JP5834803B2 - Oral solution - Google Patents
Oral solution Download PDFInfo
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- JP5834803B2 JP5834803B2 JP2011250583A JP2011250583A JP5834803B2 JP 5834803 B2 JP5834803 B2 JP 5834803B2 JP 2011250583 A JP2011250583 A JP 2011250583A JP 2011250583 A JP2011250583 A JP 2011250583A JP 5834803 B2 JP5834803 B2 JP 5834803B2
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- corn silk
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- 229940100688 oral solution Drugs 0.000 title description 2
- 240000008042 Zea mays Species 0.000 claims description 37
- 235000007244 Zea mays Nutrition 0.000 claims description 34
- 229940089639 cornsilk Drugs 0.000 claims description 32
- 239000001231 zea mays silk Substances 0.000 claims description 32
- 239000000284 extract Substances 0.000 claims description 30
- 239000007788 liquid Substances 0.000 claims description 16
- 238000001556 precipitation Methods 0.000 claims description 16
- PVNIIMVLHYAWGP-UHFFFAOYSA-N Niacin Chemical compound OC(=O)C1=CC=CN=C1 PVNIIMVLHYAWGP-UHFFFAOYSA-N 0.000 claims description 14
- 235000001968 nicotinic acid Nutrition 0.000 claims description 13
- 229960003512 nicotinic acid Drugs 0.000 claims description 13
- 239000011664 nicotinic acid Substances 0.000 claims description 13
- 238000000034 method Methods 0.000 claims description 7
- 230000000052 comparative effect Effects 0.000 description 20
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 14
- 239000003960 organic solvent Substances 0.000 description 11
- 238000002360 preparation method Methods 0.000 description 9
- DFPAKSUCGFBDDF-UHFFFAOYSA-N Nicotinamide Chemical compound NC(=O)C1=CC=CN=C1 DFPAKSUCGFBDDF-UHFFFAOYSA-N 0.000 description 8
- 239000003814 drug Substances 0.000 description 7
- QTBSBXVTEAMEQO-UHFFFAOYSA-N Acetic acid Chemical compound CC(O)=O QTBSBXVTEAMEQO-UHFFFAOYSA-N 0.000 description 6
- 230000000694 effects Effects 0.000 description 6
- -1 2-dichloroethane Substances 0.000 description 5
- 241000411851 herbal medicine Species 0.000 description 5
- 239000000203 mixture Substances 0.000 description 5
- BJEPYKJPYRNKOW-REOHCLBHSA-N (S)-malic acid Chemical compound OC(=O)[C@@H](O)CC(O)=O BJEPYKJPYRNKOW-REOHCLBHSA-N 0.000 description 4
- BJEPYKJPYRNKOW-UHFFFAOYSA-N alpha-hydroxysuccinic acid Natural products OC(=O)C(O)CC(O)=O BJEPYKJPYRNKOW-UHFFFAOYSA-N 0.000 description 4
- 230000015572 biosynthetic process Effects 0.000 description 4
- 229940079593 drug Drugs 0.000 description 4
- 238000001035 drying Methods 0.000 description 4
- 238000000605 extraction Methods 0.000 description 4
- 239000000796 flavoring agent Substances 0.000 description 4
- 239000001630 malic acid Substances 0.000 description 4
- 235000011090 malic acid Nutrition 0.000 description 4
- 235000005152 nicotinamide Nutrition 0.000 description 4
- 239000011570 nicotinamide Substances 0.000 description 4
- 239000002244 precipitate Substances 0.000 description 4
- 239000002904 solvent Substances 0.000 description 4
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- YMWUJEATGCHHMB-UHFFFAOYSA-N Dichloromethane Chemical compound ClCCl YMWUJEATGCHHMB-UHFFFAOYSA-N 0.000 description 3
- RTZKZFJDLAIYFH-UHFFFAOYSA-N Diethyl ether Chemical compound CCOCC RTZKZFJDLAIYFH-UHFFFAOYSA-N 0.000 description 3
- XEKOWRVHYACXOJ-UHFFFAOYSA-N Ethyl acetate Chemical compound CCOC(C)=O XEKOWRVHYACXOJ-UHFFFAOYSA-N 0.000 description 3
- OKKJLVBELUTLKV-UHFFFAOYSA-N Methanol Chemical compound OC OKKJLVBELUTLKV-UHFFFAOYSA-N 0.000 description 3
- ZMXDDKWLCZADIW-UHFFFAOYSA-N N,N-Dimethylformamide Chemical compound CN(C)C=O ZMXDDKWLCZADIW-UHFFFAOYSA-N 0.000 description 3
- DNIAPMSPPWPWGF-UHFFFAOYSA-N Propylene glycol Chemical compound CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 description 3
