JP2024024535A - Chinese medicine eye drop and method for producing the same - Google Patents
Chinese medicine eye drop and method for producing the same Download PDFInfo
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Abstract
Description
本発明は漢方薬製剤の技術分野に関し、特に漢方薬点眼薬及びその製造方法に関する。 TECHNICAL FIELD The present invention relates to the technical field of Chinese herbal medicine formulations, and particularly to Chinese herbal medicine eye drops and a method for producing the same.
目は人間の最も重要な器官の一つであり、人々が社会生活に適応するための保障を提供している。ひとたび光を失うと、生活は暗闇に陥り、人生も多くの楽しみを失う。全世界の視覚障害者の９０％が後天的に失明している。原因は、各種の慢性眼病をきちんと治療していないからである。 Eyes are one of the most important organs of humans, providing security for people to adapt to social life. Once the light is lost, life falls into darkness and life loses much of its joy. 90% of visually impaired people worldwide have acquired blindness. The cause is that various chronic eye diseases are not properly treated.
生活リズムの加速に伴い、携帯電話、パソコンなどの電子製品の使用率が増加し、目の不調、目の疲労や目の乾燥などの眼病の発病率がますます高くなっている。点眼薬は眼科疾患に最もよく使われる薬物剤形の一つであり、多くの眼疾患に対して、点眼薬はすべて直接、迅速な治療作用がある。伝統的な漢方薬は湯剤を始め、丸剤、散剤、膏剤、丹剤を使用し、数千年以来、人の病気を予防、治療してきた。 With the acceleration of life rhythms, the use of electronic products such as mobile phones and computers is increasing, and the incidence of eye diseases such as eye disorders, eye fatigue, and dry eyes is increasing. Eye drops are one of the most commonly used drug dosage forms for eye diseases, and all eye drops have direct and rapid therapeutic action for many eye diseases. Traditional Chinese medicine has been used to prevent and treat human diseases for thousands of years using hot water solutions, pills, powders, ointments, and balm.
発明の実施過程において、発明者は、関連技術において、眼疾患を治療する点眼外用薬の多くが西洋薬の成分であることを発見し、一方、西洋薬の点眼薬は目への刺激が大きく、眼病を治療すると同時に、大きな副作用をもたらすことがある。市販の漢方薬点眼薬はまた健康維持用の点眼薬が多く、目の疲労によるさまざまな症状を緩和することができるが、治療効果を備えているわけではない。 In the process of implementing the invention, the inventor discovered that in the related art, many of the topical eye drops to treat eye diseases are ingredients of Western medicine, while Western medicine eye drops are highly irritating to the eyes. , while treating eye diseases, can have major side effects. Many of the herbal medicine eye drops available on the market are for maintaining health, and although they can alleviate various symptoms caused by eye fatigue, they do not have any therapeutic effects.
上記の技術的課題を解決するために、本発明の実施例は以下の技術案を提供する。
第１態様によれば、本発明の実施例は、漢方薬成分と補助材料とで製造され、重量百分率基準で、前記漢方薬成分は、
コウライニンジン５～１０ｗｔ％、ゲンジン１５～２０ｗｔ％、ソウジシ５～１０ｗｔ％、ゴオウ５～１０ｗｔ％、コウカ５～１０ｗｔ％、ボルネオール５～１０ｗｔ％、タイキンギク２５～３５ｗｔ％、オウトウ５～１５ｗｔ％、及びジュウイシ５～１０ｗｔ％を含む、漢方薬点眼薬を提供する。
In order to solve the above technical problems, the embodiments of the present invention provide the following technical solutions.
According to the first aspect, the embodiment of the present invention is made of Chinese herbal medicine ingredients and auxiliary materials, and on a weight percentage basis, the Chinese medicine ingredients are:
5 to 10 wt% of ginseng, 15 to 20 wt% of Japanese ginseng, 5 to 10 wt% of Japanese sour 5 to 10 wt%, 5 to 10 wt% of Japanese ginseng, 5 to 10 wt% of ginseng, 5 to 10 wt% of borneol, 25 to 35 wt% of Japanese chrysanthemum, 5 to 15 wt% of Japanese ginseng, and To provide Chinese herbal medicine eye drops containing 5 to 10 wt% of Juishi.
好ましくは、重量百分率基準で、前記漢方薬成分は、
前記コウライニンジン７．５ｗｔ％、前記ゲンジン１５ｗｔ％、前記ソウジシ７．５ｗｔ％、前記ゴオウ７．５ｗｔ％、前記コウカ７．５ｗｔ％、前記天然ボルネオール７．５ｗｔ％、前記タイキンギク３０ｗｔ％、前記オウトウ１０ｗｔ％、及び前記ジュウイシ７．５ｗｔ％を含む。
Preferably, on a weight percentage basis, the herbal medicine ingredients are:
7.5 wt% of the ginseng, 15 wt% of the chinese ginseng, 7.5 wt% of the ginseng, 7.5 wt% of the chinensis, 7.5 wt% of the ginseng, 7.5 wt% of the natural borneol, 30 wt% of the chinese chrysanthemum, 10 wt% of the chinensis. %, and 7.5 wt% of the above-mentioned Juishi.
好ましくは、前記補助材料は精製水、塩化ナトリウム注射液、及びｐＨ調整剤を含む。 Preferably, the auxiliary materials include purified water, sodium chloride injection, and a pH adjusting agent.
好ましくは、前記補助材料は防腐剤をさらに含む。 Preferably, the auxiliary material further includes a preservative.
好ましくは、前記ｐＨ調整剤はホウ酸を含み、前記防腐剤はエチルパラベンを含み、且つ／又は
前記ｐＨ調整剤と前記防腐剤との質量比が１：１である。
Preferably, the pH adjuster includes boric acid, the preservative includes ethylparaben, and/or the mass ratio of the pH adjuster to the preservative is 1:1.
好ましくは、前記漢方薬点眼薬のｐＨ値が５～９である。 Preferably, the pH value of the herbal medicine eye drops is 5-9.
第２態様によれば、本発明の実施例はまた、
漢方薬成分全量に対してコウライニンジン５～１０ｗｔ％、ゲンジン１５～２０ｗｔ％、ソウジシ５～１０ｗｔ％、コウカ５～１０ｗｔ％、タイキンギク２５～３５ｗｔ％、オウトウ５～１５ｗｔ％、及びジュウイシ５～１０ｗｔ％を精製水に加えて煎じた後、ろ過して、第１抽出液を得るステップと、
塩化ナトリウム注射液を精製水に加え、加熱して沸騰させ、７０～９０℃に冷却した後、前記第１抽出液を加え、５０～７０℃に降温して、第１混合液を得るステップと、
前記漢方薬成分全量に対してゴオウ５～１０ｗｔ％と天然ボルネオール５～１０ｗｔ％をエタノールで加熱して還流し、ろ過して第２抽出液を得るステップと、
前記第２抽出液を前記第１混合液に滴下した後、防腐剤及び精製水を加え、漢方薬点眼薬半製品を製造するステップと、を含む、漢方薬点眼薬の製造方法を提供する。
According to a second aspect, embodiments of the invention also include:
Based on the total amount of Chinese herbal medicine ingredients, 5 to 10 wt% of ginseng, 15 to 20 wt% of ginseng, 5 to 10 wt% of sorcery, 5 to 10 wt% of red chinensis, 25 to 35 wt% of golden daisy, 5 to 15 wt% of chinensis, and 5 to 10 wt% of chinensis. Adding it to purified water, decocting it, and filtering it to obtain a first extract;
Adding sodium chloride injection solution to purified water, heating to boil, cooling to 70 to 90°C, adding the first extract, and cooling to 50 to 70°C to obtain a first mixed liquid. ,
Heating 5 to 10 wt% of Goukou and 5 to 10 wt% of natural borneol with ethanol to reflux and filtering to obtain a second extract, based on the total amount of the herbal medicine ingredients;
Provided is a method for producing a Chinese herbal eye drop, comprising the steps of dropping the second extract into the first mixed liquid, and then adding a preservative and purified water to produce a semi-finished Chinese herbal eye drop.
