他医疗服务系统结合使用，医师将早产出生3.5小时的男患儿的信息：患儿胎龄26周，出生体重0.83kg，超未成熟儿，新生儿重 度窒息，新生儿呼吸暂停，新生儿低血糖症，新生儿高血糖症，新生儿低体温，凝血功能异常，混合性酸中毒和医嘱为静注人免疫球蛋白1.6g ST ivgtt免疫支持输入信息输入单元1中，信息处理单元2收到信息后进行分析和管理，检测到患儿血糖有波动，入院以来始终以采用葡萄糖脱氢酶吡咯喹啉醌(GDH-PQQ)酶技术的血糖监测系统定时监测血糖的记录，信息处理单元2发现人免疫球蛋白含有辅料麦芽糖，信息处理单元2分析得出静注人免疫球蛋白后监测血糖可能产生假性高血糖的预警信息，信息处理单元2将预警信息通过结果反馈单元3发送至窗口显示单元4，医师根据窗口显示单元4显示的预警信息，分析结果并改变用药医嘱或改用不同工作机理的血糖监测系统，避免受药用辅料影响导致的血糖值误差，开具错误的处方。The pharmaceutical excipient analysis management device according to the embodiment is embedded in the server of the medical institution and used in combination with other medical service systems, and the doctor will prematurely give birth to the information of the male child born 3.5 hours: the gestational age of the child is 26 weeks, and the birth weight is 0.83 kg. Super immature child, newborn weight Asphyxia, neonatal apnea, neonatal hypoglycemia, neonatal hyperglycemia, neonatal hypothermia, abnormal coagulation, mixed acidosis and medical advice for intravenous immunoglobulin 1.6g ST ivgtt immune support input In the input unit 1, the information processing unit 2 analyzes and manages the information, and detects that the blood sugar of the child is fluctuating. Since the hospital admission, the blood glucose monitoring system using the glucose dehydrogenase pyrroloquinoline quinone (GDH-PQQ) enzyme technology has been used. Regularly monitoring the blood glucose record, the information processing unit 2 finds that the human immunoglobulin contains the adjuvant maltose, and the information processing unit 2 analyzes and obtains the early warning information that the blood glucose may generate pseudo-hyperglycemia after the intravenous injection of the immunoglobulin, and the information processing unit 2 The warning information is sent to the window display unit 4 through the result feedback unit 3, and the physician analyzes the result according to the warning information displayed by the window display unit 4, and changes the medication order or the blood glucose monitoring system using different working mechanisms to avoid the influence of the medicinal auxiliary materials. Blood sugar value error, prescribing a wrong prescription.
实施例2：Example 2:
本实施例涉及的药用辅料分析管理装置的主体结构同实施例1。The main structure of the pharmaceutical excipient analysis and management device according to the present embodiment is the same as that of the first embodiment.
本实施例涉及的药用辅料分析管理装置嵌入医疗机构的服务器中与其他医疗服务系统结合使用，医师将3岁的男患儿的信息：体重15kg，发热2d，咽痛和剧烈干咳3d，体温39.5℃，临床诊断为社区获得性肺炎，医嘱为每日1次5％葡萄糖注射液加氢化泼尼松注射液静滴，每日2次0.9％氯化钠注射液加注射用头孢美唑钠静滴，每日2次0.9％氯化钠注射液加注射用乳糖酸红霉素静滴输入信息输入单元1中，信息处理单元2收到信息后进行分析和管理，信息处理单元2检测到医嘱中的氢化泼尼松注射液含有药用辅料乙醇，信息处理单元2分析得出乙醇与具有甲硫四氮唑基团(MTT)的头孢美唑钠并用有发生双硫仑样反应的可能性，信息处理单元2将预警信息通过结果反馈单元3发送至窗口显示单元4，医师根据窗口显示单元4显示的预警信息，分析结果并及时改变医嘱，避免发生双硫仑样反应。The pharmaceutical excipient analysis and management device according to the embodiment is embedded in a server of a medical institution and used in combination with other medical service systems. The doctor will information about a 3 year old male patient: body weight 15kg, fever 2d, sore throat and severe dry cough 3d, body temperature 39.5 ° C, clinical diagnosis of community-acquired pneumonia, doctor's advice is once a day 5% glucose injection hydrogenation prednisone injection intravenously, twice a day 0.9% sodium chloride injection plus cefmetazole for injection Sodium instillation, 0.9 times daily sodium chloride injection plus injection erythromycin lactobion intravenous input into the information input unit 1, the information processing unit 2 receives the information for analysis and management, and the information processing unit 2 detects The prednisolone injection in the doctor's order contains the medicinal adjuvant ethanol, and the information processing unit 2 analyzes the ethanol and cefmetazole sodium having a methylthiotetrazole group (MTT) and uses a disulfiram-like reaction. Possibility, the information processing unit 2 sends the warning information to the window display unit 4 through the result feedback unit 3, and the physician analyzes the result according to the warning information displayed by the window display unit 4 and changes the medical order in time to avoid double occurrence. Lun like reaction.