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 description 3
- YXFVVABEGXRONW-UHFFFAOYSA-N Toluene Chemical compound CC1=CC=CC=C1 YXFVVABEGXRONW-UHFFFAOYSA-N 0.000 description 3
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 description 3
- 238000011156 evaluation Methods 0.000 description 3
- 235000019634 flavors Nutrition 0.000 description 3
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- 239000011521 glass Substances 0.000 description 3
- 230000002209 hydrophobic effect Effects 0.000 description 3
- VLKZOEOYAKHREP-UHFFFAOYSA-N n-Hexane Chemical compound CCCCCC VLKZOEOYAKHREP-UHFFFAOYSA-N 0.000 description 3
- 239000008213 purified water Substances 0.000 description 3
- 238000003756 stirring Methods 0.000 description 3
- PUPZLCDOIYMWBV-UHFFFAOYSA-N (+/-)-1,3-Butanediol Chemical compound CC(O)CCO PUPZLCDOIYMWBV-UHFFFAOYSA-N 0.000 description 2
- HEDRZPFGACZZDS-UHFFFAOYSA-N Chloroform Chemical compound ClC(Cl)Cl HEDRZPFGACZZDS-UHFFFAOYSA-N 0.000 description 2
- RGHNJXZEOKUKBD-SQOUGZDYSA-N D-gluconic acid Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@@H](O)C(O)=O RGHNJXZEOKUKBD-SQOUGZDYSA-N 0.000 description 2
- IAZDPXIOMUYVGZ-UHFFFAOYSA-N Dimethylsulphoxide Chemical compound CS(C)=O IAZDPXIOMUYVGZ-UHFFFAOYSA-N 0.000 description 2
- 241000196324 Embryophyta Species 0.000 description 2
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 2
- VZCYOOQTPOCHFL-OWOJBTEDSA-N Fumaric acid Chemical compound OC(=O)\C=C\C(O)=O VZCYOOQTPOCHFL-OWOJBTEDSA-N 0.000 description 2
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 description 2
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 description 2
- 240000007594 Oryza sativa Species 0.000 description 2
- 235000007164 Oryza sativa Nutrition 0.000 description 2
- JUJWROOIHBZHMG-UHFFFAOYSA-N Pyridine Chemical compound C1=CC=NC=C1 JUJWROOIHBZHMG-UHFFFAOYSA-N 0.000 description 2
- WYURNTSHIVDZCO-UHFFFAOYSA-N Tetrahydrofuran Chemical compound C1CCOC1 WYURNTSHIVDZCO-UHFFFAOYSA-N 0.000 description 2
- 235000011054 acetic acid Nutrition 0.000 description 2
- 239000002253 acid Substances 0.000 description 2
- 230000002378 acidificating effect Effects 0.000 description 2
- WNLRTRBMVRJNCN-UHFFFAOYSA-N adipic acid Chemical compound OC(=O)CCCCC(O)=O WNLRTRBMVRJNCN-UHFFFAOYSA-N 0.000 description 2
- 230000002421 anti-septic effect Effects 0.000 description 2
- 239000003125 aqueous solvent Substances 0.000 description 2
- RYYVLZVUVIJVGH-UHFFFAOYSA-N caffeine Chemical compound CN1C(=O)N(C)C(=O)C2=C1N=CN2C RYYVLZVUVIJVGH-UHFFFAOYSA-N 0.000 description 2
- 239000003795 chemical substances by application Substances 0.000 description 2
- 235000019441 ethanol Nutrition 0.000 description 2
- JVTAAEKCZFNVCJ-UHFFFAOYSA-N lactic acid Chemical compound CC(O)C(O)=O JVTAAEKCZFNVCJ-UHFFFAOYSA-N 0.000 description 2
- 239000006193 liquid solution Substances 0.000 description 2
- 239000000463 material Substances 0.000 description 2
- 239000000843 powder Substances 0.000 description 2
- ZUFQODAHGAHPFQ-UHFFFAOYSA-N pyridoxine hydrochloride Chemical compound Cl.CC1=NC=C(CO)C(CO)=C1O ZUFQODAHGAHPFQ-UHFFFAOYSA-N 0.000 description 2
- 229960004172 pyridoxine hydrochloride Drugs 0.000 description 2
- 235000019171 pyridoxine hydrochloride Nutrition 0.000 description 2
- 239000011764 pyridoxine hydrochloride Substances 0.000 description 2
- 239000002994 raw material Substances 0.000 description 2
- 229950001574 riboflavin phosphate Drugs 0.000 description 2
- 235000009566 rice Nutrition 0.000 description 2
- 150000003839 salts Chemical class 0.000 description 2
- 235000002639 sodium chloride Nutrition 0.000 description 2
- VZGDMQKNWNREIO-UHFFFAOYSA-N tetrachloromethane Chemical compound ClC(Cl)(Cl)Cl VZGDMQKNWNREIO-UHFFFAOYSA-N 0.000 description 2
