CN101543461B - Notoginseng triterpenes medical liquor soft package - Google Patents
Notoginseng triterpenes medical liquor soft package Download PDFInfo
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- CN101543461B CN101543461B CN 200810084887 CN200810084887A CN101543461B CN 101543461 B CN101543461 B CN 101543461B CN 200810084887 CN200810084887 CN 200810084887 CN 200810084887 A CN200810084887 A CN 200810084887A CN 101543461 B CN101543461 B CN 101543461B
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Abstract
A notoginseng triterpenes medical liquor soft package (1) comprises an outer pocket (2) and an inner pocket (3). The medical liquor is filled in the inner pocket (3); the inner pocket is provided with an inner pocket body (4) and a combined lid (12) for sealing the inner pocket body (4); and the combined lid (12) comprises an infusion piece (5), one end of the infusion piece (5) is encapsulated on an opening (17) of the inner pocket body (4), and the infusion piece (5) is provided with an inner bore communicated with the inner pocket body (4) in the length direction. The soft package is characterized in that the outer pocket (2) and the inner pocket (3) are transparent; the outer pocket (2) at least separates the inner pocket body (4) from the outside; and a separated space between the outer pocket (2) and the inner pocket (3) is filled with inert gas.
Description
Technical field
The present invention relates to notoginseng triterpenes medical liquor soft package.
Background technology
Chinese medicine is because complicated component is hard to know its whole components.Except vial, still find no all or most of herb liquid of the suitable dress of other material.But though some composite plastic film short term stored herb liquids, time one long easily with herb liquid in some active component play chronic reaction, or, cause medicinal liquid to go bad because composite membrane is bigger to the transit dose of steam and oxygen.This can allow anything but to medicament.Adopt vial so the herb liquid that uses at present packing is main, but the shortcoming of glass bottle packaging clearly: volume is big, Heavy Weight and frangible.It is that Pharmaceutical circle is pursued that herb liquid adopts flexible package.
High capacity Western medicine injection generally adopts PVC and non-PVC bag at present.Potential harm more and more causes people's attention to human body owing to the PVC material in recent years, thereby the application of non-PVC composite membrane has the trend of rising.Because all the transit dose to steam and oxygen is bigger for medicinal PVC and non-PVC composite membrane, to the steady quality generation adverse influence of medicinal liquid (comprising herb liquid), shortened the quality guarantee period of medicine, reduced the safety of medicine.Concerning herb liquid, PVC and non-PVC composite membrane also may react with some composition in the medicine, and its safety needs to carry out the case checking through experiment.In addition, the flexible package of adopting at present damages in being transported to a series of processes of use easily, has also brought unsafe factor.
Application number is that 200610022330.6 Chinese patent application discloses a kind of transfusion flexible bag, its objective is to allow medical personnel accurately simply and not can check out just by checkout equipment whether soft bag has trickle seepage phenomenon before medicinal liquid uses.The technical scheme of Cai Yonging is for this reason, will infuse and adopt double casing, with liquid medicine filling in inner packing; put layer protecting film in the inner packing outside; make packaged medicinal liquid place the protecting film the inside, and protecting film is sealed, yet at protecting film and the middle evacuation of inner packing.Described inner packing and protecting film are transparent, so that observe.Although this application has adopted double casing, the transit dose of steam and oxygen is still bigger, and the shockproof and protection to internal bag of its structure is ineffective, thereby can not satisfy the demand.
Application number is that the theme of 200710017686.5 Chinese patent application relates to the outer package that nontoxic clad aluminum foil is used for PVC or the packed infusion preparation of non-PVC-soft and uses, this application also adopts double casing, with liquid medicine filling in inner packing, outer package is opaque composite aluminium film bag, put into different types of PVC or packed infusion preparation of finishing of non-PVC-soft of having packed in the bag, add antioxidant simultaneously and charge into nitrogen or evacuation, compound membrane bag seals the most at last.Because opaque material is adopted in the outer package of this application; can't carry out medically necessary clarity test; between two bags, must add antioxidant and nitrogen simultaneously; or add antioxidant and evacuation simultaneously; the latter is unfavorable for shockproof and protection to internal bag; and the influence to the pH value of some medicinal liquid under higher temperature of nontoxic clad aluminum foil is bigger, is unfavorable for promoting the use of.
Summary of the invention
Main purpose of the present invention is to overcome the deficiency of above-mentioned prior art, a kind of notoginseng triterpenes medical liquor soft package is provided, it adopts the structure of inflation between inner bag and the outer bag, can intercept steam and oxygen effectively, prolonged the quality guarantee period of medicine, be convenient to clarity test medically simultaneously, and have be convenient to the transportation and non-damageable advantage.