好ましくは、前記第２抽出液を前記第１混合液に滴下した後、防腐剤及び精製水を加え、漢方薬点眼薬半製品を製造する前記ステップの後、前記方法は、
前記漢方薬点眼薬のｐＨ値を測定するステップと、
測定した結果前記漢方薬点眼薬のｐＨ値が所定のｐＨ値範囲内ではない場合、ｐＨ調整剤で前記漢方薬点眼薬のｐＨ値を調整するステップと、をさらに含む。
Preferably, after the step of adding a preservative and purified water after dropping the second extract to the first mixed solution to produce a semi-finished product of Chinese herbal medicine eye drops, the method includes:
Measuring the pH value of the herbal medicine eye drops;
The method further includes the step of adjusting the pH value of the herbal medicine eye drops with a pH adjuster if the pH value of the herbal medicine eye drops is not within a predetermined pH value range as a result of the measurement.
好ましくは、前記ｐＨ調整剤はホウ酸を含み、前記防腐剤はエチルパラベンを含む。 Preferably, the pH adjusting agent includes boric acid and the preservative includes ethylparaben.
好ましくは、前記第１抽出液の製造において、前記コウライニンジン、前記ゲンジン、前記ソウジシ、前記コウカ、前記タイキンギク、前記オウトウ及び前記ジュウイシの全質量と精製水の質量との比が１：２０である。 Preferably, in the production of the first extract, the ratio of the total mass of the ginseng, the genus chinensis, the chinese ginseng, the kooka, the golden daisy, the chinese daisy, and the chinensis to the mass of the purified water is 1:20. .
本発明の実施形態の有益な効果は以下のとおりである。従来技術と異なり、本発明の実施例は、漢方薬点眼薬及び漢方薬点眼薬の製造方法を提供し、漢方薬点眼薬は漢方薬成分と補助材料とで製造され、重量百分率基準で、漢方薬成分はコウライニンジン５～１０ｗｔ％、ゲンジン１５～２０ｗｔ％、ソウジシ５～１０ｗｔ％、ゴオウ５～１０ｗｔ％、コウカ５～１０ｗｔ％、ボルネオール５～１０ｗｔ％、タイキンギク２５～３５ｗｔ％、オウトウ５～１５ｗｔ％、及びジュウイシ５～１０ｗｔ％を含む。本発明の実施例による漢方薬点眼薬は、上記の漢方薬成分を配合することで、白内障を治療して視力を高め、体内の熱毒を取り除いて毒素を除去し、血や経絡の気の流れを良くし、鬱血を除去して痛めを鎮めることができ、風火赤眼（急性結膜炎、病症として、目が赤くなり、灼熱感、腫れや痛みがあり、暑さや光に弱く、風が当たると涙が出て、かゆみと乾燥が感じる）、円翳内障（白内障、発症初期に瞳孔が白く濁って、視界がぼんやりし、視界内に小さな薄い影のようなものが現れ、深刻な場合は失明する）や緑風内障（緑内障、病症として物がぼやけて、目の膨満感を伴う痛みや頭痛、吐き気と嘔吐が認められる）、糖尿病性網膜症（糖尿病性眼底黄斑変性症、病症として物が歪んで見え、まっすぐのものが曲がるように見え、視界がかすんで見え、ぼやけて見え、視力が低下する。）、及び能近怯遠（近視眼、例えば青年期の軽度の近視、病症として近くのものが見えて、遠くが見えにくい）のいずれにも良好な効果がある。 Beneficial effects of embodiments of the present invention are as follows. Unlike the prior art, the embodiments of the present invention provide Chinese herbal eye drops and a method for producing Chinese herbal eye drops, where the Chinese herbal eye drops are prepared with Chinese herbal ingredients and auxiliary materials, and on a weight percentage basis, the Chinese herbal ingredients are ginseng. 5 to 10 wt%, Genjin 15 to 20 wt%, Soujishi 5 to 10 wt%, Gooh 5 to 10 wt%, Kouka 5 to 10 wt%, Borneol 5 to 10 wt%, King Chrysanthemum 25 to 35 wt%, Oriental chinensis 5 to 15 wt%, and Juishi 5 Contains ~10wt%. The Chinese herbal medicine eye drops according to the embodiments of the present invention are formulated with the above Chinese medicine ingredients to treat cataracts, improve eyesight, remove heat toxins from the body, remove toxins, and improve the flow of blood and meridians. It improves the health, removes congestion, and soothes pain. It can improve wind and fire red eyes (acute conjunctivitis, a disease in which the eyes become red, burning, swollen and painful, and are sensitive to heat and light, and when exposed to wind. In severe cases, the pupils become cloudy and blurry vision, and something like a small thin shadow appears in the field of vision. blindness), glaucoma (glaucoma, a disease in which things become blurry, pain and headache accompanied by a feeling of swelling in the eyes, nausea and vomiting), diabetic retinopathy (diabetic macular degeneration, a disease in which objects become blurry and a disease in which the eyes become blurry, causing pain and headaches, nausea and vomiting), diabetic retinopathy (diabetic macular degeneration, Things appear distorted, straight objects appear to be curved, vision appears blurry, blurry vision, and visual acuity deteriorates. It has a positive effect on both the ability to see things and the difficulty in seeing far away.
本発明の実施例の技術案をより明確に説明するために、以下、本発明の実施例に必要な図面を簡単に説明する。明らかに、以下で説明される図面は本発明のいくつかの実施例に過ぎず、当業者にとって、創造的な努力を必要とせずに、これらの図面に基づいて他の図面を取得することができる。
本発明の目的、技術案及び利点をより明瞭にするために、以下、図面及び実施例を参照して、本発明をさらに詳細に説明する。なお、ここで説明する具体的な実施例は本発明を解釈するために過ぎず、本発明を限定するものではない。 In order to make the objects, technical solutions and advantages of the present invention more clear, the present invention will be described in more detail below with reference to the drawings and embodiments. Note that the specific examples described here are only for interpreting the present invention, and do not limit the present invention.
なお、矛盾しない限り、本発明の実施例における各特徴は相互に組み合わせられてもよく、この組み合わせは全て本発明の特許範囲である。また、装置概略図において機能性モジュールが区分されており、流れ図においてロジックの順番が示されているが、場合によっては、装置概略図におけるモジュールの区分、又は流れ図における順番と異なるものをもって示される又は記載されるステップが実施されてもよい。 It should be noted that, unless inconsistent, the features in the embodiments of the present invention may be combined with each other, and all such combinations are within the patent scope of the present invention. In addition, although the functional modules are divided in the device schematic diagram and the order of logic is shown in the flowchart, in some cases, the module divisions in the device schematic diagram or the order of logic are shown in a different order than in the flowchart. The steps described may be performed.
特に断らない限り、本明細書に使用されている全ての技術的用語及び科学的用語は当業者が通常理解するものと同義である。本明細書では、本発明の明細書に使用される用語は具体的な実施形態を説明することにのみ使用され、本発明を限定するものではない。本明細書に使用される用語「及び／又は」は１つ又は複数の関連する記載の項目のいずれか又は全ての組み合わせを含む。 Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art. The terms used herein are used only to describe specific embodiments and are not intended to limit the invention. As used herein, the term "and/or" includes any or all combinations of one or more of the associated listed items.
本発明の実施例は点眼薬を提供し、該点眼薬は漢方薬成分と補助材料とで製造され、重量百分率基準で、漢方薬成分は、コウライニンジン５～１０ｗｔ％、ゲンジン１５～２０ｗｔ％、ソウジシ５～１０ｗｔ％、ゴオウ５～１０ｗｔ％、コウカ５～１０ｗｔ％、ボルネオール５～１０ｗｔ％、タイキンギク２５～３５ｗｔ％、オウトウ５～１５ｗｔ％、及びジュウイシ５～１０ｗｔ％を含む。 Embodiments of the present invention provide eye drops, the eye drops are prepared with Chinese herbal medicine ingredients and auxiliary materials, and on a weight percentage basis, the Chinese medicine ingredients are 5-10 wt% of Panax ginseng, 15-20 wt% of Panax ginseng, 5 wt% ~10 wt%, 5 to 10 wt% of Japanese chinensis, 5 to 10 wt% of kooka, 5 to 10 wt% of borneol, 25 to 35 wt% of chinese chrysanthemum, 5 to 15 wt% of chinensis, and 5 to 10 wt% of chinensis.