- VZCYOOQTPOCHFL-UHFFFAOYSA-N trans-butenedioic acid Natural products OC(=O)C=CC(O)=O VZCYOOQTPOCHFL-UHFFFAOYSA-N 0.000 description 2
- 229940088594 vitamin Drugs 0.000 description 2
- 235000013343 vitamin Nutrition 0.000 description 2
- 239000011782 vitamin Substances 0.000 description 2
- 229930003231 vitamin Natural products 0.000 description 2
- 229940058015 1,3-butylene glycol Drugs 0.000 description 1
- RYHBNJHYFVUHQT-UHFFFAOYSA-N 1,4-Dioxane Chemical compound C1COCCO1 RYHBNJHYFVUHQT-UHFFFAOYSA-N 0.000 description 1
- XDTMQSROBMDMFD-UHFFFAOYSA-N Cyclohexane Chemical compound C1CCCCC1 XDTMQSROBMDMFD-UHFFFAOYSA-N 0.000 description 1
- RGHNJXZEOKUKBD-UHFFFAOYSA-N D-gluconic acid Natural products OCC(O)C(O)C(O)C(O)C(O)=O RGHNJXZEOKUKBD-UHFFFAOYSA-N 0.000 description 1
- FEWJPZIEWOKRBE-JCYAYHJZSA-N Dextrotartaric acid Chemical compound OC(=O)[C@H](O)[C@@H](O)C(O)=O FEWJPZIEWOKRBE-JCYAYHJZSA-N 0.000 description 1
- WHUUTDBJXJRKMK-UHFFFAOYSA-N Glutamic acid Natural products OC(=O)C(N)CCC(O)=O WHUUTDBJXJRKMK-UHFFFAOYSA-N 0.000 description 1
- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 description 1
- LPHGQDQBBGAPDZ-UHFFFAOYSA-N Isocaffeine Natural products CN1C(=O)N(C)C(=O)C2=C1N(C)C=N2 LPHGQDQBBGAPDZ-UHFFFAOYSA-N 0.000 description 1
- CKLJMWTZIZZHCS-REOHCLBHSA-N L-aspartic acid Chemical compound OC(=O)[C@@H](N)CC(O)=O CKLJMWTZIZZHCS-REOHCLBHSA-N 0.000 description 1
- WHUUTDBJXJRKMK-VKHMYHEASA-N L-glutamic acid Chemical compound OC(=O)[C@@H](N)CCC(O)=O WHUUTDBJXJRKMK-VKHMYHEASA-N 0.000 description 1
- 208000004880 Polyuria Diseases 0.000 description 1
- OFOBLEOULBTSOW-UHFFFAOYSA-N Propanedioic acid Natural products OC(=O)CC(O)=O OFOBLEOULBTSOW-UHFFFAOYSA-N 0.000 description 1
- 240000004808 Saccharomyces cerevisiae Species 0.000 description 1
- KDYFGRWQOYBRFD-UHFFFAOYSA-N Succinic acid Natural products OC(=O)CCC(O)=O KDYFGRWQOYBRFD-UHFFFAOYSA-N 0.000 description 1
- FEWJPZIEWOKRBE-UHFFFAOYSA-N Tartaric acid Natural products [H+].[H+].[O-]C(=O)C(O)C(O)C([O-])=O FEWJPZIEWOKRBE-UHFFFAOYSA-N 0.000 description 1
- 235000005824 Zea mays ssp. parviglumis Nutrition 0.000 description 1
- 235000002017 Zea mays subsp mays Nutrition 0.000 description 1
- 239000000654 additive Substances 0.000 description 1
- 239000001361 adipic acid Substances 0.000 description 1
- 235000011037 adipic acid Nutrition 0.000 description 1
- 150000001298 alcohols Chemical class 0.000 description 1
- 235000001014 amino acid Nutrition 0.000 description 1
- 150000001413 amino acids Chemical class 0.000 description 1
- 239000003963 antioxidant agent Substances 0.000 description 1
- 235000003704 aspartic acid Nutrition 0.000 description 1
- OQFSQFPPLPISGP-UHFFFAOYSA-N beta-carboxyaspartic acid Natural products OC(=O)C(N)C(C(O)=O)C(O)=O OQFSQFPPLPISGP-UHFFFAOYSA-N 0.000 description 1
- 210000000941 bile Anatomy 0.000 description 1
- 230000004531 blood pressure lowering effect Effects 0.000 description 1
- 235000019437 butane-1,3-diol Nutrition 0.000 description 1
- KDYFGRWQOYBRFD-NUQCWPJISA-N butanedioic acid Chemical compound O[14C](=O)CC[14C](O)=O KDYFGRWQOYBRFD-NUQCWPJISA-N 0.000 description 1
- 229960001948 caffeine Drugs 0.000 description 1
- VJEONQKOZGKCAK-UHFFFAOYSA-N caffeine Natural products CN1C(=O)N(C)C(=O)C2=C1C=CN2C VJEONQKOZGKCAK-UHFFFAOYSA-N 0.000 description 1
- 235000015165 citric acid Nutrition 0.000 description 1
- 239000003086 colorant Substances 0.000 description 1
- 238000013329 compounding Methods 0.000 description 1
- 238000007796 conventional method Methods 0.000 description 1
- 235000005822 corn Nutrition 0.000 description 1
- WPUMTJGUQUYPIV-JIZZDEOASA-L disodium (S)-malate Chemical compound [Na+].[Na+].[O-]C(=O)[C@@H](O)CC([O-])=O WPUMTJGUQUYPIV-JIZZDEOASA-L 0.000 description 1
