WO2023155321A1 - 一种egfr类分子靶向抗肿瘤药物的制备方法 - Google Patents

一种egfr类分子靶向抗肿瘤药物的制备方法 Download PDF

Info

Publication number
WO2023155321A1
WO2023155321A1 PCT/CN2022/094837 CN2022094837W WO2023155321A1 WO 2023155321 A1 WO2023155321 A1 WO 2023155321A1 CN 2022094837 W CN2022094837 W CN 2022094837W WO 2023155321 A1 WO2023155321 A1 WO 2023155321A1
Authority
WO
WIPO (PCT)
Prior art keywords
drug
test
preparation
tumor
drugs
Prior art date
Application number
PCT/CN2022/094837
Other languages
English (en)
French (fr)
Inventor
李小维
Original Assignee
上海龙翔生物医药开发有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 上海龙翔生物医药开发有限公司 filed Critical 上海龙翔生物医药开发有限公司
Publication of WO2023155321A1 publication Critical patent/WO2023155321A1/zh

Links

Images

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents

Definitions

  • the invention relates to the technical field of preparation of anti-tumor drugs, in particular to a preparation method of EGFR molecular-targeted anti-tumor drugs.
  • Lung cancer is the cancer with the highest morbidity and mortality, which seriously threatens human health and life.
  • Lung cancer is mainly divided into small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC), of which about 80% are NSCLC.
  • SCLC small cell lung cancer
  • NSCLC non-small cell lung cancer
  • SCLC mainly relies on surgical treatment, but most NSCLC patients are already in the middle and advanced stages when they are first diagnosed, and can only be treated with drugs.
  • SCLC mainly relies on combined chemotherapy or radiotherapy.
  • the treatment of lung cancer has been advancing in exploration. With the continuous development of medicine, new lung cancer treatment modes such as small molecule targeted therapy and immunotherapy are becoming more and more common.
  • non-small cell lung cancer has entered the stage of "individualized" treatment, and targeted drugs with better effects and fewer side effects are gradually replacing traditional chemotherapy drugs as first-line drugs. Now lung cancer patients will more or less undergo genetic testing to see if there are suitable targeted drugs.
  • the most common mutation in non-small cell lung cancer and targeted drugs is "epidermal growth factor receptor” (EGFR) mutation. Therefore, the use of epidermal growth factor receptor EGFR molecular targeting drugs is one of the biggest research hotspots in the treatment of lung cancer.
  • EGFR epidermal growth factor receptor
  • the purpose of the present invention is to solve the problem that the existing molecular targeting antineoplastic drug preparation technology still has low drug effect due to simple preparation technology, and proposes a preparation method of EGFR class molecular targeting antineoplastic drug.
  • a preparation method of EGFR molecular targeting antitumor drug comprising the following steps:
  • S1 Raw material preparation and preparation: prepare the raw materials required for the preparation of the drug, and prepare the drug;
  • S3 drug test: carry out drug test on the drug that is judged to meet the quality standard of the drug
  • professionals select icotinib hydrochloride as the raw material for the preparation of the EGFR molecule-targeted antineoplastic drug, and transport the selected preparation raw materials to a sterile room, and prepare the icotinib hydrochloride by professionals.
  • EGFR molecules target anti-tumor drugs, and put the prepared drugs into a tablet machine to obtain solid tablets of equal weight, wherein the weight of the solid tablets is kept within 100-140 mg;
  • the prepared solid tablet is subjected to drug inspection, wherein the drug inspection is a sampling inspection performed manually by a professional, the number of sampling tablets: the total number of tablets is 1:150, and the inspection is performed by a professional
  • the personnel check the weight, properties, and raw material content of the drug, and judge whether the drug meets the drug quality standard through the inspection results manually, and process the prepared drug through the judgment result, wherein the judgment result is that the drug does not meet the requirements.
  • the drug quality standard is to recover the drug prepared in the same batch, and if the result of the judgment is that the drug meets the drug quality standard, the prepared drug will be tested;
  • the drug test is carried out on the drug that is judged to meet the drug quality standard, wherein the prepared drug is regularly and quantitatively delivered to the test subject through direct oral administration and oral administration of drug dissolution during the drug test, so that
  • the above-mentioned test subjects are selected by professionals, and the interval time and dose of drug delivery are selected by professionals through the test subjects, and the test subjects are monitored in real time during the test, wherein the real-time monitoring is carried out by professionals on the test subjects.
  • Real-time observation of the activity status and regular physical fitness testing of the test subjects, and professionals can judge whether there is rejection of the drug through the test subject's activity status.
  • the tumor cell clearance rate of the drug is calculated by the change in the number of cells.
  • the delivery of the drug will be stopped for the same type of test subject, and the test subject will be fully tested, and the drug rejection will be analyzed through the comprehensive test results.
  • Response factors wherein the drug rejection factor comes from the drug, then the test subject is changed, and the drug rejection factor comes from the test subject itself, and the drug delivery is continued to other test subjects of the same type;
  • the treatment is performed by a professional, and before the treatment, the treatment is carried out by the professional according to the change in the activity state of the test subject during the drug test.
  • grade 1 is less than 10% of BSA papules, pustules, itching and tenderness
  • grade 2 is 10-30% of BSA papules, pustules, itching, Papules, pustules, itching, tenderness, and limitation of daily self-care with greater than 30% BSA in grade 3
  • papules, pustules, with papules, pustules, and Pruritus, tenderness, and superinfection the test subjects with rejection reactions were treated by professionals according to grades, and the test subjects with grade 1 were treated with topical antibiotics, topical steroids, and emollients.
  • Treatment treatment the test subjects with grade 2 are treated with oral antibiotics for 4-5 weeks, and the test subjects with grade 3 are treated with oral antibiotics for 7-8 weeks;
  • the drug is subpackaged, coded, packaged and stored in the warehouse, wherein the drug is covered with aluminum foil during subpackaging, and the internal air is pumped out for storage in the warehouse
  • the relative humidity of the storage environment is kept at 50-60%, and the storage temperature is kept at 18-22°C.
  • the purpose of the present invention is to test the medicine during the preparation process of the medicine, and recover the medicine that does not meet the quality standards of the medicine, so that the produced medicine has sufficient medicinal properties, and at the same time, the tumor resistance of the medicine is improved by testing the medicine. Cell clearance, enhancing drug performance.
  • Fig. 1 is a flow chart of a preparation method of an EGFR molecule-targeted anti-tumor drug proposed by the present invention.
  • a kind of preparation method of EGFR molecular targeting antitumor drug comprises the following steps:
  • Raw material preparation and preparation Professionals select icotinib hydrochloride as the raw material for the preparation of the EGFR molecular-targeted anti-tumor drug, and transport the selected raw materials to the sterile room, and the professional prepares EGFR Molecule-like targeted anti-tumor drugs, and put the prepared drugs into a tablet press to obtain solid tablets of equal weight, wherein the weight of the solid tablets is kept within 100-140 mg;
