KR20100090409A - Method of manufacturing porous film for anti-adhesive-membrane and slow emission materials - Google Patents
Method of manufacturing porous film for anti-adhesive-membrane and slow emission materials Download PDFInfo
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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
- A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
- A61K9/7007—Drug-containing films, membranes or sheets
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
Abstract
Description
본 발명은 폴리락티드를 이용하여 인체 내에서 생분해가 가능하고, 미세기공이 형성된 다공성 필름에 항생제나 소염제를 도포하여 제조되는 다공성 조직유착 방지용 서방성 제제 필름의 제조방법에 관한 것이다.The present invention relates to a method for producing a sustained release formulation film for preventing porous tissue adhesion by applying an antibiotic or an anti-inflammatory agent to a porous film biodegradable in the human body using polylactide and having micropores formed thereon.
일반적인 개복수술 후에는 세포재생에 따른 현상으로 피부나 장기조직의 유착현상이 발생한다. 이러한 피부나 장기조직의 유착현상은 자연적인 현상이지만 유착이 발생하는 부위가 적절하지 못하면 환자에게 위험을 초래할 수 있어 유착을 차단하거나, 유착속도를 적절하게 지연해야 하는 상황이 발생한다.After general open surgery, adhesion of skin or organ tissue occurs due to cell regeneration. Although the adhesion of skin or organ tissues is a natural phenomenon, if the site where adhesion occurs is not appropriate, it may cause a danger to the patient, so that the adhesion should be blocked or the adhesion rate should be appropriately delayed.
이러한 이유로 인해 수술 부위에 피부나 장기조직의 유착이 발생되지 않도록 얇은 멤브레인 필름막이나 겔 타입의 유착 방지막이 사용되고 있는데, 멤브레인 필름막은 구부러지기 쉬워 해부학적 구조에 잘 맞고 조직의 상호 작용을 허용하지 않 는 차단막을 형성하는데 용이하기 때문에 개복수술과 같이 수술부위가 넓고 장시간에 걸쳐 피부나 장기조직이 재건되는 부위에 주로 사용되며, 겔 타입의 유착방지막은 복강수술과 같이 수술부위가 좁고 1 내지 2주 사이에 조직이 재건되는 부위에 발라서 사용된다.For this reason, a thin membrane film or a gel type anti-adhesion film is used to prevent adhesion of skin or organ tissue to the surgical site. The membrane film film is easily bent, which fits well with anatomical structure and does not allow tissue interaction. Because it is easy to form the barrier film, it is mainly used for wide surgical area like open surgery and reconstruction of skin or organ tissue over a long period of time. Gel type anti-adhesion film is narrow like surgical procedure for one to two weeks. It is applied to the area where tissue is rebuilt.
이외에도 조직유착을 방지하기 위해 여러가지 방법이 이용되고 있는데, 복강세척을 통해 장막 표면의 부착을 최소화시키거나, 헤파린 용액을 첨가하는 방법 등이 있다.In addition, various methods have been used to prevent tissue adhesion. There are methods of minimizing the adhesion of the surface of the intima membrane through peritoneal washing, or adding a heparin solution.
그러나 전술한 멤브레인 필름막 형태의 경우는 필름막이 피부나 장기조직과 유착할 수 있으며, 필름막이 세균에 오염될 수 있는 문제점이 있었다.However, in the case of the aforementioned membrane film film form, the film film may adhere to skin or organ tissues, and the film film may be contaminated with bacteria.
또한, 겔 타입의 유착 방지막, 복강세척 및 헤파린 용액을 이용하는 방법은 외과적 기법을 응용한 것으로 적용부위에 제약이 있는 문제점이 있었다.In addition, the method of using a gel-type anti-adhesion film, intraperitoneal washing, and heparin solution has a problem in that it is applied to a surgical technique and has limitations in application area.
본 발명의 목적은, 피부나 장기조직과의 유착이 발생하지 않고 인체 내에서 생분해되는 폴리락티드를 이용하며, 미세기공이 다수 형성된 다공성 조직유착 방지용 필름의 제조방법을 제공하는 것이다.It is an object of the present invention to provide a method for producing a porous tissue adhesion preventing film using polylactide biodegradable in the human body without adhesion to skin or organ tissues.
