阅读说明：本技术 多剂量滴眼用无菌粉末给药系统 (Multi-dose ophthalmic sterile powder delivery system ) 是由 王成 于 2020-05-18 设计创作，主要内容包括：本发明涉及一种多剂量滴眼用无菌粉末给药系统,包括盛稀释剂的供液瓶A和盛固体粉末并带有多剂量无菌给药滴头的滴液瓶B。其中所述的供液瓶A由七部分组成,包括罐头帽1、带螺纹罐头2和内针3、空筒4、活塞5、活塞轴6、托柄7。活塞轴带有固定卡扣8,能够防止活塞轴脱落；带螺纹罐头2用于与B瓶带内置螺纹的瓶底衔接,内针3用于扎破B瓶防菌塞9保护的瓶底10；其罐头帽1用于保护A瓶罐头和内针。滴眼瓶B由四部分组成,包括瓶底防菌塞9、带内置螺纹瓶底10、瓶身11、多剂量无菌给药滴头12。本发明结构新颖,设计合理,可以实现液体状态化学性质不稳定的药物或特殊微粒给药系统如纳米粒、脂质体、胶束等用于眼部给药。(The invention relates to a multi-dose ophthalmic sterile powder administration system, which comprises a liquid supply bottle A containing diluent and a liquid dropping bottle B containing solid powder and provided with a plurality of doses of sterile administration drippers. The liquid supply bottle A consists of seven parts, including a can cap 1, a threaded can 2, an inner needle 3, an empty cylinder 4, a piston 5, a piston shaft 6 and a support handle 7. The piston shaft is provided with a fixing buckle 8, so that the piston shaft can be prevented from falling off; the threaded can 2 is used for being connected with the bottle bottom of the B bottle with built-in threads, and the inner needle 3 is used for puncturing the bottle bottom 10 protected by the B bottle antibacterial plug 9; the can cap 1 is used for protecting the A-bottle can and the inner needle. The eye drop bottle B consists of four parts, including an antibacterial plug 9 at the bottom, a bottle bottom 10 with internal thread, a bottle body 11 and a multi-dose aseptic administration dropper 12. The invention has novel structure and reasonable design, and can realize that drugs with unstable chemical properties in a liquid state or special particle drug delivery systems such as nanoparticles, liposomes, micelles and the like are used for eye drug delivery.)

1. A multi-dose eye sterile powder delivery system comprises a liquid supply bottle A capable of containing diluent and an eye drop bottle B capable of containing solid powder and provided with a multi-dose sterile delivery dropper.

2. A sterile powder delivery system for multiple dose instillation according to claim 1, wherein said fluid supply bottle a is comprised of seven parts including a cap, a threaded can and inner needle, an empty cylinder, a plunger shaft, and a holder.

3. The sterile powder delivery system for multi-dose instillation according to claim 1, wherein the eye dropper bottle B is comprised of four parts, including a bottom stopper, a bottom with internal threads, a body, and a multi-dose sterile administration dropper.

4. The piston shaft of claim 2, with a retaining clip to prevent piston shaft dropout and backflow.

5. The threaded can and inner needle of claim 2, wherein the threads are adapted to engage a bottom of a B-bottle with internal threads, and the inner needle is adapted to puncture the bottom of the B-bottle protected by the anti-microbial stopper.

6. The multi-dose sterile administration dripper of claim 3, wherein the dripper has a dripper, a spring, a top seal, an air filter, and a tip hole.

7. The multi-dose sterile powder delivery system for ophthalmic use of claim 1, wherein the method of use comprises removing the cap of the can of the a bottle, removing the bottom of the bottle of the B bottle, screwing the threaded can of the a bottle against the bottom of the bottle of the B bottle with the built-in threads, puncturing the bottom of the bottle of the B bottle by the inner needle of the threaded can of the a bottle, pushing the holder of the a bottle to push the diluent contained in the a bottle into the B bottle, shaking the B bottle, and dissolving the powder in the B bottle to obtain the eye drops for therapeutic use; the external cover is removed when the eye drops are dropped, and the eye drop can be used. After the dripping is finished, the outer cover of the dripper is covered.

