Instructions for Penciclovir for Injection
Release time:
2020-07-31
核准日期:2007年8月31日
第1次修改日期:2008年 05月28日
第2次修改日期:2014年 10月31日
恒奥普康
注射用喷昔洛韦说明书
请仔细阅读说明书并在医师指导下使用
【药品名称】
通用名称:注射用喷昔洛韦
商品名称:恒奥普康
英文名称:Penciclovir for Injection
汉语拼音:Zhusheyong Penxiluowei
【成份】
本品主要成份为喷昔洛韦,辅料为低分子右旋糖酐和氢氧化钠。
化学名称:9-[4-羟基-3-(羟甲基)-丁基]鸟嘌呤。
化学结构式:

分子式:C10H15N5O3
分子量:253.26
【性状】
本品为白色疏松块状物或粉末。
【适应症】
适用于严重带状疱疹患者,如出血性带状疱疹,坏疽性带状疱疹,播散性带状疱疹,三叉神经支带状疱疹,带状疱疹脑膜炎,严重疼痛的早期带状疱疹等和免疫机能障碍并发的带状疱疹。
【规格】0.25g。
【用法用量】
一次每公斤体重5mg,一日2次,隔12小时滴注一次,每次滴注时间应持续1小时以上,5-7日为一疗程。
临用前,取本品1瓶(含喷昔洛韦0.25g),用适量灭菌注射用水或氯化钠注射液使之溶解,再用氯化钠注射液至少100ml稀释,供静脉滴注用。
有肾脏疾病、脱水或同时使用其它对肾脏有毒性药物的病人,应调整剂量,缓慢静脉滴注(1小时以上)。
【不良反应】
1、静脉用药在注射部位可发生静脉炎和局部刺激,这是注射液pH值高(大于9.0)的缘故,而非喷昔洛韦的直接效应。
2、喷昔洛韦浓度过高可导致肾小管和集合管损害,并引起血肌酐值升高和肾功能损害,可引起肾区疼痛,这常发生于快速静脉滴注。
3、临床试验中曾见胃肠道反应、尿中红细胞高于正常值、头痛、头晕、双下肢及内踝水肿、手足发热、鼻塞、腹泻和寒战等。
【禁忌】
对本品有过敏反应史者禁用,肾功能异常者、儿童及孕妇慎用。
【注意事项】
1、对更昔洛韦过敏者也可能对本品过敏。
2、本品为静脉滴注用药,忌用作其它途径给药。
3、静脉滴注时应缓慢(1小时以上),防止局部浓度过高,引起疼痛及炎症。
4、溶液配制后应立即使用,不能冷藏,因冷藏时会析出结晶,用剩溶液应废弃,稀释药液时出现白色浑浊或结晶则不能使用。
5、本品呈碱性,与其它药物混合时易引起溶液pH值改变,应尽量避免配伍使用。
6、有肾脏疾病、脱水或同时使用其它对肾脏有毒性药物的病人,应调整剂量,缓慢静脉滴注(1小时以上)。
【孕妇及哺乳期妇女用药】
药物能通过胎盘,虽动物实验证实对胚胎无影响,但孕妇用药仍需权衡利弊。
药物在乳汁中的浓度为血药浓度的0.6~4.1倍,虽未发现婴儿异常,但哺乳期妇女应慎用。
【儿童用药】
儿童中虽未发现特殊不良反应,但应慎用。新生儿不宜以含苯甲醇的稀释液配制滴注液,否则易引起致命性的综合征,包括酸中毒、中枢抑制、呼吸困难、肾功能衰竭、低血压、癫痫和颅内出血等。
【老年用药】
由于生理性肾功能的衰退,应用本品需注意调整剂量。
【药物相互作用】
1.与干扰素或甲氨蝶呤(鞘内)合用,可能引起精神异常,应慎用。
2.与肾毒性药物合用可加重肾毒性,特别是肾功能不全者更易发生。
3.与齐多夫定(Zidovudine)合用可引起肾毒性,表现为深度昏睡和疲劳。
4.与丙磺舒竞争性抑制有机酸分泌,合并用丙磺舒可使本品的排泄减慢,半衰期延长,体内药物蓄积。
【药物过量】尚不明确。
【临床试验】
本项临床试验采用多中心、随机双盲、阳性药对照的方法评价注射用喷昔洛韦治疗严重带状疱疹的疗效和安全性。对于带状疱疹患者,给予注射用喷昔洛韦粉针剂每次0.25g(1瓶),临用前将药物加适量注射用水或氯化钠注射液使之溶解,再加入到250ml氯化钠注射液中,供静脉滴注。每日两次,每8~12小时静脉滴注1次。用药疗程:7天。总观察时间为21天(必要时需随访至第28天)。患者于用药后第1~7,8,14,21天,(必要时增加第28天)接受观察,对时间指标:开始结痂时间、全部结痂时间、开始脱痂时间、全部脱痂时间,以及疼痛开始减轻时间、疼痛完全消失时间、新水疱停止出现时间、水疱完全消退时间;主观指标:有无后遗神经痛及后遗神经痛的持续时间;客观指标:包括丘疱疹/水疱、血疱、坏死、糜烂、红斑/水肿、皮损分布范围三方面进行疗效评价。
Ⅱ期109例带状疱疹临床试验结果表明:注射用喷昔洛韦治疗带状疱疹,水疱停止出现时间1.44±1.21天,水疱消退时间4.53±3.29天,开始结痂时间2.85±1.74天,全部结痂时间6.07±3.35,开始脱痂时间7.24±3.51天,全部脱痂时间13.72±5.14,疼痛减轻时间3.22±3.32天,疼痛消失时间11.82±8.63天。
对于后遗神经痛的发生率,注射用喷昔洛韦组为2.75%。对于客观指标治疗7天、14天、28天的总有效率分别为80.74%、、97.25%、100%。对于疼痛指标,
治疗7天、14天、28天的总有效率分别为66.35%、85.04%、98.13%。
Ⅲ期345例带状疱疹临床试验结果表明:
注射用喷昔洛韦治疗带状疱疹,水疱停止出现时间为1.08±1.13天,水疱消退时间为2.52±1.31天,开始结痂时间为2.92±1.56天,全部结痂时间为5.98±2.87天,开始脱痂时间为6.42±2.72天,全部脱痂时间为12.65±4.42天,疼痛减轻时间为3.34±2.63天,疼痛消失时间为11.56±6.26天。
对于后遗神经痛的发生率,注射用喷昔洛韦组为8.3%。
在有效率方面,第4、8、14、21天时,注射用喷昔洛韦组的有效率分别为18.2%、69.6%、96.4%和99.1%。
25例严重带状疱疹患者,如出血性带状疱疹,坏疽性带状疱疹,播散性带状疱疹,三叉神经支带状疱疹,带状疱疹脑膜炎、严重疼痛的早期带状疱疹等和免疫机能障碍并发的带状疱疹补充临床试验结果表明:
注射用喷昔洛韦治疗带状疱疹,水疱停止出现时间为1.42±0.83天,水疱消退时间为5.88±3.53天,开始结痂时间为2.33±1.13天,全部结痂时间为5.65±2.21天,开始脱痂时间为7.17±4.32天,全部脱痂时间为14.83±5.73天,疼痛开始减轻时间为2.33±1.37天,疼痛消失时间为12.90±5.86天。
对于后遗神经痛的发生率,注射用喷昔洛韦组为33.3%。
在有效率方面,第4、8、14、21天时,注射用喷昔洛韦组的有效率分别为32.0%、84.0%、88.0%和96.0%。
在安全性方面,通过对患者的询问、观察及在用药前后进行血常规(白细胞、红细胞、血红蛋白、血小板),尿常规(尿蛋白、红细胞、白细胞、尿糖、酮体),肝功能(ALT、AST),肾功能(BUN、CREA),心电图的化验结果来发现不良事件,进行安全性评价:
通过对Ⅱ期临床试验109例,Ⅲ期临床试验345例及补充临床试验25例患者应用该药后的观察,无严重不良事件发生。经医生判断,与本药物相关的不良事件偶见:注射部位疼痛、恶心、呕吐、头痛、头晕、鼻塞、手足发热、寒战、静脉炎、腹泻、大便次数增多、双下肢及内踝水肿。经实验室检查分析,用药后血常规化验中有3例白细胞低于4.0×109/L、2例红细胞低于4.0×1012/L且血红蛋白低于130g/L,1例血小板低于100×109/L。用药后的尿常规化验中,有4例白细胞高于正常值,有3例红细胞高高于正常值。心电图检查中有3例用药前正常,用药后心电图出现心率不齐,心电图医师认为无临床意义。
【药理毒理】
药理作用
本品为核苷类抗病毒药,体外对Ι型和П型单纯性疱疹病毒有抑制作用。在病毒感染的细胞中,病毒胸腺嘧啶脱氧核苷激酶将本品磷酸化为喷昔洛韦单磷酸盐,然后细胞激酶将喷昔洛韦单磷酸盐转化为喷昔洛韦三磷酸盐。体外实验表明,喷昔洛韦三磷酸盐与脱氧鸟嘌呤核苷三磷酸盐竞争性抑制单纯疱疹病毒多聚酶,从而选择性抑制单纯疱疹病毒DNA 的合成和复制。
耐本品的单纯疱疹病毒突变株的产生是由于病毒胸腺嘧啶脱氧核苷激酶或DNA多聚酶性质发生了改变,最常见耐阿昔洛韦的病毒突变株缺乏胸腺嘧啶核苷激酶,它们对本品也耐药。
毒理研究