实施例3：Example 3:
本实施例涉及的药用辅料分析管理装置的主体结构同实施例1。The main structure of the pharmaceutical excipient analysis and management device according to the present embodiment is the same as that of the first embodiment.
本实施例涉及的药用辅料分析管理装置嵌入医疗机构的服务器中与其他医疗服务系统结合使用，医师将28岁的女用药者的信息： 黄体功能不全的诊断结果和肌肉注射绒促性素的医嘱处方输入信息输入单元1中，信息处理单元2收到信息后进行分析和管理，信息处理单元2检测到绒促性素含有右旋糖酐40，信息处理单元2分析得出含有右旋糖酐40具有致敏特性，过敏体质者必须先行皮试以策安全，应予注意，信息处理单元2将预警信息通过结果反馈单元3发送至窗口显示单元4，医师根据窗口显示单元4显示的预警信息，分析结果并询问用药者后，暂停开具处方，安排用药者先做皮试，再根据皮试结果完成处方药品的遴选。The pharmaceutical excipient analysis management device according to the embodiment is embedded in a server of a medical institution and used in combination with other medical service systems, and the physician will information on a 28-year-old female drug user: The diagnosis result of luteal insufficiency and the prescription of the intramuscular injection of velvet stimulating hormone into the information input unit 1, the information processing unit 2 receives the information, analyzes and manages, and the information processing unit 2 detects that the chorionic gonadotropin contains dextran 40, The information processing unit 2 analyzes that the dextran-containing 40 has a sensitizing property, and the allergic physique must first perform a skin test for safety. It should be noted that the information processing unit 2 sends the warning information to the window display unit 4 through the result feedback unit 3, the physician According to the warning information displayed by the window display unit 4, after analyzing the result and asking the drug user, the prescription is suspended, the drug user is arranged to do the skin test, and the prescription drug selection is completed according to the skin test result.
实施例4：Example 4:
本实施例涉及的药用辅料分析管理装置的主体结构同实施例1。The main structure of the pharmaceutical excipient analysis and management device according to the present embodiment is the same as that of the first embodiment.
本实施例涉及的药用辅料分析管理装置在药房单独使用时，药师将一组包括注射用维生素C和葡萄糖酸钙注射液的抗过敏药处方输入信息输入单元1中，信息处理单元2收到信息后进行分析和管理，信息处理单元2检测到维生素C粉针辅料含有无水碳酸钠，信息处理单元2分析得出维生素C粉针辅料含有无水碳酸钠，可能与葡萄糖酸钙注射液产生配伍禁忌，信息处理单元2将预警信息通过结果反馈单元3发送至窗口显示单元4，药师根据窗口显示单元4显示的预警信息，分析结果并及时与开具处方的医师沟通后退回处方。When the pharmaceutical excipient analysis management device according to the embodiment is used alone in the pharmacy, the pharmacist inputs a group of anti-allergic prescriptions including vitamin C for injection and calcium gluconate injection into the information input unit 1, and the information processing unit 2 receives After the information is analyzed and managed, the information processing unit 2 detects that the vitamin C powder needle auxiliary contains anhydrous sodium carbonate, and the information processing unit 2 analyzes that the vitamin C powder needle auxiliary material contains anhydrous sodium carbonate, which may be produced with calcium gluconate injection. Incompatibility, the information processing unit 2 sends the warning information to the window display unit 4 through the result feedback unit 3, and the pharmacist analyzes the result according to the warning information displayed by the window display unit 4, and communicates with the doctor who prescribes the prescription in time to return the prescription.
实施例5：Example 5:
本实施例涉及的药用辅料分析管理装置的主体结构同实施例1。The main structure of the pharmaceutical excipient analysis and management device according to the present embodiment is the same as that of the first embodiment.
本实施例涉及的药用辅料分析管理装置的单机版或网络版在用药者自行使用时，用药者将自行购买的一组药品名称输入信息输入单元1中，信息处理单元2收到信息后进行药用辅料配伍分析和服用信息管理，信息处理单元2检测到药用辅料配伍禁忌和服用信息及饮食禁忌管理，信息处理单元2将预警信息通过结果反馈单元3发送至窗口显示单元4，用药者根据窗口显示单元4显示的预警信息分析结果进行服用或及时前往医疗机构咨询医师。 The stand-alone version or the online version of the pharmaceutical excipient analysis management device according to the embodiment is used by the user to input a set of drug names purchased by the user into the information input unit 1 when the user uses the information, and the information processing unit 2 receives the information. The medicinal auxiliary material compatibility analysis and the administration information management, the information processing unit 2 detects the contraindications and the taking information and the dietary taboo management of the medicinal auxiliary materials, and the information processing unit 2 sends the warning information to the window display unit 4 through the result feedback unit 3, the medicinal user According to the analysis result of the warning information displayed by the window display unit 4, the patient or the medical institution is consulted in time.