- 230000001882 diuretic effect Effects 0.000 description 1
- 239000002552 dosage form Substances 0.000 description 1
- 235000013355 food flavoring agent Nutrition 0.000 description 1
- 235000003599 food sweetener Nutrition 0.000 description 1
- 238000009472 formulation Methods 0.000 description 1
- 239000003205 fragrance Substances 0.000 description 1
- 239000001530 fumaric acid Substances 0.000 description 1
- 235000011087 fumaric acid Nutrition 0.000 description 1
- 239000000174 gluconic acid Substances 0.000 description 1
- 235000012208 gluconic acid Nutrition 0.000 description 1
- 239000004220 glutamic acid Substances 0.000 description 1
- 235000013922 glutamic acid Nutrition 0.000 description 1
- 235000011187 glycerol Nutrition 0.000 description 1
- 238000010438 heat treatment Methods 0.000 description 1
- 239000012676 herbal extract Substances 0.000 description 1
- 238000007602 hot air drying Methods 0.000 description 1
- 238000007603 infrared drying Methods 0.000 description 1
- 230000002401 inhibitory effect Effects 0.000 description 1
- 150000007529 inorganic bases Chemical class 0.000 description 1
- 229910052500 inorganic mineral Inorganic materials 0.000 description 1
- 239000004310 lactic acid Substances 0.000 description 1
- 235000014655 lactic acid Nutrition 0.000 description 1
- VZCYOOQTPOCHFL-UPHRSURJSA-N maleic acid Chemical compound OC(=O)\C=C/C(O)=O VZCYOOQTPOCHFL-UPHRSURJSA-N 0.000 description 1
- 239000011976 maleic acid Substances 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 239000011707 mineral Substances 0.000 description 1
- 235000010755 mineral Nutrition 0.000 description 1
- 150000007522 mineralic acids Chemical class 0.000 description 1
- 238000002156 mixing Methods 0.000 description 1
- 229960003966 nicotinamide Drugs 0.000 description 1
- 150000007524 organic acids Chemical class 0.000 description 1
- 235000005985 organic acids Nutrition 0.000 description 1
- 239000003002 pH adjusting agent Substances 0.000 description 1
- 238000010979 pH adjustment Methods 0.000 description 1
- 230000000144 pharmacologic effect Effects 0.000 description 1
- 239000003755 preservative agent Substances 0.000 description 1
- 239000000047 product Substances 0.000 description 1
- 230000001737 promoting effect Effects 0.000 description 1
- 235000013772 propylene glycol Nutrition 0.000 description 1
- UMJSCPRVCHMLSP-UHFFFAOYSA-N pyridine Natural products COC1=CC=CN=C1 UMJSCPRVCHMLSP-UHFFFAOYSA-N 0.000 description 1
- 229940109850 royal jelly Drugs 0.000 description 1
- 230000028327 secretion Effects 0.000 description 1
- 239000011734 sodium Substances 0.000 description 1
- 229910052708 sodium Inorganic materials 0.000 description 1
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- 238000000638 solvent extraction Methods 0.000 description 1
- 241000894007 species Species 0.000 description 1
- 239000003381 stabilizer Substances 0.000 description 1
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- 239000003765 sweetening agent Substances 0.000 description 1
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- 235000002906 tartaric acid Nutrition 0.000 description 1
- YLQBMQCUIZJEEH-UHFFFAOYSA-N tetrahydrofuran Natural products C=1C=COC=1 YLQBMQCUIZJEEH-UHFFFAOYSA-N 0.000 description 1
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- 150000003722 vitamin derivatives Chemical class 0.000 description 1
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- Medicinal Preparation (AREA)
- Medicines Containing Plant Substances (AREA)
Description
本発明は、沈殿生成を抑制したコーンシルクエキスを含有する内服液剤に関する。 The present invention relates to an internal solution containing a corn silk extract that suppresses the formation of precipitates.
