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中央人民政府卫生部通知 (53)卫药字第八三八号为氨硫脲(T.B.A.)药品业经初步临床试用,特另作规定,希查照并转所属知照由关于「氨硫脲」俗称「结核胺、B.T.A.等,化学名为对乙醯氨基苯甲醛—氨硫脲(CH_3—缩写氨硫脲类药品的使用问题,我部会于一九五二年八月七日以52卫药字第四一五号通知各地管制试用,继续研究并提出四项管制试用的办法办理在案。兹根据各地试用结果,并经中国防痨协会专家审查,提出氨硫脲临床试用的初步总结报告,并建议此药应予管制使用,药商不得任意售与病人,同时擬定使用的常规;我部基本同意该会意见,并征得中央轻工业部、对外贸易部、商业部同意,擬定对「氨硫脲」药品管制使用的规定如后,即希遵照,蓝转知所属遵照实行:一、名称:此药暂采用「氨硫脲」为统一的名称。二、管制使用:此药之应用,限于医院及门诊部、所等,使用时应遵照附发「使用常规」之规定。(前52卫医字第一○三七号附发之常规作废)。三、制造:凡经当地卫生主管机关及工商部门核准开业而有条件制造此药之公私药厂均可制造此药,但须统一采用前项规定之名称。四、供应:中国医药公司及经当地卫生主管机关及工商部门核准开业之药商均可出售此药,但销售对象应为医院及门诊部、所,不得任意售与其他任何人或任何单位,此外,在未经中央卫生部核准前,不得向国外订货、进口。此致各省、市卫生厅、局各大区行政委员会卫生局,铁道部卫生局。附发:1、「氨硫脲」临床试用总结(初步报告)一份2、使用「氨硫脲」暂行常规一份中央人民政府卫生部一九五三年七月二十日
The Ministry of Health of the Central People’s Government notified (53) Weiyao Zi No. 388 for preliminary clinical trial of the Thiosemicarbazide (TBA) pharmaceutical industry, with special provisions as well. According to “Thiourea” Tuberculosis amine, BTA, etc., the chemical name of paracetamol benzaldehyde - thiourea (CH_3- abbreviation, the use of thiosemicarbazide drugs, the Department will be August 7, 1952 to 52 health medicine word On April 15, it notified all localities about the probation and continued to study and put forward four measures for controlling probation. Based on the results of the trials and the review by experts of China Antituberculosis Association, a preliminary summary report on clinical trials of thiourea was proposed. It is recommended that this medicine should be used in a controlled manner, and the drug dealers should not sell it to patients at will and make routine use. Our ministry basically agreed with the opinion of the society and obtained the consent of the Central Light Industry Dept., the Ministry of Foreign Trade and the Ministry of Commerce, Urea “under the control of the use of drugs, such as the follow-up, that Xi follow the blue turn to comply with their respective follow-up: First, the name: the drug temporarily use” Thiourea “as a unified name Second, the regulatory use: Hospitals and clinics, etc., so that Use should comply with the attached ”use of conventional“ requirements. (Before the first 523 Medical word appendices issued by the general set aside.) Third, manufacturing: Where the local health authorities and the business sector approved the opening and conditional manufacturing This medicine can be manufactured by both public and private pharmaceutical companies under the preconditions as specified in the preceding paragraph 4. Supply: This medicine can be sold by Chinese pharmaceutical companies and by pharmaceutical companies approved by the local health authorities and the business sector Sales targets should be hospitals and clinics, and may not be sold to any other person or any unit, in addition, without the approval of the Central Ministry of Health, shall not order and import from abroad, In this regard, the provincial health department, the Bureau of the major District Board of Health Bureau of Health, Ministry of Health Bureau of the Ministry of Railways. Attachment: 1, ”Thiourea,“ a summary of clinical trial (preliminary report) 2, the use of ”Thiocarbamide," Interim Provisions of a Central People’s Government Ministry of Health 195 July 20, 2003