또한, 본 발명의 다른 목적은, 서로 연결되어 있는 미세기공에 항생제 또는 소염제가 채워져 세균증식을 억제할 수 있는 다공성 조직유착 방지용 필름의 제조방법을 제공하는 것이다.In addition, another object of the present invention is to provide a method for producing a porous tissue adhesion prevention film that can suppress bacterial growth by filling the micropores connected to each other antibiotics or anti-inflammatory.
전술한 본 발명의 목적은, 폴리락티드 1 내지 20 중량부에 제1유기용매 100중량부를 혼합하여 혼합용액을 제조하는 제1혼합단계, 상기 제1혼합단계를 거친 혼합용액에 제2유기용매 10 내지 100 중량부를 첨가하는 제2혼합단계, 상기 제2혼합단계를 거친 혼합용액을 금형에 투입하고, 건조의 과정을 거쳐 다공성 필름으로 제조하는 필름제조단계, 상기 필름제조단계를 거쳐 제조된 다공성 필름에 약품을 도포하는 약품도포단계 및 상기 약품도포단계를 거친 다공성 필름에 유기용매를 제거하는 유기용매제거단계를 포함하여 이루어지는 것을 특징으로 하는 다공성 조직유착 방지용 필름의 제조방법을 제공함에 의해 달성된다.An object of the present invention described above, the first mixing step of preparing a mixed solution by mixing 100 parts by weight of the first organic solvent to 1 to 20 parts by weight of polylactide, the second organic solvent in the mixed solution after the first mixing step The second mixing step of adding 10 to 100 parts by weight, the mixed solution passed through the second mixing step into a mold, the film manufacturing step of producing a porous film through a drying process, the porous prepared through the film manufacturing step It is achieved by providing a method for producing a film for preventing porous tissue adhesion, comprising a chemical coating step of applying a drug to the film and an organic solvent removal step of removing the organic solvent in the porous film subjected to the chemical coating step. .
본 발명의 바람직한 특징에 따르면, 상기 제1유기용매는 에틸아세테이트, 메틸렌클로라이드 및 클로로포름으로 이루어진 그룹으로부터 선택된 하나 이상을 포 함하여 이루어지는 것으로 한다.According to a preferred feature of the present invention, the first organic solvent comprises at least one selected from the group consisting of ethyl acetate, methylene chloride and chloroform.
본 발명의 더 바람직한 특징에 따르면, 상기 제2유기용매는 메틸알콜, 에틸알콜 및 아세톤으로 이루어진 그룹으로부터 선택된 하나 이상을 포함하여 이루어지는 것으로 한다.According to a more preferred feature of the invention, the second organic solvent is to comprise at least one selected from the group consisting of methyl alcohol, ethyl alcohol and acetone.
본 발명의 더욱 바람직한 특징에 따르면, 상기 제2유기용매에는 0.001 내지 10 중량부의 항생제 또는 소염제가 더 포함되는 것으로 한다.According to a more preferred feature of the invention, the second organic solvent is to be further included 0.001 to 10 parts by weight of antibiotic or anti-inflammatory agent.
본 발명의 더욱 더 바람직한 특징에 따르면, 상기 다공성 필름은 10 내지 100㎛의 두께로 형성되며, 직경 1 내지 5㎛ 크기의 미세기공이 형성되는 것으로 한다.According to a still more preferred feature of the present invention, the porous film is formed to a thickness of 10 to 100㎛, micropores having a diameter of 1 to 5㎛ size is to be formed.
본 발명의 더욱 더 바람직한 특징에 따르면, 상기 약품도포단계는 진공밸브가 장착된 밀폐 용기에 항생제 0.01 내지 1.0 중량부를 식염수 100중량부에 용해시켜 제조하거나, 소염제 0.01 내지 1.0 중량부를 에틸알콜 100 중량부에 용해시켜 제조한 약품용액을 넣고, 상기 필름제조단계에서 제조된 다공성 필름을 상기 약품용액에 함침하여 이루어지는 것으로 한다.According to a further preferred feature of the present invention, the chemical coating step is prepared by dissolving 0.01 to 1.0 parts by weight of antibiotics in 100 parts of saline solution in a sealed container equipped with a vacuum valve, or 0.01 to 1.0 parts by weight of anti-inflammatory agents 100 parts by weight of ethyl alcohol A chemical solution prepared by dissolving the same is added, and the porous film prepared in the film manufacturing step is impregnated into the chemical solution.
