JP2005232083A - Therapeutic agent for hepatic failure and method for producing the same - Google Patents
Therapeutic agent for hepatic failure and method for producing the same Download PDFInfo
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Abstract
Description
本発明は、肝疾患の治療薬に関するものであり、特に、慢性の肝疾患に対して顕著な治癒効果を奏するとともに、長期間に亘って服用した場合でも、副作用を生じない治療薬に関するものである。 The present invention relates to a therapeutic agent for liver disease, and particularly relates to a therapeutic agent that exhibits a remarkable curative effect on chronic liver disease and does not cause side effects even when taken over a long period of time. is there.
肝臓は、解毒、各種の代謝、栄養素の貯蔵など、種々の機能を有する重要な臓器であるが、ウイルス、薬物、アルコール等の様々な原因により障害を受け、急性肝炎、慢性肝炎、脂肪肝等の肝疾患を生じ、最終的には、肝硬変に至ることがある。特に、細胞の浸潤および肝線維化等の間葉系反応を伴う慢性肝炎および肝硬変は、難治療性の疾患として知られている。従来、このような肝障害の治療剤としては、ステロイド剤、シクロスポリン等の免疫抑制剤、グルコガン・インスリン、インターフェロン等が知られている(特許文献1)。 The liver is an important organ with various functions such as detoxification, various metabolisms, and nutrient storage, but it is damaged by various causes such as viruses, drugs, alcohol, etc., and acute hepatitis, chronic hepatitis, fatty liver, etc. May eventually lead to cirrhosis. In particular, chronic hepatitis and cirrhosis with mesenchymal reactions such as cell infiltration and liver fibrosis are known as intractable diseases. Conventionally, steroids, immunosuppressants such as cyclosporine, glucogan insulin, interferon, and the like are known as therapeutic agents for such liver disorders (Patent Document 1).
しかしながら、上記従来の治療薬は、ある程度の治癒効果を奏しうるものの、長期間に亘って服用された場合には、副作用が生じてしまう虞れがあるため、慢性肝疾患の患者に対して効果的であるとはいえない。本発明の目的は、上記従来の治療薬の問題点を解消し、種々の肝疾患に対して顕著な治癒効果を奏するとともに、長期間に亘って服用した場合でも副作用が生じない治療薬、およびその製造方法を提供することにある。 However, although the above-mentioned conventional therapeutic agents can exhibit a certain degree of curative effect, there is a possibility that side effects may occur when taken over a long period of time, so that they are effective for patients with chronic liver diseases. It's not the right one. An object of the present invention is to solve the above-mentioned problems of conventional therapeutic agents, have a remarkable curative effect on various liver diseases, and have no side effects even when taken over a long period of time, and It is in providing the manufacturing method.
かかる本発明の内、請求項1に記載された発明の構成は、カン黄草の根から抽出されるサポニンを有効成分とする肝疾患治療薬にある。なお、カン黄草は、中国広西省および四川省の奥地に自生している植物である。 Among the present inventions, the constitution of the invention described in claim 1 resides in a therapeutic agent for liver diseases comprising saponin extracted from roots of corn yellow grass as an active ingredient. Kang yellow grass is a plant that grows in the outback of Guangxi and Sichuan, China.
請求項2に記載された発明の構成は、カン黄草の根菜粉末を第一のアルコールに溶解させた後に当該第一のアルコールを回収し、しかる後、残査を前記第一のアルコールとは異なる第二のアルコールに溶解させた後に当該第二のアルコールを回収する工程を含む肝疾患治療薬の製造方法にある。 The structure of the invention described in claim 2 is that the first alcohol is collected after dissolving the root vegetable powder of corn yellow grass in the first alcohol, and then the residue is different from that of the first alcohol. It exists in the manufacturing method of the therapeutic agent of a liver disease including the process of collect | recovering the said 2nd alcohol after making it melt | dissolve in a 2nd alcohol.