漢方薬点眼薬に好ましい眼疾治療効果を持たせるために、いくつかの実施例では、重量百分率基準で、漢方薬成分は、具体的には、前記コウライニンジン７．５ｗｔ％、前記ゲンジン１５ｗｔ％、前記ソウジシ７．５ｗｔ％、前記ゴオウ７．５ｗｔ％、前記コウカ７．５ｗｔ％、前記天然ボルネオール７．５ｗｔ％、前記タイキンギク３０ｗｔ％、前記オウトウ１０ｗｔ％、及び前記ジュウイシ７．５ｗｔ％を含む。 In order to make the Chinese herbal medicine eye drops have a favorable eye disease treatment effect, in some embodiments, on a weight percentage basis, the Chinese herbal medicine ingredients are specifically 7.5 wt% of the said Panax ginseng, 15 wt% of the said Genjin, and the 7.5 wt% of the same, 7.5 wt% of the said Japanese carp, 7.5 wt% of the natural borneol, 30 wt% of the natural borneol, 30 wt% of the common chrysanthemum, 10 wt% of the same 10 wt%, and 7.5 wt% of the same.
いくつかの実施例では、補助材料は精製水、塩化ナトリウム注射液、及びｐＨ調整剤を含む。補助材料は防腐剤をさらに含んでもよく、ここで、ｐＨ調整剤と前記防腐剤との質量比が１：１である。ｐＨ調整剤はホウ酸を含み、防腐剤はエチルパラベンを含む。ｐＨ調整剤は漢方薬点眼薬のｐＨ値を５～９に調整するものである。 In some examples, supplementary materials include purified water, sodium chloride injection, and pH adjusting agents. The auxiliary material may further include a preservative, where the weight ratio of the pH adjusting agent to the preservative is 1:1. The pH adjuster includes boric acid and the preservative includes ethylparaben. The pH adjuster is used to adjust the pH value of Chinese herbal eye drops to 5-9.
中国伝統医学によれば、風が軽く浮き上がり、熱も上方に行き、風熱の邪気が目まで至ると、眼部に蓄積し、目が掻痒したり、ぐりぐりしていたり、痛んだりし、目が赤くなり、灼熱感、腫れや痛みがあり、熱や明らかなもの（光）に弱く、また、眼瞼が赤く腫れ、白目が浮腫し、熱により血の動きが促進されて、脈外部まで至ると、白目には点状又はフレーク状の出血が見られ、体に至ると熱が出て頭が痛み、口腔が乾燥しており、口の中が苦く、尿が黄色く、糞便が乾燥し、舌が赤く舌苔が黄色く見え、弦脈や数脈が認められ、以上は全て風熱邪毒に起因する症状である。治療手段としては、体内の熱毒を取り除いて毒素を除去し、風や痒みを取り除き、目赤を解消して視力を高める。 According to traditional Chinese medicine, when the wind lifts up, the heat also moves upwards, and when the evil energy of the wind reaches the eyes, it accumulates in the eye area, causing the eyes to become itchy, stinging, and painful. The eyelids become red, have a burning sensation, swelling and pain, are sensitive to heat and obvious things (light), and the eyelids become red and swollen, the whites of the eyes become edematous, and heat accelerates blood movement, reaching outside the vein. Then, dots or flakes of bleeding are seen in the whites of the eyes, and when it reaches the body, there is a fever, a headache, dry mouth, bitterness in the mouth, yellow urine, and dry feces. The tongue is red, the tongue coating appears yellow, and chordal or multipulse pulses are observed; all of the above are symptoms caused by cold fever. As a therapeutic measure, it removes heat toxins from the body, eliminates wind and itching, eliminates redness of the eyes and improves vision.
『目経大成』によれば、「特に病気がないが目が見えなくなり、瞳孔では、翳障が体液に覆われるものは、内障と呼ばれる。」が記載されている。『秘伝眼科龍木論・七十二証方論』においては、「円翳内障では、疾患に罹患する初期において視界内に小さな薄い影のようなものが現れる場合が多い。視界には薄い煙や霧があるような気がしており、次第に進行していき、痛いや痒みがないが、経時的に失明に至る。」が記載され、また、「氷翳は水のようなものであり、硬さを有し、陰陽の調子が不調になる傾向にあり、側面から瞳孔を観察すると、表面に透明性のある白色のものが認められる。」も記載されており、これらの記載から分かるように、円翳内障という疾患では、最初に瞳孔が白く濁って、自覚的に視界がぼんやりし、深刻な場合は失明してしまう。 According to the Mekyo Taisei, ``Those who have no particular disease but become blind and the pupil is covered with fluid are called internal disorders.'' In "Secret Ophthalmology Ryukiron/Seventy-Nine Evidence Methodology", it is stated that ``In the early stages of the disease, something like a small thin shadow often appears in the visual field. It feels like there is smoke or fog, and it gradually progresses. There is no pain or itching, but over time it leads to blindness." "The pupil is hard, has a tendency to have an imbalance in yin and yang, and when the pupil is observed from the side, a transparent white substance is observed on the surface." As you can see, in the disease called erectile dysfunction, the pupils first become cloudy and the patient's vision becomes blurred, leading to blindness in severe cases.
『秘伝眼科龍木論・巻之二』において、「緑風内障では、罹患初期には、つむじやこめかみに偏痛があり、眼瞼骨及び鼻の頬骨に痛みがあり、目の中が痛んだりぐりぐりしたりし、物がぼやけて見える。又は、吐き気、嘔吐や吐逆により、最初に１つの目がこの疾患に罹患する。」が記載されており、この記載から分かるように、緑風内障病症として物がぼやけて、頭や目の痛み、吐き気と嘔吐が見られ、多くの場合には、最初には１つの目が疾患に罹患している。 In ``Hiden Ophthalmology Ryukiron Vol. 2,'' ``In the early stages of glaucoma, there is migraine pain in the whorls and temples, pain in the eyelids and cheekbones of the nose, and pain inside the eyes. "One eye is affected by the disease first due to nausea, vomiting, or vomiting." As can be seen from this description, glaucoma Symptoms include blurred vision, pain in the head and eyes, nausea and vomiting, and in many cases one eye is affected initially.
消渇病の機序は主に陰津不足、燥熱過剰になり、陰虚が病因、燥熱が病症となり、両方には因果関係があり、陰虚が酷いほど燥熱が蓄積しておき、燥熱が蓄積するほど陰虚が進み、消渇が長くなると燥熱により目中の血絡が損傷を受け、その結果として目内の血が経絡から流れてしまう。陰損傷、燥熱、鬱血とは糖尿病性網膜症の主な機序であり、また、気虚の場合も考えられる。 The mechanism of thirst disease is mainly a lack of yin and an excess of dry heat, yin deficiency is the cause, and dry heat is the disease. There is a causal relationship between the two, and the more yin deficiency is, the more dry heat accumulates, and the more dry heat accumulates. The more Yin deficiency progresses, and the longer the quenching period, the more the blood vessels in the eyes are damaged by the dry heat, and as a result, the blood in the eyes flows out of the meridians. Yin damage, dry heat, and congestion are the main mechanisms of diabetic retinopathy, and cases of qi deficiency are also considered.