본 발명의 더욱 더 바람직한 특징에 따르면, 상기 소염제는 sulindac, ketoprofen, naproxen, fenbufen, felbinac, flurbiprofen, ibuprofen, mefenamic acid, ioxoprofen 및 piroxican으로 이루어진 그룹으로부터 선택된 하나로 이루어지는 것으로 한다.According to a further preferred feature of the invention, the anti-inflammatory agent is to be made of one selected from the group consisting of sulindac, ketoprofen, naproxen, fenbufen, felbinac, flurbiprofen, ibuprofen, mefenamic acid, ioxoprofen and piroxican.
본 발명의 더욱 더 바람직한 특징에 따르면, 상기 유기용매제거단계는 상기 다공성 필름을 30 내지 50℃의 온도로 가열하고, 10-3 Torr의 진공을 가하여 이루어지는 것으로 한다.According to a further preferred feature of the invention, the organic solvent removal step is to be made by heating the porous film to a temperature of 30 to 50 ℃, and applying a vacuum of 10 -3 Torr.
본 발명에 따른, 다공성 조직유착 방지용 필름의 제조방법은 필름의 두께가 10 내지 100㎛로 형성되어 피부나 장기조직과의 유착이 발생하지 않고, 폴리락티드로 이루어져 인체 내에서 생분해가 가능한 다공성 조직유착 방지용 필름을 제공하는 탁월한 효과를 나타낸다.According to the present invention, the method for producing a porous tissue adhesion prevention film is formed with a thickness of 10 to 100㎛ does not occur adhesion to the skin or organ tissues, made of polylactide porous tissue biodegradable in the human body Excellent effect of providing an anti-adhesion film.
또한, 필름의 표면과 내부에 형성되며, 서로 연결되어 있는 미세기공에 항생제 또는 소염제가 채워져 세균증식을 억제하고 염증유발을 차단할 수 있으며, 항생제나 소염제가 서서히 방출되어 서방성 제제의 특성을 갖는 다공성 조직유착 방지용 필름을 제공하는 탁월한 효과를 나타낸다.In addition, it is formed on the surface and inside of the film, the micropores connected to each other is filled with antibiotics or anti-inflammatory agents to inhibit bacterial growth and block the induction of inflammation, porosity having the characteristics of sustained-release formulations by slowly released antibiotics or anti-inflammatory agents It shows an excellent effect of providing a film for preventing tissue adhesion.
이하에는, 본 발명의 바람직한 실시예와 각 성분의 물성을 상세하게 설명하되, 이는 본 발명이 속하는 기술분야에서 통상의 지식을 가진 자가 발명을 용이하게 실시할 수 있을 정도로 상세하게 설명하기 위한 것이지, 이로 인해 본 발명의 기술적인 사상 및 범주가 한정되는 것을 의미하지는 않는다.In the following, preferred embodiments of the present invention and the physical properties of each component will be described in detail, which is intended to explain in detail enough to be able to easily carry out the invention by one of ordinary skill in the art, This does not mean that the technical spirit and scope of the present invention is limited.
본 발명에 따른 다공성 조직유착 방지용 필름의 제조방법은 폴리락티드 1 내지 20 중량부에 제1유기용매 100 중량부를 혼합하여 혼합용액을 제조하는 제1혼합단계(S101), 전술한 제1혼합단계(S101)를 거친 혼합용액에 제2유기용매 10 내지 100 중량부를 첨가하는 제2혼합단계(S103), 전술한 제2혼합단계(S103)를 거친 혼합용액을 금형에 투입하고, 건조의 과정을 거쳐 다공성 필름으로 제조하는 필름제조단계(S105), 전술한 필름제조단계(S105)를 거쳐 제조된 다공성 필름에 약품을 도포하는 약품도포단계(S107) 및 전술한 약품도포단계(S107)를 거친 다공성 필름에 유기용매를 제거하는 유기용매제거단계(S109)를 포함하여 이루어진다.Method for producing a porous tissue adhesion prevention film according to the present invention is a first mixing step (S101) for preparing a mixed solution by mixing 100 parts by weight of the first organic solvent to 1 to 20 parts by weight of polylactide, the first mixing step described above After the second mixing step (S103) for adding 10 to 100 parts by weight of the second organic solvent to the mixed solution having passed through (S101), the mixed solution which has been subjected to the above-described second mixing step (S103) to a mold and dried Through the film manufacturing step (S105) to produce a porous film through the above-described film manufacturing step (S105), the chemical coating step (S107) and the chemical coating step (S107) It comprises a step of removing the organic solvent (S109) to remove the organic solvent on the film.