8. The sterile powder delivery system for multi-dose eyedrops according to claim 1, wherein said eyedrop bottle B contains solid powder which can be sterile packaged powder or powder obtained by lyophilization.

9. The sterile powder delivery system for multi-dose eyedrops according to claim 1, wherein the materials used for the eyedrop bottle A and the eyedrop bottle B are selected from polyethylene, polypropylene, polystyrene, polyethylene terephthalate, polyester, and the like, which are single materials or mixed materials thereof.

Technical Field

The invention belongs to the technical field of drug delivery containers, and particularly relates to a multi-dose eye drop sterile powder drug delivery system.

Background

Most of eye drops in the current market exist in a solution form, but chemical properties of a plurality of medicines are unstable, and the degradation of the medicines is accelerated in a water solution state, so that hidden danger is brought to the medication safety; especially, some special microparticle drug delivery systems such as nanoparticles, liposomes, micelles and the like are unstable in a liquid state and cannot be stored for a long time, so that the application of the drug delivery systems to the treatment of eye diseases is limited. The traditional liquid eye drops are prepared into a solid preparation added with diluent and dissolved before use, so that the stability of the medicine can be improved, the medicine is prevented from being degraded in the solution, the stability of the micro-particle administration system is improved, and the eye disease administration by the eye drop method is possible.

The existing eye drop bottle package designs mainly include the following types:

(1) common solution type multi-dose eye drop bottle: the eye drop bottle is a common plastic packaging bottle which takes low-density polyethylene and polypropylene as materials, and the content is added with the bacteriostatic agent more, so that the eye drop bottle is ensured not to be infected with bacteria after being opened and can be used repeatedly, but the bacteriostatic agent can damage eyes after being used for a long time.

(2) Solid formulation + multi-dose eye drop bottle in solution form: the eye drop is prepared by separately packaging solid medicine and solvent, adding a bottle of solvent, making the medicine into tablet (pill) or powder, and adding the tablet (or powder) into the solvent according to the dosage of the specification before use to make it fully dissolved and uniformly shaken to obtain eye drop.

(3) Multi-dose sterile eye drops bottles: restasis Multidose from Allergan corporation^TM(Cyclosporine opthalmic 0.05% w/v) the multi-dose sterile eye drop bottle is provided with a special administration dropper, so that the liquid eye drop does not contain bacteriostatic agent, and the eye drop bottle sample is ensured not to be polluted and infected by bacteria after being used for multiple times.

However, these prior designs all have certain disadvantages such as: (1) the existing 'solid + liquid' form eye drop administration device can not realize seamless mixing and dissolving of liquid and solid, and the operation process of a common patient is easy to contaminate bacteria, thereby bringing risks to application. (2) Multiple dose eye drops and sterile multiple dose eye drops are also not suitable for use in liquid form for ophthalmic delivery of chemically unstable drugs or special microparticle delivery systems.

Disclosure of Invention

Based on the above problems, the present inventors have tried and designed several times to provide a multi-dose eye drop sterile powder delivery system which can be used for solid powders, especially for some drugs which are unstable chemically in liquid state, and some special particulate delivery systems such as nanoparticles, liposomes, micelles which are unstable in liquid state and must be stored in solid powder form, and can be dissolved by adding a diluent at the time of use to facilitate the delivery.

The invention provides a multi-dose eye sterile powder delivery system, which comprises a liquid supply bottle A containing diluent and an eye drop bottle B containing solid powder and provided with a multi-dose sterile delivery dropper. The liquid supply bottle A consists of seven parts, including a support handle, a piston shaft, a piston, an empty cylinder, a can with screw threads, an inner needle and a can cap. The piston shaft is provided with a fixing buckle, so that the piston shaft can be prevented from falling off and flowing back; the can with the threads and the inner needle are provided with the threads for being connected with the bottom of the B bottle with the built-in threads, and the inner needle is used for puncturing the bottom protected by the B bottle antibacterial plug; the can cap is used for protecting the can head and the inner needle of the bottle A and isolating the outside from contacting with the liquid contained in the bottle A, thereby ensuring the sterility. The eye drop bottle B consists of four parts, including an antibacterial plug at the bottom of the bottle, a bottle bottom with internal threads, a bottle body and a multi-dose aseptic administration dropper; the multi-dose aseptic administration dripper is provided with a dripper, a spring, a top seal, an air filter and a tip hole, and can also adopt a multi-dose aseptic administration dripper which is currently marketed, such as those adopted by Allergan company or other commercialized drippers.