能近怯遠（近視眼）は、多くの場合、青少年が勉強や仕事をするときに目を不適切に使用し、目が過度に苦労したり、先天的な不備があったり、先天性遺伝病があったりすることによる。その機序としては、主に心陽が弱まり、目が満足に機能することができず、遠くのものが見えにくくなり、或いは、肝臓と腎臓の調子が悪く、精血が不足し、目の働きを損ない、遠くのものが見えにくくなる。本処方では、先天的な不備があって肝臓と腎臓の調子が悪く、精血が不足し、栄養素などが目に行き渡らず、また、青少年が小さいから長期間にわたって電子デバイスを使用し、目が過労になり、目中の気や血が多く消費され、気や血が双目に必要な栄養を提供できない。 Nearsightedness (myopia) is often caused by adolescents using their eyes inappropriately when studying or working, causing excessive eye strain, a congenital defect, or a congenital genetic disease. It depends on what happens. The main mechanisms are that the heart and yang are weakened, the eyes cannot function satisfactorily, and it becomes difficult to see things far away, or the liver and kidneys are not in good condition, resulting in a lack of seminal blood, which causes the eyes to become weak. It impairs function and makes it difficult to see things far away. With this prescription, young people have congenital defects that cause their livers and kidneys to be in poor condition, resulting in a lack of seminal blood and nutrients not being delivered to the eyes. Due to overwork, a lot of the qi and blood in the eyes are consumed, and the qi and blood cannot provide the necessary nutrients to the two eyes.
処方においては、タイキンギク、天然ボルネオール（Ｄ－ボルネオール）、ゲンジンは君薬として使用され、これらのうち、タイキンギク（別名：キュウジュウコウ又はキュウリコウ）は、味わいが苦く、寒性のものであり、体内の熱毒を取り除いて毒素を除去し、血中の熱邪をなくして腫れを解消し、肝を丈夫にして視力を高める効果があり、風火赤眼、目翳によく使用されており、従来からよく使われている視力向上用の漢方薬であり、『百草鏡』に記載のとおり、「視界がぼやけて、赤目や白内障があり、風が与えると涙が出る」という疾患に効く。ゲンジンは、体内の熱毒を取り除いて血中の熱邪をなくして、陰を強くして火邪を下げて体外に排出し、目がぐりぐりしてはっきりと見えないのに有効であり、『神農本草経』には、「腎臓の気を強めて、視力を高める」が記載されており、『医学衷中参西録』において、さらに、「『本経』によれば、ゲンジンは能視力を高め、肝の働きを向上させることで目の機能をよくし、ゲンジンは体内の水分を増やして肝や目に栄養素などを与え、これにより視力を高め、また、目が見えるのは、瞳孔に液体が十分であり、液体が腎臓のエッセンスを反映するものである」とのように解釈されており、天然ボルネオール（Ｄ－ボルネオール）は、辛くて強い香りがしており、人体の腔の通りをよくして熱を放散し、体におけるさまざまな腔の通りをよくして、蓄積した火を取り除き、目翳をなくして視力を高め、腫れを解消して痛みを鎮める。『本草経疎』によれば、「目が赤くて肌色が悪いことは、火熱が過剰になるものであり、ボルネオールは辛くて性質が温和であり、主に放散機能を果たし、火熱が含まれた気を体外へ導き、これにより、目が正常に働き、赤目や目の痛み、肌色が改善される」ことが分かり、また、内眼疾患、外眼疾患によく効き、『海薬本草』においては、「主に内眼疾患、外眼疾患に効き、視力を高める」ことが記載されており、上記の３種類の生薬を併用することにより、体内の熱毒を取り除いて血内の熱邪を除去し、陰を増やして視力を高める効果が向上する。 In prescriptions, D-borneol, natural borneol (D-borneol), and genjin are used as medicines, and among these, D-borneol (also known as D-borneol) is bitter in taste and cold. It has the effect of removing heat toxins and toxins from the body, eliminating fever and swelling in the blood, strengthening the liver and improving eyesight, and is often used to treat wind, fire, red eyes, and dark eyes. It is a herbal medicine that has traditionally been used to improve eyesight, and as described in the ``Hyakusakyo'', it is effective for diseases such as ``blurred vision, red eyes, cataracts, and tears that come out when exposed to wind.'' Genjin removes heat toxins from the body, eliminates heat and evil in the blood, strengthens the yin, lowers the heat and expels it from the body, and is effective in preventing round eyes from seeing clearly. The Shennong Bencaojing states that ``it strengthens the kidney qi and improves visual acuity,'' and in the ``Medicine Zhongsan Xiroku,'' it is further stated that ``According to the Honjing, Genjin is capable of improving visual acuity. Genjin improves the function of the eyes by increasing the function of the liver and increasing the water content in the body, providing nutrients to the liver and eyes, thereby improving visual acuity. Natural borneol (D-borneol) has a pungent and strong odor and is found in the cavities of the human body. It improves circulation and dissipates heat, improves the circulation of various cavities in the body, removes accumulated fire, eliminates shadows and improves vision, eliminates swelling and calms pain. According to ``Honzo Keiko'', ``Red eyes and poor skin color are due to excessive fire heat, and borneol is spicy and mild in nature, and mainly plays a dissipating function, and contains fire heat. It has been found that ``Kai Yakuhonso'' is effective for internal and external eye diseases, and is effective for treating internal and external eye diseases. It is stated that it is ``mainly effective against internal and external eye diseases, and improves visual acuity.'' By using the three types of herbal medicines mentioned above, the heat toxins in the body are removed and the heat in the blood is reduced. The effect of removing evil, increasing yin and improving eyesight is improved.
目が肝臓に関係しているので、ゴオウは心臓や肝臓を介して機能し、味わいが苦く、性質が涼しく、肝臓の熱邪を鎮めて風を緩和させ、体内の熱毒を取り除いて毒素を除去することができ、「風は痒みの原因となり、痒みを解消するのに風の解除が必要であり、血の流れを良くすると風が消える」ため、コウカ、ジュウイシと組み合わせることで、血の流れ及び脈の通りをよくし、これらのうち、コウカは血を和らげて痛みを鎮めることもでき、ジュウイシは風を放散して体内の熱毒を取り除いて、精に有利であり、視力を高めることもでき、『神農本草経』によれば、目赤、腫れや痛み、目の翳障に効くことができ、コウカ、ジュウイシは共同で臣薬として使用される。 Since the eyes are related to the liver, gouou functions through the heart and liver, has a bitter taste, and is cool in nature. "Wind causes itching, and to eliminate itching it is necessary to remove the wind, and when you improve the blood flow, the wind disappears." It improves blood flow and pulse, and among these, kouka can soften the blood and calm pain, and juuishi dissipates wind and removes heat toxins from the body, which is beneficial for energy and improves eyesight. According to the ``Shennong Bencao-jing,'' it can be effective against redness, swelling, pain, and ocular problems, and Kouka and Juuishi are jointly used as medicines.
オウトウ（別名：ドオウレン、ダイオウトウ）は、『銀海精微』によれば、甘みをしている苦さがあり、寒性であり、心臓及び肝臓の両方に作用し、体内の熱毒を取り除いて毒素を除去し、赤眼に効き、病症として目赤が現れる場合、目がよく痛み、佐薬として使用される。 According to the ``Yinkai Eseiwei,'' cherries (also known as ``dou ren,'' or ``daiou tō'') have a sweet, bitter taste, and are cold. They act on both the heart and liver, and remove heat toxins from the body. It removes toxins and is effective against red eyes, and is often used as an adjuvant when red eyes appear as a disease or for eye pain.
コウライニンジンは体を元気にして、天然ボルネオール（Ｄ－ボルネオール）による疎通機能を支援し、気の消費を減少し、使薬として使用される。 Panax ginseng energizes the body, supports communication function with natural borneol (D-borneol), reduces Qi consumption, and is used as a herbal medicine.