某些动物试验显示高浓度的喷昔洛韦可致突变,但无染色体改变的依据。在对细胞无害的浓度下喷昔洛韦未表现出致突变作用。
大鼠和兔静脉注射喷昔洛韦的I~Ш段生殖毒性试验中,大鼠最高剂量为80mg/kg/d,兔为50mg/kg/d,结果表明喷昔洛韦对受试动物的胚胎发育和生活能力、多代发育、生殖能力及生殖行为等仅有轻微或没有影响。长期大剂量注射可致动物睾丸萎缩和精子数减少,停药可部分恢复。
动物实验未见致癌依据。
【药代动力学】
10名受试者单次静脉滴注喷昔洛韦后,血浆浓度-时间曲线经WinNonLin程序采用非房室模型进行拟和计算,消除速率常数ke为0.3680 ±0.04891/hr,消除半衰期t1/2为1.91 ±0.26 hr,达峰时间Tmax为1.00 ±0.00 hr,达峰浓度Cmax为9.7745 ±1.5866 mg/L,药时曲线下面积AUC0-t为19.106 ±2.853 hr*mg/L,药时曲线下面积AUC0-∞为19.619 ±2.868 hr*mg/L,表观分布容积Vd为1.451 ±0.382 L/kg,表观清除率CL为0.520 ±0.079 L/hr/kg。
文献报道滴注相同剂量后主要药代动力学参数:消除半衰期t1/2为1.90 ±0.25 hr,达峰时间Tmax为0.95 ±0.1 hr,达峰浓度Cmax为12.1 ±3.1 mg/L,
药时曲线下面积AUC0-∞为21.1 ±3.4 hr*mg/L。本研究结果与文献报道基本一致。
文献报道滴注相同剂量后表观分布容积V为102 ±20 L,表观清除率CL为37.6 ±9.5 L/hr。经体重校正后进行对比,本研究结果与文献报道基本一致。
10 名受试者单次静脉滴注喷昔洛韦后,约50%的喷昔洛韦在给药后2小时经尿排出,10小时后排出量很少,12小时尿喷昔洛韦累积排出率为68.8±11.9%。
文献报道滴注相同剂量后72小时尿喷昔洛韦累积排出率为73.1±5.8%。因此,喷昔洛韦主要经肾排泄,本研究结果与文献报道基本一致。
表6.1 主要药代动力学参数对比表
|
参数 |
试验测定结果 |
文献数值 |
|
剂量 |
10 mg•kg-1 |
10 mg•kg-1 |
|
t1/2 |
1.91 ±0.26 hr |
1.90 ±0.25 hr |
|
Tmax |
1.00 ±0.00 hr |
0.95 ±0.1 hr |
|
Cmax |
9.775 ±1.587 mg/L |
12.1 ±3.1 mg/L |
|
AUC0-t |
19.106 ±2.853 hr*mg/L |
21.1 ±3.4 hr*mg/L |
|
Vd |
1.451 ±0.382 L/kg |
102 ±20 L |
|
CL |
0.520 ±0.079 L/hr/kg |
37.6 ±9.5 L/hr |
|
12小时尿累积排出率 |
68.8±11.9% |
- |
|
72小时尿累积排出率 |
- |
73.1±5.8% |
据文献报道,药物能通过胎盘,虽动物实验证实对胚胎无影响,但孕妇用药仍需权衡利弊。药物在乳汁中的浓度为血药浓度的0.6~4.1倍,虽未发现婴儿异常,但哺乳期妇女应慎用。
【贮藏】遮光,密闭,在阴凉处(不超过20℃)保存。
【包装】管制抗生素瓶装,1瓶/盒。
【有效期】暂定24个月。
【执行标准】YBH02122007
【批准文号】国药准字H20070186
【生产单位】
企业名称:浙江尖峰药业有限公司
地 址:浙江省金华市婺城区白汤下线高畈段58号
电 话:0579-82661998(咨询) 0579-82131973(销售)
传 真:0579-82661998
邮 编:321075
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Recently, the national high-tech enterprise certification management network announced the "list of the first batch of high-tech enterprises to be recognized in Zhejiang Province in 2020". Jianfeng health technology company successfully entered the list through the municipal, provincial and national three-level examination, and officially entered the ranks of national high-tech enterprises. The identification of high-tech enterprises is a comprehensive evaluation and identification of the core independent intellectual property rights, the ability to transform scientific and technological achievements, the organization and management level of research and development, growth indicators and talent structure of the enterprise. Since its establishment, Jianfeng Health has been relying on technological innovation and technological progress to promote the development of enterprises, keeping up with the cutting-edge technology of the industry, and constantly improving the value, scientific and technological content and market share of products. As a provincial agricultural science and technology research and development center, Jianfeng Health has a high-quality technical team and advanced equipment, and has long-term cooperation with well-known scientific research institutions across the country. The person in charge of the company said that being recognized as a national high-tech enterprise is the recognition of Jianfeng Health's innovative research and development in biology and new medicine, natural medicine and sustainable utilization of traditional Chinese medicine resources over the years by the competent government departments at all levels. it will further promote the process of independent innovation and independent research and development of the company. In the future, Jianfeng Health will continue