CN1723998A - Compound red-rooted salvia prepn., and its prepn. method - Google Patents
Compound red-rooted salvia prepn., and its prepn. method Download PDFInfo
- Publication number
- CN1723998A CN1723998A CN 200510036067 CN200510036067A CN1723998A CN 1723998 A CN1723998 A CN 1723998A CN 200510036067 CN200510036067 CN 200510036067 CN 200510036067 A CN200510036067 A CN 200510036067A CN 1723998 A CN1723998 A CN 1723998A
- Authority
- CN
- China
- Prior art keywords
- salviae miltiorrhizae
- concentrated
- hours
- ethanol
- tablet
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
Links
- 150000001875 compounds Chemical class 0.000 title claims abstract description 59
- 238000000034 method Methods 0.000 title claims abstract description 6
- 240000007164 Salvia officinalis Species 0.000 title abstract description 19
- 235000017276 Salvia Nutrition 0.000 title description 5
- 235000003143 Panax notoginseng Nutrition 0.000 claims abstract description 38
- 241000180649 Panax notoginseng Species 0.000 claims abstract description 38
- DTGKSKDOIYIVQL-WEDXCCLWSA-N (+)-borneol Chemical compound C1C[C@@]2(C)[C@@H](O)C[C@@H]1C2(C)C DTGKSKDOIYIVQL-WEDXCCLWSA-N 0.000 claims abstract description 30
- 239000002775 capsule Substances 0.000 claims abstract description 26
- 239000003826 tablet Substances 0.000 claims abstract description 22
- 239000007938 effervescent tablet Substances 0.000 claims abstract description 11
- 239000000654 additive Substances 0.000 claims abstract description 5
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims description 140
- 239000000203 mixture Substances 0.000 claims description 49
- 239000000284 extract Substances 0.000 claims description 46
- 239000000843 powder Substances 0.000 claims description 45
- 238000002360 preparation method Methods 0.000 claims description 44
- 239000000706 filtrate Substances 0.000 claims description 36
- 238000000576 coating method Methods 0.000 claims description 32
- 239000011248 coating agent Substances 0.000 claims description 30
- 229920002472 Starch Polymers 0.000 claims description 29
- 239000008107 starch Substances 0.000 claims description 29
- 235000019698 starch Nutrition 0.000 claims description 29
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 29
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims description 27
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 claims description 27
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims description 26
- 239000007901 soft capsule Substances 0.000 claims description 26
- 239000007788 liquid Substances 0.000 claims description 25
- 238000004064 recycling Methods 0.000 claims description 24
- 239000003795 chemical substances by application Substances 0.000 claims description 22
- GUBGYTABKSRVRQ-QKKXKWKRSA-N lactose group Chemical group OC1[C@H](O)[C@@H](O)[C@H](O[C@H]2[C@H](O)[C@@H](O)[C@@H](O)[C@H](O2)CO)[C@H](O1)CO GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 claims description 21
- 239000007919 dispersible tablet Substances 0.000 claims description 18
- 239000008101 lactose Substances 0.000 claims description 18
- 239000002671 adjuvant Substances 0.000 claims description 17
- 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 claims description 16
- 125000002057 carboxymethyl group Chemical group [H]OC(=O)C([H])([H])[*] 0.000 claims description 16
- 238000009472 formulation Methods 0.000 claims description 16
- 239000011734 sodium Substances 0.000 claims description 16
- 229910052708 sodium Inorganic materials 0.000 claims description 16
- -1 antiseptic Substances 0.000 claims description 15
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims description 13
- 238000001035 drying Methods 0.000 claims description 13
- 239000000945 filler Substances 0.000 claims description 13
- 235000019359 magnesium stearate Nutrition 0.000 claims description 13
- 239000000463 material Substances 0.000 claims description 13
- 239000008108 microcrystalline cellulose Substances 0.000 claims description 13
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims description 13
- 229940016286 microcrystalline cellulose Drugs 0.000 claims description 13
- 239000012567 medical material Substances 0.000 claims description 11
- 229940031703 low substituted hydroxypropyl cellulose Drugs 0.000 claims description 10
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 claims description 9
- 229930195725 Mannitol Natural products 0.000 claims description 9
- DPXJVFZANSGRMM-UHFFFAOYSA-N acetic acid;2,3,4,5,6-pentahydroxyhexanal;sodium Chemical compound [Na].CC(O)=O.OCC(O)C(O)C(O)C(O)C=O DPXJVFZANSGRMM-UHFFFAOYSA-N 0.000 claims description 9
- 230000002421 anti-septic effect Effects 0.000 claims description 9
- 239000000314 lubricant Substances 0.000 claims description 9
- 239000000594 mannitol Substances 0.000 claims description 9
- 235000010355 mannitol Nutrition 0.000 claims description 9
- CIWBSHSKHKDKBQ-JLAZNSOCSA-N Ascorbic acid Chemical compound OC[C@H](O)[C@H]1OC(=O)C(O)=C1O CIWBSHSKHKDKBQ-JLAZNSOCSA-N 0.000 claims description 8
- 108010010803 Gelatin Proteins 0.000 claims description 8
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims description 8
- UIIMBOGNXHQVGW-UHFFFAOYSA-M Sodium bicarbonate Chemical compound [Na+].OC([O-])=O UIIMBOGNXHQVGW-UHFFFAOYSA-M 0.000 claims description 8
- 239000008273 gelatin Substances 0.000 claims description 8
- 229920000159 gelatin Polymers 0.000 claims description 8
- 235000019322 gelatine Nutrition 0.000 claims description 8
- 235000011852 gelatine desserts Nutrition 0.000 claims description 8
- 239000000741 silica gel Substances 0.000 claims description 8
- 229910002027 silica gel Inorganic materials 0.000 claims description 8
- 238000003756 stirring Methods 0.000 claims description 8
- 239000000375 suspending agent Substances 0.000 claims description 8
- 210000000214 mouth Anatomy 0.000 claims description 7
- 229920002785 Croscarmellose sodium Polymers 0.000 claims description 6
- 229940063834 carboxymethylcellulose sodium Drugs 0.000 claims description 6
- 239000008187 granular material Substances 0.000 claims description 6
- 238000002156 mixing Methods 0.000 claims description 6
- 238000010992 reflux Methods 0.000 claims description 6
- 239000003963 antioxidant agent Substances 0.000 claims description 5
- 230000003078 antioxidant effect Effects 0.000 claims description 5
- 235000006708 antioxidants Nutrition 0.000 claims description 5
- 235000009508 confectionery Nutrition 0.000 claims description 5
- 229920000858 Cyclodextrin Polymers 0.000 claims description 4
- XUJNEKJLAYXESH-REOHCLBHSA-N L-Cysteine Chemical compound SC[C@H](N)C(O)=O XUJNEKJLAYXESH-REOHCLBHSA-N 0.000 claims description 4
- FEWJPZIEWOKRBE-UHFFFAOYSA-N Tartaric acid Natural products [H+].[H+].[O-]C(=O)C(O)C(O)C([O-])=O FEWJPZIEWOKRBE-UHFFFAOYSA-N 0.000 claims description 4
- 235000010323 ascorbic acid Nutrition 0.000 claims description 4
- 229960005070 ascorbic acid Drugs 0.000 claims description 4
- 239000011668 ascorbic acid Substances 0.000 claims description 4
- 238000007872 degassing Methods 0.000 claims description 4
