TWI595881B - A use of an extract of asplenium australasicum (j. sm.) hook. - Google Patents

A use of an extract of asplenium australasicum (j. sm.) hook. Download PDF

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TWI595881B
TWI595881B TW105137325A TW105137325A TWI595881B TW I595881 B TWI595881 B TW I595881B TW 105137325 A TW105137325 A TW 105137325A TW 105137325 A TW105137325 A TW 105137325A TW I595881 B TWI595881 B TW I595881B
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hepatitis
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virus
nanyangshansu
nanyangshan sushui
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TW201818950A (en
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黃昆暄
陳景川
黃瑞齡
何淑禎
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景鑫生物科技股份有限公司
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Priority to CN201780071348.1A priority patent/CN110621330A/en
Priority to PCT/US2017/061395 priority patent/WO2018093734A1/en
Publication of TW201818950A publication Critical patent/TW201818950A/en

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/16—Drugs for disorders of the alimentary tract or the digestive system for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/11—Pteridophyta or Filicophyta (ferns)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12—Antivirals
    • A61P31/20—Antivirals for DNA viruses
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine

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Description

南洋山蘇水萃物的用途 Use of Nanyangshan Sushui Extract

本發明係關於一種南洋山蘇水萃物的用途，特別關於一種南洋山蘇水萃物應用於製備B型肝炎治療用藥物的用途。 The invention relates to the use of a Nanyangshan Sushui extract, in particular to a use of a Nanyangshan Sushui extract for the preparation of a medicament for treating hepatitis B.

B型肝炎(hepatitis B)係為一種國人常見之疾病，成人中約有15%體內帶有B型肝炎病毒(hepatitis B virus)，且B型肝炎病毒造成之慢性肝病、肝硬化(cirrhosis)及肝癌(hepatocellular carcinoma)等衍生疾患，更是位居國人十大死因之榜首。 Hepatitis B is a common disease in Chinese. About 15% of adults have hepatitis B virus, and chronic liver disease, cirrhosis caused by hepatitis B virus and Derived diseases such as liver cancer (hepatocellular carcinoma) are the top ten causes of death among Chinese people.

肝安能(Lamivudine)為一種用以治療B型肝炎之習用藥物，肝安能係屬於胞苷類似物(cytidine analogue)，可以抑制B型肝炎病毒之反轉錄酶，進而抑制B型肝炎病毒之複製。惟，肝安能用於治療慢性B型肝炎時，卻容易因為療程較長，使B型肝炎病毒發生突變，而產生抗藥性病毒株，可能會使肝安能之治療效果變得不佳，是以，確實仍有必要發展新的抗B型肝炎藥物。 Lamivudine is a conventional drug for the treatment of hepatitis B. The liver energy system belongs to the cytidine analogue, which can inhibit the reverse transcriptase of hepatitis B virus and inhibit the hepatitis B virus. copy. However, when liver ampoules can be used to treat chronic hepatitis B, it is easy to cause a mutation in the hepatitis B virus due to a long course of treatment, and a drug-resistant virus strain may cause poor healing effects of the liver. Therefore, it is still necessary to develop new anti-hepatitis B drugs.

為解決上述問題，本發明提供一種南洋山蘇水萃物的用途，係將萃取自南洋山蘇之活性成分，應用於製備B型肝炎治療用的藥物者。 In order to solve the above problems, the present invention provides a use of a Nanyangshan Sushui extract, which is an active ingredient extracted from Nanyangshansu, and is used for preparing a medicament for treating hepatitis B.

本發明之南洋山蘇水萃物的用途，係應用於製備B型肝炎治療用的藥物，其中，該南洋山蘇水萃物係水於115~125℃之溫度、0.35~0.5Kg/cm2G之壓力下萃取1.5~3小時所獲得；如此藉由萃取自南洋山蘇 之活性成分，可以抑制B型肝炎病毒之存活，清除體內之B型肝炎病毒，因而可以應用於製備B型肝炎治療用的藥物，為本發明之功效。 The use of the Nanyangshan Sushui extract of the present invention is applied to the preparation of a medicament for treating hepatitis B, wherein the water of the Nanyangshan Sushui extract is at a temperature of 115 to 125 ° C, 0.35 to 0.5 kg/cm 2 . Extracted under the pressure of G for 1.5~3 hours; thus, by extracting the active ingredient from Nanyangshansu, it can inhibit the survival of hepatitis B virus and eliminate the hepatitis B virus in the body, so it can be used for the preparation of hepatitis B treatment. The drug used is the efficacy of the present invention.