Further purpose of the present invention provides a kind of interior bag constructions of improved medical liquor soft package, is beneficial to use safely notoginseng triterpenes medical liquor.
For this reason, the invention provides a kind of notoginseng triterpenes medical liquor soft package, comprise outer bag and inner bag, liquid medicine filling is in the inner bag the inside; The composite cover that described inner bag has the inner bag body and the inner bag body is sealed; Described composite cover comprises infusion spare, one end of this infusion spare is encapsulated on the opening of inner bag body, and this infusion spare has the endoporus that is communicated with the inner bag body at its length direction, it is characterized in that: outer bag and inner bag are transparent, and described outer bag to major general's inner bag body and the external world separates, and is filled with inertness gas in the insulating space outside described bag and between the inner bag.
According to a further general feature of the present invention, described inertness gas is nitrogen, also can be noble gas.
For improving safety, described inner bag also is provided with filtration members, and this filtration members is located at infusion spare and puts in the intrinsic end of inner bag, and covers the endoporus of infusion spare fully.The filtering degree of filtration members is preferably in the 0.22um-0.45 mu m range.
According to the present invention,, also be provided with on above-mentioned inner bag body top and make medicinal liquid and the isolated weak tape splicing of described filtration members for further improving the safety of medication.
The applicant finds, is filled with inertness gas in the sealed space outside described between bag and the inner bag and just intercepts steam and oxygen basically effectively.Inertness gas can be nitrogen, also can be noble gas.Add oxygen absorbent and can further strengthen above effect.It is reactionless when inner bag is made by composite membrane commonly used at present to Radix Notoginseng total glycosides.
Be understood that, be filled with gas in the sealed space between bag and the inner bag outside and help damping and insulation blocking, improved the safety of medicine.
But the applicant finds, if outer bag adopts nontoxic clad aluminum foil, its influence to the pH value of some medicinal liquid under higher temperature is bigger, Chinese medicine especially, and as SHENQI FUZHENG ZHUSHEYE, Oleum Curcumae medicinal liquid or Radix Notoginseng total glycosides preparation, this is flagrant.
Description of drawings
Below, further describe the present invention referring to accompanying drawing, wherein:
Fig. 1 is the front view according to first embodiment of medical liquor soft package of the present invention;
Fig. 2 is the exploded view of first embodiment of the inner bag of medical liquor soft package shown in Figure 1;
Fig. 3 is the front view according to second embodiment of medical liquor soft package of the present invention;
Fig. 4 is the exploded view of second embodiment of inner bag of the present invention;
Fig. 5 is the exploded view of the 3rd embodiment of inner bag of the present invention.
The specific embodiment
At first with reference to Fig. 1 and 2, they show first embodiment of notoginseng triterpenes medical liquor soft package of the present invention and inner bag.Described packing is totally represented with 1, comprises the outer bag 2 and the inner bag 3 of band tearing port 9, and they are by transparent material, and medicinal liquid 8 fills are in inner bag 3 the insides.This inner bag is generally made by known non-PVC composite membrane.Outer bag can be made by the high barrier material with resistance oxygen water resistance characteristic.
The composite cover 12 that inner bag 3 has inner bag body 4 and inner bag body 4 is sealed.Composite cover 12 also further comprise cover 6, infusion spare 5 and the plug 18 between lid 6 and infusion spare 5, see also Fig. 2.The structure of infusion spare 5 is structure commonly used.One end of this infusion spare 5 is encapsulated on the opening 17 of inner bag body 4, and this infusion spare 5 has the endoporus that is communicated with inner bag body 4 at its length direction.Infusion spare 5 and plug 18 are made by known medical material, and wherein the material of infusion spare 5 can be identical or inequality with the material of inner bag 3.If it is inequality, preferably chemical compatible.If chemistry is inconsistent, then compatilizer is added at least wherein a kind of material, be used to improve two kinds of bond vitrifieds between the material.
The effect of outer bag 2 is with inner bag 3 and isolated from atmosphere.The material of outer bag 2 is the material with resistance oxygen, water preventing ability, but transparent, to use lamp inspection.Be filled with inertness gas in the insulating space between this external described outer bag 2 and the inner bag 3.Inertness gas is preferably nitrogen, but noble gas also suits.
After taking above measure, just can intercept steam and oxygen effectively.In order to reach better effect, consider the oxygen that the residual oxygen that may occur or infiltration are come in, between inner bag 3 and outer bag 2, add oxygen absorbent, even put into desiccant etc.These are all at thought range of the present invention.