전술한 제1혼합단계(S101)는 폴리락티드 1 내지 20 중량부에 제1유기용매 100중량부를 혼합하여 혼합용액을 제조하는 단계로, 전술한 제1유기용매는 에틸아세테이트, 메틸렌클로라이드 및 클로로포름으로 이루어진 그룹으로부터 선택된 하나 이상을 포함하여 이루어진다.The first mixing step (S101) is a step of preparing a mixed solution by mixing 100 parts by weight of the first organic solvent to 1 to 20 parts by weight of polylactide, wherein the first organic solvent is ethyl acetate, methylene chloride and chloroform It consists of one or more selected from the group consisting of.
이때, 폴리락티드의 분자량은 100,000 내지 400,000인 것을 사용하는데, 분자량이 100,000 미만은 폴리락티드를 사용하게 되면 제조되는 필름의 인장강도가 약하기 때문에 외력에 의해 쉽게 파손되고, 소염제나 항생제를 투입하는 단계에서 미세기공의 구조가 파손되는 현상이 발생하며, 분자량이 400,000을 초과하면 인장강도는 향상되지만 생체 내에서 흡수되는 기간이 길어지며, 필름에 형성되는 미세기공의 수가 줄어들게 된다.At this time, the molecular weight of the polylactide is used 100,000 to 400,000, the molecular weight is less than 100,000 when the polylactide is used because the tensile strength of the film is weak, easily broken by external force, and the anti-inflammatory or antibiotic In this step, the structure of the micropores is broken, and when the molecular weight exceeds 400,000, tensile strength is improved, but the period of absorption in the living body is long, and the number of micropores formed in the film is reduced.
제1혼합단계(S101)에서 혼합용액을 제조할 때, 제1유기용매에 대한 폴리락티 드의 혼합비율이 1 중량부 미만이면 필름의 두께가 10㎛ 이하로 형성되어 미세기공의 형성이 어렵고, 폴리락티드의 혼합비율이 20 중량부를 초과하게 되면, 혼합용액의 점도가 지나치게 상승하여 균일한 혼합물의 제조가 어렵고, 금형을 이용해 100㎛이하의 두께를 갖는 필름의 제조가 용이하지 않다.When preparing the mixed solution in the first mixing step (S101), if the mixing ratio of the polylactide to the first organic solvent is less than 1 part by weight, the thickness of the film is formed to 10㎛ or less, it is difficult to form micropores, When the mixing ratio of polylactide exceeds 20 parts by weight, the viscosity of the mixed solution is excessively increased, making it difficult to produce a uniform mixture, and it is not easy to produce a film having a thickness of 100 μm or less using a mold.
전술한 제2혼합단계(S103)는 전술한 제1혼합단계(S101)를 거쳐 제조된 혼합용액에 제2유기용매 10 내지 100 중량부를 첨가하는 단계로, 전술한 제2유기용매는 메틸알콜, 에틸알콜 및 아세톤으로 이루어진 그룹으로부터 선택된 하나 이상을 포함하여 이루어진다.The second mixing step (S103) described above is a step of adding 10 to 100 parts by weight of the second organic solvent to the mixed solution prepared through the first mixing step (S101) described above, wherein the second organic solvent is methyl alcohol, It comprises one or more selected from the group consisting of ethyl alcohol and acetone.