The invention provides a multi-dose eye drop sterile powder delivery system, which is used by the following method: taking down the can cap of the bottle A, taking down the antibacterial plug at the bottle bottom of the bottle B, aligning the can with the thread of the bottle A with the bottle bottom of the bottle B with the thread, screwing up the can with the thread of the bottle A, puncturing the bottle bottom of the bottle B by an inner needle of the can with the thread of the bottle A, pushing the supporting handle of the bottle A to push the diluent contained in the bottle A into the bottle B, shaking the bottle B, dissolving the powder of the bottle B, and preparing the eye drops for treatment; the external cover is removed when the eye drops are dropped, and the eye drop can be used. After the dripping is finished, the outer cover of the dripper is covered. Because the piston shaft of the bottle A is provided with the fixing buckle, the piston shaft can be ensured not to fall off to cause liquid backflow, the screw of the can head of the bottle A is tightly connected with the bottle bottom of the built-in thread of the bottle B through the screw, and the bottle A at the back stably exists as the bottom support of the whole drug delivery system.

The solid powder contained in the eye drop bottle B provided by the invention can be sterile subpackaged powder or freeze-dried powder obtained by a freeze-drying process. The materials used for forming the eye drop bottle A and the eye drop bottle B of the multi-dose eye drop sterile powder delivery system provided by the invention are single materials such as polyethylene, polypropylene, polystyrene, polyethylene terephthalate, polyester and the like or mixed materials thereof.

Drawings

FIG. 1 is a drawing of a multi-dose sterile powder delivery system for eye use according to the present invention, wherein A is a bottle A containing a diluent, B is an eye drop bottle B containing a solid powder and having a multi-dose sterile delivery dropper

FIG. 2 is a view showing the A bottle of the diluent-containing liquid supply bottle in the sterile powder administration system for multi-dose ophthalmic use according to the present invention

FIG. 3 is a cross-sectional view of the diluent-containing bottle A of the sterile powder drug delivery system for multi-dose ophthalmic use according to the present invention

FIG. 4 shows an eye dropper bottle B containing solid powder and having multiple-dose sterile administration dropper according to the present invention

FIG. 5 is a drawing showing an eye dropper bottle B containing solid powder and having a multi-dose sterile administration dropper, according to the present invention, in the multi-dose sterile powder administration system for eyes

FIG. 6 shows a multi-dose sterile powder dropper for eyes according to the invention, wherein the dropper B can contain solid powder and has multiple-dose sterile administration dropper

FIG. 7 is a multi-dose ophthalmic sterile powder delivery system of the present invention

In the figure, 1-can cap, 2-can with screw thread, 3-inner needle, 4-empty cylinder, 5-piston, 6-piston shaft, 7-support handle, 8-buckle, 9-bottle bottom anti-bacteria plug, 10-bottle bottom with internal screw thread, 11-bottle body, 12-multi-dose aseptic administration dropper part, 13-air filter, 14-applicator, 15-spring, 16-tip hole, 17-core, 18-top seal, 19-spray needle, 20-dropper cap, 21-dropper.

Detailed Description

The invention will be illustrated in more detail in the following non-limiting examples in connection with the description.

Referring to fig. 1-7, the present invention relates to a multi-dose sterile powder delivery system for ophthalmic use, comprising a liquid supply bottle a containing a diluent and an eye drop bottle B containing a solid powder and having a multi-dose sterile administration dropper. Mainly used for some medicines which are unstable in chemical properties in a liquid state, and some special particle administration systems which are unstable in a liquid state and must be stored in a solid powder form, such as nanoparticles, liposomes, micelles and the like, are dissolved by adding a diluent when in use, so that the ophthalmic administration of the medicines is realized, and the multi-dose sterile eye drop administration of the solid powder without adding any bacteriostatic agent is possible.

