KR20100032514A - Composition and the manufacturing method of the pharmacy treatment and inflammation prevention of the postoperative anal wound - Google Patents
Composition and the manufacturing method of the pharmacy treatment and inflammation prevention of the postoperative anal wound Download PDFInfo
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Abstract
Description
본 발명은 치질과 같은 항문질환 수술 후 항문수술부위에 발생될 수 있는 염증 및 부종을 예방 및 치료할 수 있도록 한 항문 관련수술부위 염증 예방 및 치료 제약 조성물에 관한 것이다. The present invention relates to a pharmaceutical composition for preventing and treating inflammation related to an anal surgery site for preventing and treating inflammation and edema that may occur in an anal surgery site after an anal disease operation such as hemorrhoids.
현대인들은 공해, 환경오염, 복잡한 사회생활 등에 의한 스트레스로 다양한 질병에 노출되어 있으며, 이중에서도 현대인들의 직업 및 생활습관에 따른 형태의 질병이 급격하게 증가세를 보이고 있다. Modern people are exposed to various diseases due to stress due to pollution, environmental pollution, and complicated social life, and among them, the types of diseases are increasing rapidly according to the occupation and lifestyle of modern people.
가장 일반적으로 생활습관에 따라 발병되고 있는 것으로, 일반적으로 치질이 있으며, 이러한 치질은 항문질환으로 변비나 설사 등 나쁜 배변습관, 과로 및 스트레스, 과음, 오래 서 있거나 앉아 있는 직업, 임신 등에 의해 발병되고 있다고 알려져 있다. It is most commonly caused by lifestyle, and generally hemorrhoids, which is an anal disease caused by bad bowel habits such as constipation or diarrhea, overwork and stress, heavy drinking, long standing or sitting occupation, and pregnancy. It is known.
치질전문외과의 통계에 따르면 대한민국 전체 성인인구 중 약 절반 이상이 항문 질환을 갖고 있다고 밝히고 있으며, 질병의 특성상 밝히기를 꺼려하기 때문에 진료의 시기를 놓쳐 간단한 약물치료로 치료 될 수 있는 부분도 수술까지 해야 하는 경우가 대부분이라고 한다. According to the statistics of hemorrhoids specialists, more than half of the adult population in Korea has anal disease, and because of the nature of the disease, they are reluctant to reveal the period of treatment, so they must be treated with simple medication. Most of the time it is said.
이와 같이 항문질환에 대해서 대다수의 사람들이 본의 아니게 수술을 선택하고 있으며, 수술을 하게 되는 경우 수술부위의 특성상 회복되는데 어려움을 겪게 된다.As such, the majority of people are unintentionally choosing surgery for anal disease, and when the surgery is performed, it is difficult to recover due to the nature of the surgical site.
항문 수술후에도 변을 계속해서 봐야 하기 때문에 항문수술상처는 부종과 동통, 피부괴사, 출혈, 치유지연 등 많은 합병증을 초래하는 경우가 많다. Because of the need to continue to see the stool after the anal surgery, the surgical wound often causes many complications such as edema, pain, skin necrosis, bleeding, delay in healing.
일반적으로 종래에는 헤모렉스 크림, 프록토세딜연고, 푸레파레숀 에치연과와 레토젠식 연고 등과 같은 항문질환에 사용되는 연고나 크림제제를 사용하곤 했으나, 이와 같은 치료제는 수술 후에 사용되기 보다는 수술 전 증상의 개선을 위해 사용되어져 왔다.In general, ointments or creams used for anal diseases such as hemorex cream, proctocedil ointment, purepareshon etch and retogen-type ointment were used. It has been used to improve symptoms.
