TWI339176B - Protected vial, and method for manufacturing same - Google Patents

Description

1339.176 IX. DESCRIPTION OF THE INVENTION: TECHNICAL FIELD OF THE INVENTION The present invention relates to a method of manufacturing a protective bottle and a protective bottle which can be manufactured according to the method. [Prior Art] Pill bottles are often used in medical care. The vials are usually made up of a container containing the medical fluid and plugged with a stopper that can be pierced with an injection needle. This vial usually also includes a protective cover that needs to be removed before use. In the method of producing such a vial, the liquid is likely to overflow beyond two watts. Therefore, after filling and sealing the vial, the vial needs to be rinsed to remove the liquid outside the vial. However, it is known from practice that the outer wall of the vial is not necessarily clean, so that it is clean and that it is not contaminated with active substances. In this case, the washing does not completely leave the active material. 1 initial > remove 'and there are still traces of active substance residue ά ϊ 'Residue of tongue substance i $食#合# #& This residual pass does not pose a serious problem, but in a certain two conditions The next 'for example, the system is fine. For example, the public... Antibiotics, 5, the situation is different than the p and Hua total cytotoxic agent will be adsorbed on the glass. This may allow the staff of the materials to contact the toxic substances when handling these vials. If it is an antibiotic, it is expected to occur outside the vial, K sa, 1 $JJ 疋 的 antibiotics contact with the microorganisms carried by the hospitals and staff of the house, the microbes have _ 素 素 (4) (4) ^ can cause [ SUMMARY OF THE INVENTION One of the objects of the present invention is to eliminate the above-mentioned various defects, thereby avoiding the negative consequences of 105022.doc U39176. Therefore, the method of protecting the bottle of the present invention, Huangzhong in the medicine ', ', manufacturing warranty, τ will be wrapped around the bottle after the bottle is filled, which will be at the bottom of the bottle, there is ~ ~ 丄 && The mouth is known to wear, and the 苴φ r left ^ - tight matching tube will wrap at least the entire side wall of the vial, and the surrounding edge of the η circle overlaps the label portion of the bottom portion. and>. The bottom is therefore between the bottle may be left in the medicine bottle and the tightly fitted envelope. The envelope is divided into two parts that are wrapped in the bottom of the bottle and a tight matching tube. The heart, the user: Under the toxic substance, because If you use the squad to get rid of the sputum, you will not touch the medicinal sputum itself, but the cover of the vial. Because the dill & 44 too & +, the stalker bottle cover tightly surrounds the vial Therefore, the use will maintain normal, touch sense, so its &, the operation of the step and the processing is 1:: In terms of development of resistance, microorganisms now have no chance to contact the outside of the bottle A small amount of antibiotics. Another advantage is that if the bottle breaks a bottle of envelopes, it can still wrap the broken pieces together, which may prevent the liquid from leaking out. This protective envelope is used after filling the medicine ship; Preferably, the step of sealing the vial is better. Preferably, the bottom mark is self-drying and will be closely located at the bottom of the vial. The present invention is preferably a specific implementation, which is a tightly fitting envelope (which is a tightly fitted envelope $ π π And will cover at least the entire bottle ) is made of synthetic material. The sleeve slides over the vial with a small empty space f01 and is reduced by the application of heat 'and thus fits tightly around the vial. It is noted that the vial is outsourced. A method of tightly fitting an envelope is found in U.S. Patent No. 3,82,59. According to the known method, a filled and sealed drug '05022.doc bottle is placed in a synthetic envelope envelope including a fee of one, shrinking under the influence of the set party heat. This (5) covers the bottom part of the optimistic bottom, and the upright cylindrical shape of the outer wall of the bottle is used for covering-covering. And a method on the vial according to the known method, the envelope is wrapped in a piece on the periphery of the vial 'the composition of the method relative to the method of the invention, .u , ^ ^ , according to the method of the invention, the envelope is used to play 4 (five) Ding cut a set of officials. The important advantage of this design is that the method of enclosing the vial envelope is simplified. Moreover, the bottom label and the cylindrical sleeve are easier to produce than an envelope with a bottom and a cylindrical 4 knife extending from the bottom. Furthermore, when the known method is applied, the vial is pushed into the closed-end envelope, which is more difficult than pulling a sleeve through the bottle because the air needs to be removed from the envelope and the air is spilled. The space is very small. In addition, when the envelope shrinks on the vial, the air may remain between the sleeve and the vial. When the envelope is assembled in two steps, the adverse effects will not occur. The step includes attaching the bottom label to the &<>> of the vial and wherein the first step comprises wrapping the sleeve around the periphery of the vial and allowing the eight to contract on the vial, wherein the sleeve is located at the outer wall of the vial 'and overlapping with the bottom label along the edge of the circumference of the bottom of the bottle. [Embodiment] Various aspects, features and advantages of the present invention will be further described by the following description with reference to the accompanying drawings. A cross-sectional view of the filled and sealed protective bottle 1. The protective bottle is composed of a glass vial 2 having a side wall 2, a bottom 4202 and a access port 3. The vial 2 has been There is a liquid 7. Protect I05022.doc to And a protection = having a pierceable sealing film 4, such as a rubber crucible 5, such as a metal. On the outer wall of the vial 2, the main + roll m aw l tightly covers almost the entire vial 2, W墁盍Except for 5, the seal & a community 2 2, the cover 6 includes a bottom label 602 covering the medicine, 氐. P 202 ; and a sleeve ^ ^ , ^ .a .. which covers the side wall 201 and the bottom The dressing 602 has a partial overlap along the circumferential edge of the bottle 2 〇 2. The ρνίΓΓ·1 is preferably made of a transparent synthetic material, such as a film of ΡΕ, ΡΡ, and 80% Ml. In addition, the bottom label 6. 2 is preferably also made of a transparent synthetic material. Moreover, the bottom label 602 is preferably self-adhesive, which is not a requirement within the scope of the present invention. The combination of the casing 601 is 又疋〇.05 mm; but the thickness value can also be the same or lower. The bottom standard hoop, the thickness of the paper 602 is preferably about 15 mm, in comparison with the Chu, the protection bottle 1 in the circle 1 The thickness of these parts is shown in a more arrogant manner. The protection (6) is manufactured according to the following steps to simplify the process. First, provide the empty vial of the etheric bottle, (which is known per se) (Fig. 2Α). Then fill the vial 2 through the access port 3 into the sputum, brothers into the liquid 7 (Fig. 2B). The sealing film 4 is attached to the access opening 3' and then the protective cover 5 is attached (Fig. 2C). Then, the entire medicine is rinsed to remove the liquid medicine which may overflow the outside of the vial 2 during the filling process. Then 'in the vial 2 The bottom portion 202 is affixed with a synthetic bottom label 6〇2, and the synthetic sleeve 6G1 is slid over the vial 2 (Fig. 2D). The final step is to heat treat the sleeve 60 1 and burn it to shrink and tighten It is tightly wrapped around the vial 2 (Fig. 2E). Nine lengths: the vial of the sputum cannula 6〇1 and the bottom label 602 is subjected to a series of tests on the effect of external contamination on the vial 105022.doc 1339176 ( Report f()l_

