CN109130124A - 一种药物用卡式瓶的制备方法 - Google Patents
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C45/00—Injection moulding, i.e. forcing the required volume of moulding material through a nozzle into a closed mould; Apparatus therefor
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- B—PERFORMING OPERATIONS; TRANSPORTING
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- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C45/00—Injection moulding, i.e. forcing the required volume of moulding material through a nozzle into a closed mould; Apparatus therefor
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
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- B—PERFORMING OPERATIONS; TRANSPORTING
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- B29C2945/00—Indexing scheme relating to injection moulding, i.e. forcing the required volume of moulding material through a nozzle into a closed mould
- B29C2945/76—Measuring, controlling or regulating
- B29C2945/76494—Controlled parameter
- B29C2945/76531—Temperature
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
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- B29C2945/00—Indexing scheme relating to injection moulding, i.e. forcing the required volume of moulding material through a nozzle into a closed mould
- B29C2945/76—Measuring, controlling or regulating
- B29C2945/76494—Controlled parameter
- B29C2945/76595—Velocity
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Abstract
本发明公开了一种药物用卡式瓶的制备方法,以环烯烃聚合物COP为原材料,生产步骤如下:(1)原材料预干燥、(2)氮封上料、(3)注塑成型、(4)清洗灭菌。该方法采用具有热塑性的环烯烃聚合物COP为原材料,通过注塑成型工艺生产卡式瓶。与传统玻璃卡式瓶生产方法相比,工艺简单,效率高,同时避免了传统卡式瓶加工中玻璃管切割时玻璃碎屑的产生,污染小。此外,通过该方法生产的COP卡式瓶具有绝佳的理化稳定性、低蛋白质吸附性、透明度高、重量轻、不易破碎、耐各种方式灭菌,且灭菌后仍能保持高透明性的优点,析出物和萃取物含量极低、耐药品性好。
Description
技术领域
本发明涉及医药包装生产技术领域,具体涉及一种高端药物用卡式瓶的制备方法。
背景技术
卡式瓶是笔式注射器的重要构件,在使用过程中直接与药品接触,其性能的优劣,对封装药品的稳定性有至关重要的影响。传统的卡式瓶主要是硼硅玻璃管经预热工序、制口工序、定长工序、分断工序和坯料断口修复工序制成。该方法对设备要求高,分断时易产生玻璃碎屑,且生产的卡式瓶在运输、储存和销售的过程中易破损;与特殊药品有时会发生反应;封装pH值高于9的药品时容易产生脱片,与生物制剂接触易产生表面吸附现象,从而影响药品质量,无法满足高端生物制剂及高pH值药物的使用要求。所以开发一种工艺简单、产品机械强度高、与药物相容性好的卡式瓶生产方法,很有必要。
COP材料是具有环状烯烃结构的非晶性透明共聚高聚物,具有透明度好、重量轻、不容易破碎、耐药品性好等特点,是一种代替玻璃的高端产品,可以采用注塑工艺加工结构较为复杂的制件。
发明内容
本发明提出了一种药物用卡式瓶的制备方法,解决了现有制备工艺中药瓶质量无法满足高端生物制剂及高pH值药物的使用要求的问题。
实现本发明的技术方案是:一种药物用卡式瓶的制备方法,步骤如下:
(1)原材料干燥:采用有充氮气功能的干燥上料机,在氮气环境下对环烯烃聚合物进行干燥,去除颗粒中的空气;
(2)氮封上料:将步骤(1)干燥后的环烯烃聚合物在氮气保护下送入注塑机;
(3)注塑成型:将注塑机内的环烯烃聚合物进行高温熔融,经由注塑机喷嘴进入热流道模具生产卡式瓶产品;
(4)清洗灭菌:采用注射用水清洗,并进行高压蒸汽灭菌。
所述步骤(1)中环烯烃聚合物为日本瑞翁的zeonex系列或zeonor系列。
所述步骤(1)中干燥温度为100-105 ℃,干燥时间为6-24h。
所述步骤(3)中料筒温度为加料段220-280℃,优选为220-250℃,压缩段为235-265℃,计量段为250-280℃,喷嘴温度为250-275℃,模具温度为105-115 ℃,注射压力为50-100 MPa,保压压力为30-60 MPa,注射速度为50-150 mm/s,螺杆压缩比为2.0-2.5。