- 239000002552 dosage form Substances 0.000 claims description 4
- 239000003995 emulsifying agent Substances 0.000 claims description 4
- 238000010438 heat treatment Methods 0.000 claims description 4
- 238000009413 insulation Methods 0.000 claims description 4
- HFHDHCJBZVLPGP-UHFFFAOYSA-N schardinger α-dextrin Chemical compound O1C(C(C2O)O)C(CO)OC2OC(C(C2O)O)C(CO)OC2OC(C(C2O)O)C(CO)OC2OC(C(O)C2O)C(CO)OC2OC(C(C2O)O)C(CO)OC2OC2C(O)C(O)C1OC2CO HFHDHCJBZVLPGP-UHFFFAOYSA-N 0.000 claims description 4
- 229910000030 sodium bicarbonate Inorganic materials 0.000 claims description 4
- 235000017557 sodium bicarbonate Nutrition 0.000 claims description 4
- GEHJYWRUCIMESM-UHFFFAOYSA-L sodium sulfite Chemical compound [Na+].[Na+].[O-]S([O-])=O GEHJYWRUCIMESM-UHFFFAOYSA-L 0.000 claims description 4
- 239000000126 substance Substances 0.000 claims description 4
- 235000002906 tartaric acid Nutrition 0.000 claims description 4
- 239000011975 tartaric acid Substances 0.000 claims description 4
- 238000007907 direct compression Methods 0.000 claims description 3
- 239000000758 substrate Substances 0.000 claims description 3
- OWEGMIWEEQEYGQ-UHFFFAOYSA-N 100676-05-9 Natural products OC1C(O)C(O)C(CO)OC1OCC1C(O)C(O)C(O)C(OC2C(OC(O)C(O)C2O)CO)O1 OWEGMIWEEQEYGQ-UHFFFAOYSA-N 0.000 claims description 2
- 235000013878 L-cysteine Nutrition 0.000 claims description 2
- 239000004201 L-cysteine Substances 0.000 claims description 2
- GUBGYTABKSRVRQ-PICCSMPSSA-N Maltose Natural products O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@@H](CO)OC(O)[C@H](O)[C@H]1O GUBGYTABKSRVRQ-PICCSMPSSA-N 0.000 claims description 2
- UEDUENGHJMELGK-HYDKPPNVSA-N Stevioside Chemical compound O([C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@H]1O[C@]12C(=C)C[C@@]3(C1)CC[C@@H]1[C@@](C)(CCC[C@]1([C@@H]3CC2)C)C(=O)O[C@H]1[C@@H]([C@@H](O)[C@H](O)[C@@H](CO)O1)O)[C@@H]1O[C@H](CO)[C@@H](O)[C@H](O)[C@H]1O UEDUENGHJMELGK-HYDKPPNVSA-N 0.000 claims description 2
- 229930006000 Sucrose Natural products 0.000 claims description 2
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 claims description 2
- GUBGYTABKSRVRQ-QUYVBRFLSA-N beta-maltose Chemical compound OC[C@H]1O[C@H](O[C@H]2[C@H](O)[C@@H](O)[C@H](O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@@H]1O GUBGYTABKSRVRQ-QUYVBRFLSA-N 0.000 claims description 2
- HRZFUMHJMZEROT-UHFFFAOYSA-L sodium disulfite Chemical compound [Na+].[Na+].[O-]S(=O)S([O-])(=O)=O HRZFUMHJMZEROT-UHFFFAOYSA-L 0.000 claims description 2
- 229940001584 sodium metabisulfite Drugs 0.000 claims description 2
- 235000010262 sodium metabisulphite Nutrition 0.000 claims description 2
- 235000010265 sodium sulphite Nutrition 0.000 claims description 2
- 229940013618 stevioside Drugs 0.000 claims description 2
- OHHNJQXIOPOJSC-UHFFFAOYSA-N stevioside Natural products CC1(CCCC2(C)C3(C)CCC4(CC3(CCC12C)CC4=C)OC5OC(CO)C(O)C(O)C5OC6OC(CO)C(O)C(O)C6O)C(=O)OC7OC(CO)C(O)C(O)C7O OHHNJQXIOPOJSC-UHFFFAOYSA-N 0.000 claims description 2
- 235000019202 steviosides Nutrition 0.000 claims description 2
- 239000005720 sucrose Substances 0.000 claims description 2
- 239000000047 product Substances 0.000 claims 3
- 229920000881 Modified starch Polymers 0.000 claims 1
- 150000007516 brønsted-lowry acids Chemical class 0.000 claims 1
- 150000007528 brønsted-lowry bases Chemical class 0.000 claims 1
- 229960002433 cysteine Drugs 0.000 claims 1
- 239000000469 ethanolic extract Substances 0.000 claims 1
- 239000002994 raw material Substances 0.000 claims 1
- 229940001482 sodium sulfite Drugs 0.000 claims 1
- 235000005412 red sage Nutrition 0.000 abstract description 14
- 239000003814 drug Substances 0.000 abstract description 9
- 239000006187 pill Substances 0.000 abstract description 3
- REPVLJRCJUVQFA-UHFFFAOYSA-N (-)-isopinocampheol Natural products C1C(O)C(C)C2C(C)(C)C1C2 REPVLJRCJUVQFA-UHFFFAOYSA-N 0.000 abstract 1
- 239000002253 acid Substances 0.000 abstract 1
- 230000000996 additive effect Effects 0.000 abstract 1
- 229940116229 borneol Drugs 0.000 abstract 1
- CKDOCTFBFTVPSN-UHFFFAOYSA-N borneol Natural products C1CC2(C)C(C)CC1C2(C)C CKDOCTFBFTVPSN-UHFFFAOYSA-N 0.000 abstract 1
- DTGKSKDOIYIVQL-UHFFFAOYSA-N dl-isoborneol Natural products C1CC2(C)C(O)CC1C2(C)C DTGKSKDOIYIVQL-UHFFFAOYSA-N 0.000 abstract 1
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 description 12
- 229920000036 polyvinylpyrrolidone Polymers 0.000 description 12
- 230000001476 alcoholic effect Effects 0.000 description 10
- 239000001267 polyvinylpyrrolidone Substances 0.000 description 10
- LBZFKNUMOLETLH-UHFFFAOYSA-N CCCCCCCCCCCCCCCCO[S-](=O)=O.OC(CCC(O)=O)=O.[Na+] Chemical compound CCCCCCCCCCCCCCCCO[S-](=O)=O.OC(CCC(O)=O)=O.[Na+] LBZFKNUMOLETLH-UHFFFAOYSA-N 0.000 description 9
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 description 9
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 description 9
- SNKFFCBZYFGCQN-UHFFFAOYSA-N 2-[3-[3-[1-carboxy-2-(3,4-dihydroxyphenyl)ethoxy]carbonyl-2-(3,4-dihydroxyphenyl)-7-hydroxy-2,3-dihydro-1-benzofuran-4-yl]prop-2-enoyloxy]-3-(3,4-dihydroxyphenyl)propanoic acid Chemical compound C=1C=C(O)C=2OC(C=3C=C(O)C(O)=CC=3)C(C(=O)OC(CC=3C=C(O)C(O)=CC=3)C(O)=O)C=2C=1C=CC(=O)OC(C(=O)O)CC1=CC=C(O)C(O)=C1 SNKFFCBZYFGCQN-UHFFFAOYSA-N 0.000 description 8
- SNKFFCBZYFGCQN-VWUOOIFGSA-N Lithospermic acid B Natural products C([C@H](C(=O)O)OC(=O)\C=C\C=1C=2[C@H](C(=O)O[C@H](CC=3C=C(O)C(O)=CC=3)C(O)=O)[C@H](OC=2C(O)=CC=1)C=1C=C(O)C(O)=CC=1)C1=CC=C(O)C(O)=C1 SNKFFCBZYFGCQN-VWUOOIFGSA-N 0.000 description 8
- STCJJTBMWHMRCD-UHFFFAOYSA-N salvianolic acid B Natural products OC(=O)C(Cc1ccc(O)c(O)c1)OC(=O)C=Cc2cc(O)c(O)c3OC(C(C(=O)OC(Cc4ccc(O)c(O)c4)C(=O)O)c23)c5ccc(O)c(O)c5 STCJJTBMWHMRCD-UHFFFAOYSA-N 0.000 description 8
- GUBGYTABKSRVRQ-XLOQQCSPSA-N Alpha-Lactose Chemical compound O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@H]1O[C@@H]1[C@@H](CO)O[C@H](O)[C@H](O)[C@H]1O GUBGYTABKSRVRQ-XLOQQCSPSA-N 0.000 description 7
- DBMJMQXJHONAFJ-UHFFFAOYSA-M Sodium laurylsulphate Chemical compound [Na+].CCCCCCCCCCCCOS([O-])(=O)=O DBMJMQXJHONAFJ-UHFFFAOYSA-M 0.000 description 7
- 239000004141 Sodium laurylsulphate Substances 0.000 description 7
- 235000019333 sodium laurylsulphate Nutrition 0.000 description 7
- 239000003921 oil Substances 0.000 description 6
- 235000019198 oils Nutrition 0.000 description 6
- 239000006185 dispersion Substances 0.000 description 5
- 239000003292 glue Substances 0.000 description 5
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 description 5
- UFVKGYZPFZQRLF-UHFFFAOYSA-N hydroxypropyl methyl cellulose Chemical compound OC1C(O)C(OC)OC(CO)C1OC1C(O)C(O)C(OC2C(C(O)C(OC3C(C(O)C(O)C(CO)O3)O)C(CO)O2)O)C(CO)O1 UFVKGYZPFZQRLF-UHFFFAOYSA-N 0.000 description 5
- 235000015112 vegetable and seed oil Nutrition 0.000 description 5
- 239000008158 vegetable oil Substances 0.000 description 5
- 229920002565 Polyethylene Glycol 400 Polymers 0.000 description 4
- GWEVSGVZZGPLCZ-UHFFFAOYSA-N Titan oxide Chemical compound O=[Ti]=O GWEVSGVZZGPLCZ-UHFFFAOYSA-N 0.000 description 4
- 239000012153 distilled water Substances 0.000 description 4