Pharmachemie BV, Haarlem, New Zealand, by Exp0sure C〇ntr〇1 BV, Wijchen, The Netherlands and University Medical Center Nijmegen, Nijmegen, New Zealand), measuring the protective bottle containing cisplatin 1 And external contaminants from unprotected vials. The extract from the outside of the vial was destroyed to form platinum, which was then analyzed by stripping voltammetry (Metrohm Application Bulletin No. 220/1. Using the voltammetry to measure the ultra-micron). The test details are listed in Ding

The test vial is placed in a single volume φ. Six. . In the case of Chengyu 0, the 6-year-old state is filled with 0.5 盐 of hydrochloric acid, and the vial is completely immersed. The Rongma private ^ ^ ^ ^ Zhu Guyi was closed, and after ultrasonic treatment for 30 minutes, the medicine bottle was taken out of the container. During the protection process, the ammonia-platinum contamination of the cis-gas outside the vial is assumed to be dissolved in the hydrochloric acid solvent. The pretreatment of the sample and the analysis of the 彳φ 0 a u, ^ volts method were performed according to standard procedures. 1 ml of the cis-ammonia platinum extract was hydrolyzed with hydrogen peroxide 'formaldehyde and ultraviolet light to cause the formation of the surface complex ' g and w 2, z θ ^ thus forming a pt (pt). It is a well-known fact that 顺 'cis chlorine j contains about 65 % of platinum. The analysis of platinum was repeated three times with a relative private bias of 2-3%. Pick up the recognition "The limit is 〇Nike / liter of extract. 105022.doc to the high concentration of the sample 'samples are diluted and then analyzed. Ten blank samples (empty bottles) are also extracted, analyzed and Compare the bottle of Shunqi ammonia to correct the background value of the chain (50 Ng / liter of extract). The absolute value of the contaminant found on the protective bottle! and the unprotected vial 2 (for example) Use Wilc〇x〇n test to compare 污染物. This test is also applicable to the pollutant value per unit area (Pt_area), the value of the pollutant is related to the contents of the vial (within/outside) and is blank It is related to the corrected value. The value of p is 〇.〇5 or less. It is considered to be meaningful. The data is characterized by median, range and quartile. The test results are listed in the table below. Batches without protective bottle protection bottle PT -area (Nike/cm squared)