請求項3に記載された発明の構成は、カン黄草の根菜粉末をアルコールに溶解させた後に当該アルコールを回収し、しかる後、そのアルコール回収後の溶液にアセトンを加えた液体から沈殿物を回収する工程を含む肝疾患治療薬の製造方法にある。 According to a third aspect of the present invention, the alcohol is recovered after dissolving the root vegetable powder of corn yellow grass in alcohol, and then the precipitate is recovered from the liquid obtained by adding acetone to the solution after the alcohol recovery. A method for producing a therapeutic agent for liver disease comprising the step of:
請求項4に記載された発明の構成は、カン黄草の根菜粉末を水とともに煮沸した後、その煮沸後の溶液を濾過して濾液を回収する工程を含む肝疾患治療薬の製造方法にある。 According to a fourth aspect of the present invention, there is provided a method for producing a therapeutic agent for liver disease, comprising the step of boiling roots of corn yellow grass with water and then filtering the solution after the boiling and collecting the filtrate.
請求項1に記載された肝疾患治療薬は、急性肝炎、小児急性黄疸性肝炎、慢性病毒性肝炎、重型肝炎、B型肝炎等の肝疾患患者のALT,ASTおよびビリルビンのレベルを効果的に低下させることができ、高い治癒効果を奏することができる。また、肝炎患者のHBV−DNAの複製を阻止することも可能である。そして、長期間に亘って服用した場合でも、副作用を生じることがない。加えて、糖分の摂取を制限されている患者に投与した場合でも悪影響を及ぼすことがない。 The therapeutic agent for liver disease according to claim 1 effectively reduces the levels of ALT, AST and bilirubin in patients with liver diseases such as acute hepatitis, childhood acute jaundice hepatitis, chronic toxic hepatitis, hepatitis C and hepatitis B And can exhibit a high healing effect. It is also possible to prevent HBV-DNA replication in hepatitis patients. And even if it takes for a long time, a side effect does not arise. In addition, even when administered to patients whose sugar intake is restricted, there is no adverse effect.
請求項2〜4に記載された肝疾患治療薬の製造方法によれば、カン黄草から高い収率でサポニンを抽出することができるので、肝疾患に対して効果的な治療薬を非常に安価に、かつ効率的に製造することができる。 According to the method for producing a therapeutic agent for liver disease described in claims 2 to 4, saponin can be extracted from can yellow grass with a high yield. It can be manufactured inexpensively and efficiently.
以下、本発明に係る肝疾患治療薬およびその製造方法について、図面にしたがって詳細に説明する。 Hereinafter, the therapeutic agent for liver disease and the method for producing the same according to the present invention will be described in detail with reference to the drawings.
[カン黄草サポニンの抽出形態1]
採取したカン黄草の根を、乾燥させた後に細かく粉砕することによって、カン黄草の根菜粉末を得た。そして、得られたカン黄草の根菜粉末5gを濾紙で包んだものを、80%の濃度のメタノール200mlとともにソックスレー抽出器の溶媒フラスコ内に投入し、溶液が無色になるまで約8時間に亘って回流させた。しかる後、メタノールを回収し、回収後の溶液中に50%のn−ブチルアルコールを50ml入れて回流させる作業を3回繰り返した。そして、減圧下でn−ブチルアルコールを取り除き、無水硫酸ナトリウム(Na2SO4)1gを入れて残査を乾燥させることによって、約0.6835gのカン黄草のサポニンを得た(なお、図1は、上記抽出方法を図示したものである)。収率は、13.6%であった。
[Extracted form 1 of can yellow grass saponin]
The collected roots of corn yellow grass were dried and then finely pulverized to obtain a root vegetable powder of corn yellow grass. Then, 5 g of the rooted vegetable powder of kan yellow grass obtained by wrapping with filter paper is put into a solvent flask of a Soxhlet extractor together with 200 ml of 80% concentration methanol, and it takes about 8 hours until the solution becomes colorless. Circulated. Thereafter, methanol was recovered, and 50 ml of 50% n-butyl alcohol was added to the recovered solution and circulated three times. Then, n-butyl alcohol was removed under reduced pressure, 1 g of anhydrous sodium sulfate (Na 2 SO 4 ) was added, and the residue was dried to obtain about 0.6835 g of corn saponin (in addition, FIG. 1 illustrates the above extraction method). The yield was 13.6%.