本発明の実施例における点眼薬は、コウライニンジン、ゲンジン、ソウジシ、ゴオウ、コウカ、天然ボルネオール、タイキンギク、オウトウ、及びジュウイシの生薬を併用することで、白内障を治療して視力を高め、体内の熱毒を取り除いて毒素を除去し、血や経絡の気の流れを良くし、鬱血を除去して痛めを鎮めるような効果を奏する。主として、風火赤眼（急性結膜炎、病症として、目が赤くなり、灼熱感、腫れや痛みがあり、暑さや光に弱く、風が当たると涙が出て、かゆみと乾燥が感じる）、円翳内障（白内障、発症初期に瞳孔が白く濁って、視界がぼんやりし、視界内に小さな薄い影のようなものが現れ、深刻な場合は失明する）や緑風内障（緑内障、病症として物がぼやけて、目の膨満感を伴う痛みや頭痛、吐き気と嘔吐が認められる）、糖尿病性網膜症（糖尿病性眼底黄斑変性症、病症として物が歪んで見え、まっすぐのものが曲がるように見え、物がぼけて見え、小さな影が出現し、視力が低下する）、及び能近怯遠（近視眼、例えば、青年期の軽度の近視眼、病症として近くのものが見えて、遠くが見えにくい）を治療する。 The eye drops according to the embodiment of the present invention treat cataracts, improve visual acuity, and increase the heat in the body by combining the herbal medicines of ginseng, genjin, scutellariae, chinensis, kooka, natural borneol, chinese daisy, chinensis, and jaundice. It removes toxins, improves the flow of blood and meridians, removes congestion, and soothes pain. Mainly, wind and fire red eyes (acute conjunctivitis, as a disease, the eyes become red, have a burning sensation, swelling and pain, are sensitive to heat and light, tear when exposed to wind, and feel itchy and dry), circles In severe cases, glaucoma (cataract) and glaucoma (glaucoma, a disease that causes the pupil to become cloudy and cloudy, blurring vision, and in severe cases, leading to blindness) diabetic retinopathy (diabetic macular degeneration), a disease in which objects appear distorted and straight objects appear to bend. , objects appear blurry, small shadows appear, and visual acuity deteriorates), and nearsightedness (myopia, for example, mild nearsightedness in adolescence, a disease in which you can see things close up and have difficulty seeing far away) treat.
本発明の実施例による漢方薬点眼薬の使用方法及び用量は、１日当たり２～３回、１回に２～３滴である。 The usage method and dosage of the Chinese herbal medicine eye drops according to the embodiment of the present invention is 2-3 times per day, 2-3 drops at a time.
本発明の実施例はまた、漢方薬点眼薬の製造方法を提供し、図１には漢方薬点眼薬の製造の流れが模式的に示されており、図１に記載の方法は以下のステップを含む。
Ｓ１１、漢方薬成分全量に対してコウライニンジン５～１０ｗｔ％、ゲンジン１５～２０ｗｔ％、ソウジシ５～１０ｗｔ％、コウカ５～１０ｗｔ％、タイキンギク２５～３５ｗｔ％、オウトウ５～１５ｗｔ％、及びジュウイシ５～１０ｗｔ％を精製水に加えて煎じた後、ろ過して、第１抽出液を得る。
本実施例では、漢方薬成分のうちコウライニンジン５～１０ｗｔ％、ゲンジン１５～２０ｗｔ％、ソウジシ５～１０ｗｔ％、コウカ５～１０ｗｔ％、タイキンギク２５～３５ｗｔ％、オウトウ５～１５ｗｔ％、及びジュウイシ５～１０ｗｔ％をかき混ぜて、これらの生薬の混合物を粉砕して篩にかけて、均一に混合し、生薬の混合物に対して２０倍の精製水を加えて、１回ずつ１時間２回煎じ、漢方薬液を適切な体積となるまで減圧濃縮させ、静置して、上澄み液を吸引してろ過して、第１抽出液を得て、使用時まで保存する。
The embodiment of the present invention also provides a method for manufacturing Chinese herbal eye drops, and FIG. 1 schematically shows the manufacturing flow of Chinese herbal eye drops, and the method shown in FIG. 1 includes the following steps. .
S11, based on the total amount of Chinese herbal medicine ingredients, 5 to 10 wt% of ginseng, 15 to 20 wt% of ginseng, 5 to 10 wt% of sorcery, 5 to 10 wt% of chinensis, 25 to 35 wt% of golden chrysanthemum, 5 to 15 wt% of chinensis, and 5 to 10 wt% of chinensis % in purified water, decocted, and filtered to obtain a first extract.
In this example, among the Chinese herbal medicine ingredients, 5 to 10 wt% of ginseng, 15 to 20 wt% of ginseng, 5 to 10 wt% of sorcery, 5 to 10 wt% of chinensis, 25 to 35 wt% of golden daisy, 5 to 15 wt% of chinensis, and 5 to 15 wt% of chinensis. Stir 10wt%, crush the mixture of these herbal medicines, pass through a sieve, mix evenly, add 20 times the amount of purified water to the mixture of herbal medicines, decoct twice for 1 hour each time, and make the herbal medicine liquid. Concentrate under reduced pressure to an appropriate volume, leave to stand, and aspirate and filter the supernatant to obtain a first extract, which is stored until use.
Ｓ１２、塩化ナトリウム注射液を精製水に加え、加熱して沸騰させ、７０～９０℃に冷却した後、前記第１抽出液を加え、５０～７０℃に降温して、第１混合液を得る。
塩化ナトリウム注射液を適量の精製水に加え、加熱して沸騰させ、冷却して漢方薬点眼薬完成品を得て、抽出液を加え、撹拌しながら５０～７０℃に降温する。
S12, add sodium chloride injection to purified water, heat to boil, cool to 70-90°C, then add the first extract and lower the temperature to 50-70°C to obtain a first mixed solution. .
Add the sodium chloride injection solution to an appropriate amount of purified water, heat to boil, and cool to obtain the finished Chinese herbal eye drops. Add the extract and lower the temperature to 50-70°C with stirring.
Ｓ１３、前記漢方薬成分全量に対してゴオウ５～１０ｗｔ％と天然ボルネオール５～１０ｗｔ％をエタノールで加熱して還流し、ろ過して第２抽出液を得る。
また、ゴオウ、天然ボルネオール（Ｄ－ボルネオール）をエタノールで加熱して半時間還流し、エタノールを回収してアルコール臭をなくし、ろ過して、ろ液を使用時まで保存する。
S13, 5 to 10 wt% of Goukou and 5 to 10 wt% of natural borneol are heated with ethanol to reflux and filtered to obtain a second extract.
Alternatively, D-borneol, natural borneol (D-borneol), is heated with ethanol and refluxed for half an hour, the ethanol is recovered to eliminate the alcohol odor, filtered, and the filtrate is stored until use.
Ｓ１４、前記第２抽出液を前記第１混合液に滴下した後、防腐剤及び精製水を加え、漢方薬点眼薬を得る。
以上の抽出液を撹拌しながら、以上の溶液に滴下し、エチルパラベン（防腐剤））及び水を加え、３０分間以上撹拌する。
S14: After dropping the second extract into the first mixed solution, a preservative and purified water are added to obtain Chinese herbal medicine eye drops.
The above extract is added dropwise to the above solution while stirring, ethylparaben (preservative) and water are added, and the mixture is stirred for 30 minutes or more.
好ましくは、いくつかの実施例では、上記方法は以下のステップをさらに含む。
Ｓ１５、前記漢方薬点眼薬のｐＨ値を測定する。
Ｓ１６、測定した結果、前記漢方薬点眼薬のｐＨ値が所定のｐＨ値範囲内ではない場合、ｐＨ調整剤で前記漢方薬点眼薬のｐＨ値を調整する。
Preferably, in some embodiments, the method further includes the following steps.
S15: Measure the pH value of the herbal medicine eye drops.
S16: As a result of the measurement, if the pH value of the herbal medicine eye drops is not within a predetermined pH value range, the pH value of the herbal medicine eye drops is adjusted with a pH adjuster.