Pt-abs PT-area (Nike/cm square)

Pt-abs (Nike)

* BV = background value From the above table, especially the median data, it can be clearly seen that for the protective bottle 1, all parameters are significantly lower than those without the protective bottle 2. This proves that the vial 2 containing the envelope 6 causes a significant drop in the contamination outside the vial 2. In order to investigate the effect of the bottle 2 with the cannula 601 and the bottom label 6〇2 on the risk of accidental dropping of the protective bottle obtained, the following drop test was performed (Report for Pharmachemie BV, Haarlem, New Zealand Kiss I05022) .doc 1339176

Topa Irmituut, Voorh〇Ut, New Zealand Jane; called State τ〇4 1 0 6 8). The test procedure applied consisted of the following: 1) Drop test with a drop height of 120 cm This test was carried out to simulate the protective bottle 1 accidentally falling from the table to the floor of the hospital. ^The drop height is 120 cm. The position of the vial is random (top, bottom or side). The surface of the drop bottle is simulated on the hospital floor, linoleum " board. Three different types of vials, ie 1 cc '5 〇 ml and 100 cc bottles, were tested for 5 drops respectively. 2) Drop test with a drop height of 185 cm This test is used to observe what happens when the protective bottle is dropped from the shelf onto the hospital floor. The drop height is 185 cm and the position of the vial is random (top, bottom or side). The surface of the drop bottle is the above-mentioned "linseed oil" plate. The results of the drop test with a drop height of 120 cm are listed in the table below. For the sake of completeness, it is noted that in the table, The protective bottle i refers to the covered medicine bottle, and the non-proof bottle 2 (ie, the 2 without the envelope 6) refers to the uncovered medicine bottle. Falling height 120 cm ~ 10 ml medicine bottle 50 ml medicine bottle 100 ML vial has coverage without coverage, no coverage, no coverage, no coverage, no results, results, results, bottom results, 1 ok ok ok ok ok ok ok 105022.doc 1339176 2 ok ok ok ok ok ok top landing 1 ok ok ok ok Ok ok 2 ok ok ok ok ok ok Side landing 1 ok ok ok ok ok ok Integrity percentage % 100% 100% 100% 100% 100% 100% The drop test results with a drop height of 1 85 cm are listed in the table below. .

Falling height 185 cm 10 ml vial 50 ml vial 100 ml vial covered with no cover Covered without cover Covered without coverage Results Results Results Results Results bottom landing 1 ok ok ok ok ok ok 2 ok ok ok ok ok Ok 3 broken ok ok ok ok ok 4 ok ok ok ok broken ok 5 ok ok ok ok ok ok 6 ok ok ok ok - - 7 ok ok ok ok - 8 ok broken ok ok - - 9 ok ok ok ok - - 10 Ok ok ok ok - - I05022.doc 12 1339176