[カン黄草サポニンの抽出形態2]
採取したカン黄草の根を、乾燥させた後に粉砕することによって、20メッシュのカン黄草の根菜粉末を得た。そして、得られたカン黄草の根菜粉末5gを濾紙で包んだものを、45%の濃度の石油エーテル200mlとともにソックスレー抽出器の溶媒フラスコ内に投入して脱脂した。しかる後、95%の濃度のエタノール200mlをソックスレー抽出器の溶媒フラスコ内に投入し、溶液が無色になるまで約8時間に亘って回流させた。さらに、エタノールを回収し、回収後の水溶液中に50%のアセトンを50ml入れた液体を濾過することによって沈殿物を回収した。しかる後、その沈殿物を20mlのアセトンで洗浄することによって、約0.6555gのカン黄草のサポニンを得た(なお、図2は、上記抽出方法を図示したものである)。収率は、13.21%であった。
[Extraction Form 2 of Can Yellow Grass Saponin]
The roots of the collected corn yellow grass were dried and pulverized to obtain 20 mesh corn yellow grass root vegetable powder. Then, 5 g of the obtained corn yellow grass root vegetable powder wrapped with filter paper was put into a solvent flask of a Soxhlet extractor together with 200 ml of 45% concentration of petroleum ether for defatting. Thereafter, 200 ml of ethanol having a concentration of 95% was put into the solvent flask of the Soxhlet extractor and circulated for about 8 hours until the solution became colorless. Further, ethanol was recovered, and a precipitate was recovered by filtering a liquid containing 50 ml of 50% acetone in the recovered aqueous solution. Thereafter, the precipitate was washed with 20 ml of acetone to obtain about 0.6555 g of corn saponin (note that FIG. 2 illustrates the above extraction method). The yield was 13.21%.
[カン黄草サポニンの抽出形態3]
採取した直後のカン黄草の根を、乾燥させた後に粉砕することによって、カン黄草の根菜粉末を得た。そして、得られたカン黄草の根菜粉末5kgに、イオンを含有しない水10kgを加えて約10分程度煮沸し、しかる後、その液体を濾過して濾液を採取した。さらに、濾過した残差に、再度、イオンを含有しない水10kgを加えて約10分程度煮沸した後に、その液体を濾過して濾液を採取する、という一連の作業を2回繰り返した。そして、得られた3回分の濾液を混合し、加熱して水分を蒸発させることによって、約0.125kgのカン黄草のサポニンを得た(なお、図3は、上記抽出方法を図示したものである)。収率は、2.5%であった。
[Extracted form 3 of corn yellow saponin]
The roots of corn yellow grass immediately after collection were dried and pulverized to obtain root vegetables powder of corn yellow grass. Then, 10 kg of water containing no ions was added to 5 kg of the root beetroot powder of corn yellow grass thus obtained and boiled for about 10 minutes, and then the liquid was filtered to collect the filtrate. Furthermore, a series of operations of adding 10 kg of water not containing ions to the filtered residue and boiling for about 10 minutes and then filtering the liquid and collecting the filtrate was repeated twice. Then, the filtrate obtained three times was mixed and heated to evaporate the water to obtain about 0.125 kg of corn saponin (note that FIG. 3 illustrates the above extraction method). Is). The yield was 2.5%.
[臨床結果1]
カン黄草のサポニンを、急性肝炎の患者(189人)に3ヶ月に亘って投与した続けたところ、93.65%の患者に治癒効果が認められ、6.35%の患者に顕著な治癒効果が認められた。また、カン黄草のサポニンを急性肝炎の患者(54人)に3ヶ月に亘って投与した続けたところ、表1の如く、96.30%の患者に治癒効果が認められ、3.70%の患者に顕著な治癒効果が認められた(下記表1参照)。また、カン黄草のサポニンを投与した患者には、特に副作用は見られなかった。
[Clinical result 1]
When kanpon grass saponin was administered to acute hepatitis patients (189) for 3 months, 93.65% of patients had curative effects and 6.35% had significant healing. The effect was recognized. In addition, when Kang yellow grass saponin was continuously administered to patients with acute hepatitis (54 patients) for 3 months, as shown in Table 1, 96.30% of patients had a curative effect, and 3.70% A significant curative effect was observed in these patients (see Table 1 below). In addition, no side effects were observed in patients who received saponin of corn yellow grass.