제2혼합단계(S103)에서는 대한 제1혼합단계(S101)를 통해 제조된 혼합용액에 대한 제2유기용매의 혼합비율이 10 중량부 미만이면 금형에서 필름을 제조하고 건조할 때 필름표면과 내부에 기공이 형성되지 않으며, 100 중량부를 초과하게 되면 혼합용액에서 폴리락티드가 석출되는 현상이 발생하여 다공성 필름이 제조되지 않는다.In the second mixing step (S103), when the mixing ratio of the second organic solvent to the mixed solution prepared through the first mixing step (S101) is less than 10 parts by weight, the film surface and the inside when the film is manufactured and dried in a mold Pore is not formed in, if more than 100 parts by weight of the polylactide is precipitated in the mixed solution is not produced a porous film.
이때, 제2유기용매에는 0.001 내지 10 중량부의 항생제 또는 소염제가 더 포함될 수도 있는데, 소염제는 sulindac, ketoprofen, naproxen, fenbufen, felbinac, flurbiprofen, ibuprofen, mefenamic acid, ioxoprofen 및 piroxican으로 이루어진 그룹으로 부터 선택된 하나로 이루어지며, 항생제는 범용적으로 사용되고 있는 항생제를 사용한다.At this time, the second organic solvent may further comprise 0.001 to 10 parts by weight of antibiotics or anti-inflammatory agents, anti-inflammatory agents selected from the group consisting of sulindac, ketoprofen, naproxen, fenbufen, felbinac, flurbiprofen, ibuprofen, mefenamic acid, ioxoprofen and piroxican Antibiotics are commonly used antibiotics.
전술한 필름제조단계(S105)는 전술한 제2혼합단계(S103)를 거친 혼합용액을 금형에 투입하고, 건조의 과정을 거쳐 다공성 필름으로 제조하는 단계로, 금형에 투입후 상온에서 4시간 이상 건조하는 과정으로 진행되며, 이러한 건조의 과정을 거치면 두께는 10 내지 100㎛이며, 직경 1 내지 5㎛ 크기의 미세기공이 형성되는데, 이러한 미세기공들은 서로 연결되어 있는 통기성의 구조를 갖는다.The above-described film manufacturing step (S105) is a step of adding the mixed solution passed through the second mixing step (S103) described above to a mold and manufacturing a porous film through a drying process. In the drying process, the thickness of the drying process is 10 to 100 μm, and micropores having a diameter of 1 to 5 μm are formed, and the micropores have a breathable structure connected to each other.
이때, 상온 이상의 열을 가하거나 진공을 가하게 되면, 필름에 주름이 발생하고, 미세기공의 크기가 확장되어 조직유착 방지용 필름으로 사용하기가 부적합하게 된다.At this time, when heat or room temperature or more vacuum is applied, wrinkles occur in the film, and the size of the micropores expands, making it unsuitable for use as a film for preventing tissue adhesion.
전술한 약품도포단계(S107)는 전술한 필름제조단계(S105)를 통해 미세기공이 형성된 다공성 필름에 약품을 도포하는 단계로, 진공밸브가 장착된 밀폐 용기에 항생제 0.01 내지 1.0 중량부를 식염수 100 중량부에 용해시켜 제조하거나, 소염제 0.01 내지 1.0 중량부를 에틸알콜 100 중량부에 용해시켜 제조한 약품용액을 넣고, 상기 필름제조단계(S105)에서 제조된 다공성 필름을 상기 약품용액에 함침하여 이루어지며, 이러한 약품도포단계(S107)를 거치게 되면, 다공성 필름에 형성된 미세기공에 항생제나 소염제가 포함된 약품용액이 채워지고, 이러한 방법으로 채워진 약품용액은 서서히 방출되어 다공성 조직유착 방지용 필름이 서방성 제재의 특성을 갖도록 한다.The above-described chemical application step (S107) is a step of applying the drug to the porous film formed with micropores through the above-described film manufacturing step (S105), 0.01 to 1.0 parts by weight of the saline solution in a sealed container equipped with a vacuum valve 100 weight It is made by dissolving in a portion, or a drug solution prepared by dissolving 0.01 to 1.0 parts by weight of an anti-inflammatory agent in 100 parts by weight of ethyl alcohol, is made by impregnating the porous film prepared in the film manufacturing step (S105) in the drug solution, When the chemical application step (S107), the micropore formed in the porous film is filled with the drug solution containing antibiotics or anti-inflammatory agents, the drug solution filled in this way is gradually released to prevent the porous tissue adhesion film of the sustained-release agent Have characteristics.