近年、生薬の原料となるような薬用植物が有する効果への期待は高まりつつあり、医薬分野の他に、一般食品、健康食品、機能性食品、特定保健用食品及び保健機能食品等の各種食品の素材として応用されつつある。その商品形態の一つとして、生薬の原料となるような薬用植物を含有する液剤が多数市販されている。液剤は、服用がしやすいこと、速やかに薬効が発揮されること、などの利点を有することから、好ましい剤形の一つとして用いられている。
「コーンシルク（corn silk）」は欧米で民間的に使用されており、日本でも「ナンバンゲ」などの名で市販されている。また、漢方生薬として南蛮毛としても知られ、中国では「玉蜀黍柱頭」、「玉蜀黍蕊」、「玉米鬚」の名で用いられている。薬理作用として、利尿効果、血圧降下作用、胆汁分泌促進効果などが報告されている（非特許文献１〜４）。
In recent years, expectations for the effects of medicinal plants that can be used as raw materials for herbal medicines are increasing. It is being applied as a material. As one of the product forms, many liquid medicines containing medicinal plants that are raw materials for herbal medicine are commercially available. A liquid preparation is used as one of the preferable dosage forms because it has advantages such as easy administration and quick drug efficacy.
“Corn silk” is used privately in Europe and America, and is also marketed in Japan under the name “Nambange”. In addition, it is also known as a traditional Chinese herbal medicine, Minami Hashige, and is used in China under the names of “onion stigma”, “onion”, and “onion rice bowl”. As a pharmacological action, a diuretic effect, a blood pressure lowering effect, a bile secretion promoting effect and the like have been reported (Non-Patent Documents 1 to 4).
コーンシルクエキスは食品素材として知られているものである（特許文献１）。そこで、本発明者らは、コーンシルクを含有する内服液剤を調製したところ、内服液剤中に沈殿を生じることを発見した。風味および防腐性の観点から酸性領域が好ましく、酸性領域で沈殿を少しでも抑制する技術が望まれるが、今までに、内服液剤中のコーンシルクエキスの沈殿を抑制する方法について、検討された報告はない。 Corn silk extract is known as a food material (Patent Document 1). Accordingly, the present inventors have found that when an internal liquid preparation containing corn silk is prepared, precipitation occurs in the internal liquid preparation. From the viewpoint of flavor and antiseptic properties, the acidic region is preferable, and a technique for suppressing precipitation in the acidic region as much as possible is desired, but so far, a method for suppressing the precipitation of corn silk extract in oral liquids has been studied. There is no.
本発明は、コーンシルクエキスを含有する内服液剤の沈殿生成を抑制することを課題とする。 This invention makes it a subject to suppress the precipitation production | generation of the internal use liquid agent containing a corn silk extract.
そこで、この問題を解決すべく鋭意検討を重ねた結果、ナイアシンがこの沈殿生成を抑制できることを見出し、本発明を完成するに至った。 Thus, as a result of intensive studies to solve this problem, it was found that niacin can suppress the precipitation, and the present invention has been completed.
即ち本発明は、
（１）ａ）コーンシルクエキス、及びｂ）ナイアシンを含有し、ｐＨが２．５〜４．５であることを特徴とする内服液剤、
（２）コーンシルクエキスを含有し、ｐＨが２．５〜４．５である内服液剤において、ナイアシンを配合することにより沈殿生成を抑制する方法、
である。
That is, the present invention
(1) An oral liquid preparation containing a) corn silk extract, and b) niacin, and having a pH of 2.5 to 4.5,
(2) A method for suppressing precipitation formation by blending niacin in an internal liquid containing corn silk extract and having a pH of 2.5 to 4.5,
It is.
本発明により、コーンシルクエキスを含有する内服液剤の沈殿の生成を容易に抑制し、安定なコーンシルクエキス含有内服液剤を提供することが可能となった。 According to the present invention, it has become possible to easily suppress the formation of a precipitate of an internal liquid solution containing corn silk extract and to provide a stable corn silk extract-containing internal liquid solution.
本発明のコーンシルクは、イネ科（Gramineae）のトウモロコシ（Zea mays L.）の雌花の花柱と柱頭を乾燥したものである。生薬の南蛮毛としても知られ、トウモロコシの雌花の花柱や柱頭をむしりとって乾燥させたものである。その乾燥方法は特に限定されないが、例えば、熱風乾燥、真空凍結乾燥、遠赤外線乾燥、マイクロ波加熱乾燥、天日干し等が挙げられる。上記のイネ科（Gramineae）のトウモロコシ（Zea mays L.）とは、その近縁種或いは栽培品種も含むものとする。 The corn silk of the present invention is obtained by drying the female flower pillars and stigmas of Gramineae maize (Zea mays L.). It is also known as the crude herb of the herbal medicine. The drying method is not particularly limited, and examples include hot air drying, vacuum freeze drying, far-infrared drying, microwave heating drying, and sun drying. The above Gramineae corn (Zea mays L.) includes its related species or cultivars.
本発明のコーンシルクエキスを得るための抽出方法は特に限定されないが、溶媒抽出法が好適に用いられる。 Although the extraction method for obtaining the corn silk extract of this invention is not specifically limited, A solvent extraction method is used suitably.