[臨床結果2]
カン黄草のサポニンを、慢性病毒性肝炎の患者(104人)に3ヶ月に亘って投与した続けたところ、80.76%の患者に顕著な治癒効果が認められた。また、カン黄草のサポニンを重型肝炎の患者(12人)に3ヶ月に亘って投与した続けたところ、50.00%の患者に顕著な治癒効果が認められた。さらに、カン黄草のサポニンを、B型肝炎の患者(155人)に3ヶ月に亘って投与した続けたところ、36.12%の患者に顕著な治癒効果が認められた(下記表2参照)。また、カン黄草のサポニンを投与した患者には、特に副作用は見られなかった。
[Clinical result 2]
When kanpon grass saponin was continuously administered to chronic toxic hepatitis patients (104) for 3 months, a remarkable curative effect was observed in 80.76% of the patients. In addition, when Kang yellow grass saponin was continuously administered to patients with hepatitis C (12 people) over 3 months, a remarkable curative effect was observed in 50.00% of patients. Furthermore, when Kang yellow grass saponin was continuously administered to patients with hepatitis B (155 patients) over 3 months, 36.12% of the patients had a remarkable curative effect (see Table 2 below). ). In addition, no side effects were observed in patients who received saponin of corn yellow grass.
[臨床結果3]
カン黄草のサポニンを、慢性肝炎の患者(30人)に3ヶ月に亘って投与した続けた場合のALT値(平均値)の変化を表3に示す。また、比較のために、別の慢性肝炎の患者(30人)にSilibinin−N−Meflyglucamineを投与した続けた場合のALT値(平均値)の変化も表3に示す。なお、カン黄草のサポニンを投与した患者には、特に副作用は見られなかった。表3から、カン黄草のサポニンを投与し続けた場合(表3における“Gansu”)には、Silibinin−N−Meflyglucamineを投与し続けた場合よりもALT値の低下の度合いが大きいことが分かる。
[Clinical result 3]
Table 3 shows changes in the ALT value (average value) when kanpon grass saponin was continuously administered to chronic hepatitis patients (30 people) over 3 months. For comparison, Table 3 also shows the change in the ALT value (average value) when Silibinin-N-Meflylucamine was continuously administered to another chronic hepatitis patient (30 people). There were no side effects observed in patients who received saponin of corn yellow grass. From Table 3, it can be seen that when the saponin of corn yellow grass is continuously administered (“Gansu” in Table 3), the degree of decrease in the ALT value is greater than when silibinin-N-Meflylucamine is continuously administered. .
[臨床結果4]
カン黄草のサポニンを、慢性B型肝炎の患者(25人)に3ヶ月に亘って投与した続けた場合のG値(平均値)の変化を表4に示す。また、比較のために、別の慢性B型肝炎の患者(20人)にYiganlingおよびcarmineを投与した続けた場合のG値(平均値)の変化も表4に示す。なお、カン黄草のサポニンを投与した患者には、特に副作用は見られなかった。表4から、カン黄草のサポニンを投与し続けた場合には、Yiganlingおよびcarmineを投与し続けた場合よりもG値の低下の度合いが大きいことが分かる。
[Clinical result 4]
Table 4 shows the change in G value (average value) when saponin of can yellow grass was continuously administered to patients with chronic hepatitis B (25 people) over 3 months. For comparison, Table 4 also shows changes in the G value (average value) when Yiganling and carmine were continuously administered to another chronic hepatitis B patient (20 patients). There were no side effects observed in patients who received saponin of corn yellow grass. From Table 4, it can be seen that the degree of decrease in the G value is greater when kanpon grass saponin is continuously administered than when Yiganling and carmine are continuously administered.
