CN2917637Y - Precharge preparation of antitumor agent - Google Patents

Abstract

The pre-filled preparation of an antitumor drug of the utility mode relates to the field of pharmaceutical preparation. A pre-filled syringe is adoped as the inner package of a hydro-acupuncture therapy of antitumor drugs. The pre-filled syringe has the structure as bellow: the back-end of an outerwear 1 is open, the conehead at the front-end of the pre-filled syringe is sleeved with a protecting cap 5; the coaxial line on the protecting cap 5 is provided with a needle 4; a piston 2 connects with a core pin 3; and the needle is sealed with a rubber plug 9. The outerwear 1 has a volume of 1ml or 2ml or 2.5ml or 5ml; and the diameter of the needle 4 is 0.2-0.5mm. The antitumor drugs comprise Changchunruibin, paclitaxel, docetaxel, homoharringtonine, vincristine sulphate, Hydroxycamptothecin, mannopeptin and so on. The utility mode has the advantages of reduction of drug residues, accurate dosage, avoidance of the application of repeated suction of the diluent and production of the leftovers from the rubber plug, reduction of pollution risk, increase of the safety of patients, small volume making the packaging convenient and lowering the medical cost, a thin needle for convenient operation, and decrease of the toxicity from the antitumor drugs to operators.

Description

A kind of precharging preparation of antitumor drug

Technical field

This utility model relates to a kind of precharging preparation of medicine, especially a kind of precharging preparation of antitumor drug Ah liquid drugs injection.

Background technology

Precharging preparation is with the inner packing of precharging type syringe as product, and precharging type syringe is a kind of more high-grade medicine packaging material.Form as the drug packages system, it is directly packed liquid medicine into and preserves in the syringe, and simple and convenient during use, while syringe itself has good sealing, and medicine can long term storage.Its syringe needle is different from traditional syringe needle, is three inclined-planes, can alleviate the misery that patient infusion brings like this.At some medicaments injection packaging fields, it replaces traditional glass ampule and cillin bottle just fast, both made things convenient for the fill of medicine and the use of user, had very high safety again, avoided the trouble of medicinal liquid suction syringe and the medicinal liquid secondary pollution that may bring.

This product is divided into the band pin and is not with two kinds on pin, all produces 10,000 grades of cleaning shops.

The prior art the most close with this utility model is that name is called the Chinese invention patent application of " the recombinant human interferon alpha 2 b injection of prefilled injector package ", publication number CN1748788A.Precharging preparation is applied to the packing of biological preparation mostly at home, and as fields such as interferon, vaccine, human growth hormones, but the application in the pharmaceutical preparation of the very big antitumor class of toxicity does not but also occur.

Tumor class drug products all uses cillin bottle or ampoule bottle packing on the present domestic medical market, in use, usually need unpack, and then use syringe pump, be easy to cause secondary pollution like this, the joint of syringe and pin chamber are long easily causes medicinal liquid residual, and use amount is inaccurate, bring toxicity, subcutaneous injection area big to operation medical care operator easily, pain increase etc.

The utility model content

The technical problems to be solved in the utility model provides a kind of precharging preparation, and it is in use not enough to overcome antitumor class pharmaceutical preparation in the past, is suitable for packing the small-volume injection of activity stabilized antitumor drug liquid drugs injection.

The precharging preparation of a kind of antitumor drug of the present utility model, adopt the inner packing of precharging type syringe, it is characterized in that said precharging type syringe structure is as the antitumor drug liquid drugs injection, the overcoat open rearward end of hollow circular cylinder is set with helmet on the conehead of front end; Coaxial line is installed syringe needle on the helmet; One piston is arranged in the overcoat, and piston is connected with core bar, and core bar has one section to be inserted in the overcoat; Syringe needle seals with plug; Integral body encapsulates with aluminium foil behind the antitumor medicinal liquid that charges into.

Syringe needle uses three thin, the most sharp-pointed beveled, and diameter is at 0.2～0.5mm, and the patient has only slight sensation during injection.

Said overcoat volume is 1ml, 2ml, 2.5 ml and 5ml, according to the medical treatment and the market demand, and the use amount difference of various medicinal liquids, the specification of the precharging preparation of antitumor drug of the present invention can be diversified.

The inwall of overcoat adopts polypropylene material, has reduced the absorption of medicine.

In the making of precharging type syringe, through sterilization treatment, after the detection, can be directly used in the fill of carrying out tumor class medicine, program is simple, and is easy to use.The embedding of precharging type syringe, quality testing, decals, stubborn bar, plastic packaging all adopt automatic assembly line.

