TW201417805A - 用於增加人類生長激素位準之組成物 - Google Patents
用於增加人類生長激素位準之組成物 Download PDFInfo
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- TW201417805A TW201417805A TW102134099A TW102134099A TW201417805A TW 201417805 A TW201417805 A TW 201417805A TW 102134099 A TW102134099 A TW 102134099A TW 102134099 A TW102134099 A TW 102134099A TW 201417805 A TW201417805 A TW 201417805A
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Classifications
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- A—HUMAN NECESSITIES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
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- A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
- A61K31/4015—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil having oxo groups directly attached to the heterocyclic ring, e.g. piracetam, ethosuximide
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- A—HUMAN NECESSITIES
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- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
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- A—HUMAN NECESSITIES
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Abstract
本發明之實施態樣一般而言係有關用於增加健康人類之人類生長激素(hGH)位準之補充劑。
Description
本發明之實施態樣一般而言係有關用於增加健康人類之人類生長激素(hGH)位準之補充劑。
hGH之主要生物學功能包含刺激生長、細胞修復及再生。一旦青春期之主要生長期結束，hGH於成年之主要功能成為細胞再生及修復，其幫助皮膚、骨骼、心臟、肺臟、肝臟及腎臟之再生至它們最佳、年輕之細胞水平。如同我們諸多的其他激素或它們的前驅物，諸如睪固酮、雌激素、黃體素、DHEA及褪黑激素的狀況，hGH之位準隨著年紀下降。在治療上，諸多此等激素可被替換來抵消一些老化的影響，諸如女性的更年期症狀或男性的勃起障礙。如同每一其他活著的實體，人體以每日或晝夜(circadian)節律，以及每月及每年的節律在運作。每日的生長激素分泌隨著年齡減少，到了四十歲我們具有的位準大致是我們二十歲時的一半，且在六十歲時其係約青年時位準的三分之一。在一些六十歲的人中，其位準如同一個二十歲的人
的hGH位準的25%。老化的症狀包括肌肉的喪失、脂肪的增加、身體的可動性的降低、能量位準的減少，以及因此社會化的減弱、復原能力的減弱及心血管疾病風險的增加，以及減少的預期壽命。低的hGH位準與老化過程及疾病的早發相關。例如，Rosen及Bengtsson注意到心血管疾病的死亡率在hGH缺乏的病患中係增加的(Rosen,T.,Bengtsson,B.A.,Lancet 336(1990)：285-2880)。