  • Drug inspection The prepared solid tablets are subjected to drug inspection, wherein the drug inspection is a sampling inspection performed manually by professionals. The weight, properties, and raw material content of the drug, and manually judge whether the drug meets the drug quality standard through the inspection results, and process the prepared drug through the judgment result, wherein the judgment result is that the drug does not meet the drug quality standard Then, the medicine prepared in the same batch is recovered, and if the result of the judgment is that the medicine meets the quality standard of the medicine, the prepared medicine is inspected;
  • Drug test The drug test is carried out on the drug that is judged to meet the quality standards of the drug, wherein the prepared drug is regularly and quantitatively delivered to the test subject through direct oral administration and drug dissolving oral administration during the drug test, and the test subject It is selected by professionals, and the drug delivery interval and dose are selected by professionals through the test subjects, and the test subjects are monitored in real time during the test, wherein the real-time monitoring is carried out by professionals on the activity status of the test subjects. Real-time observation and regular physical fitness testing of the test subjects, and professionals judge whether there is rejection of the drug through the activity status of the test subjects. The tumor cell clearance rate of the drug is calculated by the change.
  • the drug delivery will be stopped for the same type of test subject, and the test subject will be comprehensively tested, and the factors of drug rejection will be analyzed through the comprehensive test results. Among them, if the drug rejection factor comes from the drug, the test subject will be changed; if the drug rejection factor comes from the test subject itself, the drug delivery will continue to other test subjects of the same type;
  • S4 Therapeutic treatment: The test subject who is judged to have a rejection reaction to the drug will be treated by a professional after the drug delivery is stopped, and before the treatment, the professional will grade the change in the activity state of the test subject during the drug test, among which The classification is divided into four grades, grade 1 is papules, pustules, itching and tenderness in less than 10% of BSA, and grade 2 is papules, pustules, itching and tenderness in 10-30% of BSA and limited activities of daily living. Grade 3 is more than 30% BSA with papules, pustules, itching, tenderness, and daily self-care limitation. Grade 4 is papules, pustules, itching, and pain with BSA percentage.
  • test subjects with rejection reaction will be treated by professionals according to grades, and the test subjects with grade 1 will be treated with topical antibiotics, topical steroids, and emollients,
  • the test subjects with grade 2 were treated with oral antibiotics for 4-5 weeks, and the test subjects with grade 3 were treated with oral antibiotics for 7-8 weeks;
  • a kind of preparation method of EGFR molecular targeting antitumor drug comprises the following steps:
  • Raw material preparation and preparation Professionals select icotinib hydrochloride as the raw material for the preparation of the EGFR molecular-targeted anti-tumor drug, and transport the selected raw materials to the sterile room, and the professional prepares EGFR Molecule-like targeted anti-tumor drugs, and put the prepared drugs into a tablet press to obtain solid tablets of equal weight, wherein the weight of the solid tablets is kept within 100-140 mg;
  • Drug inspection The prepared solid tablets are subjected to drug inspection, wherein the drug inspection is a sampling inspection performed manually by professionals. The weight, properties, and raw material content of the drug, and manually judge whether the drug meets the drug quality standards through the inspection results;
  • Drug test The drug test is carried out on the drug that is judged to meet the quality standards of the drug, wherein the prepared drug is regularly and quantitatively delivered to the test subject through direct oral administration and drug dissolving oral administration during the drug test, and the test subject It is selected by professionals, and the drug delivery interval and dose are selected by professionals through the test subjects, and the test subjects are monitored in real time during the test, wherein the real-time monitoring is carried out by professionals on the activity status of the test subjects. Real-time observation and regular physical fitness testing of the test subjects, and professionals judge whether there is rejection of the drug through the activity status of the test subjects. The tumor cell clearance rate of the drug is calculated by the change.
  • the drug delivery will be stopped for the same type of test subject, and the test subject will be comprehensively tested, and the factors of drug rejection will be analyzed through the comprehensive test results. Among them, if the drug rejection factor comes from the drug, the test subject will be changed; if the drug rejection factor comes from the test subject itself, the drug delivery will continue to other test subjects of the same type;
  • S4 Therapeutic treatment: The test subject who is judged to have a rejection reaction to the drug will be treated by a professional after the drug delivery is stopped, and before the treatment, the professional will grade the change in the activity state of the test subject during the drug test, among which The classification is divided into four grades, grade 1 is papules, pustules, itching and tenderness in less than 10% of BSA, and grade 2 is papules, pustules, itching and tenderness in 10-30% of BSA and limited activities of daily living. Grade 3 is more than 30% BSA with papules, pustules, itching, tenderness, and daily self-care limitation. Grade 4 is papules, pustules, itching, and pain with BSA percentage.
  • test subjects with rejection reaction will be treated by professionals according to grades, and the test subjects with grade 1 will be treated with topical antibiotics, topical steroids, and emollients,
  • the test subjects with grade 2 were treated with oral antibiotics for 4-5 weeks, and the test subjects with grade 3 were treated with oral antibiotics for 7-8 weeks;
  • a kind of preparation method of EGFR molecular targeting antitumor drug comprises the following steps:
  • Raw material preparation and preparation Professionals select icotinib hydrochloride as the raw material for the preparation of the EGFR molecular-targeted anti-tumor drug, and transport the selected raw materials to the sterile room, and the professional prepares EGFR Molecule-like targeted anti-tumor drugs, and put the prepared drugs into a tablet press to obtain solid tablets of equal weight, wherein the weight of the solid tablets is kept within 100-140 mg;
  • Drug inspection The prepared solid tablets are subjected to drug inspection, wherein the drug inspection is a sampling inspection performed manually by professionals. The weight, properties, and raw material content of the drug, and manually judge whether the drug meets the drug quality standard through the inspection results, and process the prepared drug through the judgment result, wherein the judgment result is that the drug does not meet the drug quality standard Then, the medicine prepared in the same batch is recovered, and if the result of the judgment is that the medicine meets the quality standard of the medicine, the prepared medicine is inspected;
  • Drug test The drug test is carried out on the drug that is judged to meet the quality standards of the drug, wherein the prepared drug is regularly and quantitatively delivered to the test subject through direct oral administration and drug dissolving oral administration during the drug test, and the test subject It is selected by professionals, and the drug delivery interval and dose are selected by professionals through the test subjects;