- 238000005469 granulation Methods 0.000 description 4
- 230000003179 granulation Effects 0.000 description 4
- JLFNLZLINWHATN-UHFFFAOYSA-N pentaethylene glycol Chemical compound OCCOCCOCCOCCOCCO JLFNLZLINWHATN-UHFFFAOYSA-N 0.000 description 4
- DNIAPMSPPWPWGF-UHFFFAOYSA-N Propylene glycol Chemical compound CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 description 3
- 235000006040 Prunus persica var persica Nutrition 0.000 description 3
- 239000001768 carboxy methyl cellulose Substances 0.000 description 3
- 239000007766 cera flava Substances 0.000 description 3
- FPAFDBFIGPHWGO-UHFFFAOYSA-N dioxosilane;oxomagnesium;hydrate Chemical compound O.[Mg]=O.[Mg]=O.[Mg]=O.O=[Si]=O.O=[Si]=O.O=[Si]=O.O=[Si]=O FPAFDBFIGPHWGO-UHFFFAOYSA-N 0.000 description 3
- 239000008188 pellet Substances 0.000 description 3
- HNJBEVLQSNELDL-UHFFFAOYSA-N pyrrolidin-2-one Chemical compound O=C1CCCN1 HNJBEVLQSNELDL-UHFFFAOYSA-N 0.000 description 3
- 210000000582 semen Anatomy 0.000 description 3
- 235000019812 sodium carboxymethyl cellulose Nutrition 0.000 description 3
- 229920001027 sodium carboxymethylcellulose Polymers 0.000 description 3
- 239000003549 soybean oil Substances 0.000 description 3
- 235000012424 soybean oil Nutrition 0.000 description 3
- 239000000080 wetting agent Substances 0.000 description 3
- JLPULHDHAOZNQI-ZTIMHPMXSA-N 1-hexadecanoyl-2-(9Z,12Z-octadecadienoyl)-sn-glycero-3-phosphocholine Chemical compound CCCCCCCCCCCCCCCC(=O)OC[C@H](COP([O-])(=O)OCC[N+](C)(C)C)OC(=O)CCCCCCC\C=C/C\C=C/CCCCC JLPULHDHAOZNQI-ZTIMHPMXSA-N 0.000 description 2
- 244000144730 Amygdalus persica Species 0.000 description 2
- FEWJPZIEWOKRBE-JCYAYHJZSA-N Dextrotartaric acid Chemical compound OC(=O)[C@H](O)[C@@H](O)C(O)=O FEWJPZIEWOKRBE-JCYAYHJZSA-N 0.000 description 2
- 235000010489 acacia gum Nutrition 0.000 description 2
- 239000001785 acacia senegal l. willd gum Substances 0.000 description 2
- 239000000470 constituent Substances 0.000 description 2
- 230000000694 effects Effects 0.000 description 2
- 238000000605 extraction Methods 0.000 description 2
- JEIPFZHSYJVQDO-UHFFFAOYSA-N iron(III) oxide Inorganic materials O=[Fe]O[Fe]=O JEIPFZHSYJVQDO-UHFFFAOYSA-N 0.000 description 2
- 239000004006 olive oil Substances 0.000 description 2
- 235000008390 olive oil Nutrition 0.000 description 2
- 239000000049 pigment Substances 0.000 description 2
- 229940093429 polyethylene glycol 6000 Drugs 0.000 description 2
- 229940083466 soybean lecithin Drugs 0.000 description 2
- 239000006188 syrup Substances 0.000 description 2
- 235000020357 syrup Nutrition 0.000 description 2
- 239000004408 titanium dioxide Substances 0.000 description 2
- ZEMPKEQAKRGZGQ-AAKVHIHISA-N 2,3-bis[[(z)-12-hydroxyoctadec-9-enoyl]oxy]propyl (z)-12-hydroxyoctadec-9-enoate Chemical compound CCCCCCC(O)C\C=C/CCCCCCCC(=O)OCC(OC(=O)CCCCCCC\C=C/CC(O)CCCCCC)COC(=O)CCCCCCC\C=C/CC(O)CCCCCC ZEMPKEQAKRGZGQ-AAKVHIHISA-N 0.000 description 1
- 239000004925 Acrylic resin Substances 0.000 description 1
- 229920000178 Acrylic resin Polymers 0.000 description 1
- 235000019489 Almond oil Nutrition 0.000 description 1
- 241000208838 Asteraceae Species 0.000 description 1
- 239000001856 Ethyl cellulose Substances 0.000 description 1
- ZZSNKZQZMQGXPY-UHFFFAOYSA-N Ethyl cellulose Chemical compound CCOCC1OC(OC)C(OCC)C(OCC)C1OC1C(O)C(O)C(OC)C(CO)O1 ZZSNKZQZMQGXPY-UHFFFAOYSA-N 0.000 description 1
- 229920002153 Hydroxypropyl cellulose Polymers 0.000 description 1
- 240000008415 Lactuca sativa Species 0.000 description 1
- 239000004372 Polyvinyl alcohol Substances 0.000 description 1
- 240000005809 Prunus persica Species 0.000 description 1
- 206010039509 Scab Diseases 0.000 description 1
- 238000010521 absorption reaction Methods 0.000 description 1
- 239000000853 adhesive Substances 0.000 description 1
- 230000001070 adhesive effect Effects 0.000 description 1
- 238000013019 agitation Methods 0.000 description 1
- 239000008168 almond oil Substances 0.000 description 1
- 239000011230 binding agent Substances 0.000 description 1
- GJHXGOBGPWPCCK-UHFFFAOYSA-N blechnic acid Natural products OC(=O)C1C=2C(C=CC(=O)O)=CC=C(O)C=2OC1C1=CC=C(O)C(O)=C1 GJHXGOBGPWPCCK-UHFFFAOYSA-N 0.000 description 1
- 230000015556 catabolic process Effects 0.000 description 1
- 235000015165 citric acid Nutrition 0.000 description 1
- 238000009833 condensation Methods 0.000 description 1
- 230000005494 condensation Effects 0.000 description 1
- 239000006071 cream Substances 0.000 description 1
- 230000006866 deterioration Effects 0.000 description 1
- UGMCXQCYOVCMTB-UHFFFAOYSA-K dihydroxy(stearato)aluminium Chemical compound CCCCCCCCCCCCCCCCCC(=O)O[Al](O)O UGMCXQCYOVCMTB-UHFFFAOYSA-K 0.000 description 1
- 229940079593 drug Drugs 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- 235000019325 ethyl cellulose Nutrition 0.000 description 1
- 229920001249 ethyl cellulose Polymers 0.000 description 1
- 229960001617 ethyl hydroxybenzoate Drugs 0.000 description 1
- 235000010228 ethyl p-hydroxybenzoate Nutrition 0.000 description 1
- 239000004403 ethyl p-hydroxybenzoate Substances 0.000 description 1
- NUVBSKCKDOMJSU-UHFFFAOYSA-N ethylparaben Chemical compound CCOC(=O)C1=CC=C(O)C=C1 NUVBSKCKDOMJSU-UHFFFAOYSA-N 0.000 description 1
- 239000007941 film coated tablet Substances 0.000 description 1
- 239000007888 film coating Substances 0.000 description 1
- 239000000796 flavoring agent Substances 0.000 description 1
- 235000019634 flavors Nutrition 0.000 description 1
- 239000008899 fufang danshen Substances 0.000 description 1
- 230000002496 gastric effect Effects 0.000 description 1
- 239000001863 hydroxypropyl cellulose Substances 0.000 description 1
- 235000010977 hydroxypropyl cellulose Nutrition 0.000 description 1
- 229920000609 methyl cellulose Polymers 0.000 description 1
- 239000001923 methylcellulose Substances 0.000 description 1
- 235000010981 methylcellulose Nutrition 0.000 description 1
- 238000005457 optimization Methods 0.000 description 1
- 230000003647 oxidation Effects 0.000 description 1
- 238000007254 oxidation reaction Methods 0.000 description 1
- 239000000825 pharmaceutical preparation Substances 0.000 description 1
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 description 1
- 229920000053 polysorbate 80 Polymers 0.000 description 1
- 229920002451 polyvinyl alcohol Polymers 0.000 description 1
- 235000019422 polyvinyl alcohol Nutrition 0.000 description 1
- 238000003908 quality control method Methods 0.000 description 1
- 235000012045 salad Nutrition 0.000 description 1
- 235000015424 sodium Nutrition 0.000 description 1
- QAIPRVGONGVQAS-DUXPYHPUSA-N trans-caffeic acid Chemical class OC(=O)\C=C\C1=CC=C(O)C(O)=C1 QAIPRVGONGVQAS-DUXPYHPUSA-N 0.000 description 1
Landscapes
- Medicinal Preparation (AREA)
- Medicines Containing Plant Substances (AREA)
Abstract
A compound Chinese medicine containing stable content of danshinolic acid B in the form of dispersing tablet, dripping pill, capsule, oral disintegrating tablet, effervescent tablet, etc is prepared from red sage root, borneol, notoginseng and proper additive. Its preparing process is also disclosed.