直到近期人類生長激素(此後另稱為hGH)僅有昂貴的注射劑型可用，且能受益於該hGH位準恢復的只有那些有能力支付的人。最近已有能從個體自己的腦下腺前葉引起人類生長激素分泌的物質可用。這些被統稱為促泌素(secretagogues)。促泌素具有潛在能恢復hGH至青年時期之位準的能力。參見由美國抗老學會(American Academy of Anti-Aging)會長Dr.Ronald Klatz所著作的“Grow Young with hGH”一書，其係於1997年由Harper Collins所出版。
hGH缺乏之成年人具有顯著之瘦體質量的減少，且經數個月的hGH治療觀察到瘦體質量、皮膚厚度及肌肉質量之增加。(Cuneo RC et al.J Appl Physiol 1991；70：695-700；Cuneo RC et al.J Appl Physiol 1991；70：688-694；Rudman D et al.N Engl J Med 1969；280：1434-1438)。
靜脈注射某些胺基酸可導致顯著地hGH分泌是早已確立的。於女性中靜脈輸液183mg精胺酸/kg體重可使hGH位準增加>20倍，且在男性中靜脈輸液30g精胺酸/kg體
重可將血清hGH位準提昇8.6倍(Merimee TJ et al.N Engl J Med 1969；280：1434-1438；Alba-Roth J et al.J Clin Endocrinol Metab 1988；67：1186-1189)。其他胺基酸，諸如甲硫胺酸、苯丙胺酸、離胺酸、組胺酸及鳥胺酸，亦可導致hGH顯著地增加(Alba-Roth,Muller,Schopohl,& von Werder,1988；Chromiak & Antonio,2002；Gourmelen,M.,M.Donnadieu,et al.(1972)Ann Endocrinol(Paris)33(5)：526-528)。
有鑑於IV注射胺基酸於廣泛使用上的困難，對於解析hGH對口服胺基酸補充劑之反應的興趣提起對此等補充劑的測試，該補充劑主要包含不同量之精胺酸、離胺酸及鳥胺酸。然而此等研究之間之結果顯著的變異性，其具差異之面相包括受試群體、補充劑之組成及劑量方法學，該結果變異性確立了設計一有效補充劑於一般大眾中支援hGH位準所涉及之複雜性。(Suminski RR et al.Int J Sport Nutr 1997；7：48-60；Lambert MI et al.Int J Sport Nutr 1993；3：298-305；Corpas E et al.J Gerontol 1993；48：M128-M133；Isidori A et al.Curr Med Res Opin 1981；7：475-481；Fogelholm GM et al.Int J Sport Nutr 1993；3：290-297；Chromiak JA,Antonio J.Nutrition 2002 Jul；18(7-8)：657-61)。
由於運動員、演藝人員及現在的一般大眾尋求有效之hGH支援補充劑且了解到hGH具有回復年輕之特性，因此確立一有效且安全之口服功能性摻混物，其能於一般
大眾中刺激hGH分泌係重要的。
確實，一度部分對於運動員及演藝人員，其對有效引起生長激素(hGH)增加之補充劑的渴求現在延伸至一般大眾。他們不只有建構瘦肉組織及減少脂肪之目標，亦有改善膚質及其他回復年輕性質之目標，其等係被理解到可由hGH提供。儘管有現行文獻關於作為刺激hGH用途之口服胺基酸，有關可於包含一廣泛年齡範圍之男性及女性的一般大眾中刺激hGH之含胺基酸的最佳化口服摻混物之證據仍不明確。
提供一用於提昇hGH釋放之營養補充劑係所欲的，特別是一含有胺基酸之組成物，其具有良好之耐受性且對於那些hGH釋放率隨年齡的增加而減緩或那些渴求更高之hGH位準之個體，其具有增加或提昇hGH釋放之結果。雖然一些現有之營養補充劑主張能影響天然之人類生長激素之製造，但對於能於一般大眾中有效增進天然之人類生長激素的製造及功效的一改善之營養補充劑仍是需要的。
本發明係一種營養補充劑。其為一種新穎之含胺基酸之促泌素組成物，當口服該組成物，其能刺激腦下腺增加hGH之血清位準。
本揭露內容之一特定實施態樣係有關於一口服營養補充劑，其包含l-離胺酸、l-精胺酸、氧代-脯胺酸及半
胱胺酸或麩胺醯胺酸之一者等胺基酸。該等胺基酸可以其無毒鹽類、其有效錯合物、其穩定螯合物、其活性酯類、其功能性衍生物及其等之混合物被傳遞，其於增加一般大眾之hGH位準係有效的。