Top landing 1 ok ok ok ok ok ok 2 ok ok ok ok ok ok 3 ok ok ok ok ok ok 4 ok ok ok ok ok ok 5 ok ok ok ok ok ok 6 ok ok ok ok - - 7 ok ok ok ok - - 8 ok ok ok ok - - 9 ok ok ok ok - - 10 ok ok ok ok - - Side landing 1 ok ok broken broken broken 2 ok ok crack ok broken broken 3 ok ok ok broken broken broken 4 ok ok Ok ok broken broken 5 ok ok ok ok broken broken 6 ok ok ok broken crack ok 7 ok ok crack ok crack broken 8 ok ok crack ok ok broken 9 ok ok ok ok crack broken 10 ok ok ok ok broken broken 105022.doc - 13 - 1339176 Integrity Percentage % 96,7% 96,7% 86,7% 90,0% 50,0% 50,0% From the results of the drop test it can be concluded that it has a casing 6〇1 and a bottom label The cans have no enhanced protection against the damage resistance of the vial 2. However, when this drug flight 2 is damaged, cracks often occur instead of being broken. In the case where the vial is broken or cracked, the vial 2 can still hold its contents in the case of 5 %. In the case of unprotected pill 2, all contents are spattered on the floor. Because &, the conclusion is that the application of the cannula state and the bottom standard 602 can make the treatment of the vials safer. The above is a concrete example; the examples are merely illustrative of the possibilities of the present invention. The changes and adjustments may also be included in the scope of the patent scope definition: within the scope of protection of the present invention. ...like a smudge of the wind, such as a cytostatic or antibiotic, which may overflow during filling and fill the outside of the drug, so in the final step of the production process, a bottle 2 is assembled. A tightly fitted protective envelope 6. The envelope 6 includes a bottom # sign 6〇2 attached to the bottom 202' of the vial 2 and a tight matching tube (6) which is shrunk to the side wall 201 of the vial 2 while the bottom label 6〇2 is along the vial The bottom of the 2 〇 two-week edge has a partial overlap. Remaining in the vial due to the configuration of the envelope 6

outer. Possible contaminants of P will be sealed between the vial 2 and the envelope 6. The user of P^ will no longer be violently toxic, because the user will: β contact the vial 2 itself, but contact the envelope 6. # . ^ L 一 另一个 另一个 另一个 另一个 另一个 另一个 另一个 另一个 〇 〇 〇 另一个 另一个 ’ ’ ’ ’ ’ ’ ’ ’ ’ ’ ’ ’ ’ ’ ’ ’ ’ ’ ’ ’ ’ ’ ’ ’ ’ ’ ’ ’ ’ * 〇5〇22.d〇c 1339176 BRIEF DESCRIPTION OF THE DRAWINGS Fig. 1 shows a cross-sectional view of a protective bottle of the present invention, and Figs. 2A-E are diagrams showing successive steps of manufacturing the protective bottle of Fig. 1. [Main component symbol description] 1 Protective bottle 2 Pill bottle 3 Access port 4 Sealing film ® 5 Protective cover 6 Envelope 7 Liquid medicine 201 Side wall 202 Bottom 601 Sleeve 602 Bottom label 105022.doc

Claims (1)

1339176 Patent Application No. 094丨33581. Replacement of Chinese Patent Application (99 years ι〇月) X. Patent application scope: 1. A method for manufacturing a protective bottle (1), comprising the following steps: - providing a medicine bottle ( 2), which comprises a side wall (201), a bottom part (202) and a pick-up 〇 (3); - a filling liquid (7) into the vial (2); - a sealing film (4) is attached to the access opening ( 3); _ After the filling step of the vial (2) is completed, or after the sealing film is attached (the step of the sentence, the envelope (6) is tightly placed around the circumference of the vial (2), and the vial is (2) The bottom (2〇2) is equipped with a bottom label (6〇2), and then a tight matching officer (6〇1) is used to cover at least the entire side wall (201) of the vial 'at the same time along the bottom ( 2() 2) There is a partial overlap with the label (602) at the bottom of the circumference. 2. The method of claim 2, wherein the assembly step of the envelope (6) is after the step of attaching the sealing film (4). 3. As in the method of β or the method of 2, in which a protective cover (7) is attached to the sealing film (4). The method of claim 3, wherein in the process of arranging the envelope (6), loosening A protective cover (5). The method of claim 1 or 2, wherein the sleeve (6〇丨) is made of a synthetic material and slides through the vial (2) almost without gaps, and wherein the heat treatment is subsequently performed In this way, the cannula (60 1) will contract so as to fit tightly around the vial. (2) 6. The protective bottle (丨) contains a filled and filled wall (201) and bottom (202) Sealing the vial (2), which is placed around the filled and sealed vial (2) 105022-991008.doc 1339176. (^存^月丨I卜.丨*页一一------ Tightly fitted with the envelope (6) 'and its Yin envelope (6) includes a tight matching tube (6〇) and a bottom label (602), wherein the bottom label (6〇2) is attached to the bottom of the vial (2) (202) Above, and wherein the sleeve (6〇υ is disposed on at least the entire side wall (2〇丨) of the vial (2) while having a partial overlap with the bottom label (602) along the circumferential edge of the bottom (2〇2). , " _ 士 士 - strive for item 6 of the protective bottle, which medicine" is as follows, please take any of the 丄.. 9 1 to 5 items 105022.991008.doc