Description
Technical field:
The invention belongs to field of medicaments, be specifically related to a kind of compound Salviae Miltiorrhizae novel formulation and preparation method thereof.
Background technology:
FUFANG DANSHEN PIAN is recorded respectively in " Chinese pharmacopoeia version in 2000, version in 2005.Form by three flavors such as Radix Salviae Miltiorrhizae, Radix Notoginseng, Borneolum Syntheticum.
Along with the deepen continuously research of people, quality control, the dosage form of said preparation are had higher requirement to compound red sage root preparation.
Salvianolic acid B is one of aqueous soluble active constituent in the Radix Salviae Miltiorrhizae, is one of important content's index of control compound red sage root preparation quality.But because the structure of salvianolic acid B, it is unstable under conventional state.
Summary of the invention:
The object of the invention provides a kind of salvianolic acid B of stablizing content, compound red sage root preparation that reaches convenient use and preparation method thereof of containing.
The invention provides Compositae Salviae Miltiorrhizae medicine Radix Salviae Miltiorrhizae/Borneolum Syntheticum/Radix Notoginseng etc. is made the extract of suitable formulations through extraction, and make dispersible tablet, coated dispersing tablet, drop pill, soft capsule, micropill, coated micropill or novel forms such as oral cavity disintegration tablet or effervescent tablet with suitable adjuvant.
The present invention is achieved in that
Used medical material proportioning is:
Radix Salviae Miltiorrhizae 450g Radix Notoginseng 141g Borneolum Syntheticum 8g
The treated medicinal substances extract of making of above-mentioned medical material is made soft capsule or peroral dosage forms such as dispersible tablet or drop pill or oral cavity disintegration tablet or effervescent tablet or micropill with pharmaceutically alleged adjuvant or substrate.
Or more can be preferably:
Radix Salviae Miltiorrhizae 450g Radix Notoginseng 141g Borneolum Syntheticum 8g.
Extraction of the present invention is to make through following steps:
Radix Salviae Miltiorrhizae added alcohol reflux 1.5 hours, and extracting solution filters, and filtrate recycling ethanol also is concentrated into an amount of, standby; Medicinal residues add 50% alcohol reflux 1.5 hours, and extracting solution filters, and filtrate recycling ethanol also is concentrated into an amount of, standby; Medicinal residues add water and refluxed 2 hours, and decocting liquid filters, and filtrate is concentrated in right amount; Radix Notoginseng powder is broken into fine powder, mixes with above-mentioned concentrated solution; Get the mixture that above-mentioned Radix Salviae Miltiorrhizae extracts concentrated solution and Radix Notoginseng fine powder, add the Borneolum Syntheticum fine powder, be the extract of preparation compound red sage root preparation.
Or make through following steps:
Radix Salviae Miltiorrhizae added alcohol reflux 1.5 hours, and extracting solution filters, and filtrate recycling ethanol also is concentrated into an amount of, standby; Medicinal residues add 50% alcohol reflux 1.5 hours, and extracting solution filters, and filtrate recycling ethanol also is concentrated into an amount of, standby; Medicinal residues add water and refluxed 2 hours, and decocting liquid filters, and filtrate is concentrated in right amount; Radix Notoginseng powder is broken into fine powder, mixes with above-mentioned concentrated solution; Get the mixture that above-mentioned Radix Salviae Miltiorrhizae extracts concentrated solution and Radix Notoginseng fine powder, add Borneolum Syntheticum and doubly reach the cyclodextrin inclusion compound fine powder, be the extract of preparation compound red sage root preparation.
Soft capsule of the present invention is made like this:
I) modulation capsule liquid: get compound Salviae Miltiorrhizae extract, add one or more of vegetable oil, suspending agent, antiseptic, emulsifying agent etc., stir, grind homogenizing, promptly get soft capsule liquid;
Ii) get gelatin, water mixing,, add glycerol, antiseptic, additives, stir in heating in water bath dissolving down, the degassing, insulation is left standstill, and it is standby to make the capsule material;
Iii) suppress or drip and make soft capsule: with preparation soft capsule equipment capsule liquid is encapsulated in the capsule material of compositions such as glycerol, gelatin, water, makes soft capsule.
Used vegetable oil is one or more in soybean oil, salad oil, Oleum Sesami, Oleum Arachidis hypogaeae semen, Semen Maydis oil, almond oil, peach kernel oil, Oleum Gossypii semen, Oleum Helianthi, Oleum Ricini, the olive oil, and best use peach kernel oil and soybean oil weight ratio are 1: 3.5 mixture.
The suspending agent of making soft capsule is: glycerol, tween--80, in Petiolus Trachycarpi oil, aluminum monostearate, soybean lecithin, Cera Flava etc. any one or a few.
Its vegetable oil, and the suspending agent consumption be 100 parts of compound Salviae Miltiorrhizae extracts: 50～120 parts of vegetable oil, 15～45 parts of suspending agents; Its capsule material formula is weight ratio 1: 0.24: 0.74: 0.12: 1.42 gelatin: arabic gum: glycerol: syrup: distilled water etc. are mixed and made into.
Dispersible tablet of the present invention is made like this:
Get compound Salviae Miltiorrhizae extract, add filler and part disintegrating agent mix homogeneously, granulate with wetting agent or adhesive, drying, granulate adds adjuvants such as residue disintegrating agent, lubricant, mix homogeneously, tabletting promptly gets dispersible tablet; Or coating behind the tabletting, promptly get coated dispersing tablet.
Filler in the dispersible tablet is: starch, or lactose or microcrystalline Cellulose, or one or more of precoking starch etc.,
The disintegrating agents of dispersible tablets is: crospolyvinylpyrrolidone, carboxymethyl starch sodium, and low-substituted hydroxypropyl cellulose, one or more of cross-linked carboxymethyl cellulose sodium etc.,
Binding agent in the dispersible tablet is: the alcoholic solution of 40% ethanol～95% alcoholic solution or 4～11% polyvinylpyrrolidones.
Lubricant in the dispersible tablet is a magnesium stearate, or micropowder silica gel, or Pulvis Talci, or cetyl sulfo-sodium succinate, or one or more of sodium lauryl sulphate etc.,
Its consumption is: 150 parts of compound Salviae Miltiorrhizae extracts cooperate 15～200 parts of filleies, 10～65 parts of disintegrating agents, 0.3～6 part of lubricant; Or being preferably 150 parts of 72.5 parts of filleies of compound Salviae Miltiorrhizae extracts cooperation, 25 parts of disintegrating agents, lubricant is 2.5 parts;
Or the best is preferably:
A lactose: 52.5%
B mannitol: 20%
C carboxymethyl starch sodium: 6%
D sodium carboxymethyl cellulose: 1%
The e hydroxypropyl emthylcellulose: 3%,
F microcrystalline Cellulose: 5%
G crospolyvinylpyrrolidone: 10%
H cetyl sulfo-sodium succinate: 0.25%
I sodium lauryl sulphate: 0.25%
J magnesium stearate: 2.0%.
Mix with compound Salviae Miltiorrhizae extract successively before above-mentioned adjuvant branch is granulated with before the tabletting, used adjuvant is before granulating: used adjuvant is before lactose, carboxymethyl starch sodium, the sodium carboxymethyl cellulose, tabletting: magnesium stearate, sodium lauryl sulphate, cetyl sulfo-sodium succinate, crospolyvinylpyrrolidone, microcrystalline Cellulose, sodium carboxymethyl cellulose.
Oral cavity disintegration tablet of the present invention is made like this:
Get compound Salviae Miltiorrhizae extract, with filler, disintegrating agent, fluidizer, correctives mix homogeneously, direct compression promptly, or coating is made coated tablet again;
Described disintegrating agent is: crospolyvinylpyrrolidone, carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose, one or more of cross-linked carboxymethyl cellulose sodium etc.;
Described fluidizer is: micropowder silica gel, or one or more of magnesium stearate etc.;
Described correctives is: A Basi is sweet, stevioside, sucrose, maltose alcohol, citric acid etc. are edible or one or more of medicinal correctives; Preferably use A Basi sweet with citric acid 3: 1.