另一特定之態樣係關於一口服營養補充劑，其基本上係由下列所組成：l-離胺酸HCl、l-精胺酸HCl、氧代-脯胺酸、N-乙醯-l-半胱胺酸、l-麩胺醯胺酸及荊芥(schizonepeta)(地上部分)粉末。
圖1顯示與施予安慰劑相比，施予補充劑後之生長激素位準。
本發明係關於供一人類使用之營養補充劑。該營養補充劑係一含有胺基酸之促泌素(secretagogue)組成物，其當以口服服用能刺激該腦下垂體來增加hGH之血清位準。增加之hGH位準可導致胰島素壓抑之抑制、高血糖症之抑制，以及胰島素效用之增加、脂肪轉換之增進、膽固醇下降及脂質平衡之正常化。本發明之補充劑作為一膳食補充劑，其以安全且有效之方式藉由協助身體自己的能力來分泌hGH，而其亦是平價的。
本發明之一特定態樣係關於一口服營養補充劑，其包含l-離胺酸、l-精胺酸、氧代-脯胺酸，以及半胱胺酸或麩胺醯胺酸二者之一。該補充劑可額外包含半胱胺酸
及麩胺醯胺酸兩者，及/或荊芥粉末。在特定之態樣中，一功能性劑量包含一位準在0.1-6mmol之間之該l-精胺酸及0.1-8mmol之間之該氧代-脯胺酸，及/或含量在0.1-12mmol之間之該l-離胺酸。該半胱胺酸及/或麩胺醯胺酸可以位準0.001-6mmol之間被包含。在特定之態樣中，一功能性劑量包含一位準在2.5-4.5mmol間之該l-精胺酸HCl及4-6mmol之間之該氧代-脯胺酸，及/或含量在7-9mmol之間之該l-離胺酸HCl。該半胱胺酸及/或麩胺醯胺酸可以位準0.001-0.5mmol之間被包含。該半胱胺酸可為n-乙醯基L-半胱胺酸以及該麩胺醯胺酸可為l-麩胺醯胺酸。該等胺基酸可被以下列形式投遞：其無毒性鹽類、其有效錯合物、其穩定螯合物、其活性酯類、其功能性衍生物及其等之混合物，其係有效於增加一般民眾之hGH位準。該營養補充劑可以2.9克之量存在。該營養補充劑可為任何可接受及已知之口服製劑，諸如粉末、錠劑、膠囊、液體或薄片(wafer)形式。
另一特定之態樣係關於一口服營養補充劑，其基本上係由下列所組成：l-離胺酸HCl、l-精胺酸HCl、氧代-脯胺酸、N-乙醯-l-半胱胺酸、l-麩胺醯胺酸及荊芥(地上部分)粉末。在特定之態樣中，一功能性劑量包含一位準在0.1-6mmol之間之該l-精胺酸HCl及0.1-8mmol之間之該氧代-脯胺酸，及/或含量在0.1-12mmol之間之該l-離胺酸HCL。該n-乙醯基L-半胱胺酸及/或l-麩胺醯胺酸可以0.001-6mmol之間之位準被包含。在另一特定之態樣中，一功能性劑量包含一位準在2.5-4.5mmol之間之該l-精胺酸
HCl及4-6mmol之間之該氧代-脯胺酸，及/或含量在7-9mmol之間之該l-離胺酸HCL。該n-乙醯基L-半胱胺酸及/或l-麩胺醯胺酸可以0.001-0.5mmol之間之位準被包含。該營養補充劑可為任何可接受以及已知之口服製劑，諸如粉末、錠劑、膠囊、液體或薄片形式。
其他態樣係有關於增加人類之人類生長激素之方法，其包含口服施予該所揭露之營養補充劑於一健康人類。在此所用之「健康人類」，其意指無關年齡沒有任何hGH之生理缺陷的人類。本發明之特定態樣係關於口服施予該所揭露之營養補充劑於一至少30歲之人類。該營養補充劑可以每日自一至三次施予，或者，可以隔日施予，或可以一週一次施予。於特定態樣中，該營養補充劑可空腹施予。
依照「基本上由...組成」及「基本上以...組成」之語句，該第三態樣之該營養補充劑基本上係受限於該等前述之成分，且不包含任何意圖添加營養成分(如維他命、礦物質等)之額外活性成分，但可包含非意圖添加營養成分之額外成分，諸如意圖滿足一非營養性之目的(如著色劑、填充劑、調味劑、用於維持該結構型式之成分等)。
本發明之該營養補充劑之每一成分可依照一熟習此藝者已知之任何方法製備。或者，每一成分可從一完整製備之市售來源所獲得。
本發明之該營養補充劑可為任何合適之口服施予型式，其包含但不限於：一咀嚼劑型式、一液體型式、一噴霧型式、一膠囊型式、一栓劑型式、可溶性薄片及一
粉末型式。
無關該營養補充劑之結構型式，該營養補充劑之該等成分可均質地或非均質地分布於該營養補充劑中。
本發明之該營養補充劑可定期攝入，諸如每天或每週攝入一根據個人所需求之劑量；例如，該營養補充劑係根據該個人之需求以該結構單元(片劑、錠劑、膠囊、液體劑量等)之倍數(1x、2x等)被定期服用。例如，相較於一從事經常性劇烈運動之年輕人(例如一舉重運動員)，一生活主要久坐的老年人可能需要較高之每日劑量。或者，本發明之該營養補充劑可根據個人所需劑量，以視需要攝入。醫學或營養諮詢可能有利於達成根據該個人需求之一理想的或最佳的劑量。