第1圖：投予本發明南洋山蘇水萃物對野生型B型肝炎病毒株之B肝表面抗原的影響結果柱狀圖。 Fig. 1 is a bar graph showing the effect of the Nanyangshan Sushui extract of the present invention on the B liver surface antigen of the wild type hepatitis B virus strain.

第2圖：投予本發明南洋山蘇水萃物對抗藥性B型肝炎病毒株之B肝表面抗原的影響結果柱狀圖。 Fig. 2 is a bar graph showing the effect of administration of the Nanyangshan Sushui extract of the present invention against the hepatitis B surface antigen of the drug-induced hepatitis B virus strain.

為讓本發明之上述及其他目的、特徵及優點能更明顯易懂，下文特舉本發明之較佳實施例，並配合所附圖式，作詳細說明如下：本發明所述之「南洋山蘇(Asplenium australasicum(J.Sm.)Hook.)」，係指鐵角蕨科(Aspleniaceae)鐵角蕨屬(Asplenium)的植物，其新生嫩葉(young emerging frond)常被作為食用菜葉。 The above and other objects, features and advantages of the present invention will become more <RTIgt; Asplenium australasicum (J.Sm.) Hook.) refers to the plant of the Asplenaceae Asplenium , whose young emerging frond is often used as a edible leaf.

本發明之南洋山蘇水萃物，係可以抑制B型肝炎病毒之存活，清除體內之B型肝炎病毒，因而可以應用於製備B型肝炎治療用的藥物，該南洋山蘇水萃物與醫藥學上可以接受之載劑或賦形劑組合形成一醫藥組合物，其中，該南洋山蘇水萃物係可以製備成任何方便食用之型式，如錠劑、膠囊、粉劑、粒劑或液劑等，或者將該南洋山蘇水萃物與其他食品或飲料組合，以適於食用之樣態供生物體以口服方式服用。 The Nanyangshan Sushui extract of the invention can inhibit the survival of the hepatitis B virus and eliminate the hepatitis B virus in the body, and thus can be applied to the preparation of the medicine for treating hepatitis B, the Nanyangshan Sushui extract and medicine A medically acceptable carrier or combination of excipients is combined to form a pharmaceutical composition, wherein the aqueous extract of Nanyangshansu can be prepared into any convenient form such as a tablet, capsule, powder, granule or liquid. Etc., or combine the Nanyangshan Sushui extract with other foods or beverages for oral administration for the organism to take.

其中，該南洋山蘇水萃物較佳係可以藉由一包含以下步驟之方法所製得：提供一南洋山蘇樣品；以水作為一萃取溶劑萃取該南洋山蘇樣品；及將南洋山蘇粗萃液進行濃縮，以獲得該南洋山蘇水萃物。 Wherein, the Nanyangshan Sushui extract can be obtained by a method comprising the steps of: providing a sample of Nanyangshansu; extracting the sample of Nanyangshansu with water as an extraction solvent; and using Nanyangshansu The crude extract is concentrated to obtain the aqueous extract of Nanyangshansu.

詳而言之，該南洋山蘇樣品係可以為南洋山蘇之成熟老葉(三年以上，背面分布孢子)，較佳係可以預先將該南洋山蘇樣品於110~ 120℃之溫度下進行乾燥(將100克南洋山蘇樣品乾燥至20克)，得到一南洋山蘇乾燥物；此外，該南洋山蘇樣品亦可以預先碎成粉粒(粒徑約為1~2mm)，以增加該南洋山蘇樣品與該萃取溶劑之接觸表面積，藉此提升後續萃取之萃取效率。 In detail, the Nanyangshansu sample system can be the mature old leaves of Nanyangshansu (more than three years, spores are distributed on the back), and the preferred system can pre-sample the Nanyangshansu in 110~ Drying at a temperature of 120 ° C (drying 100 g of Nanyangshansu sample to 20 g), to obtain a dry product of Nanyangshansu; in addition, the sample of Nanyangshansu can also be broken into powder particles (particle size is about 1~) 2mm) to increase the contact surface area of the Nanyangshansu sample with the extraction solvent, thereby improving the extraction efficiency of the subsequent extraction.

舉例而言，每4.8kg之南洋山蘇樣品係能夠混合該萃取溶劑，使二者總體積達80L，並於115~125℃之溫度、0.35~0.5Kg/cm2G之壓力下進行萃取1.5~3小時，上述萃取亦可以重複數次，使該南洋山蘇樣品所富含之活性成分可以完整溶出於該萃取溶劑，此為本發明所屬技術領域中具有通常知識者所廣泛應用，在此不加以贅述。 For example, each 4.8 kg of Nanyangshansu sample can mix the extraction solvent to a total volume of 80 L, and extract at a temperature of 115-125 ° C and a pressure of 0.35-0.5 Kg/cm 2 G. ~3 hours, the above extraction may also be repeated several times, so that the active ingredient rich in the sample of Nanyangshansu can be completely dissolved in the extraction solvent, which is widely used by those having ordinary knowledge in the technical field of the invention. Do not repeat them.

