速效救心丸不速效也不救心国家保密处方的秘密

  • 日期:07-24
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China Business News

The well-known Chinese medicine variety Suxiao Jiuxin Pill has been controversial in the recent past, and it has been accused of neither “quick effect” nor “rescue”.

Recently, a number of popular science “big V” issued a document questioning that the quick-acting rescue heart pill, as a non-ancestral new Chinese medicine, has been rushed to the market without undergoing rigorous medical tests, and there has been no review so far. In addition, as a drug that relieves angina pectoris, its name is strongly misleading and even violates medical principles.

In fact, as a drug with an annual sales of 1 billion yuan, the quick-acting rescue pills are state secrets.

According to the instructions of the quick-acting rescue pills, the ingredients are Chuanxiong and borneol (national secret prescription), and according to the supplementary material of Tianjin No. 6 Chinese Medicine Factory《速效救心丸的生产工艺》, the prescription of Suxiao Jiuxin Pill is: total alkaloids of Chuanxiong 3.3mg, borneol 0.7mg, Polyethylene glycol 6000 30mg.

However,《中国经营报》The reporter found that there is public literature showing that "Shuxiao Jiuxin Pill is an essential medicine for the treatment of angina pectoris of coronary heart disease, such as Chuanxiong, borneol, musk, medlar and other valuable Chinese medicine prescriptions and western medicine nitroglycerin."

The three different interpretations of the prescription also make the real effect of the quick-acting rescue heart pills more confusing.

In response to related matters, the reporter sent a letter to Tianjin Zhongxin Pharmaceutical Co. Ltd. (600. s. hereinafter referred to as “Zhongxin Pharmaceutical”), a member of the Securities Department. Said that the company does not currently have leadership to deal with related matters.

The manufacturer of Suxiao Jiuxin Pill is the Sixth Chinese Medicine Factory of Zhongxin Pharmaceutical (hereinafter referred to as the “Sixth Chinese Medicine Factory”). In order to win the right to the results of the quick-acting rescue heart pills with the Sixth Chinese Medicine Factory, the original Chinese medicine physician Hao Bin of Tianjin Tianjin Hospital has collected and published a large number of original materials for the approval of quick-acting rescue pills since 2011.

xx相关资料显示,速效救生心丸名称为“佳洁士心脏速效丸”。 1981年1月12日,第六中药厂向天津市卫生局提交了速效救生药生产申请报告。据报道,“苏小救心丸的研发始于1977年,已连续几年被观察到。临床病例数达到312例,有近100例分散病例。根据临床认识,该药具有快速疗效,无副作用。“

关于处方设计,数据记录表明,没有“国家秘方”看起来神秘,只有川芎和冰片。 “临床医生希望我们可以开始一种可以起到与中药硝酸甘油类似作用的药物。根据这一要求,我们与医生密切合作,多年来参考该领域在冠心病治疗方面取得的成就。医生的长期筛查证实了药物的味道(川芎,冰片)。

例如,中国受保护的中药品种分为一年级和二年级。国务院卫生行政部门负责对中药品种保护的监督管理。品种保护期长达30年,您可以在到期后申请延期。根据这些数据,速效救生心丸于1995年被国家药品监督管理局和国家科学技术保密办公室确定为国家秘密保密项目。

根据数据,该项目“开始研究从(19)77年,(19)78年正式投入临床实践,通过天津医院,工人医院,虹桥区第三预防医院,254医院临床观察310例,总数有效率97.20%,其中效率为38.71%,有效率为51.83%。“

从1981年3月17日开始,天津市药品检验所和药品研究所前后三次发出口头或书面通知,要求第六中药厂补充相关的处方来源和其他相关信息。当年6月10日,该公司决定暂停批准速效救生丸,因为它没有收到任何补充材料。

On June 5, 1982, the sixth Chinese medicine factory reported the supplementary materials to the Tianjin Municipal Health Bureau. On September 27 of that year, the Tianjin Institute of Drug Testing and Drugs issued a review opinion, agreeing that the Sixth Chinese Medicine Factory will conduct trial production and sales for two years according to the interim quality standards and production process, collecting and summarizing clinical reflections during the production and sales process, and improving the production process. Improve quality standards and accumulate inspection data. On October 7 of that year, the Tianjin Municipal Health Bureau agreed to trial production and quick fix. In July 1985, the Tianjin Municipal Health Bureau officially approved the production of the quick-acting rescue pills by the Sixth Chinese Medicine Factory.

The quick-acting rescue pills instructions show that the ingredients are Chuanxiong and borneol (national secret prescription). Function Indications to promote blood circulation, relieve pain, increase coronary blood flow, relieve angina. For qi stagnation and blood stasis type coronary heart disease, angina pectoris. Adverse drug reactions and contraindications are not clear.

An emergency doctor at a top three hospital in Weibo named "Emergency Nighthawk" questioned that the name of the quick-acting rescue heart has a strong marketing meaning. Strictly speaking, its naming has violated medical principles. This kind of drug with a strong inductive nomenclature can cause public abuse.