This utility model provides a kind of precharging preparation of antitumor class medicine liquid drugs injection, comprises vinorelbine, calcium leucovorin, paclitaxel, docetaxel, homoharringtonine, vincristine sulfate, hydroxycamptothecin, etoposide, vindesine sulfate, vinblastine sulfate, the liquor epinephrinae bitartratis ophthalmicus vinorelbine, doxorubicin hydrochloride, Bleomycin A5 hydrochloride., epirubicin hydrochloride, NSC 654509, doxorubicin hydrochloride, daunorubicin hydrochloride, cytosine arabinoside, fluorouracil, methotrexate, ftorafur, cyclophosphamide, plug is for group, mustine hydrochlcride, carmustine, nitrocaphane, ifosfamide, calcium folinate, carboplatin, amsacrine, the citric acid dacarbazine, cisplatin, mitoxantrone hydrochloride, oxaliplatin, doxifluridine, docetaxel, fludarabine phosphate, the hydrochloric acid bleomycin, clindamycin phosphate, matrine, thymosin, mannatide, plug is for group, Injectio natarii norcantharidatis, U.S.'s monoclonal antibody of appropriate former times, mitomycin, actinomycin D, rich Lay enzyme element, the precharging preparation of antineoplastic agent composition injections such as amycin.

The advantage that precharging preparation is used for the pharmaceutical preparation of antitumor class mainly contains:

1. simplify clinical manipulation, easy to use, reduce medical treatment cost.

2. avoid using diluent to aspirate repeatedly, reduce the generation that the rubber plug is inhaled bits, reduce residual and secondary pollution.

3. do not have dead space volume, dosage is accurate.

4. unit volume is little, packaged convenience.

5. syringe needle is sharp keen, handled easily.

6. reduce the toxicity of antitumor drug to operator.

7. disposable use, direct injection uses, and reduces pollution risk, increases patient's the security.

Because the particularity of antitumor class medicine, the precharging preparation of decision antitumor class medicine liquid drugs injection will have higher using value and prospect, so the precharging preparation of invention antitumor class medicine is necessary.

Description of drawings

Fig. 1 is the structural representation of a kind of precharging type syringe of the present utility model.

The specific embodiment

Further specify structure of the present utility model with embodiment below, but do not limit protection domain of the present utility model.

The structure of the precharging preparation of embodiment 1 accompanying drawings antitumor drug liquid drugs injection of the present utility model.

The precharging preparation of antitumor drug of the present utility model is by precharging type syringe and antineoplastic agent composition injection, and injection charges in the overcoat of hollow circular cylinder of precharging type syringe.

The precharging type syringe structure is seen Fig. 1.Among Fig. 1,1 is overcoat, and 2 is piston, and 3 is core bar, and 4 is syringe needle, and 5 is helmet, and 6 is medicinal liquid, and 7 is label, and 8 is aluminium foil, and 9 is plug.Overcoat 1 is a hollow circular cylinder, is set with helmet 5 on the conehead of its front end, open rearward end; Be provided with the capping of a piston 2 as overcoat 1 herb liquid 7 in the hollow circular cylinder overcoat 1, can slide in overcoat 1 and seal, piston 2 is connected with core bar 3; Core bar 3 has part to be inserted in the overcoat 1; Syringe needle 4 is socketed in an end of overcoat 1,9 sealings of reuse plug; Whole with aluminium foil 8 encapsulation behind the medicinal liquid that charges into.

The preparation and the specifications and models of the precharging preparation of embodiment 2 antitumor drug of the present utility model

1, preparation: at first select 1ml vinorelbine medicinal liquid for use, charge into the 1ml precharging type syringe, carry out sterilization treatment; Seal with aluminium foil 8 behind the medicinal liquid that charges into 9 sealings of piston 2 and plug; Through ethylene oxide sterilizing.Should adopt the mechanization operation to finish the fill program of medicinal liquid.The embedding of precharging type syringe, quality testing, decals, stubborn bar, plastic packaging all adopt automatic assembly line.

2, silicidation in the preparation and purifying and sterilizing are handled:

1) overcoat 1 can adopt the I class borosilicate glass tube that meets American Pharmacopeia/European Pharmacopoeia regulation; Syringe needle 4 can be with hypodermic AISI304 rustless steel entry needle; Overcoat 1 and syringe needle 4 should be in ten thousand grades of purifying areas, and purified water, water for injection clean, to guarantee its cleaning.

2) overcoat 1 inwall and syringe needle 4 all pass through DC360 silicone oil silicidation, inject puncture with pin in easy to use.

3) after the syringe needle 4 on the overcoat 1 adds helmet 5, should be through dress nest machine dress nest, the nest box and carry out sealing operation of packing in hundred grades of districts more finally also will pass through ethylene oxide sterilizing, thereby guarantee the product cleaning sterile.