抽出溶媒として、水系溶媒又は有機溶媒のいずれも使用することができる。前記水系溶媒としては、水、熱水等が好適に使用される。水の種類は特に限定されず、純水、精製水等であってもよい。尚、抽出溶媒として熱水を使用する場合、その熱水の温度は５０〜１００℃、好ましくは８０〜１００℃である。 As the extraction solvent, either an aqueous solvent or an organic solvent can be used. As the aqueous solvent, water, hot water or the like is preferably used. The type of water is not particularly limited and may be pure water, purified water, or the like. In addition, when using hot water as an extraction solvent, the temperature of the hot water is 50-100 degreeC, Preferably it is 80-100 degreeC.
抽出溶媒として有機溶媒が用いられる場合、親水性有機溶媒、疎水性有機溶媒のいずれでもよい。親水性有機溶媒としては、例えば、メチルアルコール、エチルアルコール、グリセリン、プロピレングリコール、１、３−ブチレングリコール等のアルコール、アセトン、テトラヒドロフラン、アセトニトリル、１、４−ジオキサン、ピリジン、ジメチルスルホキシド、Ｎ、Ｎ−ジメチルホルムアミド、酢酸等の公知の有機溶媒が挙げられる。上記の親水性有機溶媒は水との混合物として用いられてもよい。疎水性有機溶媒としては、例えば、ヘキサン、シクロヘキサン、四塩化炭素、クロロホルム、ジクロロメタン、１、
２−ジクロロエタン、ジエチルエーテル、酢酸エチル、ベンゼン、トルエン等の公知の有機溶媒が挙げられる。上記の親水性有機溶媒および疎水性有機溶媒はそれぞれ単独で用いることもできるし、２種以上を組み合わせて用いることもできる。
When an organic solvent is used as the extraction solvent, either a hydrophilic organic solvent or a hydrophobic organic solvent may be used. Examples of the hydrophilic organic solvent include alcohols such as methyl alcohol, ethyl alcohol, glycerin, propylene glycol, and 1,3-butylene glycol, acetone, tetrahydrofuran, acetonitrile, 1,4-dioxane, pyridine, dimethyl sulfoxide, N, N -Well-known organic solvents, such as a dimethylformamide and acetic acid, are mentioned. The hydrophilic organic solvent may be used as a mixture with water. Examples of the hydrophobic organic solvent include hexane, cyclohexane, carbon tetrachloride, chloroform, dichloromethane,
Well-known organic solvents, such as 2-dichloroethane, diethyl ether, ethyl acetate, benzene, toluene, are mentioned. Said hydrophilic organic solvent and hydrophobic organic solvent can also be used individually, respectively, and can also be used in combination of 2 or more type.
また、本発明で使用するコーンシルクエキスは、産業上入手することも可能であり、例えば福田龍株式会社製のコーンシルク乾燥エキスや松浦薬業株式会社製のコーンシルクエキスパウダーＰを挙げることができる。 In addition, the corn silk extract used in the present invention can be obtained industrially, and examples thereof include a dried corn silk extract manufactured by Ryu Fukuda and a corn silk extract powder P manufactured by Matsuura Pharmaceutical Co., Ltd. it can.
コーンシルクエキスの含有量は内服液剤中、０．０５〜１質量％であり、好ましくは０．１〜０．６質量％である。本発明に用いられるナイアシンはニコチン酸およびニコチン酸アミドの総称であり，公知の方法によって合成したものを使用しても良いし，酵母，米ぬか等から抽出したものを用いても良い。ナイアシンの含有量は内服液剤中、０．００１〜１質量％であり、好ましくは０．０１〜１質量％、さらに好ましくは０．０３〜０．６質量％である。 The content of the corn silk extract is 0.05 to 1% by mass, preferably 0.1 to 0.6% by mass, in the internal solution. Niacin used in the present invention is a general term for nicotinic acid and nicotinic acid amide, and those synthesized by a known method may be used, or those extracted from yeast, rice bran and the like may be used. The content of niacin is 0.001 to 1% by mass, preferably 0.01 to 1% by mass, and more preferably 0.03 to 0.6% by mass in the oral solution.
本発明の内服液剤において、コーンシルクエキスとナイアシンの配合比は、コーンシルクエキス１質量部に対して通常０．０６〜６質量部であり、好ましくは０．１６〜１質量部である。０．０６質量部未満であると、コーンシルクエキスの沈殿防止効果が充分でないことがあるためであり，６質量部を超えると風味の点で好ましくない。そして、コーンシルクエキスの沈殿を防止させるという観点からは、コーンシルクエキス１質量部に対して０．１６質量部以上を含有させることが好ましい。 In the internal use liquid preparation of the present invention, the compounding ratio of corn silk extract and niacin is usually 0.06 to 6 parts by mass, preferably 0.16 to 1 part by mass with respect to 1 part by mass of corn silk extract. If the amount is less than 0.06 parts by mass, the effect of preventing precipitation of corn silk extract may not be sufficient, and if it exceeds 6 parts by mass, it is not preferable in terms of flavor. And from a viewpoint of preventing precipitation of a corn silk extract, it is preferable to contain 0.16 mass part or more with respect to 1 mass part of corn silk extract.