In November 2017, the former State Food and Drug Administration issued《中成药通用名称命名技术指导原则》and《关于规范已上市中成药通用名称命名的通知》clearly stated that the naming of Chinese patent medicines should adhere to the principles of scientific conciseness, avoiding duplicate names, standardizing naming, avoiding exaggeration of efficacy, and embodying traditional cultural characteristics. Exaggerated, self-proclaimed, unrealistic terms should not be used, such as strong, quick-acting, imperial, secret, and spiritual, treasure, and fine.

"Emergency Nighthawk" pointed out that angina pectoris is a manifestation of coronary artery stenosis, decreased blood flow, and insufficient blood supply to the affected myocardium. Often attacked when tired or excited, immediately sit down or lie down and rest, most of the self-remission in three or five minutes, can be repeated in similar situations. Commonly used emergency drugs include nitroglycerin and quick-acting rescue pills. The mechanism of action is similar. The coronary artery is dilated and the blood supply is increased to relieve angina.

xx如果胸痛超过15分钟,则可能是急性心肌梗塞。此时,既不能使用硝酸甘油也不能使用速效药丸。最重要的是快速呼叫救护车到医院,进行冠状动脉介入治疗或溶栓治疗,并打开梗塞血管以拯救心肌。

北京和家医院内科主任医师王德钊还公开表示,“快节丸”和“硝酸甘油”是心脏病学中常用的药物,但仅用于缓解“心绞痛”的症状。如果实际发生“急性心肌梗塞”,这两种药物将不会在轮回中发挥作用,在某些情况下,盲目使用,特别是“硝酸甘油”,会使病情恶化!

一位具有多年紧急工作经验的医生告诉记者,在临床实践中,医生通常在心肌梗塞患者中使用溶栓药物,如阿司匹林,替卡格雷和尿激酶。真正的心肌梗塞是心脏血管的闭塞。速效心丸的主要成分是川芎和冰片。从成分的角度来看,它既不溶解也不能血管。

但是,医生认为,人情绪激动,心情恐惧也会加重心肌缺血,引起血管痉挛和心肌梗塞。速效救生心丸具有扩张血管的作用,并且具有舒适功能。长期服用可以建立侧支循环,减少心肌缺血。因此,它可以缓解慢性,不太严重的症状。在家庭中,尤其是那些有老年人的家庭中,每天备用速效药片仍然是有意义的。

速效救生丸的注意事项表明,不应单独使用冷血瘀,阴虚,血瘀,胸痛和心痛。应谨慎使用心肌缺血伴中度至重度心力衰竭。在治疗期间,继续发生心绞痛,并且应该添加硝酸盐药物。

第六家中药厂,前身为第六家中药厂,成立于1974年,是天津市重点骨干企业之一。主要生产滴丸系列中药产品。 1997年12月,它通过了国内药品生产商GMP认证。 2000年6月,中信药业有限公司取消了原天津市第六中药厂的法律地位,并将其改为中新药业分公司。

销售额比上年增长6.04%,年销售收入超过10亿元。

2018年,中新药业实现营业收入63.59亿元,同比增长11.77%。速效救生丸的销售收入占当年营业收入的15%以上。速效救生心丸的心脑血管系统产品毛利率达62.08%。

太平洋(3.560,0.00,0.00%)证券于2018年发布的研究报告显示,中新药业充分利用速效和拯救心丸的品牌价值,采取差异化的促销策略,突出快速的状态 - 代理药丸和避免竞争产品。激烈的竞争,同时保持产品的高盈利能力。根据IMS数据,速效救生丸在心血管口服中药中的市场份额仅为3.54%。凭借品牌优势,太平洋证券认为,短期价格上涨后,速效救生丸的销量将逐步增加,并进入量和价格上涨的阶段。

中新药业在快速节能心丸项目上投入了大量研究经费。年报显示,2018年,公司共投入科技投入1.29亿元,开展了20个新产品研发项目,15个保健食品研究和5个品种的仿制药一致性评价工作。对临床重评,过程改进,新适应症,药理研究,实际研究等方面进行深入分析和系统研究,重点研究速效救生丸等大型品种的二次开发。

在快速救生心丸的二次开发中,中新药业于2018年投入833万元。其目的是利用现代科技手段探索和明确产品的临床使用价值;引进先进的工艺设备,确保药品质量。提高生产率。

中新药业股份有限公司官方网站显示,2016年12月14日,中新第六中药厂“精神救人心丸真实世界临床研究项目”正式启动。该项目旨在阐明该药物的特点和临床安全性,揭示长效应用速效救心丸预防和治疗冠心病心绞痛的客观效果,并评价其有效性和经济性。药物和类似药物通过药物经济学研究系统。不同的是进一步提高速效救生丸的安全用药水平和市场活力。在项目的第一阶段,将观察5,000名患者,全国50个研究机构将一起参与。时间跨度为1年,预计投资近1000万元。

但截至目前,中新尚未公布上述研究项目的成果。

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