Mix with compound Salviae Miltiorrhizae extract successively before above-mentioned adjuvant branch is granulated with before the tabletting, the adjuvant of sneaking into is before granulating: filler, disintegrating agent: low-substituted hydroxypropyl cellulose; Used adjuvant is before the tabletting: fluidizer, correctives, disintegrating agent: crospolyvinylpyrrolidone.
Effervescent tablet of the present invention is made like this:
Get compound Salviae Miltiorrhizae extract,, add disintegrating agent, lubricant with filler, effervescent acid-base pair mixing granulation, mixing, tabletting promptly gets effervescent tablet, or the coated again coating effervescent tablet of making;
Effervescent is that sodium bicarbonate is formed with citric acid or tartaric acid;
Filler is a lactose: mannitol: 5: 3: 1.5 mixture of precoking starch;
Disintegrating agent is: crospolyvinylpyrrolidone, carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose, one or more of cross-linked carboxymethyl cellulose sodium etc.; Or the best crospolyvinylpyrrolidone that uses: the mixture of low-substituted hydroxypropyl cellulose=1: 2;
Compound Salviae Miltiorrhizae extract 100g and 20～130g filler, 15～45g effervescent acid-base pair, 5～55g disintegrating agent are formed.
Micropill of the present invention or pellet capsule are made like this:
(1) gets compound Salviae Miltiorrhizae extract,, make the micropill of diameter less than 2.0mm with mix homogeneously such as carboxymethyl starch sodium, precoking starch;
(2) with gained micropill drying, or the coating after drying, promptly.Or the micropill filled capsules made pellet capsule.
(3) 100 parts of the extracts of compound Salviae Miltiorrhizae, 5～60 parts of carboxymethyl starch sodium, 2～40 parts of precoking starch, wetting agent are 60～95% alcoholic solution of 2～13% polyvinylpyrrolidones.
Or be preferably: 100 parts of the extracts of compound Salviae Miltiorrhizae, 25 parts of carboxymethyl starch sodium, 30 parts of precoking starch, wetting agent are 85% alcoholic solution of 11% polyvinylpyrrolidone.
The coating solution of making the various coated preparations of the present invention is a gastric solubility coating material, as Opadry, acrylic resin IV, hydroxypropyl cellulose, polyvinylpyrrolidone, hydroxypropyl methylcellulose, polyvinyl alcohol, methylcellulose one or more, or the coating solution formula optimization is:
Polyvinylpyrrolidone 12g
Hydroxypropyl methylcellulose 4～8g
90% alcoholic solution 200ml
Pulvis Talci 4～8g
Magnesium stearate 2g
Titanium dioxide 4～6g
Polyethylene glycol 6000 4g
Pigment 1～2g
Effect of the present invention:
Salvianolic acid B is one of aqueous soluble active constituent in the Radix Salviae Miltiorrhizae, is one of important content's index of control compound red sage root preparation quality.But because the structure of salvianolic acid B, its chemical composition is that the four poly-caffeic acid compounds catabolic processes that two molecule danshensus and the condensation of a part prolithospermic acid form remain in many uncertain factors, make the homogeneity of the quality of the pharmaceutical preparations be difficult to be guaranteed, the present invention doubly reaches cyclodextrin clathrate by using antioxidant or Radix Salviae Miltiorrhizae extract being formed, and makes the stable raising greatly of salvianolic acid B.
Use the dispersion tablet of red sage root salvianolic acid B stable content test of different antioxidant with batch dried cream:
| Antioxidant uses | 3 months | 6 months | 12 months |
| 0.5% ascorbic acid, | 10.3mg | 6.4mg | 5.2mg |
| 1.0% ascorbic acid, | 10.2mg | 7.2mg | 7.0mg |
| 1.2% ascorbic acid+L-cysteine hydrochlorate | 9.8mg | 7.4mg | 7.2mg |
| 1.35% sodium metabisulfite, | 9.65mg | 7.32mg | 7.24mg |
| 2% sodium sulfite | 10.4mg | 8.0mg | 7.8mg |
The present invention makes coated dispersing tablet with compound red sage root preparation, the adjuvant prescription design of its dispersible tablet, and helping reaching is the purpose of the rapid disintegrate of medicine.When coating can make tablet more attractive in appearance,, slow down oxidation deterioration, the moisture absorption process of medicine, make medicine more stable drug blockage.
The coating weightening finish too much can influence medicine and collapse the boundary.Coatings is thin excessively, can not reach the purpose of stablizing medicine, and the present invention has determined appropriate coating weightening finish percent.
Use the effect of different coating material, coating weightening finish percent:
| The coating solution prescription | Weightening finish percent | Salvianolic acid B content | ||
| 3 months | 6 months | 12 months | ||
| HPMC：7.5％+PEG400：1.2％、 | 1.5％ | 10.4mg | 8.2mg | 6.4mg |
| HPMC：7.2％+PEG400：0.8％、 | 2.4％ | 10.1mg | 7.4mg | 7.1mg |
| Opadry | 2.2％ | 9.8mg | 8.6mg | 8.4mg |
| The Europe crust is treated | 3.1％ | 10.6mg | 8.8mg | 8.4mg |
Specific embodiment:
Embodiment 1: the preparation of compound Salviae Miltiorrhizae extract:
Radix Salviae Miltiorrhizae adds 6 times of amounts of ethanol and refluxed 1.5 hours, and extracting solution filters, and filtrate recycling ethanol also is concentrated into an amount of, standby; Medicinal residues add 6 times of amounts of 50% ethanol and refluxed 1.5 hours, and extracting solution filters, and filtrate recycling ethanol also is concentrated into an amount of, standby; Medicinal residues add 6 times of amounts of water and refluxed 2 hours, and decocting liquid filters, and filtrate is concentrated in right amount; Radix Notoginseng powder is broken into fine powder, mixes with above-mentioned concentrated solution; Get the mixture that above-mentioned Radix Salviae Miltiorrhizae extracts concentrated solution and Radix Notoginseng fine powder, add the Borneolum Syntheticum fine powder, be the extract of preparation compound red sage root preparation.
Embodiment 2: the preparation of compound Salviae Miltiorrhizae extract:
Radix Salviae Miltiorrhizae adds 10 times of amounts of ethanol and refluxed 1.5 hours, and extracting solution filters, and filtrate recycling ethanol also is concentrated into an amount of, standby; Medicinal residues add 10 times of amounts of 50% ethanol and refluxed 1.5 hours, and extracting solution filters, and filtrate recycling ethanol also is concentrated into an amount of, standby; Medicinal residues add 10 times of amounts of water and refluxed 2 hours, and decocting liquid filters, and filtrate is concentrated in right amount; Radix Notoginseng powder is broken into fine powder, mixes with above-mentioned concentrated solution; Get the mixture that above-mentioned Radix Salviae Miltiorrhizae extracts concentrated solution and Radix Notoginseng fine powder, add the Borneolum Syntheticum fine powder, be the extract of preparation compound red sage root preparation.
Embodiment 3: the preparation of compound Salviae Miltiorrhizae extract:
Radix Salviae Miltiorrhizae adds 8 times of amounts of ethanol and refluxed 1.5 hours, and extracting solution filters, and filtrate recycling ethanol also is concentrated into an amount of, standby; Medicinal residues add 6 times of amounts of 50% ethanol and refluxed 1.5 hours, and extracting solution filters, and filtrate recycling ethanol also is concentrated into an amount of, standby; Medicinal residues add 8 times of amounts of water and refluxed 2 hours, and decocting liquid filters, and filtrate is concentrated in right amount; Radix Notoginseng powder is broken into fine powder, mixes with above-mentioned concentrated solution; Get the mixture that above-mentioned Radix Salviae Miltiorrhizae extracts concentrated solution and Radix Notoginseng fine powder, add the Borneolum Syntheticum fine powder, be the extract of preparation compound red sage root preparation.
Embodiment 4: the preparation of compound Salviae Miltiorrhizae extract:
Radix Salviae Miltiorrhizae adds 8 times of amounts of alcohol reflux 1.5 hours, and extracting solution filters, and filtrate recycling ethanol also is concentrated into an amount of, standby; Medicinal residues add 6 times of amounts of 50% ethanol and refluxed 1.5 hours, and extracting solution filters, and filtrate recycling ethanol also is concentrated into an amount of, standby; Medicinal residues add 8 times of amounts of water and refluxed 2 hours, and decocting liquid filters, and filtrate is concentrated in right amount; Radix Notoginseng powder is broken into fine powder, mixes with above-mentioned concentrated solution; Get the mixture that above-mentioned Radix Salviae Miltiorrhizae extracts concentrated solution and Radix Notoginseng fine powder, add Borneolum Syntheticum and doubly reach the cyclodextrin inclusion compound fine powder, be the extract of preparation compound red sage root preparation.