to develop high-quality new pharmaceutical products, and continue to promote the sustainable use of drug resources. At the same time, it will pay more attention to independent innovation, protect intellectual property rights, continue to increase R & D investment, cultivate professional talent team, enhance the company's core competitiveness, and enrich the enterprise's innovation and development potential; Further strengthen the company's technological innovation ability and the transformation ability of scientific and technological achievements, and provide strong technical support for the sustained, strive to become the backbone of the development of the industry. (Yang Haolou Yongzeng)
2020
12-11
Peak re-listed China's top 100 building materials enterprises
News from this newspaper China Building Materials Enterprise Management Association recently released the "2020 Top 500 Chinese Building Materials Enterprises List", and Jianfeng Group ranked among the "2020 Top 100 Chinese Building Materials Enterprises". This series of lists has been released every year since 2002, and has received extensive attention and active participation from governments at all levels, building materials authorities and building materials companies, and has become a vane of China's building materials industry. In order to enhance the authority, credibility and influence of information release, the list cooperates with various building materials professional associations and local building materials associations of the China Building Materials Federation system. Data collection is carried out through various channels such as recommendation of local building materials associations and building materials professional associations, enterprise declaration, public information, special investigation, etc. The selection scope includes registration in China (excluding foreign capital in China, wholly-owned and holding enterprises of Hong Kong, Macao and Taiwan), or registered overseas, the investment subject is a Chinese natural or legal person, the main business is in the territory, all engaged in production, service, scientific research, design, commerce, supply, logistics and other building materials enterprises and units of the whole industry chain. Peak since participating in the activities, has been ranked for many years in China's top 100 building materials enterprises. (this newspaper reporter)
2020
12-11
Huang Ping peak officially completed! The company donated education support funds to Huang Ping
According to our newspaper, the early winter in Guizhou was warm and cold, and the Huang ping peak factory area was waving colorful flags. on the morning of November 20, relevant leaders and guests from Zhejiang and Guizhou gathered in gulong town, "the world's first Miao township", to witness the completion and commissioning of the 4500t/d cement clinker production line project of Guizhou Huang ping peak cement company. The Huangping Jianfeng Cement Project is the second project in the southwest of the peak cement plate, and it is also the first east-west poverty alleviation cooperation project of the peak in Guizhou. Since the construction started in the first half of 2019, after 18 months of efforts by all the construction and construction personnel, the project construction and process technical debugging have been fully completed, the production line operation has basically reached the design