  • S4 Therapeutic treatment: The test subject who is judged to have a rejection reaction to the drug will be treated by a professional after the drug delivery is stopped, and before the treatment, the professional will grade the change in the activity state of the test subject during the drug test, among which The classification is divided into four grades, grade 1 is papules, pustules, itching and tenderness in less than 10% of BSA, and grade 2 is papules, pustules, itching and tenderness in 10-30% of BSA and limited activities of daily living. Grade 3 is more than 30% BSA with papules, pustules, itching, tenderness, and daily self-care limitation. Grade 4 is papules, pustules, itching, and pain with BSA percentage.
  • test subjects with rejection reaction will be treated by professionals according to grades, and the test subjects with grade 1 will be treated with topical antibiotics, topical steroids, and emollients,
  • the test subjects with grade 2 were treated with oral antibiotics for 4-5 weeks, and the test subjects with grade 3 were treated with oral antibiotics for 7-8 weeks;
  • a kind of preparation method of EGFR molecular targeting antitumor drug comprises the following steps:
  • Raw material preparation and preparation Professionals select icotinib hydrochloride as the raw material for the preparation of the EGFR molecular-targeted anti-tumor drug, and transport the selected raw materials to the sterile room, and the professional prepares EGFR Molecule-like targeted anti-tumor drugs, and put the prepared drugs into a tablet press to obtain solid tablets of equal weight, wherein the weight of the solid tablets is kept within 100-140 mg;
  • Drug inspection The prepared solid tablets are subjected to drug inspection, wherein the drug inspection is a sampling inspection performed manually by professionals. The weight, properties, and raw material content of the drug, and manually judge whether the drug meets the drug quality standard through the inspection results, and process the prepared drug through the judgment result, wherein the judgment result is that the drug does not meet the drug quality standard Then, the medicine prepared in the same batch is recovered, and if the result of the judgment is that the medicine meets the quality standard of the medicine, the prepared medicine is inspected;
  • Drug test The drug test is carried out on the drug that is judged to meet the quality standards of the drug, wherein the prepared drug is regularly and quantitatively delivered to the test subject through direct oral administration and drug dissolving oral administration during the drug test, and the test subject It is selected by professionals, and the drug delivery interval and dose are selected by professionals through the test subjects, and the test subjects are monitored in real time during the test, wherein the real-time monitoring is carried out by professionals on the activity status of the test subjects. Real-time observation and regular physical fitness testing of the test subjects, and professionals judge whether there is rejection of the drug through the activity status of the test subjects. The tumor cell clearance rate of the drug is calculated by the change.
  • the drug delivery will be stopped for the same type of test subject, and the test subject will be comprehensively tested, and the factors of drug rejection will be analyzed through the comprehensive test results. Among them, if the drug rejection factor comes from the drug, the test subject will be changed; if the drug rejection factor comes from the test subject itself, the drug delivery will continue to other test subjects of the same type;
  • S4 Therapeutic treatment: The test subject who is judged to have a rejection reaction to the drug will be treated by a professional after the drug delivery is stopped, and before the treatment, the professional will grade the change in the activity state of the test subject during the drug test, among which The grading is divided into four levels, and the test subjects with rejection reactions are treated by professionals according to the grading, wherein the test subjects with level 1 are treated with topical antibiotics, topical steroids, and emollients, The test subjects with grade 2 were treated with oral antibiotics for 4-5 weeks, and the test subjects with grade 3 were treated with oral antibiotics for 7-8 weeks;
  • a kind of preparation method of EGFR molecular targeting antitumor drug comprises the following steps:
  • Raw material preparation and preparation Professionals select icotinib hydrochloride as the raw material for the preparation of the EGFR molecular-targeted anti-tumor drug, and transport the selected raw materials to the sterile room, and the professional prepares EGFR Molecule-like targeted anti-tumor drugs, and put the prepared drugs into a tablet press to obtain solid tablets of equal weight, wherein the weight of the solid tablets is kept within 100-140 mg;
  • Drug inspection The prepared solid tablets are subjected to drug inspection, wherein the drug inspection is a sampling inspection performed manually by professionals. The weight, properties, and raw material content of the drug, and manually judge whether the drug meets the drug quality standard through the inspection results, and process the prepared drug through the judgment result, wherein the judgment result is that the drug does not meet the drug quality standard Then, the medicine prepared in the same batch is recovered, and if the result of the judgment is that the medicine meets the quality standard of the medicine, the prepared medicine is inspected;
  • Drug test The drug test is carried out on the drug that is judged to meet the quality standards of the drug, wherein the prepared drug is regularly and quantitatively delivered to the test subject through direct oral administration and drug dissolving oral administration during the drug test, and the test subject It is selected by professionals, and the drug delivery interval and dose are selected by professionals through the test subjects, and the test subjects are monitored in real time during the test, wherein the real-time monitoring is carried out by professionals on the activity status of the test subjects. Real-time observation and regular physical fitness testing of the test subjects, and professionals judge whether there is rejection of the drug through the activity status of the test subjects. The tumor cell clearance rate of the drug is calculated by the change.
  • the drug delivery will be stopped for the same type of test subject, and the test subject will be comprehensively tested, and the factors of drug rejection will be analyzed through the comprehensive test results. Among them, if the drug rejection factor comes from the drug, the test subject will be changed; if the drug rejection factor comes from the test subject itself, the drug delivery will continue to other test subjects of the same type;
  • S4 Therapeutic treatment: The test subject who is judged to have a rejection reaction to the drug will be treated by a professional after the drug delivery is stopped, and before the treatment, the professional will grade the change in the activity state of the test subject during the drug test, among which The classification is divided into four grades, grade 1 is papules, pustules, itching and tenderness in less than 10% of BSA, and grade 2 is papules, pustules, itching and tenderness in 10-30% of BSA and limited activities of daily living. Grade 3 is more than 30% BSA with papules, pustules, itching, tenderness, and daily self-care limitation. Grade 4 is papules, pustules, itching, and pain with BSA percentage.
  • test subjects with rejection reaction will be treated by professionals according to grades, and the test subjects with grade 1 will be treated with topical antibiotics, topical steroids, and emollients, Subjects in grade 2 were treated with oral antibiotics for 4-5 weeks, and subjects in grade 3 were treated with oral antibiotics for 7-8 weeks.
  • Example 1 The preparation method of the EGFR molecular targeted antineoplastic drug prepared in Example 1, Example 2, Example 3, Example 4 and Example 5 has significantly improved the tumor cell clearance rate compared with the existing method, and Example 1 is the best embodiment.