프록토세딜연고와 헤모렉스 크림 연고 등 부신피질 호른몬제를 포함한 대부분의 기존 치질 연고는 수술상처에 사용함에 있어 오히려 상처의 치유속도를 저하시킬 위험이 있으며, 레토제식 연고의 경우엔 많은 경우 심한 두통을 동반하는 경우가 많아서 치열환자에게 극히 제한적으로 간혹 사용되고 있다. Most existing hemorrhoidal ointments, including adrenal cortex hornmonase, such as protocedyl ointment and hemorex cream ointment, have the risk of slowing the healing of wounds when used in surgical wounds. It is often accompanied by a very limited use is sometimes used in patients with orthodontics.
상기에서 설명한 바와 같이, 이와 같은 치료제들은 수술 전 항문질환의 증상의 개선에 목적이 있는 치료제일 뿐 수술 후 상처에서는 효과가 덜하고 오히려 치유지연 등의 부작용이 발생될 수 있었다.As described above, these treatments are the only treatments aimed at improving the symptoms of preoperative anal disease, but they are less effective in the postoperative wounds and may have side effects such as delay in healing.
따라서 항문질환 수술 후 보다 빨리 수술상처를 치유하기 위한 의약이 필요하게 되었다.Therefore, it is necessary to medicament to heal surgical wounds sooner after anal disease surgery.
본 발명은 상기에서와 같이 항문수술 상처부위의 특성상 수술부위의 치유지연 및 다양한 합병증 등의 이유를 고려하여 항문수술상처부위가 합병증없이 빠르게 치유될 수 있도록 하는 효과적인 의약 조성물을 제공하고자 한 것이다. The present invention is intended to provide an effective pharmaceutical composition that allows for the healing of the wound site without complications in consideration of the reasons for the healing delay and various complications of the surgical site due to the nature of the wound surgical site as described above.
본 발명은 항문상처와 유사한 환경에 있는 궤양성 대장염의 상처를 잘 낫게 해주는 기존 물질의 특성을 고려하여 항문수술 부위의 빠른 치유를 위한 의약적 조성물을 구성하고자 한 것이다. The present invention is intended to construct a pharmaceutical composition for the rapid healing of anal surgery site in consideration of the properties of the existing material to cure ulcerative colitis wound in an environment similar to the anal wound.
또한 본 발명에 있어 의학적 조성물을 항문 수술부위에 가장 바람직하게 투여가능하도록 연고형태로 하고자 한 것이다. In addition, in the present invention, the medical composition is intended to be in an ointment form so as to be most preferably administrable to the anal surgical site.
본 발명은 메살라민(mesalamine)을 주성분으로 하고, 니트로 푸라존(nitrofurazone), 글리세린(Glycerin), 겐타마이신(gentamicin), 염산부피바카인을 유효성분으로 하는 항문 관련 수술부위 염증예방 및 치료용 약학적 조성물을 제공하고자 하는 것을 특징으로 한다. The present invention is a pharmaceutical composition for the prevention and treatment of inflammation related to the anal area of surgery related to mesalamin (mesalamine), nitrofurazone (nitrofurazone), glycerin (Glycerin), gentamicin, gentamicin, hydrophyllic acid pyrocaine as an active ingredient It is characterized by providing a suitable composition.
또한 본 발명은 항문 관련수술부위에 상기한 조성물을 연고형태로 투여하는 것을 항문관련 수술부위의 치료방법으로 제공하는 것을 특징으로 한다. In another aspect, the present invention is characterized by providing the above-mentioned composition to the anal surgical site in the ointment form as a method of treatment of the anal surgical site.
본 발명은 항문의 수술상처가 궤양성 대장염의 상처와 유사한 환경임을 착안하고 궤양성 대장염의 주치료제로 사용되어온 기존 물질의 특성을 고려하여 약학적 조성물을 구성하여 연고제제와 같은 형태로 제공하여 임상실험을 일부 진행한 결과 수술 후 상처의 합병증은 1/5이하로 줄어들고, 항문 상처 치유기간도 1/2이하로 줄어들었다.The present invention considers that the surgical wound of the anus is an environment similar to the wound of ulcerative colitis, and in consideration of the properties of the existing substances that have been used as the main treatment of ulcerative colitis, the pharmaceutical composition is composed and provided in the form of an ointment to provide clinical After some experiments, the postoperative wound complications were reduced to less than 1/5 and anal wound healing time was reduced to less than 1/2.