また、本発明の内服液剤のｐＨは２．５〜４．５である。この範囲は、風味と防腐性の観点からも好ましい。ｐＨを高くするとナイアシンによる沈殿抑制効果が小さくなることから、ｐＨは４．５以下であることが好ましく、さらに好ましくは３．６〜４．２である。本発明の内服液剤のｐＨ調整は、通常使用されるｐＨ調整剤を使用することができ、具体的には、クエン酸、リンゴ酸、酒石酸、コハク酸、乳酸、酢酸、マレイン酸、グルコン酸、アスパラギン酸、アジピン酸、グルタミン酸、フマル酸などの有機酸およびそれらの塩類、塩酸などの無機酸、水酸化ナトリウムなどの無機塩基などが挙げられる。 Moreover, the pH of the internal use liquid preparation of this invention is 2.5-4.5. This range is also preferable from the viewpoints of flavor and antiseptic properties. When the pH is increased, the effect of suppressing precipitation by niacin is reduced. Therefore, the pH is preferably 4.5 or less, and more preferably 3.6 to 4.2. For the pH adjustment of the internal liquid preparation of the present invention, a commonly used pH adjuster can be used. Specifically, citric acid, malic acid, tartaric acid, succinic acid, lactic acid, acetic acid, maleic acid, gluconic acid, Examples thereof include organic acids such as aspartic acid, adipic acid, glutamic acid and fumaric acid and salts thereof, inorganic acids such as hydrochloric acid, and inorganic bases such as sodium hydroxide.
本発明の内服液剤にはその他の成分として、ビタミン類、ミネラル類、アミノ酸類又はその塩類、生薬類、生薬抽出物類、カフェイン、ローヤルゼリーなどを本発明の効果を損なわない範囲で適宜に配合することができる。 As internal components of the present invention, vitamins, minerals, amino acids or salts thereof, herbal medicines, herbal extracts, caffeine, royal jelly, etc. are appropriately blended within the range not impairing the effects of the present invention. can do.
さらに必要に応じて、抗酸化剤、着色剤、香料、矯味剤、界面活性剤、溶解補助剤、増粘安定剤、保存剤、甘味料、酸味料などの添加物を本発明の効果を損なわない範囲で適宜に配合することができる。 Furthermore, if necessary, additives such as antioxidants, coloring agents, fragrances, flavoring agents, surfactants, solubilizers, thickening stabilizers, preservatives, sweeteners, acidulants, and the like may impair the effects of the present invention. It can mix | blend suitably in the range which is not.
本発明の内服液剤は、常法により調製することができ、その方法は特に限定されるものではない。例えば、コーンシルクエキスに適量の水と酸を加えた後、ナイアシンと残りの精製水を加えて容量調整することにより得られる。 The internal liquid preparation of the present invention can be prepared by a conventional method, and the method is not particularly limited. For example, it can be obtained by adding appropriate amounts of water and acid to corn silk extract, and then adding niacin and the remaining purified water to adjust the volume.
本発明の内服液剤は、食品飲料以外にもシロップ剤、ドリンク剤などの医薬品や医薬部外品などに適用することができる。 The internal liquid preparation of the present invention can be applied to pharmaceuticals such as syrups and drinks and quasi-drugs in addition to food drinks.
以下に、実施例、比較例及び試験例を挙げ、本発明をさらに詳細に説明するが、本発明はこれらの実施例等に何ら限定されるものではない。 Hereinafter, the present invention will be described in more detail with reference to Examples, Comparative Examples, and Test Examples, but the present invention is not limited to these Examples.
表１に実施例１〜８、表２に比較例１〜８、表３に比較例９〜１２の処方を示した。実施例および比較例ではコーンシルクエキスとして、トウモロコシの花柱及び柱頭を水で抽出して製したエキス末（以下、コーンシルクエキスと記載する）を使用した。
実施例１〜８、比較例１０、１２は、コーンシルクエキスに全量の半分程度の水を加え、ナイアシンとしてニコチン酸アミドを添加し、十分に攪拌した後、リンゴ酸を一定量添加し，リンゴ酸ナトリウムでｐＨを調整し、精製水を加えて全量を５０ｍｌとした。これをガラス瓶に充填してキャップを施し、内服液剤を得た。
Table 1 shows the formulations of Examples 1 to 8, Table 2 to Comparative Examples 1 to 8, and Table 3 to Comparative Examples 9 to 12. In Examples and Comparative Examples, as corn silk extract, an extract powder (hereinafter referred to as corn silk extract) produced by extracting corn stigma and stigma with water was used.