Fig. 3 is the front view according to second embodiment of medical liquor soft package of the present invention.Here, identical with first embodiment parts adopt identical label.As can be seen, in the inner bag among second embodiment 3 and the outer bag 2 of not exclusively packing into, have only the body 4 of inner bag 3 all or basically to pack in the outer bag 2, and composite cover 12 is exposed.The last edge fit 10 of the outer bag 2 of medical liquor soft package 1 engages hermetically with the last edge fit 11 of inner bag, and inner bag 4 and isolated from atmosphere are come.Because composite cover 12 is exposed, should improve to some extent to the material of composite cover itself, sealing and with the requirement that is connected the sealing between reaching of the body 4 of inner bag 3.
Fig. 4 is the exploded view of second embodiment of inner bag of the present invention, and as can be seen, the end in infusion spare 5 puts in inner bag body 4 is provided with flexible filtration members 19, and it covers the endoporus of infusion spare 5 fully.Described filtration members 19 can be by linking together with 5 hot pressing of infusion spare or other connecting device.The effect of filtration members 19 is not allow harmful granule enter infusion channel when transfusion, thereby extra safety assurance is provided.The material of filtration members 19 can be the microporous filter membrane of medical grade, composite fibre ester microporous filter membrane for example, and filtering degree is at 0.22um-0.45 μ m.
Fig. 5 is the exploded view of the 3rd embodiment of inner bag of the present invention, and it is the further improvement to second embodiment.Because the filtration members 19 among the embodiment two is to contact with medicinal liquid for a long time, some medicinal liquid may have to a certain degree chronic reaction with filtration members 1.For a long time contact any material that should not discharge side effect as the medical micro porouse filter membrane, comprise the material that may cause toxicity, pyrogen or haemolysis with medicinal liquid.In addition, also has biologically ask for something.Although can take new material to guarantee the safety of filtration members 19, medically the material of Shi Yonging is very limited.Therefore earlier adopt the isolated method of physics a kind of good method of can yet be regarded as.The top of inner bag body 4 shown in Figure 5 is provided with weak tape splicing 20, for example is made up of the easy-opening heat-sealable area, and medicinal liquid and described filtration members 19 are isolated.Just can open tape splicing 20 a little less than this by extruding during use.Certainly, filtration members 19 also can be located on this weak tape splicing 20 or on the opening 17.
If do not consider clarity test, outer bag can use opaque material, is in the light being used for.But the applicant finds, if adopt nontoxic clad aluminum foil, its influence to the pH value of some medicinal liquid under higher temperature is bigger, and Chinese medicine especially is as SHENQI FUZHENG ZHUSHEYE, Oleum Curcumae medicinal liquid or Radix Notoginseng total glycosides preparation.The applicant has carried out contrast test to the Radix Notoginseng total glycosides injection.
The preparation of Radix Notoginseng total glycosides
The Radix Notoginseng total glycosides intravenous fluid that is provided is the Radix Notoginseng total glycosides of 0.1mg-14.0mg (in Rg1)/ml by concentration basically, and concentration is the isotonic agent of 7.5-8.5mg/ml, and concentration is that the pH value stabilizing agent of 0.1-0.5mg/ml is formed; The solvent of described injection is a distilled water for injection.
Wherein, the concentration of described Radix Notoginseng total glycosides is preferably 1.4mg (in Rg1)/ml; Described isotonic agent can be sodium chloride, glucose, sorbitol etc., is preferably sodium chloride, and the concentration of sodium chloride is between 7.5-9.5mg/ml, and preferred concentration is 8.5mg/ml; Described pH value stabilizing agent can be sodium citrate, citric acid, phosphate, acetate., being preferably sodium citrate, the concentration of sodium citrate is 0.1-0.5mg/ml, preferred concentration is 0.3mg/ml.
Produce the method for Radix Notoginseng total glycosides injection, may further comprise the steps: (1) dissolves isotonic agent with distilled water for injection, and making it concentration is 80-300mg/ml, adds active carbon then, filters; (2) add Radix Notoginseng total glycosides in the filtrate, making it concentration is 0.1mg-14.0mg (in Rg1)/ml, stirring and dissolving; (3) add the pH value stabilizing agent, making it concentration is 0.1-0.5mg/ml, be filtered to then clear and bright, sterilization, liquid pours into flexible package, promptly obtains the soft bag of Radix Notoginseng total glycosides intravenous fluid.
Get rare dosing and divide two groups to test from the big production in bulk capacity injection workshop, two groups pH is respectively 070201:6.01 to 6.07 and 070311:6.03 to 6.06, adopts German POLYCINE film inner bag+outer bag+towards the condition of nitrogen.Outer bag of the present invention is selected PE film material for use, and selects for use different-thickness (10C, 15C) to test.