該等胺基酸之種類的組合、質量範圍及特定製劑係被選擇以達協同性平衡的，且其量係足夠以達到所欲之生理效果，即，生長激素釋放。該等胺基酸之不合適之組合可能係無效的。該等胺基酸組份當它們之幾個結合在一起時，在此意義上係具協同性的，其能協同地刺激該人類生長激素之釋放。該組合物亦是經選擇來減少或抑制該等胺基酸之間的化學性組合或反應。
一交叉、安慰劑對照、雙盲之研究，其涉及16位健康受試者[12位男性、4位女性；9位白人、6位非裔美國人及一位其他；平均年齡=32±14歲；身體質量指數=26.4±5.0自19.1至36.8kg/m2之範圍]。每一受試者至該住院病房
報到兩次，其間相隔一週。在隔夜禁食後，受試者被置入一IV管線且於-30、-15及0分鐘採基線血液。受試者隨後被要求吞下該測試補充劑之該等膠囊或樣貌相同之安慰劑。
該所施予之補充劑係一新穎之2.9g/劑量之下列混合物：l-離胺酸HCl、l-精胺酸HCl、氧代-脯胺酸、N-乙醯-l-半胱胺酸、l-麩胺醯胺酸及荊芥(地上部分)粉末。
於15、30、60及90和120分鐘採血作檢驗。於每一時間點使用Siemens Immulite 2000(組內變異係數(intra-assay CV)為3.72%、組間變異係數(inter-assay CV)為5.70%，以及GH偵測極限為0.05ng/ml)量測人類生長激素。
於施予補充劑120分鐘後，生長激素自基線0.17增加至1.33ng/ml，相較於施予安慰劑120分鐘後自0.93減少至0.45ng/ml，平均生長激素比起基線增加八倍(等同於682%)(圖1)。從基線至120分鐘之平均GH位準變化(於120分鐘之GH減GH於0分鐘)在施予補充劑後為1.15(95% CI：0.17,2.14)ng/ml，對上施予安慰劑後為-0.48(-1.47,0.50)ng/ml，顯示一統計上顯著差異之影響(P=0.01)。於施予該補充劑後，該GH之平均AUC橫跨120分鐘係20.43(95% CI：19.90,20.95)ng/ml/min，其係顯著高於(P=0.04)安慰劑之19.67(18.74,20.59)ng/ml/min。整體而言，服用該補充劑120分鐘後，GH位準係顯著高於絕對位準及AUC兩者。
在GH缺乏之受試者的治療中，於皮下注射0.06IU之HGH後所達到之平均GH位準為0.4ng/ml，該數值係清楚地落在見於我們的口服胺基酸研究中之數值範圍
(Janssen YJ et al.Br J Clin Pharmacol 1999；47：273-278)。
此研究涉及一廣泛範圍之年紀及BMI且包含兩種性別。比起先前之hGH評估，此項有關該新穎的包含胺基酸之摻混物的研究之一額外優勢在於，其包含一安慰劑對照組，且其係隨機及雙盲的。
雖然本發明之實施態樣作為說明目的已在此被描述，諸多修飾及改變對於那些熟習此藝者將是顯而易見的。因此，所附之申請專利範圍旨在涵蓋所有落在本發明之真正的精神及範圍內所有之這些修飾及改變。
Claims (21)
- 一種口服營養補充劑，其包含：L-精胺酸；氧代-脯胺酸；L-離胺酸。
- 如請求項1之補充劑，其進一步包含麩胺醯胺酸。
- 如請求項1之補充劑，其進一步包含荊芥(schizonepeta)(地上部分)粉末。
- 如請求項1之補充劑，其中該l-精胺酸係以每一份介於0.1-6mmol間之位準被包含。
- 如請求項1之補充劑，其中該氧代-脯胺酸係以每一份介於0.1-8mmol間之位準被包含。
- 如請求項1之補充劑，其中該l-離胺酸係以每一份介於0.1-12mmol間之位準被包含。
- 如請求項1之補充劑，其中該麩胺醯胺酸係以每一份介於0.001-6mmol間之位準被包含。
- 如請求項1之補充劑，其中該等胺基酸可以下列形式被投遞：其無毒性鹽類、其有效錯合物、其穩定螯合物、其活性酯類、其功能性衍生物及其等之混合物。
- 如請求項1之補充劑，其中該營養補充劑係以2.9克之量存在。
- 如請求項1之補充劑，其中該麩胺醯胺酸係L-麩胺醯胺酸。
- 如請求項1之補充劑，其中該營養補充劑係一粉劑、錠劑、膠囊、液體或薄片(wafer)之型式。
- 一種口服營養補充劑，其基本上係由下列所構成：L-精胺酸HCl；氧代-脯胺酸；L-離胺酸HCl；及N-乙醯-L-半胱胺酸。
- 如請求項12之補充劑，其進一步包含L-麩胺醯胺酸。
- 如請求項12之補充劑，其進一步包含荊芥粉末。
