WO2018192000A1 - 一种培哚普利及其盐的渗透泵片及其制备方法 - Google Patents
一种培哚普利及其盐的渗透泵片及其制备方法 Download PDFInfo
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- WO2018192000A1 WO2018192000A1 PCT/CN2017/082099 CN2017082099W WO2018192000A1 WO 2018192000 A1 WO2018192000 A1 WO 2018192000A1 CN 2017082099 W CN2017082099 W CN 2017082099W WO 2018192000 A1 WO2018192000 A1 WO 2018192000A1
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- perindopril
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
- A61K38/05—Dipeptides
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- 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
- A61K9/0002—Galenical forms characterised by the drug release technique; Application systems commanded by energy
- A61K9/0004—Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas
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- 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
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
- A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
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- 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
- A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
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- 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
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
- A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
Definitions
- the invention belongs to the technical field of medicine, and relates to a perindopril osmotic pump type controlled release tablet and a preparation method thereof. Background technique
- the osmotic pump type controlled release preparation is based on osmotic pressure and has zero release kinetics as a release characteristic, and can release the drug at a constant speed within a certain time range.
- the release of drugs is largely independent of physiological parameters such as pH value, gastric emptying time, peristalsis, etc., and the correlation between the body and the outside is good, and the drug can be adjusted.
- the release characteristics optimize the pharmacodynamic effect of the system; the phenomenon that the blood drug concentration caused by the common oral preparation fluctuates greatly, the adverse reaction is alleviated, and the safety and effectiveness of the drug are greatly improved.
- osmotic pump controlled release preparations such as nifedipine controlled release tablets, prazosin controlled release tablets, glipizide controlled release tablets, etc., which have been marketed abroad, have achieved good therapeutic and commercial effects. .
- Osmotic pump type controlled release preparations mainly include oral osmotic pumps, microporous osmotic pumps, and implantable osmotic pumps.
- oral osmotic pump preparation is an oral osmotic pump, which generally consists of a core and a coating film.
- Oral osmotic pumps include single chamber osmotic pumps, multi-chamber osmotic pumps and liquid osmotic pumps.
- the single-chamber osmotic pump has the simplest structure and preparation process, and uses a conventional tablet preparation process to compress the drug and a suitable osmotic active substance into a tablet core, and then uses a water-insoluble polymer material such as cellulose acetate to the core.
- the coating is carried out to prepare a semi-permeable coating film, and then a small hole having a suitable pore diameter is formed by laser or mechanical means on the film.
- the moisture in the environmental medium can penetrate into the core through the semipermeable membrane to dissolve the osmotic active substance and the drug in the core, thereby forming a saturated solution of high osmotic pressure in the membrane.
- the drug is released from the drug release hole and absorbed by the gastrointestinal tract.
- the drug concentration in the membrane is The osmotic pressure is maintained constant to ensure a constant release rate during this period.
- Angiotesion Converting Enzyme Inhibitors is a new and widely used antihypertensive and anti-congestive heart failure drug developed in the 1980s.
- Perindopril is the third generation of potent, long-acting angiotensin-converting enzyme inhibitor (ACEI) that was developed in the early 1980s.
- ACEI angiotensin-converting enzyme inhibitor
- Perindopril hydrolyzes in vivo and acts as an active metabolite, perindopril. Its antihypertensive mechanism is to block the conversion of angiotensin I into an active blood vessel.
- perindopril has a significant antihypertensive effect and is well tolerated. It not only effectively lowers blood pressure, but also reverses vascular abnormalities associated with hypertension and reduces cardiovascular morbidity and mortality. Therefore, perindopril plays an important role in the treatment of hypertension and the prevention and treatment of cardiovascular diseases. However, the production of perindopril is affected by diet, and the food changes the bioavailability of its active metabolite, perindopril.
- Perindopril tablets must be taken before meals.
- the commercially available preparation is an ordinary matrix-type sustained-release preparation, which is administered once a day to reduce the frequency of drug administration and improve patient compliance.