Landscapes

  • Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Medicinal Preparation (AREA)

Abstract

本发明涉及抗肿瘤药物制备技术领域，尤其涉及一种EGFR类分子靶向抗肿瘤药物的制备方法，针对当前现有的分子靶向抗肿瘤药物的制备技术仍存在制备技术简单导致药物效果低下的问题，现提出如下方案，其中包括以下步骤：S1：原料准备及制备,S2:药物检验，S3：药物试验,S4：治疗处理，S5：后续处理，本发明的目的是通过在药物制备过程中对药物进行检验，将不符合药品质量标准的药物进行药物回收，使得生产出的药物均具备足够的药性，同时通过对药物进行试验，提高药物的肿瘤细胞清除率，增强药物性能。

Description

一种EGFR类分子靶向抗肿瘤药物的制备方法 技术领域
本发明涉及抗肿瘤药物制备技术领域，尤其涉及一种EGFR类分子靶向抗肿瘤药物的制备方法。
背景技术
肺癌是发病率和死亡率居首位的癌种，严重威胁着人类的健康与生命。肺癌主要分为小细胞肺癌(SCLC)和非小细胞肺癌(NSCLC)，其中约80％为NSCLC。早期的NSCLC主要依靠手术治疗，但多数NSCLC患者初诊时已是中晚期，只能以药物治疗为主，SCLC主要依靠联合化疗或者结合放疗。针对肺癌的治疗一直在探索中前行，随着医学的不断发展，小分子靶向治疗、免疫治疗等新的肺癌治疗模式也越来越普遍。非小细胞肺癌的治疗已经进入了“个体化”治疗阶段，效果更好且副作用更小的靶向药物正在逐渐取代传统化疗药物成为一线药物。现在肺癌患者或多或少都会做基因检测，来看看是否有适用的靶向药。而非小细胞肺癌中最常见，且有针对性靶向药物的突变就是“表皮生长因子受体”(EGFR)突变。因此，表皮生长因子受体EGFR类分子靶向药的使用，是肺癌治疗的一个最大研究热点。
但是目前现有的分子靶向抗肿瘤药物的制备技术仍存在制备技术简单导致药物效果低下的问题，因此，我们提出一种EGFR类分子靶向抗肿瘤药物的制备方法用于解决上述问题。
发明内容
本发明的目的是为了解决目前现有的分子靶向抗肿瘤药物的制 备技术仍存在制备技术简单导致药物效果低下等问题，而提出的一种EGFR类分子靶向抗肿瘤药物的制备方法。
为了实现上述目的，本发明采用了如下技术方案：
一种EGFR类分子靶向抗肿瘤药物的制备方法，包括以下步骤：
S1：原料准备及制备：准备好制备药物需要的原料，并制备出药物；
S2：药物检验：将制备出的固体药片进行药物检验；
S3：药物试验：将判断结果为符合药品质量标准的药物进行药物试验；
S4：治疗处理：将判定为对药物存在排异反应的试验对象停止药物输送后由专业人员进行分级治疗处理；
S5：后续处理：将药物进行分装、打码、包装和入库储存；
优选的，所述S1中，由专业人员选取盐酸埃克替尼作为制备所述EGFR类分子靶向抗肿瘤药物的原料，并将选取好的制备原料运输至无菌室，由专业人员制备出EGFR类分子靶向抗肿瘤药物，并将制备出的药物放入压片机中获得等重量的固体药片，其中所述固体药片的重量保在在100-140mg内；
优选的，所述S2中，将制备出的固体药片进行药物检验，其中所述药物检验是由专业人工进行的抽样检验，抽样片数：总片数为1:150，且进行检验时由专业人员对药物的重量、性质以及药量的原料含量，并由人工通过检验结果判断所述药物是否符合药品质量标准，通过判断结果对制备出的药物进行处理，其中判断结果为所述药 物不符合药品质量标准则将同批次制备出的药物进行药物回收，判断结果为所述药物符合药品质量标准则将制备出的药物进行检验；
优选的，所述S3中，将判断结果为符合药品质量标准的药物进行药物试验，其中进行药物试验时通过直接口服以及药物溶化口服将所述制备出的药物定期定量输送至试验对象体内，所述试验对象由专业人员进行选取，且药物输送间隔时间及剂量由专业人员通过试验对象进行选择，并在试验过程中对试验对象进行实时监测，其中所述实时监测是通过专业人员对试验对象的活动状态进行实时观测以及对试验对象进行定时体质检测，并由专业人员通过试验对象的活动状态判定药物是否存在排异反应，同时通过对试验对象进行定时体质检测判定药物是否发生有效反应，通过肿瘤细胞的数目变化计算出药物的肿瘤细胞清除率，专业人员判定试验对象对药物存在排异反应则对同类型试验对象停止药物输送，并对试验对象进行全面检测，通过全面检测结果分析药物排异反应因素，其中药物排异反应因素来自要药物则转换实验对象，药物排异反应因素来自试验对象自身则对其他同类型试验对象进行继续药物输送；
优选的，所述S4中，将判定为对药物存在排异反应的试验对象停止药物输送后由专业人员进行治疗处理，且治疗处理前由专业人员通过药物试验过程中试验对象的活动状态变化进行分级，其中所述分级分为四级，1级为小于10％的BSA出现丘疹、脓疱、伴瘙痒以及伴触痛，2级为10-30％的BSA出现丘疹、脓疱、伴瘙痒、伴触痛以及日常生活活动受限，3级为大于30％的BSA出现丘疹、脓疱、伴瘙痒、 伴触痛以及日常自我护理受限，4级为存在BSA百分比的丘疹、脓疱、伴瘙痒、伴触痛，且存在双重感染，由专业人员通过分级对发生排异反应的试验对象进行治疗处理，其中将等级为1级的试验对象通过使用外用抗生素、外用类固醇、和润肤剂进行治疗处理，将等级为2级的试验对象通过口服4-5周抗生素进行治疗处理，将等级为3级的试验对象通过口服7-8周抗生素进行治疗处理；
优选的，所述S5中，药物试验完成后，将药物进行分装、打码、包装和入库储存，其中其中分装时将药物采用铝箔进行表面覆盖，并抽出内部空气，进行入库储存时储存环境的相对湿度保持在50-60％，储存温度保持在18-22℃。
与现有技术相比，本发明的有益效果是：
1、通过在药物制备过程中对药物进行检验，将不符合药品质量标准的药物进行药物回收，使得生产出的药物均具备足够的药性。
2、通过对药物进行试验，提高药物的肿瘤细胞清除率，增强药物性能。
本发明的目的是通过在药物制备过程中对药物进行检验，将不符合药品质量标准的药物进行药物回收，使得生产出的药物均具备足够的药性，同时通过对药物进行试验，提高药物的肿瘤细胞清除率，增强药物性能。
附图说明
图1为本发明提出的一种EGFR类分子靶向抗肿瘤药物的制备方法的流程图。
具体实施方式
下面将对本发明实施例中的技术方案进行清楚、完整地描述，显然，所描述的实施例仅仅是本发明一部分实施例，而不是全部的实施例。
实施例一
参照图1，一种EGFR类分子靶向抗肿瘤药物的制备方法，包括以下步骤：
S1：原料准备及制备：由专业人员选取盐酸埃克替尼作为制备所述EGFR类分子靶向抗肿瘤药物的原料，并将选取好的制备原料运输至无菌室，由专业人员制备出EGFR类分子靶向抗肿瘤药物，并将制备出的药物放入压片机中获得等重量的固体药片，其中所述固体药片的重量保在在100-140mg内；