4) plug 10 can adopt French STELMI company ultra-clean explained hereafter plug (through water for injection clean and by the ultra-clean program silication in advance of authentication fully), cobalt 60 radiation sterilizations are finally passed through in subpackage under hundred grades of laminar flows of ten thousand grades of purifying areas.

3, specifications and models can have 1ml, 2ml, 2.5ml, 5ml, and according to the actual requirements, the specification of precharging preparation can be diversified.

Embodiment 3 medicinal liquids

Use the medicinal liquid calcium leucovorin, paclitaxel, docetaxel, homoharringtonine, vincristine sulfate, hydroxycamptothecin, etoposide, vindesine sulfate, vinblastine sulfate, the liquor epinephrinae bitartratis ophthalmicus vinorelbine, doxorubicin hydrochloride, Bleomycin A5 hydrochloride., epirubicin hydrochloride, NSC 654509, doxorubicin hydrochloride, daunorubicin hydrochloride, cytosine arabinoside, fluorouracil, methotrexate, ftorafur, cyclophosphamide, plug is for group, mustine hydrochlcride, carmustine, nitrocaphane, ifosfamide, calcium folinate, carboplatin, amsacrine, the citric acid dacarbazine, cisplatin, mitoxantrone hydrochloride, oxaliplatin, doxifluridine, docetaxel, fludarabine phosphate, the hydrochloric acid bleomycin, clindamycin phosphate, matrine, thymosin, mannatide, plug is for group, Injectio natarii norcantharidatis, U.S.'s monoclonal antibody of appropriate former times, mitomycin, actinomycin D, rich Lay enzyme element, antitumor medicinal liquids such as amycin replace the vinorelbine medicinal liquid among the embodiment 2, can make the precharging preparation of corresponding antitumor drug liquid drugs injection.

The observation of the injection for anti-tumor stability of embodiment 4 prefilled injector packages

With injection for anti-tumor such as the vinorelbine of precharging type syringe, ampoule bottle, cillin bottle packing, paclitaxel, docetaxel, homoharringtonine, vincristine sulfate, hydroxycamptothecin, etoposide, mannatides, after depositing 1 month, 3 months, 6 months, 1 year under cold preservation (2～8 ℃), room temperature (20～25 ℃), high temperature (37 ℃) equal conditions, be the contrast experiment.Compare with the injection of ampoule bottle and cillin bottle packing through detecting the interior injection of precharging type syringe, testing results such as outward appearance, clarity, pH value, content, abnormal conditions all do not appear, show through experimental verification, precharging type syringe is can substitute existing cillin bottle and ampoule bottle fully as the inner packing of antitumor class medicaments injection.

Claims (2)

1, a kind of precharging preparation of antitumor drug, adopt the inner packing of precharging type syringe, it is characterized in that said precharging type syringe structure is as the antitumor medicine liquid drugs injection, the overcoat of hollow circular cylinder (1) open rearward end is set with helmet (5) on the conehead of front end; Helmet (5) is gone up coaxial line syringe needle (4) is installed; One piston (2) is arranged in the overcoat (1), and piston (2) is connected with core bar (3), and core bar (3) has one section to be inserted in the overcoat (1); Syringe needle (4) seals with plug (9); Whole with aluminium foil (8) encapsulation behind the antitumor medicinal liquid that charges into; Said overcoat (1) volume is 1ml or 2ml or 2.5ml or 5ml; Said syringe needle (4) diameter is at 0.2～0.5mm.

2, precharging preparation according to the described a kind of antitumor drug of claim 1, it is characterized in that said antitumor drug is a vinorelbine, calcium leucovorin, paclitaxel, docetaxel, homoharringtonine, vincristine sulfate, hydroxycamptothecin, etoposide, vindesine sulfate, vinblastine sulfate, the liquor epinephrinae bitartratis ophthalmicus vinorelbine, doxorubicin hydrochloride, Bleomycin A5 hydrochloride., epirubicin hydrochloride, NSC 654509, doxorubicin hydrochloride, daunorubicin hydrochloride, cytosine arabinoside, fluorouracil, methotrexate, ftorafur, cyclophosphamide, plug is for group, mustine hydrochlcride, carmustine, nitrocaphane, ifosfamide, calcium folinate, carboplatin, amsacrine, the citric acid dacarbazine, cisplatin, mitoxantrone hydrochloride, oxaliplatin, doxifluridine, docetaxel, fludarabine phosphate, the hydrochloric acid bleomycin, clindamycin phosphate, matrine, thymosin, mannatide, plug is for group, Injectio natarii norcantharidatis, U.S.'s monoclonal antibody of appropriate former times, mitomycin, actinomycin D, rich Lay enzyme element or amycin.