Fig. 1A is a diluent a bottle of the present invention, and fig. 1B is an eye drop bottle B of the present invention containing a solid powder and having a multi-dose sterile administration dropper. As shown in figure 2, the bottle A is composed of a can cap 1, a threaded can 2, an inner needle 3, an empty cylinder 4, a piston 5, a piston shaft 6, a support handle 7 and a buckle 8. The can cap 1 is used for protecting the can 2 and the inner needle 3 and preventing contamination caused by bacteria contamination, the inner needle 3 is used for puncturing the center position of the bottom of the bottle protected by the B bottle antibacterial plug 9, and the inner tube of the inner needle is communicated with the bottle A and the bottle B, so that the diluent of the bottle A can be conveniently infused into the bottle B; the can 2 with the screw thread is convenient to be connected and fixed with the bottle bottom 10 with the screw thread arranged in the bottle B in a rotating way; the empty cylinder 4 is used for containing a diluent, and the volume of the empty cylinder can be adjusted according to the requirement; the piston 5 is used for sealing the diluent contained in the hollow cylinder 4 and pushing the diluent into the bottle body 11 of the bottle B through the inner needle 2 by pushing through the piston shaft 6; the supporting handle 7 is convenient for pushing the piston shaft 6 and plays a role of a bracket, so that the bottles A and B can be erected on a plane after being combined; the snap 8 ensures that the piston shaft 6 does not fall off or flow back after pushing the piston 5 to transfer the diluent from the a bottle to the B bottle as shown in fig. 3.

Fig. 4 and 5 show an eye dropper bottle B for solid powder according to the invention with a multi-dose sterile administration dropper. As shown in figure 4, the bottle B consists of a bottle bottom anti-bacteria plug 9, a bottle bottom 10 with an internal thread, a bottle body 11 and a multi-dose sterile administration dropper part 12. The bottle bottom anti-bacterial plug 9 is used for protecting the bottle bottom 10 with the built-in thread and preventing the part from being infected with bacteria, so that the liquid in the bottle A is squeezed into the bottle B to pollute the bottle B in the later period; the bottle body 11 is used for containing solid powder, and the powder can be sterile subpackaged powder or freeze-dried powder obtained by adopting a freeze-drying process; the multi-dose sterile administration dropper 12 is shown in fig. 6 as comprising a dropper cap 20 and a dropper 21 comprising an air filter 13, an applicator 14, a spring 15, a tip hole 16, a core 17, a tip seal 18, and a needle 19, but the multi-dose sterile administration dropper is not limited to the above-mentioned components, and may be a multi-dose sterile administration dropper currently available on the market, such as those available from Allergan corporation, or other commercial droppers.

The specific use method comprises the following steps: the A bottle can cap 1 is taken down, the B bottle bottom antibacterial plug 9 is taken down, the A bottle can with threads is aligned to the B bottle bottom with the built-in threads 10 and screwed down in a rotating mode, the B bottle bottom can be punctured by the inner needle 3 of the A bottle can with threads, the A bottle support handle 7 is pressed afterwards to push the piston shaft 6, the diluent contained in the A bottle empty cylinder 4 is pushed into the B bottle through the piston 5, the buckle 8 is clamped at the moment, and the piston shaft 6 can be prevented from falling off or flowing back. Shaking bottle B, dissolving bottle B powder, and making into eye drop; at this time, the dropper cap 20 of the B bottle multi-dose sterile administration dropper part 12 is removed, and the dropper 21 is passed through, and the solution can be dropped into the eye. After the dripping is finished, the dripping head cap 20 is covered. The screw that A bottle tank head was taken closely links up through the screw with B bottle built-in screw thread bottle end, and A bottle holds in the palm handle 7 and exists as the collet of whole drug delivery system promptly steadily.