S2：药物检验：将制备出的固体药片进行药物检验，其中所述药物检验是由专业人工进行的抽样检验，抽样片数：总片数为1:150，且进行检验时由专业人员对药物的重量、性质以及药量的原料含量，并由人工通过检验结果判断所述药物是否符合药品质量标准，通过判断结果对制备出的药物进行处理，其中判断结果为所述药物不符合药品质量标准则将同批次制备出的药物进行药物回收，判断结果为所述药物符合药品质量标准则将制备出的药物进行检验；
S3：药物试验：将判断结果为符合药品质量标准的药物进行药物试验，其中进行药物试验时通过直接口服以及药物溶化口服将所述制备出的药物定期定量输送至试验对象体内，所述试验对象由专业人员 进行选取，且药物输送间隔时间及剂量由专业人员通过试验对象进行选择，并在试验过程中对试验对象进行实时监测，其中所述实时监测是通过专业人员对试验对象的活动状态进行实时观测以及对试验对象进行定时体质检测，并由专业人员通过试验对象的活动状态判定药物是否存在排异反应，同时通过对试验对象进行定时体质检测判定药物是否发生有效反应，通过肿瘤细胞的数目变化计算出药物的肿瘤细胞清除率，专业人员判定试验对象对药物存在排异反应则对同类型试验对象停止药物输送，并对试验对象进行全面检测，通过全面检测结果分析药物排异反应因素，其中药物排异反应因素来自要药物则转换实验对象，药物排异反应因素来自试验对象自身则对其他同类型试验对象进行继续药物输送；
S4：治疗处理：将判定为对药物存在排异反应的试验对象停止药物输送后由专业人员进行治疗处理，且治疗处理前由专业人员通过药物试验过程中试验对象的活动状态变化进行分级，其中所述分级分为四级，1级为小于10％的BSA出现丘疹、脓疱、伴瘙痒以及伴触痛，2级为10-30％的BSA出现丘疹、脓疱、伴瘙痒、伴触痛以及日常生活活动受限，3级为大于30％的BSA出现丘疹、脓疱、伴瘙痒、伴触痛以及日常自我护理受限，4级为存在BSA百分比的丘疹、脓疱、伴瘙痒、伴触痛，且存在双重感染，由专业人员通过分级对发生排异反应的试验对象进行治疗处理，其中将等级为1级的试验对象通过使用外用抗生素、外用类固醇、和润肤剂进行治疗处理，将等级为2级的试验对象通过口服4-5周抗生素进行治疗处理，将等级为3级的试验对 象通过口服7-8周抗生素进行治疗处理；
S5：后续处理：药物试验完成后，将药物进行分装、打码、包装和入库储存，其中其中分装时将药物采用铝箔进行表面覆盖，并抽出内部空气，进行入库储存时储存环境的相对湿度保持在50-60％，储存温度保持在18-22℃。
实施例二
参照图1，一种EGFR类分子靶向抗肿瘤药物的制备方法，包括以下步骤：
S1：原料准备及制备：由专业人员选取盐酸埃克替尼作为制备所述EGFR类分子靶向抗肿瘤药物的原料，并将选取好的制备原料运输至无菌室，由专业人员制备出EGFR类分子靶向抗肿瘤药物，并将制备出的药物放入压片机中获得等重量的固体药片，其中所述固体药片的重量保在在100-140mg内；
S2：药物检验：将制备出的固体药片进行药物检验，其中所述药物检验是由专业人工进行的抽样检验，抽样片数：总片数为1:150，且进行检验时由专业人员对药物的重量、性质以及药量的原料含量，并由人工通过检验结果判断所述药物是否符合药品质量标准；
S3：药物试验：将判断结果为符合药品质量标准的药物进行药物试验，其中进行药物试验时通过直接口服以及药物溶化口服将所述制备出的药物定期定量输送至试验对象体内，所述试验对象由专业人员进行选取，且药物输送间隔时间及剂量由专业人员通过试验对象进行选择，并在试验过程中对试验对象进行实时监测，其中所述实时监测 是通过专业人员对试验对象的活动状态进行实时观测以及对试验对象进行定时体质检测，并由专业人员通过试验对象的活动状态判定药物是否存在排异反应，同时通过对试验对象进行定时体质检测判定药物是否发生有效反应，通过肿瘤细胞的数目变化计算出药物的肿瘤细胞清除率，专业人员判定试验对象对药物存在排异反应则对同类型试验对象停止药物输送，并对试验对象进行全面检测，通过全面检测结果分析药物排异反应因素，其中药物排异反应因素来自要药物则转换实验对象，药物排异反应因素来自试验对象自身则对其他同类型试验对象进行继续药物输送；
S4：治疗处理：将判定为对药物存在排异反应的试验对象停止药物输送后由专业人员进行治疗处理，且治疗处理前由专业人员通过药物试验过程中试验对象的活动状态变化进行分级，其中所述分级分为四级，1级为小于10％的BSA出现丘疹、脓疱、伴瘙痒以及伴触痛，2级为10-30％的BSA出现丘疹、脓疱、伴瘙痒、伴触痛以及日常生活活动受限，3级为大于30％的BSA出现丘疹、脓疱、伴瘙痒、伴触痛以及日常自我护理受限，4级为存在BSA百分比的丘疹、脓疱、伴瘙痒、伴触痛，且存在双重感染，由专业人员通过分级对发生排异反应的试验对象进行治疗处理，其中将等级为1级的试验对象通过使用外用抗生素、外用类固醇、和润肤剂进行治疗处理，将等级为2级的试验对象通过口服4-5周抗生素进行治疗处理，将等级为3级的试验对象通过口服7-8周抗生素进行治疗处理；
S5：后续处理：药物试验完成后，将药物进行分装、打码、包装 和入库储存，其中其中分装时将药物采用铝箔进行表面覆盖，并抽出内部空气，进行入库储存时储存环境的相对湿度保持在50-60％，储存温度保持在18-22℃。
实施例三
参照图1，一种EGFR类分子靶向抗肿瘤药物的制备方法，包括以下步骤：
S1：原料准备及制备：由专业人员选取盐酸埃克替尼作为制备所述EGFR类分子靶向抗肿瘤药物的原料，并将选取好的制备原料运输至无菌室，由专业人员制备出EGFR类分子靶向抗肿瘤药物，并将制备出的药物放入压片机中获得等重量的固体药片，其中所述固体药片的重量保在在100-140mg内；
S2：药物检验：将制备出的固体药片进行药物检验，其中所述药物检验是由专业人工进行的抽样检验，抽样片数：总片数为1:150，且进行检验时由专业人员对药物的重量、性质以及药量的原料含量，并由人工通过检验结果判断所述药物是否符合药品质量标准，通过判断结果对制备出的药物进行处理，其中判断结果为所述药物不符合药品质量标准则将同批次制备出的药物进行药物回收，判断结果为所述药物符合药品质量标准则将制备出的药物进行检验；
S3：药物试验：将判断结果为符合药品质量标准的药物进行药物试验，其中进行药物试验时通过直接口服以及药物溶化口服将所述制备出的药物定期定量输送至试验对象体内，所述试验对象由专业人员进行选取，且药物输送间隔时间及剂量由专业人员通过试验对象进行 选择；