- the drug release of the matrix-type sustained-release tablet is easily affected by the gastrointestinal environment such as gastrointestinal motility and pH, especially in the case of gastrointestinal motility, the matrix is destroyed and loses the sustained release effect, and the sustained and stable drug concentration cannot be maintained. Not conducive to the treatment of the disease. Therefore, there is still a need for a controlled release formulation of perindopril which is simple in process, ideal in release, and effective in efficacy.
- the object of the present invention is to overcome the deficiencies of the currently used clinically used perindopril tablets.
- the osmotic pump type controlled release tablets were prepared with perindopril as the main drug.
- the advantage of the preparation is that the zero-order release kinetics is the release characteristic, and the drug can be released slowly and at a constant speed for a certain period of time, which is beneficial to maintaining the long-term and high-efficiency blood concentration in the body and improving the therapeutic effect of the drug.
- the drug release rate is controlled by the prescription design, and the release rate is generally not Affected by gastrointestinal physiological factors such as peristalsis, pH, gastric emptying time and other variables, the correlation between internal and external is good.
- the present invention provides an osmotic pump controlled release tablet of perindopril and a pharmaceutically acceptable salt thereof as a single chamber osmotic pump controlled release formulation comprising a single layer core, a semipermeable film coating and a drug delivery orifice.
- a single chamber osmotic pump controlled release formulation comprising a single layer core, a semipermeable film coating and a drug delivery orifice.
- the core of the osmotic pump type controlled release preparation of the invention comprises 1.0-4.0 mg of the drug, 20-50 mg of the filler, 20-60 mg of the osmotic active substance, 10-30 mg of the binder, 10 ⁇ 32 mg of the solubilizing agent and the lubricant. 3 to 6 mg.
- the semipermeable coating film coating material is 10-30 mg, the plasticizer is 2-10 mg, and an appropriate amount of solvent.
- the perindopril osmotic pump type controlled release tablet according to the present invention is selected from the group consisting of gum arabic, tragacanth, peach gum, carboxymethyl cellulose, dextrin, starch or a mixture thereof.
- the perindopril osmotic pump type controlled release tablet of the present invention the osmotic active substance used is selected from the group consisting of mannitol, glucose, lactose, sucrose, sodium chloride or a mixture thereof.
- the perindopril osmotic pump type controlled release tablet of the present invention is selected from the group consisting of starch syrup, hypromellose, povidone, sodium carboxymethylcellulose or a mixture thereof.
- the perindopril osmotic pump type controlled release tablet of the present invention uses a release rate adjusting agent selected from the group consisting of polyethylene glycol, propylene glycol, glycerin, dibutyl phthalate or a mixture thereof.
- the perindopril osmotic pump type controlled release tablet according to the present invention is selected from the group consisting of magnesium stearate, calcium stearate, talc, micronized silica gel, sodium lauryl sulfate, and polyoxyethylene single hard. Glyceryl glycerides, waxes or mixtures thereof.
- the perindopril osmotic pump type controlled release tablet of the present invention is used as a solubilizing agent, pluronic acid, sodium stearate, polyethylene glycol 4000 or a mixture thereof.
- the perindopril osmotic pump type controlled release tablet according to the invention, the semipermeable film coating material is selected from the cellulose acetate fiber Wort or hypromellose phthalate, the plasticizer is selected from dibutyl sebacate or PEG 200, and the solvent is selected from acetone or ethanol.
- a laser puncher can be used to punch 0.1-0.5 mm holes on the semi-permeable film coating layer.
- Figure 1 is a graph showing the release profiles of Perindopril osmotic pump type controlled release tablets of Examples 1 to 4 in phosphate buffer pH 7.4. As can be seen from the figure, the release of the drug exhibits a significant zero-order release characteristic, indicating that the osmotic pump-controlled release tablets prepared by perindopril can release the drug at a constant rate, thereby maintaining a stable blood concentration and efficiently exerting the drug. Therapeutic effect.