따라서 이와 같은 본 발명 연고 제제를 시험 사용한 결과 항문 수술 후 상처 합병증을 줄임으로써 환자들의 고통을 획기적으로 경감시키고 조기에 회복할 수 있게 해주게 됨에 따라서 일상생활에의 복귀도 현저히 빨라졌을 뿐만 아니라 상처의 합병증으로 인한 2차수술의 빈도도 기존의 1/5이하로 줄일 수 있게 된다. Therefore, as a result of using the ointment preparation of the present invention, it is possible to drastically reduce the pain and early recovery of the patients by reducing wound complications after anal surgery, and thus, the return to daily life is not only faster, but also the complications of the wounds. As a result, the frequency of secondary surgery can be reduced to less than one fifth.
본 발명은 궤양성 대장염 치료제인 메살라민(mesalamine)을 주성분으로 하고, 니트로 푸라존(nitrofurazone), 글리세린(Glycerin), 겐타마이신(gentamicin), 염산부피바카인을 유효성분으로 하는 약학적 조성물을 제공하며, 이의 조성물을 연고 또는 크림 제제의 형태로 제공하여 항문관련 수술부위에 투여하여 항문 관련 수술부위 치료 및 염증예방을 제공한다. The present invention provides a pharmaceutical composition comprising mesalamin (mesalamine), a treatment for ulcerative colitis, as an active ingredient, nitrofurazone, glycerin, gentamicin, and bupivacaine hydrochloride. In addition, the composition is provided in the form of an ointment or cream formulation to be administered to the anal-related surgical site to provide treatment for the anal-related surgical site and to prevent inflammation.
본 발명 조성물 제조함량 비율은 메살라민 32.6중량%, 니트로푸라존 1.7중량%, 겐타마이신 0.5중량%, 염산부피바카인 0.1중량%, 글리세린 65.1중량% 으로 이루어진다. The composition ratio of the present invention comprises 32.6% by weight of mesalamin, 1.7% by weight of nitrofurazone, 0.5% by weight of gentamicin, 0.1% by weight of bubivacaine hydrochloride, and 65.1% by weight of glycerin.
상기한 약학적 조성물은 항문관련 수술부위에 효과적으로 투여될 수 있도록 연고 또는 크림 제제 형태로 이루어진다.The pharmaceutical composition is in the form of ointment or cream formulation so that it can be effectively administered to the surgical site.
상기한 약학적 조성물은 외용 분말 제제 형태로 이루어질 수 있다.The pharmaceutical composition may be in the form of an external powder formulation.
본 명세서에서 "예방 또는 치료"라는 용어는 증상의, 개선, 악화방지, 회복 유지, 재발방지를 포함하고, 외과 수술 후의 재발방지 및 수술 부위의 협착 방지를 더욱 포함한다. As used herein, the term "prophylaxis or treatment" includes symptomatic, amelioration, prevention of exacerbation, maintenance of recovery, prevention of recurrence, further including prevention of recurrence after surgical surgery and prevention of stenosis of the surgical site.
이와 같은 본 발명 약학적 조성물에 있어서, 각 성분은 다음과 같은 특징을 갖는다. In such a pharmaceutical composition of the present invention, each component has the following characteristics.
메살라민은 경증 및 중등증의 궤양성 대장염, 원위 직장S상 결장염의 급성발작 치료 및 재발예방에 효과가 있는 성분으로 현재까지는 궤양성 대장염과 크론씨 질환 등 염증성 대장질환에 국한되어 사용되어 온 제재이다. Mesalamin is effective in treating acute seizures and preventing recurrence of mild and moderate ulcerative colitis, distal rectal S colitis, and has been used exclusively for inflammatory colon diseases such as ulcerative colitis and Crohn's disease. .