前述之南洋山蘇粗萃液可以經過減壓濃縮及冷凍乾燥，以獲得該南洋山蘇水萃物，藉由此一程序，係可以使該南洋山蘇水萃物之活性成分更加濃縮，是以僅需使用少量之該南洋山蘇水萃物即可以發揮最佳療效。 The aforementioned Nanyangshan Su crude extract liquid can be concentrated under reduced pressure and freeze-dried to obtain the Nanyangshan Sushui extract. By this procedure, the active ingredient of the Nanyangshan Sushui extract can be more concentrated. The best effect can be achieved by using only a small amount of the Nanyangshan Sushui extract.

為證實本發明之南洋山蘇水萃物係可以清除B型肝炎病毒，遂進行以下試驗，其中，以下試驗除選用野生型B型肝炎病毒株外，另選用對習用藥物肝安能具有抗藥性之抗藥性B型肝炎病毒株進行試驗，於此先行敘明。 In order to confirm that the Nanyangshan Sushui extract of the present invention can remove the hepatitis B virus, the following test is carried out, wherein the following test is in addition to the wild type hepatitis B virus strain, and the drug is resistant to the conventional drug The drug-resistant hepatitis B virus strain was tested and described first.

(A)南洋山蘇水萃物清除野生型B型肝炎病毒之效果 (A) Effect of removal of wild-type hepatitis B virus by Nanyangshan Sushui extract

請參照第1表所示，本試驗係分別以不同濃度之南洋山蘇水萃物處理野生型B型肝炎病毒株48小時後，以ELISA之方式偵測各組培養液之B肝表面抗原(HBsAg)含量，其結果如第1圖所示。 Please refer to Table 1. For the 48-hour treatment of wild-type hepatitis B virus strains with different concentrations of Nanyangshan Sushui extract, the B liver surface antigens of each group were detected by ELISA. The content of HBsAg) is shown in Fig. 1.

請參照第1圖所示，無論是添加濃度為6.25~100μL/mL之南洋山蘇水萃物，對於野生型B型肝炎病毒株均有良好之抑制效果，顯示本發明之南洋山蘇水萃物係可以抑制該野生型B型肝炎病毒株之存活，以達到清除B型肝炎病毒之功效。 Please refer to Figure 1 for the addition of the Nanyangshan Sushui extract with a concentration of 6.25~100μL/mL, which has a good inhibitory effect on the wild-type hepatitis B virus strain, showing the Nanyangshan Sushui extract of the present invention. The system can inhibit the survival of the wild-type hepatitis B virus strain to achieve the effect of clearing the hepatitis B virus.

(B)南洋山蘇水萃物清除抗藥性B型肝炎病毒之效果 (B) Effect of Nanyangshan Sushui Extract on the removal of drug-resistant hepatitis B virus

請參照第1表所示，本試驗係分別以不同濃度之南洋山蘇水萃物處理抗藥性B型肝炎病毒株48小時後，以ELISA之方式偵測各組培養液之B肝表面抗原(HBsAg)含量，其結果如第2圖所示。 Please refer to the first table. In this test, the drug-resistant hepatitis B virus strain was treated with different concentrations of Nanyangshan Sushui extract for 48 hours, and the B liver surface antigen of each group was detected by ELISA. The content of HBsAg) is shown in Fig. 2.

請參照第2圖所示，無論是添加濃度為6.25~25μL/mL之南洋山蘇水萃物，對於抗藥性B型肝炎病毒株均有良好之抑制效果，顯示本發明之南洋山蘇水萃物係可以抑制該抗藥性B型肝炎病毒株之存活，以達到清除B型肝炎病毒之功效。 Please refer to Fig. 2, the addition of Nanyangshan Sushui extract with a concentration of 6.25~25μL/mL, which has a good inhibitory effect on the drug-resistant hepatitis B virus strain, showing the Nanyangshan Sushui extract of the present invention. The system can inhibit the survival of the drug-resistant hepatitis B virus strain to achieve the effect of clearing the hepatitis B virus.