- Preparation process Perindopril and solubilizer were mixed uniformly for 15 min, mixed with filler and osmotic active substance in a mixer for 15 min, made of soft material with 1% binder aqueous solution, granulated by 20 mesh sieve, 40 ° C Dry for 6h, pass through 16 mesh sieve, and mix and evenly compress.
- the coating material and other excipients in the coating layer were dissolved in acetone, coated with a coating pan, and cured at 40 ° C for 6 h after the coating was completed. After the coating is cured, a 0.5 mm hole can be punched on the coating layer with a laser puncher.
- Perindopril and solubilizer were mixed uniformly for 15 min, mixed with filler and osmotic active substance in a mixer for 15 min, made of soft material with 1% binder aqueous solution, and sieved through 20 mesh sieve, 50 ° C Dry for 7h, pass through 16 mesh sieve, and mix and evenly compress.
- the coating material and other excipients in the coating layer were dissolved in acetone, coated in a coating pan, and cured at 50 ° C for 7 h after the coating was completed. After the coating is cured, a 0.4 mm hole can be punched on the coating layer with a laser puncher.
- Preparation process Perindopril and solubilizer were mixed uniformly for 15 min, mixed with filler and osmotic active substance in a mixer for 20 min, made of soft material with 2% binder aqueous solution, and sieved by 20 mesh sieve, 40 ° C Dry for 8 h, sieve through 16 mesh sieves, mix and evenly compress.
- the coating material and other excipients in the coating layer were dissolved in ethanol, coated in a coating pan, and cured at 40 ° C for 8 h after the coating was completed. After the coating is cured, the laser puncher is used. Apply 0.2mm holes to the coating layer.