Embodiment 5: the compound Salviae Miltiorrhizae preparation of soft capsule
Radix Salviae Miltiorrhizae 450g Radix Notoginseng 141g Borneolum Syntheticum 8g
Cera Flava 15g;
Olive oil 220g
Propylene glycol 2g
Soybean lecithin 8g
Make 1000
I) modulation capsule liquid: medical material is made extract by embodiment 1～4, add vegetable oil, antiseptic, suspending agent, emulsifying agent etc., stir, grind homogenizing, promptly get soft capsule liquid;
Ii) get gelatin, water, in heating in water bath dissolving down, mix homogeneously adds glycerol, antiseptic, additives, stirs, and after the vacuumize degassing, insulation is left standstill, and makes capsule material glue;
Iii) suppress or drip and make soft capsule: capsule liquid is encapsulated in the capsule material glue with soft capsule system of dripping or press; Control glue
The capsule grain is heavy, makes and makes 1000, promptly.
Embodiment 6: the compound Salviae Miltiorrhizae preparation of soft capsule
Radix Salviae Miltiorrhizae 450g Radix Notoginseng 141g Borneolum Syntheticum 8g
Medical material is made extract 200g by embodiment 1～4.
Peach kernel oil 25g
Soybean oil 175g:
Cera Flava: ethyl cellulose weight ratio 1.5: 3.5 30
Ethylparaben 1.0g
Make 1000
I) modulation capsule liquid: medical material is made extract by embodiment 1～4, add disperse medium, antiseptic, suspending agent, emulsifying agent etc., stir, grind homogenizing, promptly get soft capsule liquid;
Ii) its capsule material formula is weight ratio 1: 0.24: 0.74: 0.12: 1.42 gelatin: arabic gum: glycerol: syrup: distilled water etc. are mixed and made into.Get gelatin, water in heating in water bath dissolving down, mix homogeneously adds glycerol, antiseptic, additives, stirs, and after the vacuumize degassing, insulation is left standstill, and makes capsule material glue;
Iii) suppress or drip and make soft capsule: capsule liquid is encapsulated in the capsule material glue with soft capsule system of dripping or press; Promptly get soft capsule.
Embodiment 7: the preparation of compound salvia dispersion tablet:
Radix Salviae Miltiorrhizae 450g Radix Notoginseng 141g Borneolum Syntheticum 8g
Lactose: 40g
Microcrystalline Cellulose: 25g
Mannitol: 15g
Carboxymethyl starch sodium: 10g
Polyvinylpyrrolidone: 45g
Sodium lauryl sulphate: 2.5g
Magnesium stearate: 3.0g
Make extract by embodiment 1～4, use 75% alcohol granulation with lactose, carboxymethyl starch sodium, microcrystalline Cellulose, mannitol etc., drying adds polyvinylpyrrolidone, sodium lauryl sulphate, and the magnesium stearate mix homogeneously is pressed into 1000, promptly.
Embodiment 8: the preparation of compound salvia dispersion tablet:
Radix Salviae Miltiorrhizae 450g Radix Notoginseng 141g Borneolum Syntheticum 8g
Lactose: 35g
Hydroxypropyl emthylcellulose: 25g
Microcrystalline Cellulose: 25g
Crospolyvinylpyrrolidone: 35g
Cetyl sulfo-sodium succinate: 2.0g
Differential silica gel: 3.0g
Make extract by embodiment 1～4, with lactose, hydroxypropyl emthylcellulose, microcrystalline Cellulose, etc. granulate with the alcoholic solution moistening of 11% poly-second ketopyrrolidine, dry, add polyvinylpyrrolidone, cetyl sulfo-sodium succinate, differential silica gel mix homogeneously, tabletting, coating are made 1000, and coating solution is:
Polyvinylpyrrolidone 12g
Hydroxypropyl methylcellulose 4～8g
90% alcoholic solution 200ml
Pulvis Talci 4～8g
Magnesium stearate 2g
Titanium dioxide 4～6g
Polyethylene glycol 6000 4g
Pigment 1～2g.
Embodiment 9: the preparation of compound red sage root effervescent tablet agent
Radix Salviae Miltiorrhizae 450g Radix Notoginseng 141g Borneolum Syntheticum 8g
Lactose: 100g
Mannitol: 60g
Precoking starch: 20g
Crospolyvinylpyrrolidone: 15g
Low-substituted hydroxypropyl cellulose 30g
Sodium bicarbonate 30g
Citric acid 20g
Tartaric acid 15g
Sodium lauryl sulphate: 2.5g
Magnesium stearate: 3.0g
Make extract by embodiment 4, use 75% alcohol granulation with lactose, mannitol, precoking starch, sodium bicarbonate etc., drying adds all the other adjuvant mix homogeneously of magnesium stearate such as citric acid, tartaric acid, sodium lauryl sulphate, is pressed into 1000, promptly.Or coating makes Film coated tablets, and coating solution is by following preparation: HPMC:7.1%, PEG400:0.8%, red iron oxide powder: 4.1, distilled water: 88%.
Embodiment 10: the preparation of compound Salviae Miltiorrhizae micropill
Radix Salviae Miltiorrhizae 450g Radix Notoginseng 141g Borneolum Syntheticum 8g
Carboxymethyl starch sodium 120g
Precoking starch 55g
8% polyvinylpyrrolidone, 85% alcoholic solution 100ml
(1) gets compound Salviae Miltiorrhizae extract,, make the micropill of diameter less than 2.0mm with agitation procedure with mix homogeneously such as carboxymethyl starch sodium, precoking starch;
(2) with gained micropill drying, or the coating after drying, promptly.Or the micropill filled capsules made pellet capsule.
Embodiment 11: the preparation of compound Salviae Miltiorrhizae oral cavity disintegration tablet
Radix Salviae Miltiorrhizae 450g Radix Notoginseng 141g Borneolum Syntheticum 8g
Lactose: 100g
Mannitol: 60g
Crospolyvinylpyrrolidone: 15g
Hydroxypropyl methylcellulose: 30g
Magnesium stearate: 3.0g
The sweet 5.0g of A Basi
Citric acid 12g
Embodiment 1～4 makes extract, and with starch, lactose, hydroxypropyl methylcellulose 75% alcohol granulation, drying, tabletting, coating is made 1000.
Coating solution is pressed following preparation:
HPMC:7.2%, PEG400:0.8%, red iron oxide powder: 4.1, distilled water: 88%.
Embodiment 12: the preparation of compound salvia dispersion tablet:
Radix Salviae Miltiorrhizae 450g Radix Notoginseng 141g Borneolum Syntheticum 8g
Lactose: 35g
Hydroxypropyl emthylcellulose: 25g
Microcrystalline Cellulose: 25g
Crospolyvinylpyrrolidone: 35g
Cetyl sulfo-sodium succinate: 2.0g
Differential silica gel: 3.0g
Make extract by embodiment 4, with lactose, hydroxypropyl emthylcellulose, microcrystalline Cellulose, etc. granulate with the alcoholic solution moistening of 11% poly-second ketopyrrolidine, dry, add polyvinylpyrrolidone, cetyl sulfo-sodium succinate, differential silica gel mix homogeneously, tabletting, coating are made 1000, coating solution is: Opadry coating solution, coating weightening finish 1.8%.
Embodiment 13: the preparation of compound salvia dispersion tablet:
Radix Salviae Miltiorrhizae 450g Radix Notoginseng 141g Borneolum Syntheticum 8g
Lactose: 75g
Hydroxypropyl emthylcellulose: 25g
Microcrystalline Cellulose: 25g
Mannitol 30g
Crospolyvinylpyrrolidone: 35g
Cetyl sulfo-sodium succinate: 2.0g
Magnesium stearate: 2.5g
Method for making: Radix Salviae Miltiorrhizae adds 8 times of amounts of ethanol and refluxed 1.5 hours, and extracting solution filters, and filtrate recycling ethanol also is concentrated into an amount of, standby; Medicinal residues add 6 times of amounts of 50% ethanol and refluxed 1.5 hours, and extracting solution filters, and filtrate recycling ethanol also is concentrated into an amount of, standby; Medicinal residues add 8 times of amounts of water and refluxed 2 hours, and decocting liquid filters, and filtrate is concentrated in right amount; Radix Notoginseng powder is broken into micropowder, mixes with above-mentioned concentrated solution; Drying is crushed to 100 orders, and is standby;
Get Borneolum Syntheticum, make powder-beta-dextrin clathrate compound, with the mixing fine powders of above-mentioned Radix Salviae Miltiorrhizae extract and Radix Notoginseng, lactose, hydroxypropyl emthylcellulose, microcrystalline Cellulose, etc. granulate with the alcoholic solution moistening of 11% poly-second ketopyrrolidine, drying adds polyvinylpyrrolidone, cetyl sulfo-sodium succinate, differential silica gel mix homogeneously, tabletting, coating is made 1000, and coating solution is: Opadry coating solution, coating weightening finish 2.2%.