所述步骤(4)中灭菌温度为121 ℃,灭菌时间为30-60 min。
本发明的有益效果是:
(1)以环烯烃聚合物COP为原材料,采用注塑工艺生产卡式瓶,生产工艺简单,自动化程度高,注塑周期短,避免了传统卡式瓶加工过程中玻璃碎屑的产生,污染小。
(2)COP是一类具有环状烯烃结构的非晶性透明共聚高分子材料,该材料本身的纯度高,透明性好,具有良好的防潮性、机械强度、抗酸碱性和生物相容性,材料中的析出物和萃取物含量极低。
(3)该方法生产的卡式瓶具有绝佳的理化稳定性,与药品相容性好,辐射后不变色,具有优良的低蛋白质吸附性,机械强度高,不易破碎,耐各种方式灭菌,且灭菌后仍能保持高透明性,产品可迁移物少。可代替传统方法生产的卡式瓶,用于高附加值药品及碱性药物中。
具体实施方式
下面将结合本发明实施例,对本发明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。基于本发明中的实施例,本领域普通技术人员在没有付出创造性劳动前提下所获得的所有其他实施例,都属于本发明保护的范围。
实施例1
一种高端药物用COP卡式瓶的制备方法,步骤如下:在氮气氛围下将COP原材料在100℃条件下干燥24小时,去除颗粒中的空气;将干燥后的原材料,在氮气保护下送入注塑机;设置料筒温度,加料段220℃,压缩段235℃,计量段250℃,喷嘴250℃;模具温度为105℃,然后设注射压力为50MPa,保压压力为30MPa,注射速度为50mm/s,经过加料塑化、注射充模、保压冷却和脱模过程制得卡式瓶产品;在洁净环境下,经注射用水清洗,121℃高压蒸汽灭菌30min后,烘干,即得符合要求的药用COP卡式瓶。
实施例2
一种高端药物用COP卡式瓶的制备方法,步骤如下:在氮气氛围下将COP原材料在105℃下干燥6小时,去除颗粒中的空气;将干燥后的原材料,在氮气保护下送入注塑机;设置料筒温度,加料段235℃,压缩段250℃,计量段265℃,喷嘴260℃,模具温度为110℃,然后设注射压力为80MPa,保压压力为50MPa,注射速度为110mm/s,经过加料塑化、注射充模、保压冷却和脱模过程制得卡式瓶产品;在洁净环境下,经注射用水清洗,121℃高压蒸汽灭菌45min后,烘干,即得符合要求的药用COP卡式瓶。
实施例3
一种高端药物用COP卡式瓶的制备方法,步骤如下:在氮气氛围下将COP原材料在102℃下干燥15小时,去除颗粒中的空气;将干燥后的原材料,在氮气保护下送入注塑机;设置料筒温度,加料段250℃,压缩段265℃,计量段280℃,喷嘴275℃,模具温度为115℃,然后设注射压力为100MPa,保压压力为60MPa,注射速度为150mm/s,经过加料塑化、注射充模、保压冷却和脱模过程制得卡式瓶产品;在洁净环境下,经注射用水清洗,121℃高压蒸汽灭菌60min后,烘干,即得符合要求的药用COP卡式瓶。
以上所述仅为本发明的较佳实施例而已,并不用以限制本发明,凡在本发明的精神和原则之内,所作的任何修改、等同替换、改进等,均应包含在本发明的保护范围之内。
Claims (5)
1.一种药物用卡式瓶的制备方法,其特征在于步骤如下:
(1)原材料干燥:对环烯烃聚合物进行干燥;
(2)氮封上料:将步骤(1)干燥后的环烯烃聚合物在氮气保护下送入注塑机;
(3)注塑成型:将注塑机内的环烯烃聚合物进行高温熔融,经由注塑机喷嘴进入热流道模具生产卡式瓶产品;
(4)清洗灭菌:采用注射用水清洗,并进行高压蒸汽灭菌。
2.根据权利要求1所述的药物用卡式瓶的制备方法,其特征在于:所述步骤(1)中环烯烃聚合物为日本瑞翁的zeonex系列或zeonor系列。
3. 根据权利要求1所述的药物用卡式瓶的制备方法,其特征在于:所述步骤(1)在氮气环境下对环烯烃聚合物进行干燥,干燥温度为100-105 ℃,干燥时间为6-24 h。
4. 根据权利要求1所述的药物用卡式瓶的制备方法,其特征在于:所述步骤(3)中料筒温度为加料段220-280℃,压缩段为235-265℃,计量段为250-280℃,喷嘴温度为250-275℃,模具温度为105-115 ℃,注射压力为50-100 MPa,保压压力为30-60 MPa,注射速度为50-150 mm/s,螺杆压缩比为2.0-2.5。
5. 根据权利要求1所述的药物用卡式瓶的制备方法,其特征在于:所述步骤(4)中灭菌温度为121 ℃,灭菌时间为30-60 min。
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CN112451797A (zh) * | 2020-11-05 | 2021-03-09 | 山东永聚医药科技有限公司 | 高分子预灌封注射器 |
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CN103030947A (zh) * | 2011-09-29 | 2013-04-10 | 上海林静医疗器械有限公司 | 降解型一次性口咽通气道及制备方法 |
CN104191578A (zh) * | 2014-08-28 | 2014-12-10 | 京东方光科技有限公司 | 一种注塑机及应用该注塑机的注塑方法 |
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CN103030947A (zh) * | 2011-09-29 | 2013-04-10 | 上海林静医疗器械有限公司 | 降解型一次性口咽通气道及制备方法 |
CN104191578A (zh) * | 2014-08-28 | 2014-12-10 | 京东方光科技有限公司 | 一种注塑机及应用该注塑机的注塑方法 |
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CN112451797A (zh) * | 2020-11-05 | 2021-03-09 | 山东永聚医药科技有限公司 | 高分子预灌封注射器 |
CN112451797B (zh) * | 2020-11-05 | 2023-04-18 | 山东永聚医药科技有限公司 | 高分子预灌封注射器 |
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