- Preparation process Perindopril and solubilizer were mixed uniformly for 20 min, mixed with filler and osmotic active substance in a mixer for 15 min, made of soft material with 2% binder aqueous solution, granulated by 20 mesh sieve, 50 ° C Dry for 6h, pass through 16 mesh sieve, and mix and evenly compress.
- the coating material and other excipients in the coating layer were dissolved in acetone, coated with a coating pan, and cured at 50 ° C for 8 h after the coating was completed. After the coating is cured, a 0.1 mm hole can be punched on the coating layer with a laser puncher.
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Abstract
一种培哚普利渗透泵型控释片，其包含含药片芯和半透性薄膜包衣，半透性薄膜包衣层上有释药小孔，其中片芯含有培哚普利或其药学上可接受的盐1.0~4.0mg，填充剂20~50mg，渗透压活性物质20~60mg，粘合剂10~30mg，增溶剂10~32mg和润滑剂3~6mg。
Description
本发明属于医药技术领域，涉及一种培哚普利渗透泵型控释片及其制备方法。背景技术
渗透泵型控释制剂是以渗透压为驱动力，以零级释放动力学为释药特征，能够在一定的时间范围内以恒定的速度释放药物。相对于基质型以及贮库型缓释技术，药物的释放在很大程度上不依赖于pH值、胃排空时间、蠕动等生理参数的影响，体内外相关性较好，并且能够调整药物的释放特征使系统的药效作用最佳化；可避免普通口服制剂造成的血药浓度波动较大的现象，减轻不良反应，极大地提高了药物的安全性和有效性。目前,国外己上市的渗透泵型控释制剂品种如硝苯地平控释片控释片，哌唑嗪控释片，格列吡嗪控释片等，都已获得了良好的治疗和商业效果。
渗透泵型控释制剂主要有口服渗透泵，微孔渗透泵，植入式渗透泵。目前应用最广泛的渗透泵制剂为口服渗透泵，一般由片芯和包衣膜两部分组成。口服渗透泵包括单室渗透泵，多室渗透泵和液态渗透泵。其中，单室渗透泵，结构形式与制备工艺最简单，采用常规的片剂制备工艺将药物与适宜的渗透活性物质压制成片芯后，用醋酸纤维素等水不溶性高分子材料对片芯等进行包衣，制备半渗透性包衣膜，然后激光或机械方式在膜上打出孔径适宜的小孔即可。环境介质中的水分可经半渗透性衣膜渗透进入片芯内，使片芯内的渗透活性物质和药物溶解，从而在膜内形成高渗透压的饱和溶液。依赖于膜内外恒定的渗透压差，药物由释药孔释放出而被胃肠道吸收。在释药期间，膜内药物浓度以
及渗透压维持恒定，从而保证在该期间释药速率恒定。
血管紧张素转换酶抑制剂(Angiotesion Converting Enzyme Inhibitors，ACEI)，是上世纪80年代发展起来的一类新型和应用最广的抗高血压药和抗充血性心力衰竭药物。培哚普利(perindopril)是八十年代初开始研制的第三代强效、长效的血管紧张素转换酶抑制剂(ACEI)。培哚普利在体内水解为其活性代谢物培哚普利拉发挥疗效。其降压机理为阻断血管紧张素Ⅰ转化为有活性的血管
紧张素Ⅱ、减少神经末梢释放去甲肾上腺素和血管内皮细胞形成，抑制缓激肽降解，增加缓激肽和扩血管的前列腺素的形成。培哚普利的降压效果明显且耐受性好,不仅能有效地降低血压,而且能逆转与高血压相关的血管异常、减小心血管发病率和死亡率。因此，培哚普利在高血压的治疗及心血管疾病的防治中具有重要作用。但是，培哚普利拉的生成量受饮食的影响，食物会改变其活性代谢产物培哚普利拉的生物利用度，培哚普利片必须饭前服用。目前市售制剂为普通的基质型缓释制剂，一天给药一次，降低药物给药频次，提高患者依从性。但是，由于基质型缓释片的药物释放容易受到胃肠蠕动、pH值等胃肠环境影响，尤其是在胃肠蠕动情况下基质被破坏而失去缓释作用，无法维持持续稳定的药物浓度，不利于疾病的治疗。因此，仍需要有一种工艺简单、释放效果理想、疗效良好的培哚普利控释制剂。