Claims (13)
1, a kind of compound Salviae Miltiorrhizae novel formulation is characterized in that used medical material is:
Radix Salviae Miltiorrhizae, Radix Notoginseng, Borneolum Syntheticum; The treated medicinal substances extract of making is made soft capsule or dispersible tablet, oral cavity disintegration tablet or peroral dosage forms such as effervescent tablet or micropill with pharmaceutically alleged adjuvant or substrate.
2, a kind of compound Salviae Miltiorrhizae novel formulation according to claim 1 is characterized in that wherein the weight proportion of each raw material is:
225～675 parts of Radix Salviae Miltiorrhizaes, 70.5～211.5 parts of Radix Notoginseng, 4～12 parts of treated medicinal substances extracts of making of Borneolum Syntheticum are made soft capsule or peroral dosage forms such as dispersible tablet or effervescent tablet or micropill with pharmaceutically alleged adjuvant or substrate; Or more can be preferably: medical material Radix Salviae Miltiorrhizae 450g, the Radix Notoginseng 141g of per unit recipe quantity, Borneolum Syntheticum 8g make 1000 slice, or its integral multiple.
3, according to claim 1 compound Salviae Miltiorrhizae novel formulation preparation of soft capsule method, it is characterized in that:
1. Radix Salviae Miltiorrhizae adds 6～10 times of amount backflows of ethanol 1.5 hours, and extracting solution filters, and filtrate recycling ethanol also is concentrated into an amount of, standby; Medicinal residues add 6～10 times of amounts of 50% ethanol and refluxed 1.5 hours, and extracting solution filters, and filtrate recycling ethanol also is concentrated into an amount of, standby; Medicinal residues add 6～10 times of amounts of water and refluxed 2 hours, and decocting liquid filters, and filtrate is concentrated in right amount; Radix Notoginseng powder is broken into fine powder, mixes with above-mentioned concentrated solution;
2. modulate capsule liquid: get the mixture that above-mentioned Radix Salviae Miltiorrhizae extracts concentrated solution and Radix Notoginseng fine powder, add the Borneolum Syntheticum fine powder, one or more of disperse medium, antiseptic, suspending agent, emulsifying agent etc. stir, and grind homogenizing, promptly get soft capsule liquid;
3. get gelatin, water mixing, in heating in water bath dissolving down, add glycerol, antiseptic, additives, stir, after the vacuumize degassing, insulation is left standstill, and it is standby to make the capsule material;
4. make soft capsule: capsule liquid is encapsulated in the capsule material of compositions such as glycerol, gelatin, water with preparation soft capsule equipment.
4, according to claim 3 compound Salviae Miltiorrhizae novel formulation soft capsule, it is characterized in that: the supplementary product consumption of making soft capsule can be preferably: the medical material of per unit recipe quantity and disperse medium 30～350g, suspending agent 0～65g, antiseptic 0～7.5g are modulated into stable capsule liquid and make soft capsule.
5, a kind of compound Salviae Miltiorrhizae novel formulation dispersible tablet according to claim 1 is characterized in that this dispersible tablet preparation method is: Radix Salviae Miltiorrhizae adds 6～10 times of amounts of ethanol and refluxed 1.5 hours, and extracting solution filters, and filtrate recycling ethanol also is concentrated into an amount of, standby; Medicinal residues add 6～10 times of amounts of 50% ethanol and refluxed 1.5 hours, and extracting solution filters, and filtrate recycling ethanol also is concentrated into an amount of, standby; Medicinal residues add 6～10 times of amounts of water and refluxed 2 hours, and decocting liquid filters, and filtrate is concentrated in right amount; Radix Notoginseng powder is broken into fine powder, mixes with above-mentioned concentrated solution; Add the Borneolum Syntheticum fine powder, add adjuvant and granulate, drying adds adjuvants such as lubricant, mixing, and tabletting promptly gets dispersible tablet, or the coated coated dispersing tablet of making; Get 2 of this sheets, put jolting in the 100ml water, in 20 ℃ ± 1 ℃ water, the whole disintegrates of planted agent in 3 minutes are also passed through sieve No. 2.
6, according to a kind of compound Salviae Miltiorrhizae novel formulation dispersible tablet described in the claim 6,, it is characterized in that:
Its adjuvant can be preferably: the medical material of per unit recipe quantity, with filler 0～180g, disintegrating agent 3～75g, lubricant 0～25g, antioxidant 0～12g proportioning;
Its The disintegrating agents of dispersible tablets is: crospolyvinylpyrrolidone, carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose, one or more of cross-linked carboxymethyl cellulose sodium etc.
7, a kind of compound Salviae Miltiorrhizae novel formulation dispersible tablet according to claim 6, it is characterized in that: the antioxidant in its dispersible tablet is: one or more of ascorbic acid, sodium metabisulfite, sodium sulfite, L-cysteine hydrochlorate etc.
8, according to claim 1 compound Salviae Miltiorrhizae novel formulation oral cavity disintegration tablet, it is characterized in that:
Radix Salviae Miltiorrhizae adds 6～10 times of amounts of ethanol and refluxed 1.5 hours, and extracting solution filters, and filtrate recycling ethanol also is concentrated into an amount of, standby; Medicinal residues add 6～10 times of amounts of 50% ethanol and refluxed 1.5 hours, and extracting solution filters, and filtrate recycling ethanol also is concentrated into an amount of, standby; Medicinal residues add 6～10 times of amounts of water and refluxed 2 hours, and decocting liquid filters, and filtrate is concentrated in right amount; Radix Notoginseng powder is broken into fine powder, mixes with above-mentioned concentrated solution; Add the Borneolum Syntheticum fine powder, with filler, disintegrating agent, fluidizer, correctives mix homogeneously, direct compression promptly, or coating is made coated tablet again.
9, a kind of according to Claim 8 compound Salviae Miltiorrhizae novel formulation oral cavity disintegration tablet, it is characterized in that: its supplementary product consumption proportioning is: the medical material of per unit recipe quantity, filler 0～150g, disintegrating agent 3～60g, correctives 0～25g, lubricant 0.01～20g;
Described disintegrating agent is: crospolyvinylpyrrolidone, carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose, one or more of cross-linked carboxymethyl cellulose sodium etc.;
Described fluidizer is: micropowder silica gel, or one or more of magnesium stearate etc.;
Described correctives is: A Basi is sweet, stevioside, sucrose, maltose alcohol, citric acid etc. are edible or one or more of medicinal correctives; Preferably use A Basi sweet with citric acid 1: 1.2.
10, according to claim 1 compound Salviae Miltiorrhizae novel formulation effervescent tablet, it is characterized in that:
Radix Salviae Miltiorrhizae adds 6～10 times of amounts of ethanol and refluxed 1.5 hours, and extracting solution filters, and filtrate recycling ethanol also is concentrated into an amount of, standby; Medicinal residues add 6～10 times of amounts of 50% ethanol and refluxed 1.5 hours, and extracting solution filters, and filtrate recycling ethanol also is concentrated into an amount of, standby; Medicinal residues add 6～10 times of amounts of water and refluxed 2 hours, and decocting liquid filters, and filtrate is concentrated in right amount; Radix Notoginseng powder is broken into fine powder, mixes with above-mentioned concentrated solution; Add the Borneolum Syntheticum fine powder, with filler, disintegrating agent, effervescent acid-base pair, fluidizer, correctives mix homogeneously, direct compression promptly, or coating is made coated tablet again.
11, according to claim 10 compound Salviae Miltiorrhizae novel formulation effervescent tablet, it is characterized in that:
The effervescent acid-base pair is formed for two kinds of materials of bronsted lowry acids and bases bronsted lowry of meeting water and can produce gas, as the citric acid of sodium bicarbonate and equivalent or tartaric acid etc.;
Filler is a lactose, or starch, or pregelatinized Starch, or one or more of microcrystalline Cellulose etc., and the best is preferably lactose: mannitol: precoking starch: microcrystalline Cellulose 3: 4: 1: 1 mixture;
Disintegrating agent is: crospolyvinylpyrrolidone, or carboxymethyl starch sodium, or low-substituted hydroxypropyl cellulose, or one or more of cross-linked carboxymethyl cellulose sodium etc.; Or the best crospolyvinylpyrrolidone that uses: low-substituted hydroxypropyl cellulose: the mixture of carboxymethyl starch sodium=3: 1: 0.5;
Its supplementary product consumption proportioning is: the medical material of per unit recipe quantity, filler 0～100g, disintegrating agent 3～60g, correctives 0～25g, effervescent acid-base pair 5～80g, lubricant 0～20g.