target, and the "peak" brand bagged and bulk cement has been put on the market in southeast Guizhou and surrounding areas. The completion and commissioning ceremony of Huang Ping peak was presided over by Yu Jianhong, general manager of the group company. Leaders and guests attending the ceremony included relevant leaders of Jinhua Municipal people's Congress and CPPCC, leaders and heads of functional departments in Qiandongnan Prefecture, Huangping County and Gulong Town of Guizhou Province, relevant responsible persons of Zhejiang Branch and Guizhou Branch of Agricultural Bank of China, representatives of directors and supervisors of Jianfeng Group, responsible persons of Guizhou cement Association, Huangping peak project cooperation units and peer enterprises, as well as representatives of agents and end customers. Hu Hongwei, general manager of Huang Ping Jianfeng, introduced the project construction and the overall situation of the enterprise to the leaders and guests. He said that the completion and commissioning is a new beginning for Huangping Peak. In the future, it will further strengthen refined management, strengthen production quality control, safe production, and high-quality services to contribute to the construction of Southeast Guizhou and the well-being of Huangping people. Yang Zhi, head of the people's Government of Huangping County, said in a speech at the ceremony that the Huangping peak cement project is a key investment attraction project in Huangping County. It took only 18 months from the start of construction to the production, creating a "peak speed" and demonstrating the "peak spirit". The completion and commissioning of the project has laid a solid industrial foundation for solving the employment and income increase of the local poor people, expanding the total industrial economy of Huangping, promoting Huangping to win the battle against poverty, and achieving the goal of a comprehensive well-off society. In the future, Huangping County will certainly serve the development of enterprises at a higher level, constantly consolidate and develop "pro-Qing" political and business relations, earnestly safeguard the legitimate rights and interests of enterprises, and take more effective measures to constantly deepen the reform of "management and service". Improve work style, improve service quality, optimize the business environment, and create a good atmosphere of pro-business, safe business, and rich business. Sun Hongwei, a first-level inspector of the Zhejiang Branch of the Agricultural Bank of China, spoke on behalf of the Agricultural Bank and congratulated Huang Ping on the completion and commissioning of the peak. In his speech, Chen Zhishi, deputy director of the Standing Committee of Jinhua Municipal People's Congress, expressed heartfelt congratulations on the successful completion and commissioning of the new dry process cement clinker production line of Guizhou Huangping Jianfeng Cement Company on behalf of the four teams of Jinhua. He said that poverty alleviation cooperation between the east and the west is an important decision-making and deployment of the Party Central Committee and the State Council, and it is also an unshirkable political responsibility. Jianfeng Group's investment in cement projects in Huangping is not only a concrete action in response to the call of the Party Central Committee and the State Council, but also an active