发明内容
本发明的目的在于克服目前临床使用的培哚普利片的不足。以培哚普利为主药制成渗透泵型控释片。该制剂的优势在于是以零级释放动力学为释药特征，能够在一定的时间缓慢恒速的释放药物，有利于维持体内长期高效的血药浓度，提高药物的治疗效果。通过处方设计控制药物的释放速率，释放速率一般不会
受胃肠道生理因素如蠕动、pH、胃排空时间等可变因素的影响，体内外相关性好。
本发明提供了培哚普利及其药学上可接受的盐的渗透泵控释片为单室渗透泵控释制剂，包含单层片芯，半透性薄膜包衣和释药小孔。当水分通过半渗透性膜进入片芯后，渗透活性物质膨胀溶解，产生高渗透压，药物溶液则从小孔中恒速释放。
本发明所述的渗透泵型控释制剂的片芯包括药物1.0～4.0mg，填充剂20～50mg，渗透压活性物质20～60mg，粘合剂10～30mg，增溶剂10～32mg和润滑剂3～6mg。半渗透性包衣膜包衣材料10～30mg，增塑剂2～10mg和适量溶剂。
本发明所述的培哚普利渗透泵型控释片，所用填充剂选自阿拉伯胶，西黄蓍胶，桃胶，羧甲基纤维素、糊精、淀粉或它们的混合物。
本发明所述的培哚普利渗透泵型控释片，所用渗透压活性物质选自甘露醇、葡萄糖、乳糖、蔗糖、氯化钠或它们的混合物。
本发明所述的培哚普利渗透泵型控释片，所用粘合剂选自淀粉浆、羟丙甲纤维素、聚维酮、羧甲基纤维素钠或它们的混合物。
本发明所述的培哚普利渗透泵型控释片，所用释放速度调节剂选自聚乙二醇、丙二醇、甘油、邻苯二甲酸二丁酯或它们的混合物。
本发明所述的培哚普利渗透泵型控释片，所用的润滑剂选自硬脂酸镁、硬脂酸钙、滑石粉、微粉硅胶、十二烷基硫酸钠、聚氧乙烯单硬脂酸甘油酯、蜡类或它们的混合物。
本发明所述的培哚普利渗透泵型控释片，所用的增溶剂为普朗尼克、硬脂酸钠、聚乙二醇4000或它们的混合物。
本发明所述的培哚普利渗透泵型控释片，半透性薄膜包衣材料选用醋酸纤
维素或羟丙甲纤维素酞酸酯，增塑剂选自二丁基癸二酸酯或PEG 200，溶剂选自丙酮或乙醇。
本发明所述的培哚普利渗透泵型控释片，其特征在于制备过程如下：
(1)将培哚普利先与增溶剂15～20min混合均匀，加入填充剂和渗透压活性物质置混合器中混合15～20min，用粘合剂水溶液制软材，过20目筛制粒，40～60℃下干燥6～8h，过16目筛整粒，混合均匀压片。
(2)用丙酮或乙醇溶解半渗透性薄膜包衣材料和包衣层中的其它的辅料，制得半透膜包衣液，包衣锅包衣，包衣完成后40～50℃固化6～8h。
(3)包衣固化完成后用激光打孔器在半渗透性薄膜包衣层上打0.1-0.5mm孔即可。
图1为实施例1至实施例4培哚普利渗透泵型控释片在pH 7.4磷酸盐缓冲液中的释放曲线图。由图可知，药物的释放呈现明显的零级释放特征，说明我们制备培哚普利的渗透泵型控释片能够以恒定的速率释放药物，从而维持平稳的血药浓度，高效的发挥药物的治疗作用。
实施例1
处方
制备工艺：将培哚普利和增溶剂15min混合均匀，加入填充剂和渗透压活性物质置混合器中混合15min，用1％粘合剂水溶液制软材，过20目筛制粒，40℃下干燥6h，过16目筛整粒，混合均匀压片。用丙酮溶解包衣材料和包衣层中的其它的辅料，包衣锅包衣，包衣完成后40℃固化6h。包衣固化完成后用激光打孔器在包衣层上打0.5mm孔即可。
实施例2
处方
制备工艺：将培哚普利和增溶剂15min混合均匀，加入填充剂和渗透压活性物质置混合器中混合15min，用1％粘合剂水溶液制软材，过20目筛制粒，50℃下干燥7h，过16目筛整粒，混合均匀压片。用丙酮溶解包衣材料和包衣层中的其它的辅料，包衣锅包衣，包衣完成后50℃固化7h。包衣固化完成后用激光打孔器在包衣层上打0.4mm孔即可。
实施例3
处方
制备工艺：将培哚普利和增溶剂15min混合均匀，加入填充剂和渗透压活性物质置混合器中混合20min，用2％粘合剂水溶液制软材，过20目筛制粒，40℃下干燥8h，过16目筛整粒，混合均匀压片。用乙醇溶解包衣材料和包衣层中的其它的辅料，包衣锅包衣，包衣完成后40℃固化8h。包衣固化完成后用激光打孔器在
包衣层上打0.2mm孔即可。
实施例4
处方
制备工艺：将培哚普利和增溶剂20min混合均匀，加入填充剂和渗透压活性物质置混合器中混合15min，用2％粘合剂水溶液制软材，过20目筛制粒，50℃下干燥6h，过16目筛整粒，混合均匀压片。用丙酮溶解包衣材料和包衣层中的其它的辅料，包衣锅包衣，包衣完成后50℃固化8h。包衣固化完成后用激光打孔器在包衣层上打0.1mm孔即可。