상기 니트로 푸라존의 분자식은 C6H6N4O4이다. 정식명칭은 5-니트로-2-푸르알데히드 세미카르바존이며 푸라신이라고도 한다. 국소 살균소독제로 사용되는데, 각종 그람음성 및 양성균에 유효하다. The molecular formula of the nitro furazone is C6H6N4O4. The official name is 5-nitro-2-furaldehyde semicarbazone, also called furasin. It is used as a topical disinfectant and is effective for various Gram-negative and positive bacteria.
이와 같은 니트로 푸라존은 화상 또는 외상에 의한 2차 세균감염을 방지하며, 어떠한 균에도 광범위한 살균효과를 나타내면서도 국소용으로 외용할 때 인체 세포에는 하등의 손상을 주지 않는 광범위한 살균작용과 안정성이 있다.Such nitrofurazone prevents secondary bacterial infections caused by burns or trauma, and has a wide range of bactericidal effects against any bacteria, but has a wide range of bactericidal actions and stability that does not cause any damage to human cells when used for topical use. .
또한 니트로 푸라존은 이상적인 기제로 되어있어 약효가 빠르며, 수용성 기제로서 제제화하기 때문에 약물의 확산과 물질의 휴수가 빨라 약효를 배가시켜 주며 특히 이윤성 환부에 최적으로 알려져 있으며, 단일제로 되어있기 때문에 다른 약제와 조제하여 질환에 따라 다목적으로 응용하여 치료효과를 기대할 수 있다. In addition, Nitrofurazone is an ideal base for fast medicinal effects, and is formulated as a water-soluble base for rapid diffusion of the drug and suspension of substance, which doubles the medicinal effect. In particular, it is best known for profitable affected areas. Can be expected to have a therapeutic effect by multipurpose application according to the disease.
겐타마이신은 아미노글리코사이드계 항생제로서, 오랫동안 우수한 항생제로 널리 사용되고 있다. 아미노글리코사이드계의 항생물질로, 겐타마이신 C1, C2, C1a의 혼합물이다. 그람양성균 중 포도상구균과 그람음성균 중 대장균ㅇ살모넬라균 및 변형균ㅇ녹농균 등에 효과가 있다.Gentamicin is an aminoglycoside antibiotic and has been widely used as an excellent antibiotic for a long time. An aminoglycoside antibiotic, a mixture of gentamicin C1, C2, C1a. It is effective for Staphylococcus aureus among Gram-positive bacteria and Escherichia coli Salmonella and modified bacteria Pseudomonas aeruginosa among Gram-negative bacteria.
겐타마이신은 페니실린이나 앰피실린(ampicillin)과 함께 장내구균성 심내막염의 치료에도 사용된다. 비경구적인 방법으로 투여하거나 외용제로 많이 사용된다.Gentamicin is also used in the treatment of enterococcal endocarditis with penicillin or ampicillin. It can be administered by parenteral method or used as external preparation.
이와 같이 겐타마이신은 광범위한 항균효과가 있으므로 미확인된 병원균에 의한 감염증, 복합세균 감염증 및 중증 세균 감염증 등에 우선적으로 선택되는 항생제중 하나 이다. As such, gentamicin has a wide range of antimicrobial effects and is therefore one of antibiotics that is preferentially selected from infections caused by unidentified pathogens, combined bacterial infections and severe bacterial infections.
염산부피바카인 일수화물은 전달마취, 경막외마취, 전달마취, 경막외마취, 선골마취에 사용되며, 연령,마취영역, 부위, 조직, 증상, 체질, 전신상태에 따라 적절히 증감하여 사용한다.Bupivacaine hydrochloride monohydrate is used for delivery anesthesia, epidural anesthesia, delivery anesthesia, epidural anesthesia and iliac anesthesia, and is appropriately used according to age, anesthetic area, site, tissue, symptom, constitution and general condition.