[臨床結果5]
カン黄草のサポニンを、種々の肝炎の患者(155人)に3ヶ月に亘って投与した続けた後のHBV−DNAの減少率(平均値)を表5に示す。また、比較のために、別の肝炎患者(60人)にJitaileおよびcarmineを投与した続けた後のHBV−DNAの減少率(平均値)も表5に示す。なお、カン黄草のサポニンを投与した患者には、特に副作用は見られなかった。表5から、カン黄草のサポニンを投与し続けた場合には、Jitaileおよびcarmineを投与し続けた場合よりもHBV−DNAの減少の度合いが大きいことが分かる。
[Clinical result 5]
Table 5 shows the decrease rate (average value) of HBV-DNA after kanpon grass saponin was continuously administered to various hepatitis patients (155 patients) over 3 months. For comparison, Table 5 also shows the reduction rate (average value) of HBV-DNA after continuing to administer Jitaile and carmine to another hepatitis patient (60 people). There were no side effects observed in patients who received saponin of corn yellow grass. From Table 5, it can be seen that the degree of decrease in HBV-DNA is greater when kanpon grass saponin continues to be administered than when Jitaile and carmine continue to be administered.
なお、本発明の治療薬およびその製造方法の構成は、上記実施形態の態様に何ら限定されるものではなく、本発明の趣旨を逸脱しない範囲で適宜変更することができる。たとえば、カン黄草サポニンは、上記実施形態以外の抽出方法によって抽出することも可能である。また、上記各抽出方法を採用する場合には、必要に応じて抽出時間や溶媒の濃度を変更することも可能である。さらに、抽出形態1の如き態様でカン黄草サポニンを抽出する場合には、図4の如く、メタノールの代わりにエタノールを用いることも可能である。加えて、本発明の治療薬は、カン黄草サポニンのみを含有したものに限定されず、異なる成分を含有するものでも良い。 In addition, the structure of the therapeutic agent of this invention and its manufacturing method is not limited to the aspect of the said embodiment at all, and can be suitably changed in the range which does not deviate from the meaning of this invention. For example, can yellow grass saponin can be extracted by an extraction method other than the above embodiment. Moreover, when each said extraction method is employ | adopted, it is also possible to change extraction time and the density | concentration of a solvent as needed. Furthermore, in the case of extracting corn saponin in an embodiment like the extraction form 1, ethanol can be used instead of methanol as shown in FIG. In addition, the therapeutic agent of the present invention is not limited to one containing only can yellow grass saponin, and may contain different components.
本発明に係るカン黄草サポニンは、上記の如く高い治癒効果を奏するとともに副作用を生じないものであるから、肝疾患の治療薬として広範に適用することができる。 Since the corn saponin according to the present invention has a high curative effect as described above and does not cause side effects, it can be widely applied as a therapeutic agent for liver diseases.
Claims (4)
A method for producing a therapeutic agent for a liver disease, comprising the step of boiling corn yellow root powder with water and then filtering the boiled solution and collecting the filtrate.
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KR100949417B1 (en) * | 2007-11-21 | 2010-03-24 | 재단법인서울대학교산학협력재단 | Dendrobium nobile Lindl extract and compounds with the activity inhibiting hepatic fibrosis |
CN103006738A (en) * | 2012-11-27 | 2013-04-03 | 王盘虎 | Medicinal liquor for treating HBsAg, HBeAb, and HBcAb test positive and preparation method thereof |
CN104054495A (en) * | 2014-07-08 | 2014-09-24 | 何寒 | Dendrobium candidum planting method |
CN104983698A (en) * | 2015-06-26 | 2015-10-21 | 广西健宝石斛有限责任公司 | Dendrobium officinale polysaccharide buccal tablet and preparation method thereof |
CN105039107A (en) * | 2015-09-07 | 2015-11-11 | 江苏恒顺醋业股份有限公司 | Dendrobium officinale yellow wine and preparation method thereof |
CN105725200A (en) * | 2016-02-24 | 2016-07-06 | 云南久丽康源石斛开发有限公司 | Processing method for soluble dendrobium officinale freeze-dried powder |
CN105865151A (en) * | 2016-04-14 | 2016-08-17 | 西华大学 | Rapid dendrobe drying method |
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