Claims (9)
- 一种培哚普利渗透泵型控释片，包含含药片芯和半透性薄膜包衣，半透性薄膜包衣层上有释药小孔，其中片芯含有培哚普利及其药学上可接受的盐1.0～4.0mg，填充剂20～50mg、渗透压活性物质20～60mg、粘合剂10～30mg、增溶剂10～32mg和润滑剂3～6mg。
- 根据权利要求1的培哚普利渗透泵型控释片，其特征在于：培哚普利药学上可接受的盐为培哚普利叔丁胺盐、培哚普利精氨酸盐。
- 根据权利要求1的培哚普利渗透泵型控释片，所用填充剂选自海藻酸钠，阿拉伯胶，西黄蓍胶，桃胶，卡波姆，葡聚糖、羧甲基纤维素、β-环糊精、糊精、淀粉或它们的混合物。
- 根据权利要求1的培哚普利渗透泵型控释片，所用渗透压活性物质选自甘露醇、山梨醇、葡萄糖、乳糖、果糖、蔗糖或它们的混合物。
- 根据权利要求1的培哚普利渗透泵型控释片，所用粘合剂选自淀粉浆、羟丙甲纤维素、聚维酮、羧甲基纤维素钠或它们的混合物。
- 根据权利要求1的培哚普利渗透泵型控释片，所用的润滑剂选自硬脂酸镁、硬脂酸钙、滑石粉、微粉硅胶、十二烷基硫酸钠、聚氧乙烯单硬脂酸甘油酯、蜡类或它们的混合物。
- 根据权利要求1的培哚普利渗透泵型控释片，所用的增溶剂为普朗尼克、硬脂酸钠、聚乙二醇4000或它们的混合物。
- 根据权利要求1的培哚普利渗透泵型控释片，半透性薄膜包衣的组成成分为包衣材料10～30mg，增塑剂2～10mg和适量溶剂。包衣材料选用醋酸纤维素或羟丙甲纤维素酞酸酯，增塑剂选自二丁基癸二酸酯或PEG 200，溶剂选自丙酮或乙醇。
- 根据权利要求1～8所述的培哚普利渗透泵型控释片，其特征在于制备过程 如下：(1)将培哚普利与填充剂、增溶剂、粘合剂和渗透压活性物质置混合器中混合，制软材，过20目制粒，40～60℃下干燥6～8h，加入润滑剂，混合均匀压片。(2)用丙酮或乙醇溶解半渗透性薄膜包衣材料和包衣层中的其它的辅料，制得半透膜包衣液。(3)对片芯进行包衣，挥干包衣片中的包衣溶剂，用激光打孔器在半渗透性薄膜包衣层上打孔即可。
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| CN101836963A (zh) * | 2009-03-16 | 2010-09-22 | 鲁南制药集团股份有限公司 | 一种治疗高血压的药物应用制剂 |
| CN102871982A (zh) * | 2012-10-16 | 2013-01-16 | 中国科学院上海药物研究所 | 一种药物渗透泵制剂 |
| CN104473898A (zh) * | 2014-12-01 | 2015-04-01 | 郑洁 | 一种甲苯磺酸索拉非尼渗透泵片及其制备方法 |
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| KR100548925B1 (ko) * | 2002-10-23 | 2006-02-02 | 한미약품 주식회사 | 약물의 경구투여용 서방성 조성물 |
| CN1552323A (zh) * | 2003-12-19 | 2004-12-08 | 沈阳药科大学 | 尼索地平单层渗透泵控释片 |
| CN101342153B (zh) * | 2007-07-11 | 2011-04-20 | 中国人民解放军军事医学科学院毒物药物研究所 | 利培酮渗透泵控释片及其制备方法 |
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| WO1994001093A1 (en) * | 1992-07-09 | 1994-01-20 | Merck & Co., Inc. | Controlled porosity osmotic enalapril pump |
| CN101836963A (zh) * | 2009-03-16 | 2010-09-22 | 鲁南制药集团股份有限公司 | 一种治疗高血压的药物应用制剂 |
| CN102871982A (zh) * | 2012-10-16 | 2013-01-16 | 中国科学院上海药物研究所 | 一种药物渗透泵制剂 |
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