Matched group: every group of test adopted outer bag to select for use (aluminized by polyester, polyester and constitute) three to close nontoxic clad aluminum foil to carry out experimental control as the film material.
Result of the test
From above-mentioned data as can be seen:
Adopt the control sample of the outer bag of clad aluminum foil, bigger 60 ℃ of difference of pH following 0 day, 5 days, 10 days the time.And the sample of the outer bag of the PE that adds 10C or 15C is minimum 60 ℃ of difference of pH following 0 day, 5 days, 10 days the time.The total solid matters of two kinds of packings and the content of Radix Notoginseng total glycosides have no significant change.
Although for the purpose of clear understanding, specifically described above invention, obviously can in the scope of accompanying Claim book, make certain variation and change.Therefore, it is exemplary that present embodiment should be considered to, rather than restrictive, and the present invention is not subjected to the restriction of above-mentioned details, but make change in can and being equal in the scope of the foregoing description.
Claims (9)
1. a notoginseng triterpenes medical liquor soft package (1) comprises outer bag (2) and inner bag (3), and liquid medicine filling is in inner bag (3) the inside; The composite cover (12) that described inner bag has inner bag body (4) and inner bag body (4) is sealed; Described composite cover (12) comprises infusion spare (5), one end of this infusion spare (5) is encapsulated on the opening (17) of inner bag body (4), and this infusion spare (5) has the endoporus that is communicated with inner bag body (4) at its length direction, it is characterized in that: outer bag (2) and inner bag (3) are transparent, and described outer bag (2) to major general's inner bag body (4) separates with the external world, and outside described, being filled with inertness gas in the insulating space between bag (2) and the inner bag (3), described inertness gas is noble gas.
2. packing according to claim 1 (1) is characterized in that, described inertness gas is nitrogen.
3. packing according to claim 1 (1) is characterized in that, is added with oxygen absorbent described in by insulating space.
4. packing according to claim 1 (1) is characterized in that, the material of described outer bag (2) is the material with resistance oxygen, water preventing ability.
5. packing according to claim 1 (1) is characterized in that, described inner bag (3) is made by non-PVC composite membrane, and outer bag is selected PE film material for use.
6. packing according to claim 1 (1) is characterized in that, described inner bag (3) also is provided with filtration members (19).
7. packing according to claim 6 (1) is characterized in that, described filtration members (19) is located at infusion spare (5) and puts in the interior end of inner bag body (4), and covers the endoporus of infusion spare (5) fully.
8. packing according to claim 6 (1) is characterized in that, the filtering degree of described filtration members (1) is at the 0.22um-0.45 mu m range.
9. according to each described packing (1) of claim 6-8, it is characterized in that, also be provided with on described inner bag body (4) top and make medicinal liquid and the isolated weak tape splicing (20) of described filtration members (19).
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200810084887 CN101543461B (en) | 2008-03-28 | 2008-03-28 | Notoginseng triterpenes medical liquor soft package |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200810084887 CN101543461B (en) | 2008-03-28 | 2008-03-28 | Notoginseng triterpenes medical liquor soft package |
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| Publication Number | Publication Date |
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| CN101543461A CN101543461A (en) | 2009-09-30 |
| CN101543461B true CN101543461B (en) | 2013-07-31 |
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| Application Number | Title | Priority Date | Filing Date |
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| CN 200810084887 Active CN101543461B (en) | 2008-03-28 | 2008-03-28 | Notoginseng triterpenes medical liquor soft package |
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Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1082881A (en) * | 1992-05-03 | 1994-03-02 | 株式会社大制药工场 | Multi cavity container |
| CN2910192Y (en) * | 2006-06-07 | 2007-06-13 | 广州白云山侨光制药有限公司 | Transfusion bag of isolating oxygen |
| CN201194917Y (en) * | 2008-03-28 | 2009-02-18 | 丽珠集团利民制药厂 | Flexible package for liquid medicine of total saponins of panax notoginseng |
-
2008
- 2008-03-28 CN CN 200810084887 patent/CN101543461B/en active Active
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1082881A (en) * | 1992-05-03 | 1994-03-02 | 株式会社大制药工场 | Multi cavity container |
| CN2910192Y (en) * | 2006-06-07 | 2007-06-13 | 广州白云山侨光制药有限公司 | Transfusion bag of isolating oxygen |
| CN201194917Y (en) * | 2008-03-28 | 2009-02-18 | 丽珠集团利民制药厂 | Flexible package for liquid medicine of total saponins of panax notoginseng |
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| CN101543461A (en) | 2009-09-30 |
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