溶液のｐＨ値を測定し、測定した結果、前記漢方薬点眼薬のｐＨ値が所定のｐＨ値範囲内ではない場合、漢方薬点眼薬のｐＨ値に応じて適量のホウ酸を加え、溶液のｐＨ値を所定のｐＨ値の範囲に調整し、ここで、所定のｐＨ値の範囲は具体的にはｐＨ５～９の範囲であってもよく、次に、溶液をろ過して、ろ液を殺菌処理し、漢方薬点眼薬完成品を得る。 Measure the pH value of the solution, and as a result of the measurement, if the pH value of the herbal medicine eye drops is not within the predetermined pH value range, add an appropriate amount of boric acid according to the pH value of the herbal medicine eye drops, and adjust the pH value of the solution. is adjusted to a predetermined pH value range, where the predetermined pH value range may specifically be a pH range of 5 to 9, and then the solution is filtered and the filtrate is sterilized. and obtain the finished Chinese herbal medicine eye drops.
具体的には、いくつかの実施例では、コウライニンジン１．５ｇ、ゲンジン３ｇ、ソウジシ１．５ｇ、コウカ１．５ｇ、タイキンギク１．５ｇ、オウトウ２ｇ、及びジュウイシ１．５ｇを粉砕して、篩にかけて均一に混合した後、精製水３４０ｍｌを加えて、１回ずつ１時間２回煎じ、適切な体積となるまで減圧濃縮させ、静置して、上澄み液をろ過して、使用時まで保存する。塩化ナトリウム注射液１５ｇを適量の精製水に加え、加熱して沸騰させ、８０℃に冷却して、抽出液を加え、撹拌しながら６０℃に降温する。また、ゴオウ１．５ｇ、天然ボルネオール（Ｄ－ボルネオール）１．５ｇをエタノール１７５ｇで半時間加熱して還流し、エタノールを回収してエタノール臭をなくし、ろ過して、ろ液を使用時まで保存する。以上の抽出液を撹拌しながら、以上の溶液に滴下し、エチルパラベン０．２５ｇを加え、１０００ｍｌとなるまで水を添加し、３０分間以上撹拌し、溶液のｐＨ値を測定し、場合よっては、完成品に要求されるｐＨ値に応じて、ホウ酸０．２５ｇを加えて、溶液のｐＨ値をｐＨ５～９の範囲（中国薬局方に記載のｐＨ値検出法［付録ＶＩＩ Ｇ検出］によって）に調整し、溶液をろ過して、ろ液を加熱殺菌し、缶詰めすると、漢方薬点眼薬完成品を得る。 Specifically, in some examples, 1.5 g of ginseng, 3 g of genjin, 1.5 g of sardines, 1.5 g of sardines, 1.5 g of chinese daisies, 2 g of sardines, and 1.5 g of sardines are ground and sieved. Mix uniformly by adding 340 ml of purified water, decoction twice for 1 hour each time, concentrate under reduced pressure until the appropriate volume is reached, leave to stand, filter the supernatant liquid, and store until use. . Add 15 g of sodium chloride injection solution to an appropriate amount of purified water, heat to boil, cool to 80°C, add the extract, and lower the temperature to 60°C while stirring. In addition, 1.5 g of gourd and 1.5 g of natural borneol (D-borneol) are heated with 175 g of ethanol to reflux for half an hour, the ethanol is recovered to eliminate the ethanol smell, filtered, and the filtrate is stored until use. do. Add the above extract dropwise to the above solution while stirring, add 0.25 g of ethylparaben, add water to 1000 ml, stir for more than 30 minutes, measure the pH value of the solution, , according to the pH value required for the finished product, add 0.25 g of boric acid to adjust the pH value of the solution to a range of pH 5 to 9 (according to the pH value detection method described in the Chinese Pharmacopoeia [Appendix VII G detection]). ), filter the solution, heat sterilize the filtrate, and can it to obtain the finished Chinese herbal eye drops.
実施例１
本実施例の漢方薬点眼薬は以下のように製造される。
漢方薬成分全量に対してコウライニンジン７．５ｗｔ％、ゲンジン１５ｗｔ％、ソウジシ７．５ｗｔ％、コウカ７．５ｗｔ％、天然ボルネオール７．５ｗｔ％、タイキンギク３０ｗｔ％、オウトウ１０ｗｔ％、及びジュウイシ７．５ｗｔ％を精製水に加えて煎じた後、ろ過して、第１抽出液を得た。
塩化ナトリウム注射液を精製水に加え、加熱して沸騰させ、８０℃に冷却した後、前記第１抽出液を加え、６０℃に降温し、第１混合液を得た。
前記漢方薬成分全量に対してゴオウ７．５ｗｔ％と天然ボルネオール７．５ｗｔ％をエタノールで加熱して還流し、ろ過して第２抽出液を得た。
第２抽出液を第１混合液に滴下した後、エチルパラベン及び精製水を加え、漢方薬点眼薬半製品を得た。
Example 1
The Chinese herbal medicine eye drops of this example are manufactured as follows.
Based on the total amount of Chinese herbal medicine ingredients, 7.5 wt% of ginseng, 15 wt% of genjin, 7.5 wt% of sorcery, 7.5 wt% of kooka, 7.5 wt% of natural borneol, 30 wt% of golden chrysanthemum, 10 wt% of chinensis, and 7.5 wt% of chinensis. was added to purified water, decocted, and then filtered to obtain a first extract.
Sodium chloride injection solution was added to purified water, heated to boiling, and cooled to 80°C, then the first extract was added and the temperature was lowered to 60°C to obtain a first liquid mixture.
With respect to the total amount of the herbal medicine components, 7.5 wt% of Gokou and 7.5 wt% of natural borneol were heated with ethanol, refluxed, and filtered to obtain a second extract.
After dropping the second extract into the first mixed solution, ethylparaben and purified water were added to obtain a semi-finished product of herbal medicine eye drops.
前記漢方薬点眼薬のｐＨ値を測定し、ホウ酸で前記漢方薬点眼薬のｐＨ値を９に調整した。 The pH value of the herbal medicine eye drops was measured, and the pH value of the herbal medicine eye drops was adjusted to 9 with boric acid.
実施例２
本実施例の漢方薬点眼薬は以下のように製造される。
漢方薬成分全量に対してコウライニンジン１０ｗｔ％、ゲンジン１５ｗｔ％、ソウジシ５ｗｔ％、コウカ５ｗｔ％、タイキンギク３５ｗｔ％、オウトウ５ｗｔ％、及びジュウイシ５ｗｔ％を精製水に加えて煎じた後、ろ過して、第１抽出液を得た。
塩化ナトリウム注射液を精製水に加え、加熱して沸騰させ、８０℃に冷却した後、前記第１抽出液を加え、６０℃に降温し、第１混合液を得た。
前記漢方薬成分全量に対してゴオウ１０ｗｔ％と天然ボルネオール１０ｗｔ％をエタノールで加熱して還流し、ろ過して第２抽出液を得た。
第２抽出液を第１混合液に滴下した後、エチルパラベン及び精製水を加え、漢方薬点眼薬半製品を得た。
Example 2
The Chinese herbal medicine eye drops of this example are manufactured as follows.
Based on the total amount of Chinese medicinal ingredients, 10 wt% of ginseng, 15 wt% of genjin, 5 wt% of sorcery, 5 wt% of kooka, 35 wt% of golden chrysanthemum, 5 wt% of chinensis, and 5 wt% of chinensis are added to purified water and decocted, then filtered. 1 extract was obtained.
Sodium chloride injection solution was added to purified water, heated to boiling, and cooled to 80°C, then the first extract was added and the temperature was lowered to 60°C to obtain a first liquid mixture.
Based on the total amount of the Chinese herbal medicine components, 10 wt% of Gokou and 10 wt% of natural borneol were heated with ethanol, refluxed, and filtered to obtain a second extract.
After dropping the second extract into the first mixed solution, ethylparaben and purified water were added to obtain a semi-finished product of herbal medicine eye drops.
前記漢方薬点眼薬のｐＨ値を測定し、ホウ酸で前記漢方薬点眼薬のｐＨ値を６に調整する。 The pH value of the herbal medicine eye drops is measured, and the pH value of the herbal medicine eye drops is adjusted to 6 with boric acid.