S4：治疗处理：将判定为对药物存在排异反应的试验对象停止药物输送后由专业人员进行治疗处理，且治疗处理前由专业人员通过药物试验过程中试验对象的活动状态变化进行分级，其中所述分级分为四级，1级为小于10％的BSA出现丘疹、脓疱、伴瘙痒以及伴触痛，2级为10-30％的BSA出现丘疹、脓疱、伴瘙痒、伴触痛以及日常生活活动受限，3级为大于30％的BSA出现丘疹、脓疱、伴瘙痒、伴触痛以及日常自我护理受限，4级为存在BSA百分比的丘疹、脓疱、伴瘙痒、伴触痛，且存在双重感染，由专业人员通过分级对发生排异反应的试验对象进行治疗处理，其中将等级为1级的试验对象通过使用外用抗生素、外用类固醇、和润肤剂进行治疗处理，将等级为2级的试验对象通过口服4-5周抗生素进行治疗处理，将等级为3级的试验对象通过口服7-8周抗生素进行治疗处理；
S5：后续处理：药物试验完成后，将药物进行分装、打码、包装和入库储存，其中其中分装时将药物采用铝箔进行表面覆盖，并抽出内部空气，进行入库储存时储存环境的相对湿度保持在50-60％，储存温度保持在18-22℃。
实施例四
参照图1，一种EGFR类分子靶向抗肿瘤药物的制备方法，包括以下步骤：
S1：原料准备及制备：由专业人员选取盐酸埃克替尼作为制备所述EGFR类分子靶向抗肿瘤药物的原料，并将选取好的制备原料运输 至无菌室，由专业人员制备出EGFR类分子靶向抗肿瘤药物，并将制备出的药物放入压片机中获得等重量的固体药片，其中所述固体药片的重量保在在100-140mg内；
S2：药物检验：将制备出的固体药片进行药物检验，其中所述药物检验是由专业人工进行的抽样检验，抽样片数：总片数为1:150，且进行检验时由专业人员对药物的重量、性质以及药量的原料含量，并由人工通过检验结果判断所述药物是否符合药品质量标准，通过判断结果对制备出的药物进行处理，其中判断结果为所述药物不符合药品质量标准则将同批次制备出的药物进行药物回收，判断结果为所述药物符合药品质量标准则将制备出的药物进行检验；
S3：药物试验：将判断结果为符合药品质量标准的药物进行药物试验，其中进行药物试验时通过直接口服以及药物溶化口服将所述制备出的药物定期定量输送至试验对象体内，所述试验对象由专业人员进行选取，且药物输送间隔时间及剂量由专业人员通过试验对象进行选择，并在试验过程中对试验对象进行实时监测，其中所述实时监测是通过专业人员对试验对象的活动状态进行实时观测以及对试验对象进行定时体质检测，并由专业人员通过试验对象的活动状态判定药物是否存在排异反应，同时通过对试验对象进行定时体质检测判定药物是否发生有效反应，通过肿瘤细胞的数目变化计算出药物的肿瘤细胞清除率，专业人员判定试验对象对药物存在排异反应则对同类型试验对象停止药物输送，并对试验对象进行全面检测，通过全面检测结果分析药物排异反应因素，其中药物排异反应因素来自要药物则转换 实验对象，药物排异反应因素来自试验对象自身则对其他同类型试验对象进行继续药物输送；
S4：治疗处理：将判定为对药物存在排异反应的试验对象停止药物输送后由专业人员进行治疗处理，且治疗处理前由专业人员通过药物试验过程中试验对象的活动状态变化进行分级，其中所述分级分为四级，由专业人员通过分级对发生排异反应的试验对象进行治疗处理，其中将等级为1级的试验对象通过使用外用抗生素、外用类固醇、和润肤剂进行治疗处理，将等级为2级的试验对象通过口服4-5周抗生素进行治疗处理，将等级为3级的试验对象通过口服7-8周抗生素进行治疗处理；
S5：后续处理：药物试验完成后，将药物进行分装、打码、包装和入库储存，其中其中分装时将药物采用铝箔进行表面覆盖，并抽出内部空气，进行入库储存时储存环境的相对湿度保持在50-60％，储存温度保持在18-22℃。
实施例五
参照图1，一种EGFR类分子靶向抗肿瘤药物的制备方法，包括以下步骤：
S1：原料准备及制备：由专业人员选取盐酸埃克替尼作为制备所述EGFR类分子靶向抗肿瘤药物的原料，并将选取好的制备原料运输至无菌室，由专业人员制备出EGFR类分子靶向抗肿瘤药物，并将制备出的药物放入压片机中获得等重量的固体药片，其中所述固体药片的重量保在在100-140mg内；
S2：药物检验：将制备出的固体药片进行药物检验，其中所述药物检验是由专业人工进行的抽样检验，抽样片数：总片数为1:150，且进行检验时由专业人员对药物的重量、性质以及药量的原料含量，并由人工通过检验结果判断所述药物是否符合药品质量标准，通过判断结果对制备出的药物进行处理，其中判断结果为所述药物不符合药品质量标准则将同批次制备出的药物进行药物回收，判断结果为所述药物符合药品质量标准则将制备出的药物进行检验；
S3：药物试验：将判断结果为符合药品质量标准的药物进行药物试验，其中进行药物试验时通过直接口服以及药物溶化口服将所述制备出的药物定期定量输送至试验对象体内，所述试验对象由专业人员进行选取，且药物输送间隔时间及剂量由专业人员通过试验对象进行选择，并在试验过程中对试验对象进行实时监测，其中所述实时监测是通过专业人员对试验对象的活动状态进行实时观测以及对试验对象进行定时体质检测，并由专业人员通过试验对象的活动状态判定药物是否存在排异反应，同时通过对试验对象进行定时体质检测判定药物是否发生有效反应，通过肿瘤细胞的数目变化计算出药物的肿瘤细胞清除率，专业人员判定试验对象对药物存在排异反应则对同类型试验对象停止药物输送，并对试验对象进行全面检测，通过全面检测结果分析药物排异反应因素，其中药物排异反应因素来自要药物则转换实验对象，药物排异反应因素来自试验对象自身则对其他同类型试验对象进行继续药物输送；
S4：治疗处理：将判定为对药物存在排异反应的试验对象停止药 物输送后由专业人员进行治疗处理，且治疗处理前由专业人员通过药物试验过程中试验对象的活动状态变化进行分级，其中所述分级分为四级，1级为小于10％的BSA出现丘疹、脓疱、伴瘙痒以及伴触痛，2级为10-30％的BSA出现丘疹、脓疱、伴瘙痒、伴触痛以及日常生活活动受限，3级为大于30％的BSA出现丘疹、脓疱、伴瘙痒、伴触痛以及日常自我护理受限，4级为存在BSA百分比的丘疹、脓疱、伴瘙痒、伴触痛，且存在双重感染，由专业人员通过分级对发生排异反应的试验对象进行治疗处理，其中将等级为1级的试验对象通过使用外用抗生素、外用类固醇、和润肤剂进行治疗处理，将等级为2级的试验对象通过口服4-5周抗生素进行治疗处理，将等级为3级的试验对象通过口服7-8周抗生素进行治疗处理。
将实施例一、实施例二、实施例三、实施例四和实施例五中一种EGFR类分子靶向抗肿瘤药物的制备方法进行试验，得出结果如下：
Figure PCTCN2022094837-appb-000001
实施例一、实施例二、实施例三、实施例四和实施例五制得的EGFR类分子靶向抗肿瘤药物的制备方法对比现有方法肿瘤细胞清除率有了显著提高，且实施例一为最佳实施例。
以上所述，仅为本发明较佳的具体实施方式，但本发明的保护范围并不局限于此，任何熟悉本技术领域的技术人员在本发明揭露的技术范围内，根据本发明的技术方案及其发明构思加以等同替换或改变，都应涵盖在本发明的保护范围之内。