choice for enterprises to jump out of Zhejiang for development and break through the bottleneck of resource elements. He hopes that the party committees, governments and functional departments at all levels in Qiandongnan Prefecture and Huangping County will continue to care and support the development of Huangping Jianfeng Company and continue to create a high-quality development environment for the enterprise. It is hoped that Huangping Jianfeng Company will actively lead the high-quality development of Huangping industry, fully promote the development of related industries and the employment of local residents, and contribute to the enhancement of county economic strength. Looking forward to deepening cooperation and exchanges between the two places, give full play to Jinhua's industrial and market advantages and Qiandongnan's ecological and labor advantages, strengthen tourism cooperation, labor cooperation, and industrial cooperation between the two places, and promote cooperation and exchanges between the two places to a deeper level, higher level, and broader field. Jiang Xiaomeng, secretary of the party committee and chairman of the board of directors of the group company, delivered a speech at the ceremony. On behalf of the company, he expressed his heartfelt thanks to the party committees, governments and functional departments at all levels in Zhejiang and Guizhou, the special poverty alleviation fund support of Agricultural Bank of Zhejiang Province, the project cooperation construction units, equipment supply manufacturers, and all cadres and employees of Huangping peak in Guizhou for their hard work. He said that Jianfeng is an old enterprise with a history of 62 years. Huang Ping Jianfeng is the youngest member of the Jianfeng family. He hopes that all cadres and employees of Guizhou Huangping Jianfeng will inherit and carry forward the spirit and culture of Jianfeng, and be scientific and innovative. Pay attention to management and seek standardization; Dare to fight hard, love dedication, and build the enterprise into a green, environmentally friendly and efficient modern enterprise, create a good career development platform for employees, make due contributions to Guizhou's economic development and industry transformation and upgrading, and write a new chapter in the history of peak development. In order to thank Huang Ping's fellows for their support and love, with the approval of the board of directors, the company decided to donate 200000 yuan of education assistance funds to Huang Ping County to support the development of Huang Ping's education. At the completion ceremony, Chairman Jiang Xiaomeng made a donation on behalf of the company, and Lin Ganli, member of the Standing Committee of the Huangping County Party Committee, Minister of the United Front Work Department, and Secretary of the Party Committee of Gulin Town, accepted the donation on behalf of Huangping County. At the end of the ceremony, Huang Jinchao, director of Jinhua Decision-making Advisory Committee, Fu Lichang, former vice chairman of Jinhua CPPCC, Jiang Tinggui, deputy director of Qiandongnan Prefecture People's Congress Standing Committee, Lin Changfu, secretary of Huangping County Party Committee, and Chairman Jiang Xiaomeng jointly pressed the starting ball for the official completion and commissioning of the 4500-ton cement clinker production line project in Huangping, Guizhou. After the ceremony, the leaders and guests visited the Huang Ping peak factory and production line. (this newspaper reporter)