実施例３
本実施例の漢方薬点眼薬は以下のように製造される。
漢方薬成分全量に対してコウライニンジン１０ｗｔ％、ゲンジン２０ｗｔ％、ソウジシ５ｗｔ％、コウカ５ｗｔ％、タイキンギク３５ｗｔ％、オウトウ５ｗｔ％、及びジュウイシ５ｗｔ％を精製水に加えて煎じた後、ろ過して、第１抽出液を得た。
塩化ナトリウム注射液を精製水に加え、加熱して沸騰させ、８０℃に冷却した後、前記第１抽出液を加え、５０℃に降温し、第１混合液を得た。
前記漢方薬成分全量に対してゴオウ５ｗｔ％と天然ボルネオール１０ｗｔ％をエタノールで加熱して還流し、ろ過して第２抽出液を得た。
第２抽出液を第１混合液に滴下した後、エチルパラベン及び精製水を加え、漢方薬点眼薬半製品を得た。
Example 3
The Chinese herbal medicine eye drops of this example are manufactured as follows.
Based on the total amount of Chinese herbal medicine ingredients, 10 wt% of ginseng, 20 wt% of genjin, 5 wt% of sorcery, 5 wt% of kooka, 35 wt% of golden chrysanthemum, 5 wt% of chinensis, and 5 wt% of chinensis are added to purified water and decocted, then filtered. 1 extract was obtained.
Sodium chloride injection solution was added to purified water, heated to boiling, and cooled to 80°C. Then, the first extract was added and the temperature was lowered to 50°C to obtain a first liquid mixture.
Based on the total amount of the Chinese herbal medicine ingredients, 5 wt% of Gokou and 10 wt% of natural borneol were heated with ethanol, refluxed, and filtered to obtain a second extract.
After dropping the second extract into the first mixed solution, ethylparaben and purified water were added to obtain a semi-finished product of herbal medicine eye drops.
前記漢方薬点眼薬のｐＨ値を測定し、ホウ酸で前記漢方薬点眼薬のｐＨ値を５に調整した。 The pH value of the herbal medicine eye drops was measured, and the pH value of the herbal medicine eye drops was adjusted to 5 with boric acid.
試験
実施例１～３の漢方薬点眼薬について以下の臨床試験を行った。
１．被験者資料
すべての観察対象は臨床で眼疾患と診断された、男性と女性を含め、計３６例で、年齢は最小５歳、最大６６歳、平均年齢は３０歳であった。
Tests The following clinical tests were conducted on the Chinese herbal medicine eye drops of Examples 1 to 3.
1. Subject data All observation subjects were a total of 36 subjects, both male and female, who were clinically diagnosed with eye diseases, with a minimum age of 5 years and a maximum age of 66 years, with an average age of 30 years.
眼疾患の患者を３群に分け、１群ずつ１２人とし、それぞれ群１～３と命名し、ＳＰＳＳ統計ソフトを利用して３群の年齢、漢方医学による症状のスコアを比較した結果、Ｐ＞０．０５であり、差は統計学的に有意ではなく、この３群は比較可能性があることが示された。 Patients with eye diseases were divided into three groups, with 12 patients in each group, each named Groups 1 to 3. Using SPSS statistical software, the age and symptom scores according to Chinese medicine were compared for the three groups. As a result, P >0.05, the difference was not statistically significant, indicating that the three groups were comparable.
２．被験者の選択基準
２．１ 症例選択基準
（１）臨床で確診された眼疾患を患っている者
（２）年齢満５～７５歳
（３）インフォームド・コンセントに署名すること
2. Subject selection criteria 2.1 Case selection criteria (1) Subjects suffering from a clinically confirmed eye disease (2) Age between 5 and 75 years old (3) Signing an informed consent form
２．２ 症例除外基準
（１）アレルギー歴のある者
（２）他の臓器病変がある者
2.2 Case exclusion criteria (1) Persons with a history of allergies (2) Persons with lesions in other organs
３．実験方法
群１の眼疾患の患者は、実施例１の方法で製造された漢方薬点眼薬を、群２及び群３の眼疾患の患者は、実施例２及び実施例３の方法で製造された漢方薬点眼薬を、それぞれ１日に２～３回、１回に２～３滴ずつ投与され、被験者の身体反応を検査し、記録した。
3. Experimental Method Patients with eye diseases in Group 1 received Chinese herbal medicine eye drops manufactured by the method of Example 1, and patients with eye diseases in Groups 2 and 3 received Chinese herbal medicine eye drops manufactured by the methods of Example 2 and Example 3. Each Chinese herbal medicine eye drop was administered 2-3 drops at a time, 2-3 times a day, and the physical reactions of the subjects were examined and recorded.
４．中医証候に対する治療効果の評価基準
目が赤くなり、灼熱感、腫れや痛みがあり、暑さや光に弱く、風が当たると涙が出て、かゆみと乾燥が感じ、瞳孔が白く濁って、視界がぼんやりし、物がぼやけて、物が歪んで見え、視界内に小さな薄い影のようなものが現れること、目の膨満感を伴う痛み、過度の近視眼や頭痛などの症状は、無、軽、重の３つの等級に分けられ、それぞれに対応する点数は０、２、４点であり、２０日間投与した後、観察対象について採点した。
治療効果指数（ｎ）＝［（治療前点数－治療後点数）÷治療前点数］×１００％
著効：証候のうち上記症状のほとんどが消えて、有効率ｎ≧７０％である。
有効：証候のうち上記症状はほぼ消え、有効率３０％ｎ≦ｎ＜７０％である。
無効：証候のうち上記症状はある程度改善されたが、有効率ｎ＜３０％である。
有効率＝［著効症例数＋有効症例数／総症例数］×１００％。
4. Criteria for evaluating the effectiveness of treatment for Chinese medicine symptoms Eyes become red, have a burning sensation, swelling and pain, are sensitive to heat and light, tear when exposed to wind, feel itchy and dry, pupils become cloudy white, Symptoms such as blurred vision, blurry vision, distorted vision, the appearance of small thin shadows in the field of vision, pain with eye fullness, excessive nearsightedness, and headaches are absent. The drug was divided into three grades: light and heavy, and the corresponding scores were 0, 2, and 4. After administration for 20 days, the observation subjects were scored.
Treatment effect index (n) = [(pre-treatment score - post-treatment score) ÷ pre-treatment score] x 100%
Excellent response: Most of the above symptoms have disappeared, and the efficacy rate is n≧70%.
Effective: The above symptoms have almost disappeared, and the effectiveness rate is 30% n≦n<70%.
Ineffective: Among the signs, the above symptoms were improved to some extent, but the efficacy rate was n<30%.
Efficacy rate = [number of highly effective cases + number of effective cases/total number of cases] x 100%.
５．実験結果
5. Experimental result
表１の結果から分かるように、本発明で製造された漢方薬点眼薬は、目が赤くなり、灼熱感、腫れや痛みがあり、暑さや光に弱く、風が当たると涙が出て、かゆみと乾燥が感じ、視界がぼんやりし、物がぼやけて、瞳孔が白く濁って、視界内に小さな薄い影のようなものが現れること、目の膨満感を伴う痛み、過度の近視眼や頭痛などの症状に対して良好な治療効果があり、有効率は９２．６６％であった。 As can be seen from the results in Table 1, the Chinese herbal eye drops produced according to the present invention cause redness, burning sensation, swelling and pain in the eyes, are sensitive to heat and light, and cause tearing and itchiness when exposed to wind. Dryness, blurred vision, blurred vision, cloudy pupils, small thin shadows appearing in the field of vision, pain accompanied by a feeling of fullness in the eyes, excessive nearsightedness, headaches, etc. There was a good therapeutic effect on symptoms, with an efficacy rate of 92.66%.