이때, 전술한 소염제는 sulindac, ketoprofen, naproxen, fenbufen, felbinac, flurbiprofen, ibuprofen, mefenamic acid, ioxoprofen 및 piroxican으로 이루어진 그룹으로 부터 선택된 하나로 이루어지며, 항생제는 범용적으로 사용되고 있는 항생제를 사용한다.At this time, the above-described anti-inflammatory agent is made of one selected from the group consisting of sulindac, ketoprofen, naproxen, fenbufen, felbinac, flurbiprofen, ibuprofen, mefenamic acid, ioxoprofen and piroxican, and antibiotics are commonly used antibiotics.
전술한 유기용매제거단계(S109)는 전술한 약품도포단계(S107)를 거친 필름에 함유되어 있는 유기용매를 제거하는 단계로, 다공성 필름을 30 내지 50℃의 온도로 가열하고, 10-3 Torr의 진공 2시간 넘게 가하여 이루어지며, 이러한 유기용매제거단계(S109)를 통해 다공성 필름에 함유되어 있던 유기용매는 제거되고, 다공성 조직유착 방지용 필름이 제조된다.The aforementioned organic solvent removing step (S109) is a step of removing the organic solvent contained in the film subjected to the above-described chemical coating step (S107), heating the porous film to a temperature of 30 to 50 ℃, 10 -3 Torr It is made by adding a vacuum over 2 hours, through the organic solvent removal step (S109), the organic solvent contained in the porous film is removed, a film for preventing porous tissue adhesion is prepared.
이하에서는 본 발명에 따른 다공성 조직유착 방지용 필름의 제조방법을 실시예를 들어 설명한다.Hereinafter will be described with reference to the embodiment of the method for producing a porous tissue adhesion preventing film according to the present invention.
<실시예 1>≪ Example 1 >
폴리락티드 10 중량부를 메틸렌클로라이드 100 중량부와 혼합하고, 전술한 혼합물 100 중량부에 에틸알콜 30 중량부를 더 혼합하여 제조된 혼합물 1 ml를 가로 100mm × 세로 100mm의 금형에 넣고 상온에서 4시간 동안 건조시키고, 40℃의 온도에서 2시간동안 10-3 torr의 진공을 가하여 다공성 조직유착 방지용 필름을 제조하였다.10 parts by weight of polylactide is mixed with 100 parts by weight of methylene chloride, and 1 ml of the mixture prepared by further mixing 30 parts by weight of ethyl alcohol in 100 parts by weight of the above mixture is placed in a mold having a width of 100 mm x 100 mm for 4 hours at room temperature. After drying, a vacuum of 10 −3 torr was applied at a temperature of 40 ° C. for 2 hours to prepare a porous tissue adhesion prevention film.
<실시예 2><Example 2>
폴리락티드 10 중량부를 메틸렌클로라이드 100 중량부와 혼합하고, 전술한 혼합물 100 중량부에 술린닥(sulindac)이 0.01 중량부가 혼합된 에틸알콜 30 중량부를 더 혼합하여 제조된 혼합물 1 ml를 가로 100mm × 세로 100mm의 금형에 넣고 상온에서 5시간 동안 건조시키고, 40℃의 온도에서 2시간동안 10-3 torr의 진공을 가하여 다공성 조직유착 방지용 필름을 제조하였다.10 parts by weight of polylactide was mixed with 100 parts by weight of methylene chloride, and 1 ml of the mixture prepared by further mixing 30 parts by weight of ethyl alcohol, in which 0.01 parts by weight of sulindac was mixed, in 100 parts by weight of the above-described mixture. The film was placed in a mold having a length of 100 mm, dried at room temperature for 5 hours, and subjected to a vacuum of 10 −3 torr for 2 hours at a temperature of 40 ° C. to prepare a porous tissue adhesion prevention film.