2020
12-01
Jiang Xiaomeng Elected First President of Jinhua High-tech Enterprise Association
News from our newspaper On the afternoon of November 24, the inaugural meeting of Jinhua High-tech Enterprise Association was grandly held in Jinhua Cultural Center. Jiang Xiaomeng, secretary of the party committee and chairman of the group company, was elected as the first president of the association. With the strong support of the Municipal Science and Technology Bureau, Jinhua High-tech Enterprise Association was jointly initiated and established by Jianfeng Group, Jinfei Group, Wanliyang, Kehui Medical, Dawei High-tech, and Peking University Science and Technology Park. Promote the development of our city's high-tech industry, improve the independent innovation capabilities of enterprises, strengthen industry-university-research cooperation with universities and scientific research institutes, and build a bridge between the government and enterprises, provide information, technology, consulting and personnel training services for high-tech enterprises. According to statistics, Jinhua City currently has 990 national high-tech enterprises, and the number is increasing at a rate of about 300 per year, showing a good trend of accelerating cultivation and growth, and is gradually becoming the promotion of Jinhua City's industrial transformation and upgrading and high-quality economic development. Important force. Zhang Xinyu, vice mayor of Jinhua City, pointed out in his speech at the inaugural meeting that high-tech enterprises are the main force of technological innovation and the main engine of high-quality economic development. It is hoped that the association will give full play to its advantages in linkage, build a "heart-to-heart bridge" for government-enterprise communication, be a "vanguard" in scientific and technological innovation, be a "waiter" for enterprise development, and build a "gathering place" for innovative talents. we will constantly stimulate the enthusiasm and creativity of the broad masses of scientific and technological personnel and innovative subjects, and strive to create a new situation for the prosperity and development of Jinhua's high-tech industry. After democratic election by members, Jiang Xiaomeng, chairman of the group company, was elected as the first president of the High-tech Enterprise Association. In his inaugural speech, Jiang Xiaomeng said that in recent years, the state has paid unprecedented attention to scientific and technological innovation, paid unprecedented attention to private economy and entrepreneurs, and high-tech enterprises in Jinhua City have also developed rapidly. In order to better serve the majority of member units and enhance the innovation ability of Jinhua enterprises, the association should focus on three aspects in the future, namely, assisting the government to promote the development of Jinhua's high-tech industry; giving full play to the role of bridge and link between the government and high-tech enterprises; promoting exchanges and cooperation among members, members and scientific research institutes, Make the association truly become the home of high-tech enterprises and the link of communication between government and enterprises, A platform for high-quality services ". (Fonse)
2020
12-01