12, according to claim 1 compound Salviae Miltiorrhizae novel formulation micropill, it is characterized in that:
(1) Radix Salviae Miltiorrhizae adds 6～10 times of amount backflows of ethanol 1.5 hours, and extracting solution filters, and filtrate recycling ethanol also is concentrated into an amount of, standby; Medicinal residues add 6～10 times of amounts of 50% alcohol reflux 1.5 hours, and extracting solution filters, and filtrate recycling ethanol also is concentrated into an amount of, standby; Medicinal residues add 6～10 times of amounts of water and refluxed 2 hours, and decocting liquid filters, and filtrate is concentrated in right amount; Radix Notoginseng powder is broken into fine powder, mixes with above-mentioned concentrated solution;
(2) preparation of micropill: get the mixture that above-mentioned Radix Salviae Miltiorrhizae extracts concentrated solution and Radix Notoginseng fine powder, add the Borneolum Syntheticum fine powder,, make the micropill of diameter less than 2.0mm with the adjuvant mix homogeneously; With gained micropill drying, or the coating after drying, promptly.
13, a kind of compound Salviae Miltiorrhizae novel formulation according to claim 1, it is characterized in that: Radix Salviae Miltiorrhizae ethanol extract and Borneolum Syntheticum are used for the preparation of preparation behind the available cyclodextrin inclusion compound.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2005100360671A CN100370970C (en) | 2005-07-16 | 2005-07-16 | Compound red-rooted salvia prepn., and its prepn. method |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2005100360671A CN100370970C (en) | 2005-07-16 | 2005-07-16 | Compound red-rooted salvia prepn., and its prepn. method |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1723998A true CN1723998A (en) | 2006-01-25 |
| CN100370970C CN100370970C (en) | 2008-02-27 |
Family
ID=35923715
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CNB2005100360671A Expired - Fee Related CN100370970C (en) | 2005-07-16 | 2005-07-16 | Compound red-rooted salvia prepn., and its prepn. method |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN100370970C (en) |
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102138970A (en) * | 2011-03-24 | 2011-08-03 | 江苏苏南药业实业有限公司 | Method for preparing compound salvia tablet |
| WO2011103789A1 (en) * | 2010-02-23 | 2011-09-01 | 天津天士力制药股份有限公司 | Capsule of complex danshen drop pill |
| CN102247434A (en) * | 2010-05-20 | 2011-11-23 | 云南楚雄天利药业有限公司 | Przewalsk sage root blood activating medicine and preparation method thereof |
| CN106333931A (en) * | 2016-11-02 | 2017-01-18 | 山东省中医药研究院 | Compound salvia miltiorrhiza liquid-solid compressed tablets and preparation method thereof |
| TWI571257B (en) * | 2011-02-23 | 2017-02-21 | Tasly Pharmaceutical Group Co | Capsule preparation |
Family Cites Families (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1161140C (en) * | 2001-11-09 | 2004-08-11 | 天津天士力制药股份有限公司 | Medicine for preventing and treating coronary heart disease and angina pectoris and its prepn and other use |
| CN1559587A (en) * | 2004-03-09 | 2005-01-05 | 济南康众医药科技开发有限公司 | Compound red sage dispersing tablet and its preparation method |
-
2005
- 2005-07-16 CN CNB2005100360671A patent/CN100370970C/en not_active Expired - Fee Related
Cited By (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2011103789A1 (en) * | 2010-02-23 | 2011-09-01 | 天津天士力制药股份有限公司 | Capsule of complex danshen drop pill |
| AU2011220206B2 (en) * | 2010-02-23 | 2013-05-16 | Tasly Pharmaceutical Group Co., Ltd. | Capsule of compound danshen dripping pills |
| JP2013520450A (en) * | 2010-02-23 | 2013-06-06 | テースリー ファーマシューティカル グループ カンパニー リミテッド | Compound tangin drop pill capsule |
| US9205123B2 (en) | 2010-02-23 | 2015-12-08 | Tasly Pharmaceutical Group Co., Ltd. | Capsule of compound danshen dripping pills |
| EA026761B1 (en) * | 2010-02-23 | 2017-05-31 | Тасли Фармасьютикал Груп Ко., Лтд. | Capsule of compound danshen dripping pills |
| CN102247434A (en) * | 2010-05-20 | 2011-11-23 | 云南楚雄天利药业有限公司 | Przewalsk sage root blood activating medicine and preparation method thereof |
| TWI571257B (en) * | 2011-02-23 | 2017-02-21 | Tasly Pharmaceutical Group Co | Capsule preparation |
| CN102138970A (en) * | 2011-03-24 | 2011-08-03 | 江苏苏南药业实业有限公司 | Method for preparing compound salvia tablet |
| CN106333931A (en) * | 2016-11-02 | 2017-01-18 | 山东省中医药研究院 | Compound salvia miltiorrhiza liquid-solid compressed tablets and preparation method thereof |
| CN106333931B (en) * | 2016-11-02 | 2019-10-01 | 山东省中医药研究院 | A kind of compound Danshen Root liquid-solid compression tablet and preparation method thereof |
Also Published As
| Publication number | Publication date |
|---|---|
| CN100370970C (en) | 2008-02-27 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CN1819821A (en) | Modified-release tablet of bupropion hydrochloride | |
| CN1929821A (en) | Pharmaceutical composition comprising pimobendan | |
| CN1216467A (en) | Immediate release PH-independent solid dosage form of cisapride | |
| CN1762357A (en) | Oral medicinal formulation of moxifloxacin and its preparation method | |
| CN1723998A (en) | Compound red-rooted salvia prepn., and its prepn. method | |
| CN1723021A (en) | Stable solid medicinal composition for oral administration. | |
| CN1823805A (en) | Ground erythromycin enteric micropill and its preparation method | |
| CN1883479A (en) | A quantitative drop | |
| CN1723964A (en) | Medicine for treating cough and chronic bronchitis | |
| CN1499961A (en) | Pharmaceutical tablet system that floats on gastric fluid for multipulse release of active substance and respective processes of producing same and cup-shaped envelope of same | |
| CN1887315A (en) | Fukean dispersible tablet and preparation method thereof | |
| CN1698714A (en) | 'Rukuaixiao' preparation for treating mammary disease and its preparation process | |
| CN1857288A (en) | Slow released compound preparation of glycyrrhizic acid and glycyrrhizinate and its preparing process | |
| CN1682885A (en) | Hemostatic preparation for gynecology department | |
| CN1875972A (en) | Preparation of ligustrazine and ligustrazine salt drop pills utilizing nano technology | |
| CN1679901A (en) | Compound preparation of Jianganling for liver and its making method | |
| CN1814110A (en) | Medicine for treating gynecophathy | |
| CN1788747A (en) | Compound licorice root medicinal preparation and preparing method thereof | |
| CN101057837A (en) | Dextro-ketoprofen enteric coated preparation and its preparation method | |
| CN1279920C (en) | Slow release preparation of diammonium glycyrrhizate | |
| CN1736411A (en) | Pharmaceutical preparation with functions of clearing heat, removing dampness and benefiting gallbladder | |
| CN1301108C (en) | Metaducine dispersion tablet and its preparation method | |
| CN1772122A (en) | Indian stringbush prepn with antiphlogistic and detoxicating functions | |
| CN1679793A (en) | Xiaoaiping preparation against cancers and its making method | |
| CN1939318A (en) | Isoglycyrrhiza acid magnesium oral preparation and its making method |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C06 | Publication | ||
| PB01 | Publication | ||
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| C14 | Grant of patent or utility model | ||
| GR01 | Patent grant | ||
| TR01 | Transfer of patent right |
Effective date of registration: 20190307 Address after: 516133 Bianling Pai Industrial Zone of Guangshan Highway, Changning Town, Boluo County, Huizhou City, Guangdong Province (Luofushan Pharmaceutical City) Patentee after: GUANGDONG LUOFUSHAN SINOPHARM Co.,Ltd. Address before: 516100 No. 36 Qiaodong three road, Luoyang Town, Boluo County, Huizhou, Guangdong Patentee before: Ye Yaoliang |
|
| TR01 | Transfer of patent right | ||
| CF01 | Termination of patent right due to non-payment of annual fee |
Granted publication date: 20080227 |
|
| CF01 | Termination of patent right due to non-payment of annual fee |