以上のとおり、上記漢方薬点眼薬は少なくとも以下の有益な効果を有する。
白内障を治療して視力を高め、体内の熱毒を取り除いて毒素を除去し、血や経絡の気の流れを良くし、鬱血を除去して痛めを鎮めることができ、風火赤眼（急性結膜炎、病症として、目が赤くなり、灼熱感、腫れや痛みがあり、暑さや光に弱く、風が当たると涙が出て、かゆみと乾燥が感じる）、円翳内障（白内障、発症初期に瞳孔が白く濁って、視界がぼんやりし、視界内に小さな薄い影のようなものが現れ、深刻な場合は失明する）や緑風内障（緑内障、病症として物がぼやけて、目の膨満感を伴う痛みや頭痛、吐き気と嘔吐が認められる）、糖尿病性網膜症（糖尿病性眼底黄斑変性症、病症として物が歪んで見え、まっすぐのものが曲がるように見え、視界がかすんで見え、ぼやけて見え、視力が低下する。）、及び能近怯遠（近視眼、例えば青年期の軽度の近視、病症として近くのものが見えて、遠くが見えにくい）のいずれにも良好な効果がある。
As described above, the Chinese herbal medicine eye drops have at least the following beneficial effects.
It can treat cataracts to improve eyesight, remove heat toxins and toxins from the body, improve blood and meridian Qi flow, remove congestion and soothe pain, and reduce wind, fire and red eyes (acute Conjunctivitis is a disease in which the eyes become red, have a burning sensation, swelling and pain, are sensitive to heat and light, tear when exposed to wind, and feel itchy and dry. In severe cases, the pupils become cloudy, the vision becomes blurry, small pale shadows appear in the field of vision, and in severe cases, blindness occurs) and glaucoma (glaucoma, a disease in which things become blurry and the eyes feel swollen). pain, headache, nausea and vomiting), diabetic retinopathy (diabetic macular degeneration), a disease in which objects appear distorted, straight objects appear to curve, and vision becomes blurry and blurry. It has a good effect on both nearsightedness (for example, mild nearsightedness in adolescents, a disease in which people can see things close up and have difficulty seeing far away).
なお、以上の実施例は本発明の技術案を説明するために過ぎず、限定するものではなく、本発明の構想に基づいて、以上の実施例又は異なる実施例の技術的特徴は互いに組み合わせられてもよく、ステップは任意の順で実行されてもよく、また、前記した本発明の各態様に対する多くの変化が可能であり、明瞭さから、これらの変化は詳細な説明に記載されておらず、本発明は前述実施例を参照して詳細に説明されたが、当業者にとって明らかなように、前述の各実施例に記載の技術案に対する修正、又はこれらの技術的特徴の一部に対する等同置換が可能であり、これらの修正や等同置換により、対応する技術案の主旨は本発明の各実施例の技術案の範囲から逸脱することはない。 It should be noted that the above embodiments are only for explaining the technical solution of the present invention, and are not intended to limit it.Based on the concept of the present invention, the technical features of the above embodiments or different embodiments may be combined with each other. The steps may be performed in any order, and many variations to each of the aspects of the invention described above are possible, and for the sake of clarity, these variations are not set forth in the detailed description. First, the present invention has been described in detail with reference to the above-mentioned embodiments, but as is obvious to those skilled in the art, modifications to the technical solutions described in each of the above-mentioned embodiments or some of these technical features may be made. Equivalent substitutions are possible, and these modifications and equivalent substitutions do not deviate from the scope of the technical solutions of the embodiments of the present invention.
Claims (10)
コウライニンジン（高麗人参）５～１０ｗｔ％、ゲンジン（玄参）１５～２０ｗｔ％、ソウジシ(蒼耳子)５～１０ｗｔ％、ゴオウ（牛黄）５～１０ｗｔ％、コウカ（紅花）５～１０ｗｔ％、ボルネオール（冰片）５～１０ｗｔ％、タイキンギク（千里光）２５～３５ｗｔ％、オウトウ（黄藤）５～１５ｗｔ％、及び
ことを特徴とする漢方薬点眼薬。 Manufactured with Chinese herbal medicine ingredients and auxiliary materials, on a weight percentage basis, the Chinese medicine ingredients are:
Korean ginseng 5-10 wt%, Genjin 15-20 wt%, Soujishi 5-10 wt%, Goou 5-10 wt%, Kouka 5-10 wt%, 5 to 10 wt% of borneol (ice flakes), 25 to 35 wt% of chinese daisy (Sianliang), 5 to 15 wt% of yellow wisteria, and
Chinese herbal medicine eye drops.
前記コウライニンジン７．５ｗｔ％、前記ゲンジン１５ｗｔ％、前記ソウジシ７．５ｗｔ％、前記ゴオウ７．５ｗｔ％、前記コウカ７．５ｗｔ％、天然ボルネオール７．５ｗｔ％、前記タイキンギク３０ｗｔ％、前記オウトウ１０ｗｔ％、及び前記ジュウイシ７．５ｗｔ％を含む、ことを特徴とする請求項１に記載の漢方薬点眼薬。 On a weight percentage basis, the herbal medicine ingredients are:
7.5 wt% of the ginseng, 15 wt% of the chinese ginseng, 7.5 wt% of the quince, 7.5 wt% of the chinensis, 7.5 wt% of the chinese chinensis, 7.5 wt% of natural borneol, 30 wt% of the chinese chrysanthemum, 10 wt% of the chinensis. , and 7.5 wt% of the Chinese herbal medicine eye drops according to claim 1.
前記ｐＨ調整剤と前記防腐剤との質量比が１：１である、ことを特徴とする請求項４に記載の漢方薬点眼薬。 5. The pH adjusting agent includes boric acid, the preservative includes ethylparaben, and/or the mass ratio of the pH adjusting agent and the preservative is 1:1. Chinese herbal medicine eye drops as described.
塩化ナトリウム注射液を精製水に加え、加熱して沸騰させ、７０～９０℃に冷却した後、前記第１抽出液を加え、５０～７０℃に降温して、第１混合液を得るステップと、
前記漢方薬成分全量に対してゴオウ５～１０ｗｔ％と天然ボルネオール５～１０ｗｔ％をエタノールで加熱して還流し、ろ過して第２抽出液を得るステップと、
前記第２抽出液を前記第１混合液に滴下した後、防腐剤及び精製水を加え、漢方薬点眼薬半製品を製造するステップと、を含む、ことを特徴とする漢方薬点眼薬の製造方法。 Based on the total amount of Chinese herbal medicine ingredients, 5 to 10 wt% of ginseng, 15 to 20 wt% of ginseng, 5 to 10 wt% of sorcery, 5 to 10 wt% of red chinensis, 25 to 35 wt% of golden daisy, 5 to 15 wt% of chinensis, and 5 to 10 wt% of chinensis. Adding it to purified water, decocting it, and filtering it to obtain a first extract;
Adding sodium chloride injection solution to purified water, heating to boil, cooling to 70 to 90°C, adding the first extract, and cooling to 50 to 70°C to obtain a first mixed liquid. ,
Heating 5 to 10 wt% of Goukou and 5 to 10 wt% of natural borneol with ethanol to reflux and filtering to obtain a second extract, based on the total amount of the herbal medicine ingredients;
A method for producing Chinese herbal medicine eye drops, comprising the step of adding a preservative and purified water after dropping the second extract to the first mixed liquid to produce a semi-finished Chinese medicine eye drop.
前記漢方薬点眼薬のｐＨ値を測定するステップと、
測定した結果前記漢方薬点眼薬のｐＨ値が所定のｐＨ値範囲内ではない場合、ｐＨ調整剤で前記漢方薬点眼薬のｐＨ値を調整するステップと、を含む、ことを特徴とする請求項７に記載の漢方薬点眼薬の製造方法。 After the step of dropping the second extract into the first mixed solution and adding a preservative and purified water to produce a semi-finished product of Chinese herbal medicine eye drops,
Measuring the pH value of the herbal medicine eye drops;
According to claim 7, the method further comprises the step of adjusting the pH value of the Chinese herbal medicine eye drops with a pH adjusting agent if the pH value of the Chinese medicine eye drops is not within a predetermined pH value range as a result of the measurement. The method for producing the Chinese herbal medicine eye drops described above.
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