- 如請求項12之補充劑，其中該l-精胺酸係以每一份介於0.1-6mmol間之位準被包含。
- 如請求項12之補充劑，其中該氧代-脯胺酸係以每一份介於0.1-8mmol間之位準被包含。
- 如請求項12之補充劑，其中該l-離胺酸係以每一份介於0.1-12mmol間之位準被包含。
- 如請求項12之補充劑，其中該N-乙醯-L-半胱胺酸係以每一份介於0.001-6mmol間之位準被包含。
- 如請求項12之補充劑，其中該等胺基酸可以下列形式被投遞：其無毒性鹽類、其有效錯合物、其穩定螯合物、其活性酯類、其功能性衍生物及其等之混合物。
- 如請求項12之補充劑，其中該營養補充劑係以2.9克之量存在。
- 如請求項12之補充劑，其中該營養補充劑為一粉劑、錠劑、膠囊、液體或薄片之型式。
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| US13/623,117 US8715752B2 (en) | 2012-09-20 | 2012-09-20 | Compositions for increasing human growth hormone levels |
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| US8747921B2 (en) | 2012-09-19 | 2014-06-10 | Quality Ip Holdings, Inc. | Methods for improving health in humans |
| US9198889B2 (en) | 2012-09-19 | 2015-12-01 | Quality IP Holdings, LLC | Methods for treating post-traumatic stress disorder |
| US8747922B2 (en) | 2012-09-19 | 2014-06-10 | Quality Ip Holdings, Inc. | Methods and compositions for increasing sex steroids and growth hormones |
| US10300101B2 (en) | 2012-09-19 | 2019-05-28 | Quality IP Holdings, LLC | Methods and compositions for enhancing or maintaining fertility |
| US9066953B2 (en) * | 2012-09-20 | 2015-06-30 | Quality IP Holdings, LLC | Methods for increasing endurance and fat metabolism in humans |
| US8747923B2 (en) | 2012-09-20 | 2014-06-10 | Quality Ip Holdings, Inc. | Methods for improving health in canines |
| US10292957B2 (en) | 2012-09-20 | 2019-05-21 | Quality IP Holdings, LLC | Compositions and methods for treating fibromyalgia |
| US10894072B2 (en) | 2017-02-13 | 2021-01-19 | IP Quality Holdings, LLC | Compositions and methods for treating fibromyalgia |
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| TWI663970B (zh) | 2019-07-01 |
| US8715752B2 (en) | 2014-05-06 |
| US10292964B2 (en) | 2019-05-21 |
| US20140242201A1 (en) | 2014-08-28 |
| US20140079831A1 (en) | 2014-03-20 |
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