綜合上述試驗結果，南洋山蘇水萃物可以有效抑制B型肝炎病毒株之存活，因而可以清除生物體內之B型肝炎病毒，以達到治療B型 肝炎之功效；此外，針對抗藥性B型肝炎病毒株，南洋山蘇水萃物仍可以抑制其存活，進而可以作為肝安能之第二線藥物，於肝安能之投藥導致抗藥性病毒株之產生後，仍可以有效抑制該抗藥性病毒株之存活，而可以有效治療B型肝炎，降低B型肝炎之發生率。 Based on the above test results, the Nanyangshan Sushui extract can effectively inhibit the survival of the hepatitis B virus strain, thus eliminating the hepatitis B virus in the organism to achieve the treatment type B. In addition, for the drug-resistant hepatitis B virus strain, the Nanyangshan Sushui extract can still inhibit its survival, and thus can be used as a second-line drug for liver energy, and the drug-resistant virus strain is produced in the liver. After the occurrence, the survival of the drug-resistant virus strain can be effectively inhibited, and the hepatitis B can be effectively treated, and the incidence of hepatitis B can be reduced.

此外，一名罹患B型肝炎之患者，20年來肝指數GPT常超過200KU/mL，亦常出現猛爆性肝炎之症狀，於服用本發明之南洋山蘇水萃物4個月後，肝指數GPT已成功降至40KU/mL。 In addition, a patient with hepatitis B has a liver index of more than 200 KU/mL in the past 20 years. Symptoms of fulminant hepatitis often occur. After taking the Nanyangshan Sushui extract of the present invention for 4 months, the liver index GPT has been successfully reduced to 40 KU/mL.

綜合上述，本發明之南洋山蘇水萃物的用途係藉由萃取自南洋山蘇之活性成分，可以抑制B型肝炎病毒之存活，清除體內之B型肝炎病毒，因而可以應用於製備B型肝炎治療用的藥物，為本發明之功效。 In summary, the use of the Nanyangshan Sushui extract of the present invention can inhibit the survival of the hepatitis B virus and eliminate the hepatitis B virus in the body by extracting the active ingredient from Nanyangshansu, and thus can be applied to the preparation of type B. The drug for the treatment of hepatitis is the efficacy of the present invention.

再者，本發明之南洋山蘇水萃物的用途，係藉由萃取自南洋山蘇之活性成分，有效減少生物體被B型肝炎病毒感染的風險，進而可以預防慢性肝病、肝硬化、肝代償不全及肝癌等疾病的衍生，為本發明之功效。 Furthermore, the use of the Nanyangshan Sushui extract of the present invention is effective in reducing the risk of infection of the organism by the hepatitis B virus by extracting the active ingredient from Nanyangshansu, thereby preventing chronic liver disease, liver cirrhosis and liver. The decompensation and the derivation of diseases such as liver cancer are the effects of the present invention.

雖然本發明已利用上述較佳實施例揭示，然其並非用以限定本發明，任何熟習此技藝者在不脫離本發明之精神和範圍之內，相對上述實施例進行各種更動與修改仍屬本發明所保護之技術範疇，因此本發明之保護範圍當視後附之申請專利範圍所界定者為準。 While the invention has been described in connection with the preferred embodiments described above, it is not intended to limit the scope of the invention. The technical scope of the invention is protected, and therefore the scope of the invention is defined by the scope of the appended claims.

Claims (1)

一種南洋山蘇水萃物的用途，係應用於製備B型肝炎治療用藥物，其中，該南洋山蘇水萃物係以水作為一萃取溶劑，於115~125℃之溫度、0.35~0.5Kg/cm2G之壓力下萃取一南洋山蘇樣品1.5~3小時所獲得。 The invention relates to a medicine for treating hepatitis B, wherein the Nanyangshan Sushui extract uses water as an extraction solvent at a temperature of 115 to 125 ° C, 0.35 to 0.5 Kg. A sample of Nanyangshansu was extracted under the pressure of /cm 2 G for 1.5 to 3 hours.
TW105137325A 2016-11-15 2016-11-15 A use of an extract of asplenium australasicum (j. sm.) hook. TWI595881B (en)

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TW105137325A TWI595881B (en) 2016-11-15 2016-11-15 A use of an extract of asplenium australasicum (j. sm.) hook.
CN201780071348.1A CN110621330A (en) 2016-11-15 2017-11-13 Method for treating hepatitis B
PCT/US2017/061395 WO2018093734A1 (en) 2016-11-15 2017-11-13 Method for treating hepatitis b

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WO2018226450A1 (en) * 2017-06-06 2018-12-13 Jin Xin Biotechnology Co., Ltd. Method for protecting against chemical-induced hepatotoxicity
CN110177546A (en) * 2016-11-15 2019-08-27 景鑫生物科技股份有限公司 The method for treating hepatitis C

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