Claims (8)

  1. 一种EGFR类分子靶向抗肿瘤药物的制备方法，其特征在于，包括以下步骤：
    S1：原料准备及制备：准备好制备药物需要的原料，并制备出药物；
    S2：药物检验：将制备出的固体药片进行药物检验；
    S3：药物试验：将判断结果为符合药品质量标准的药物进行药物试验；
    S4：治疗处理：将判定为对药物存在排异反应的试验对象停止药物输送后由专业人员进行分级治疗处理；
    S5：后续处理：将药物进行分装、打码、包装和入库储存。
  2. 根据权利要求1所述的一种EGFR类分子靶向抗肿瘤药物的制备方法，其特征在于，所述S1中，由专业人员选取盐酸埃克替尼作为制备所述EGFR类分子靶向抗肿瘤药物的原料，并将选取好的制备原料运输至无菌室，由专业人员制备出EGFR类分子靶向抗肿瘤药物，并将制备出的药物放入压片机中获得等重量的固体药片，其中所述固体药片的重量保在在100-140mg内。
  3. 根据权利要求1所述的一种EGFR类分子靶向抗肿瘤药物的制备方法，其特征在于，所述S2中，将制备出的固体药片进行药物检验，其中所述药物检验是由专业人工进行的抽样检验，抽样片数：总片数为1:150，且进行检验时由专业人员对药物的重量、性质以及药量的原料含量，并由人工通过检验结果判断所述药物是否符合药品质量标准，通过判断结果对制备出的药物进行处理，其中判断结果为所 述药物不符合药品质量标准则将同批次制备出的药物进行药物回收，判断结果为所述药物符合药品质量标准则将制备出的药物进行检验。
  4. 根据权利要求1所述的一种EGFR类分子靶向抗肿瘤药物的制备方法，其特征在于，所述S3中，将判断结果为符合药品质量标准的药物进行药物试验，其中进行药物试验时通过直接口服以及药物溶化口服将所述制备出的药物定期定量输送至试验对象体内，所述试验对象由专业人员进行选取，且药物输送间隔时间及剂量由专业人员通过试验对象进行选择，并在试验过程中对试验对象进行实时监测，其中所述实时监测是通过专业人员对试验对象的活动状态进行实时观测以及对试验对象进行定时体质检测，并由专业人员通过试验对象的活动状态判定药物是否存在排异反应，同时通过对试验对象进行定时体质检测判定药物是否发生有效反应，通过肿瘤细胞的数目变化计算出药物的肿瘤细胞清除率。
  5. 根据权利要求4所述的一种EGFR类分子靶向抗肿瘤药物的制备方法，其特征在于，专业人员判定试验对象对药物存在排异反应则对同类型试验对象停止药物输送，并对试验对象进行全面检测，通过全面检测结果分析药物排异反应因素，其中药物排异反应因素来自要药物则转换实验对象，药物排异反应因素来自试验对象自身则对其他同类型试验对象进行继续药物输送。
  6. 根据权利要求1所述的一种EGFR类分子靶向抗肿瘤药物的制备方法，其特征在于，所述S4中，将判定为对药物存在排异反应的试验对象停止药物输送后由专业人员进行治疗处理，且治疗处理前由 专业人员通过药物试验过程中试验对象的活动状态变化进行分级，其中所述分级分为四级，1级为小于10％的BSA出现丘疹、脓疱、伴瘙痒以及伴触痛，2级为10-30％的BSA出现丘疹、脓疱、伴瘙痒、伴触痛以及日常生活活动受限，3级为大于30％的BSA出现丘疹、脓疱、伴瘙痒、伴触痛以及日常自我护理受限，4级为存在BSA百分比的丘疹、脓疱、伴瘙痒、伴触痛，且存在双重感染。
  7. 根据权利要求1所述的一种EGFR类分子靶向抗肿瘤药物的制备方法，其特征在于，所述S4中，由专业人员通过分级对发生排异反应的试验对象进行治疗处理，其中将等级为1级的试验对象通过使用外用抗生素、外用类固醇、和润肤剂进行治疗处理，将等级为2级的试验对象通过口服4-5周抗生素进行治疗处理，将等级为3级的试验对象通过口服7-8周抗生素进行治疗处理。
  8. 根据权利要求1所述的一种EGFR类分子靶向抗肿瘤药物的制备方法，其特征在于，所述S5中，药物试验完成后，将药物进行分装、打码、包装和入库储存，其中其中分装时将药物采用铝箔进行表面覆盖，并抽出内部空气，进行入库储存时储存环境的相对湿度保持在50-60％，储存温度保持在18-22℃。
PCT/CN2022/094837 2022-02-15 2022-05-25 一种egfr类分子靶向抗肿瘤药物的制备方法 WO2023155321A1 (zh)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CN202210138048.3A CN114504577A (zh) 2022-02-15 2022-02-15 一种egfr类分子靶向抗肿瘤药物的制备方法
CN202210138048.3 2022-02-15