글리세린은 무색의 맑은 끈기있는 액으로 냄새는 없고 맛은 달다.Glycerin is a colorless clear sticky liquid with no smell and sweet taste.
방부작용이 있으며, 희박용액의 자극을 완화하며 국소를 연화한다. It is antiseptic, relieves stimulation of lean solution and softens topical.
또한 관장약, 국소를 포섭보호하고 외부자극을 완화하고 유해물질의 침입을 방지할 목적으로 외용한다.It is also used externally for the purpose of enclosing and protecting enema, topical, relieving external stimulus and preventing invasion of harmful substances.
상기한 약제의 배합과정은 다음과 같다.The formulation process of the above-mentioned drugs is as follows.
겐타마이신과 염산부피바카인을 혼합하는 제 1과정과,The first process of mixing gentamicin with bubivacaine hydrochloride,
상기 제 1과정을 통해 혼합된 혼합제에 글리세린을 첨가하여 혼합하는 제 2과정과,A second step of adding and mixing glycerin to the mixture mixed through the first step,
제 2과정을 통해 혼합된 혼합제에 메살라민을 첨가하여 혼합하는 제 3과정과, A third process of adding and mixing mesalamin to the mixture mixed through the second process,
제 3과정을 통해 혼합된 혼합제에 니트로 푸라존을 혼합하는 제 4과정을 통해 조성물을 제조한다.The composition is prepared by a fourth process of mixing nitro furazone to the mixed mixture through the third process.
상기와 같은 제조방법에 따라 항문 관련수술부위 염증예방 및 치료 제약 조성물을 구성한다. According to the manufacturing method as described above, the inflammation-related surgical site inflammation prevention and treatment pharmaceutical composition.
상기 제 2과정은 농도차이로 인한 분류 현상을 최소화하여 원활한 혼합작용을 유도하여 글리세린과 제 1과정에서의 겐타마이신과 연산부피바카인의 혼합제를 혼합한다. In the second process, the classification phenomenon due to the concentration difference is minimized to induce a smooth mixing action to mix the glycerine and the mixture of gentamicin and ophthalmic volvacaine in the first process.
상기 제 3과정은 형태가 다른 혼합물을 혼합하는 과정으로, 형태가 다른 혼합물을 골고루 혼합하여 원활한 혼합작용을 유도한다. The third process is a process of mixing mixtures of different shapes, and evenly mixing mixtures of different shapes to induce smooth mixing.
제 4과정은 부드러운 피부점착력을 좋게 하기 위하여 니트로푸라존을 혼합하는 과정이다.The fourth process is a process of mixing nitrofurazone to improve the soft skin adhesion.
여기서 메살라민이 함유된 약제로부터 메살라민을 추출하는 과정을 더 포함할 수 있다.Here, the method may further include extracting mesalamine from the drug containing mesalamine.
메살라민 원제 대신에 메살라민이 포함된 약제로부터 메살라민을 추출하여 사용할 수 있는 데, 이와 같은 경우 중탕과정을 통해 메살라민을 추출하여 사용할 수 있다.Mesalamin may be extracted from the drug containing mesalamin instead of the original mesalamin. In this case, the mesalamin may be extracted through a water bath.
이와 같은 본 발명의 조성물을 연고제제 형태로 항문 외과 수술후 수술부위에 투여함으로써, 상기한 바와 같은 조성물 성분에 따라 수술부위를 외부 균으로 부터의 보호, 수술부위의 통증경감, 빠른 상처치유가 가능하게 한다.By administering the composition of the present invention to the surgical site after anal surgery in the form of an ointment, according to the composition of the composition as described above to protect the surgical site from external bacteria, pain relief of the surgical site, it is possible to quickly heal wounds do.
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