<실시예 3><Example 3>
실시예 1을 통해 제조된 다공성 조직유착 방지용 필름을 술린닥(sulindac)이 0.01 중량부가 혼합된 에틸알콜 혼합물에 함침하고 10-2 torr 진공을 2시간 동안 가하여 에틸알콜 혼합물을 전술한 다공성 조직유착 방지용 필름에 형성된 미세기공에 채워지도록 한 후에, 20℃에서 12시간 건조하고, 40℃의 온도에서 4시간 동안 10-3 torr의 진공을 가하여 필름의 미세기공과 표면에 1 ㎛이하의 술린닥이 코팅된 다공성 조직유착 방지용 필름을 제조하였다.The porous tissue adhesion preventing film prepared in Example 1 was impregnated in an ethyl alcohol mixture in which sulindac was mixed with 0.01 parts by weight, and 10 -2 torr vacuum was applied for 2 hours to prevent the porous tissue adhesion. After filling the micropores formed in the film, the film was dried at 20 ° C. for 12 hours and subjected to a vacuum of 10 −3 torr for 4 hours at a temperature of 40 ° C. to which the micropores of the film were coated with sulindac of 1 μm or less. A porous tissue adhesion prevention film was prepared.
실시예 1 내지 3을 통해 제조된 다공성 조직유착 방지용 필름의 두께, 미세기공의 크기 및 기공율을 측정하여 아래 표 1에 나타내었다.The thickness, micropore size and porosity of the porous tissue adhesion preventing film prepared through Examples 1 to 3 were measured and shown in Table 1 below.
<표 1>TABLE 1
위에 표 1에 나타낸 것처럼 실시예 1 내지 3을 통해 제조된 다공성 조직유착 방지용 필름은 미세기공의 기공율이 우수한 것을 알 수 있다.As shown in Table 1 above, it can be seen that the porous tissue adhesion preventing film prepared through Examples 1 to 3 has excellent porosity of micropores.
도 1은 본 발명에 따른 다공성 조직유착 방지용 서방성 제제 필름의 제조방법을 도시한 순서도이다.1 is a flow chart illustrating a method of manufacturing a sustained release formulation film for preventing porous tissue adhesion according to the present invention.
도 2는 본 발명의 실시예 1에 의해 제조된 다공성 조직유착 방지용 서방성 제제 필름의 표면을 도시한 확대도이다.Figure 2 is an enlarged view showing the surface of the sustained release formulation film for preventing porous tissue adhesion prepared by Example 1 of the present invention.
도 3은 본 발명의 실시예 2에 의해 제조된 다공성 조직유착 방지용 서방성 제제 필름의 단면을 도시한 확대도이다.Figure 3 is an enlarged view showing a cross section of the sustained release formulation film for preventing porous tissue adhesion prepared by Example 2 of the present invention.
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| WO2013009009A2 (en) * | 2011-07-08 | 2013-01-17 | (주)인튜이티브메디코프 | Film comprising poly octylcyanoacrylate for preventing tissue adhesion and method for manufacturing same |
| US9327049B2 (en) | 2012-02-28 | 2016-05-03 | Cg Bio Co., Ltd. | Anti-adhesion polymer composition capable of supporting growth factor |
| KR101626220B1 (en) * | 2014-11-27 | 2016-06-01 | 금오공과대학교 산학협력단 | Film-type anti-adhesion membranes comprising silk fibroin and preparing method thereof |
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| WO2013009009A2 (en) * | 2011-07-08 | 2013-01-17 | (주)인튜이티브메디코프 | Film comprising poly octylcyanoacrylate for preventing tissue adhesion and method for manufacturing same |
| WO2013009009A3 (en) * | 2011-07-08 | 2013-03-07 | (주)인튜이티브메디코프 | Film comprising poly octylcyanoacrylate for preventing tissue adhesion and method for manufacturing same |
| KR101277509B1 (en) * | 2011-07-08 | 2013-06-21 | (주)인튜이티브메디코프 | Tissue Adhesion prevention film including Polyoctylcyanoacrylate and Manufacturing Method thereof |
| US9327049B2 (en) | 2012-02-28 | 2016-05-03 | Cg Bio Co., Ltd. | Anti-adhesion polymer composition capable of supporting growth factor |
| KR101626220B1 (en) * | 2014-11-27 | 2016-06-01 | 금오공과대학교 산학협력단 | Film-type anti-adhesion membranes comprising silk fibroin and preparing method thereof |
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