Publications (1)

Publication Number Publication Date
WO2023155321A1 true WO2023155321A1 (zh) 2023-08-24

Family

ID=81551779

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/CN2022/094837 WO2023155321A1 (zh) 2022-02-15 2022-05-25 一种egfr类分子靶向抗肿瘤药物的制备方法

Country Status (2)

Country Link
CN (1) CN114504577A (zh)
WO (1) WO2023155321A1 (zh)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN114504577A (zh) * 2022-02-15 2022-05-17 上海龙翔生物医药开发有限公司 一种egfr类分子靶向抗肿瘤药物的制备方法

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103784412A (zh) * 2014-01-15 2014-05-14 青岛市肿瘤医院 一种盐酸埃克替尼分散片及其制备方法
CN114504577A (zh) * 2022-02-15 2022-05-17 上海龙翔生物医药开发有限公司 一种egfr类分子靶向抗肿瘤药物的制备方法

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103784412A (zh) * 2014-01-15 2014-05-14 青岛市肿瘤医院 一种盐酸埃克替尼分散片及其制备方法
CN114504577A (zh) * 2022-02-15 2022-05-17 上海龙翔生物医药开发有限公司 一种egfr类分子靶向抗肿瘤药物的制备方法

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
ZHANG, LI ET AL.: "Long Term Survival of a Patient with Advanced Non-small Cell Lung Cancer Under Icotinib Therapy", CHINESE JOURNAL OF NEW DRUGS, vol. 22, no. 12, 31 December 2013 (2013-12-31), pages 1435 - 1437, XP093085189 *
ZHE SONG, HU YI: "Clinical Analysis of Icteninib Hydrochloride in the Treatment of Advanced Non-small Cell Lung Cancer with Definite EGFR Mutation Status", CHINA & FOREIGN MEDICAL TREATMENT, vol. 37, no. 21, 3 September 2018 (2018-09-03), pages 90 - 92, XP093085190, ISSN: 1674-0742, DOI: 10.16662/j.cnki.1674-0742.2018.21.090 *

Also Published As

Publication number Publication date
CN114504577A (zh) 2022-05-17

Similar Documents

Publication Publication Date Title
WO2023155321A1 (zh) 一种egfr类分子靶向抗肿瘤药物的制备方法
US9005678B1 (en) Pharmaceutical composition for treating cancer and use thereof
CN110536702A (zh) 使用hsp90抑制剂治疗癌症的方法
Huang et al. A prospective randomized controlled trial on the value of prophylactic oral nutritional supplementation in locally advanced nasopharyngeal carcinoma patients receiving chemo-radiotherapy
WO2024060834A1 (zh) 一种氟代吡哆醛在制备用于抗癌症的药物中的用途
Zhu et al. Effect of kangai injection combined with platinum-based chemotherapy on the immune function of patients with advanced non-small-cell lung cancer: A meta-analysis
CN114452290A (zh) 一种抗肿瘤药物阿法替尼的合成方法
CN115154505A (zh) 香连丸在制备用于免疫治疗泛癌患者减毒增效的药物中的应用
Chenarani et al. Effect of Probiotics in Prevention of Neonatal Jaundice.
CN102512403A (zh) 和厚朴酚在制药中的应用及治疗ⅱ型糖尿病的药物
CN109758551B (zh) 一种治疗足癣和外阴阴道念珠菌病的中药组合物
He et al. Real-world study of antifibrotic drugs-related adverse events based on the United States Food and Drug Administration Adverse Event Reporting System and VigiAccess databases
MM et al. Meta-Analysis of Efficacy and Safety of Prone Enteral Nutrition in Critically Ill Ventilated Patients
CN113368140A (zh) 螺旋藻在制备防治白细胞减少症的产品中的应用
Sekiguchi et al. Drug repositioning of antipsychotic drugs for cisplatin-induced pica behavior in mice
Sereni et al. 5PSQ-168 Interest and implementation of rapid daratumumab infusion during the health crisis
Senko et al. P2. 04-11 overcoming resistance to immunotherapy using CVA21: initial results from a phase II study
Karajannis et al. Carboplatin During Craniospinal Radiotherapy for Children With Group 3 Medulloblastoma—A New Standard of Care?
Chung et al. 3037 Development of the Analgesic Quantification Algorithm (AQA): a new scale to assess changes in analgesic use
Chen et al. EP1. 12-35 Comparison of Long Term Results Between Matched Chemoradiotherapy and Surgery for Limited Stage Small Cell Lung Cancer
Pan et al. A meta-analysis of the effectiveness and safety of Sintilimab combined with chemotherapy in the trea tment of advanced non-small cell lung cancer
Monsel et al. Focusing on the alveolar epithelium: Alveolar fluid clearance in ciffuse versus focal ARDS
Aliska et al. Clinical Outcome of Antiviral Therapy on COVID-19 Patients
Aliska et al. Clinical Outcome of Antiviral Therapy on Covid-19 Patients. Open Access Maced J Med Sci. 2022 Apr 28; 10 (A): 1058-1061
Cruz et al. P1. 01-130 Clinical Experience with Nintedanib in Previously Treated Non-Small Cell Lung Cancer in Spain: A Retrospective Multicenter Study

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 22926632

Country of ref document: EP

Kind code of ref document: A1