Claims (1)

  1. 一种药用辅料分析管理装置，其特征在于主体结构包括信息输入单元、信息处理单元、结果反馈单元和窗口显示单元；信息输入单元与信息处理单元之间、信息处理单元与结果反馈单元之间和结果反馈单元与窗口显示单元之间均电连接，信息输入单元的输入方式包括手动输入、联机输入和扫码输入，信息处理单元记录、存储、分析和管理信息输入单元输入的信息，结果反馈单元将信息处理单元分析处理后的信息发送给窗口显示单元，窗口显示单元将结果反馈单元反馈的结果显示；能够嵌入医疗机构的服务器中使用，也能够在计算机、通讯设备和移动数据手持终端设备上联机或单机使用；管理者使用时，将药品和药用辅料的综述资料、药学研究资料、药用辅料的饮食禁忌、因药用辅料自身性质而出现的不良后果信息、药用辅料之间以及药用辅料与药品主药之间的配伍禁忌信息输入到信息输入单元中，信息输入单元将上述信息发送给信息处理单元进行记录和存储，管理者定期维护、更新、修改、补充和删减上述信息；医师使用时，将用药者信息和医嘱处方输入信息输入单元中，信息处理单元收到信息后进行分析和管理并将分析结果通过结果反馈单元发送至窗口显示单元，医师根据窗口显示单元显示的分析结果进行处方开具或处方更正的操作，并将用药期间的注意事项和饮食禁忌告知处方使用者；药师使用时，将处方输入信息输入单元中，信息处理单元收到信息后进行分析和管理并将分析结果通过结果反馈单元发送至窗口显示单元，药师根据窗口显示单元显示的分析结果进行处方反馈至医师或直接提取处方的操作，并将注意事项和饮食禁忌告知处方药品拿取者；用药者使用时，将药品名称输入信息输入单元中，信息处理单元收到药品名称后进行分析和管理并将分析结果通过结果反馈单元发送至窗口显示单元，用药者根据窗口显示单元显示的分析结果进行用药或者放弃用药前往医疗机构咨询并开具新的处方，用药时根据窗口显示单元显示的注意事项和饮食禁忌提示信息服用药品。 A pharmaceutical excipient analysis management device, characterized in that the main structure comprises an information input unit, an information processing unit, a result feedback unit and a window display unit; between the information input unit and the information processing unit, between the information processing unit and the result feedback unit And the result feedback unit and the window display unit are electrically connected, the input mode of the information input unit includes manual input, online input and scan code input, and the information processing unit records, stores, analyzes and manages the information input by the information input unit, and the result feedback The unit sends the information processed by the information processing unit to the window display unit, and the window display unit displays the result fed back by the result feedback unit; can be embedded in the server of the medical institution, and can also be used in the computer, the communication device, and the mobile data handheld terminal device. On-line or stand-alone use; when using the manager, the review information of pharmaceuticals and pharmaceutical excipients, pharmaceutical research materials, dietary contraindications for pharmaceutical excipients, information on adverse effects due to the nature of pharmaceutical excipients, and excipients And pharmaceutical excipients and medicines The incompatibility information between the main drugs is input into the information input unit, and the information input unit sends the above information to the information processing unit for recording and storage, and the manager periodically maintains, updates, modifies, supplements, and deletes the above information; The medication information and the medical prescription are input into the information input unit, and the information processing unit analyzes and manages the information, and sends the analysis result to the window display unit through the result feedback unit, and the physician performs the prescription according to the analysis result displayed by the window display unit. Initiating or correcting the prescription, and notifying the prescribing user of the precautions and dietary contraindications during the medication; when using the pharmacist, input the prescription into the information input unit, and the information processing unit will analyze and manage the information and pass the analysis result. The result feedback unit is sent to the window display unit, and the pharmacist performs the prescription feedback to the physician or directly extracts the prescription according to the analysis result displayed by the window display unit, and informs the prescription drug taker of the precaution and the dietary contraindication; when the drug user uses, Drug name input In the information input unit, the information processing unit analyzes and manages the drug name, and sends the analysis result to the window display unit through the result feedback unit, and the drug user uses the analysis result displayed by the window display unit to administer the drug or abandon the drug to the medical institution for consultation. And prescribe a new prescription, take the medicine according to the precautions and dietary taboo information displayed on the window display unit.
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