In Examples 1 to 8 and Comparative Examples 10 and 12, about half the total amount of water was added to corn silk extract, nicotinamide was added as niacin, and after sufficient stirring, a certain amount of malic acid was added. The pH was adjusted with sodium acid, and purified water was added to make the total volume 50 ml. This was filled in a glass bottle and capped to obtain an internal solution.
比較例１〜６、９、１１は、コーンシルクエキスに全量の半分程度の水を加え、リンゴ酸を一定量添加した後、十分に攪拌し，リンゴ酸ナトリウムでｐＨを調整し，精製水を加えて全量を５０ｍｌとし、ガラス瓶に充填してキャップを施して内服液剤を得た。
比較例７、８は、ナイアシンの代わりに水溶性ビタミンであるリボフラビンリン酸エステル（ＶＢ２）、塩酸ピリドキシン（ＶＢ６）のいずれかを添加し、十分攪拌した後、リンゴ酸を一定量添加し，精製水を加えて全量を５０ｍｌとした。これをガラス瓶に充填してキャップを施して内服液剤を得た。
Comparative Examples 1-6, 9, and 11 add about half of the total amount of water to corn silk extract, add a certain amount of malic acid, and then stir well, adjust the pH with sodium malate, In addition, the total amount was 50 ml, filled in a glass bottle and capped to obtain an internal solution.
In Comparative Examples 7 and 8, either riboflavin phosphate ester (VB2) or pyridoxine hydrochloride (VB6), which is a water-soluble vitamin, was added instead of niacin, and after sufficient stirring, a certain amount of malic acid was added and purified. Water was added to make a total volume of 50 ml. This was filled in a glass bottle and capped to obtain an internal solution.
（試験例）
実施例１〜８及び比較例１〜１２のコーンシルクエキス含有液剤を室温で１日保管後、沈殿を目視により観察した。表４の基準で沈殿生成度合いを評価した。 各コントロールの評価を３とし、コントロールに対する相対評価を行った。「コントロールと同程度の沈殿がある」を３とし、「コントロールよりもやや少ない」を２，「コントロールよりも少ない」を１，「コントロールよりもやや多い」を４，「コントロールより多い」を５とした。実施例１は比較例１をコントロールとし、実施例２、３および比較例７，８は比較例２をコントロールとし、実施例４、５は比較例３、実施例６は比較例４、実施例７は比較例５、実施例８は比較例６、比較例１０は比較例９、比較例１２は比較例１１をそれぞれコントロールとし、沈殿生成の度合いを評価した。評価結果は表４〜表６に示した。
(Test example)
After the corn silk extract-containing liquid agents of Examples 1 to 8 and Comparative Examples 1 to 12 were stored at room temperature for 1 day, the precipitates were visually observed. The degree of precipitate formation was evaluated according to the criteria in Table 4. The evaluation of each control was set to 3, and the relative evaluation with respect to the control was performed. “Same degree of precipitation as control” is 3, 3 is “slightly less than control”, 2 is “less than control”, 1 is “slightly more than control”, 4 is “5 more than control” It was. Example 1 uses Comparative Example 1 as a control, Examples 2 and 3 and Comparative Examples 7 and 8 use Comparative Example 2 as a control, Examples 4 and 5 use Comparative Example 3, Example 6 uses Comparative Example 4 and Example 7 was Comparative Example 5, Example 8 was Comparative Example 6, Comparative Example 10 was Comparative Example 9, and Comparative Example 12 was Comparative Example 11, and the degree of precipitation was evaluated. The evaluation results are shown in Tables 4-6.
表５〜表７から明らかなように、ニコチン酸アミドを配合するとコーンシルクエキス配合液剤の沈殿生成が抑制された。一方で、リボフラビンリン酸エステルや塩酸ピリドキシンを配合した比較例７、８では沈殿抑制効果は得られなかった。また、ｐＨ５．０以上では、ニコチン酸アミドを添加しても沈殿抑制効果は得られなかった。 As apparent from Tables 5 to 7, when nicotinic acid amide was blended, the precipitation of corn silk extract blend liquid was suppressed. On the other hand, in Comparative Examples 7 and 8 in which riboflavin phosphate ester or pyridoxine hydrochloride was blended, no precipitation suppressing effect was obtained. Moreover, at pH 5.0 or more, even if nicotinic acid amide was added, the precipitation inhibitory effect was not acquired.
本発明により、内服液剤中におけるコーンシルクエキスの沈殿を抑制することが可能となったので、医薬品、医薬部外品及び食品の分野において、商品性の高いコーンシルクエキス含有内服液剤を提供することが期待される。 According to the present invention, it has become possible to suppress the precipitation of corn silk extract in an internal solution, and therefore, in the fields of pharmaceuticals, quasi-drugs and foods, a highly commercial corn silk extract-containing internal solution is provided. There is expected.
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