CN1651024A - Salvia root capsule and its preparation technology - Google Patents
Salvia root capsule and its preparation technology Download PDFInfo
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- CN1651024A CN1651024A CN 200410155513 CN200410155513A CN1651024A CN 1651024 A CN1651024 A CN 1651024A CN 200410155513 CN200410155513 CN 200410155513 CN 200410155513 A CN200410155513 A CN 200410155513A CN 1651024 A CN1651024 A CN 1651024A
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- soft capsule
- acid
- amount
- hydroxybenzoate
- adjuvant
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- 238000002360 preparation method Methods 0.000 title claims description 25
- 239000002775 capsule Substances 0.000 title abstract 2
- 241001072909 Salvia Species 0.000 title 1
- 235000017276 Salvia Nutrition 0.000 title 1
- 239000007901 soft capsule Substances 0.000 claims description 48
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims description 30
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims description 28
- DNIAPMSPPWPWGF-UHFFFAOYSA-N Propylene glycol Chemical compound CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 claims description 18
- 239000000706 filtrate Substances 0.000 claims description 14
- 239000003814 drug Substances 0.000 claims description 13
- WPYMKLBDIGXBTP-UHFFFAOYSA-N benzoic acid Chemical compound OC(=O)C1=CC=CC=C1 WPYMKLBDIGXBTP-UHFFFAOYSA-N 0.000 claims description 12
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 claims description 12
- 241000304195 Salvia miltiorrhiza Species 0.000 claims description 11
- 235000011135 Salvia miltiorrhiza Nutrition 0.000 claims description 11
- KFZMGEQAYNKOFK-UHFFFAOYSA-N Isopropanol Chemical compound CC(C)O KFZMGEQAYNKOFK-UHFFFAOYSA-N 0.000 claims description 9
- 239000000203 mixture Substances 0.000 claims description 9
- 239000000843 powder Substances 0.000 claims description 9
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 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
- 239000002671 adjuvant Substances 0.000 claims description 7
- 230000002421 anti-septic effect Effects 0.000 claims description 7
- 239000003963 antioxidant agent Substances 0.000 claims description 7
- 230000003078 antioxidant effect Effects 0.000 claims description 7
- 235000006708 antioxidants Nutrition 0.000 claims description 7
- 238000001035 drying Methods 0.000 claims description 7
- -1 hydroxypropyl Chemical group 0.000 claims description 7
- 238000002156 mixing Methods 0.000 claims description 7
- 239000000546 pharmaceutical excipient Substances 0.000 claims description 7
- 238000004064 recycling Methods 0.000 claims description 7
- 238000010992 reflux Methods 0.000 claims description 7
- 239000005711 Benzoic acid Substances 0.000 claims description 6
- KCXVZYZYPLLWCC-UHFFFAOYSA-N EDTA Chemical compound OC(=O)CN(CC(O)=O)CCN(CC(O)=O)CC(O)=O KCXVZYZYPLLWCC-UHFFFAOYSA-N 0.000 claims description 6
- 235000010233 benzoic acid Nutrition 0.000 claims description 6
- 239000003085 diluting agent Substances 0.000 claims description 5
- 239000000375 suspending agent Substances 0.000 claims description 5
- LKAPTZKZHMOIRE-KVTDHHQDSA-N (2s,3s,4s,5r)-3,4-dihydroxy-5-(hydroxymethyl)oxolane-2-carbaldehyde Chemical compound OC[C@H]1O[C@H](C=O)[C@@H](O)[C@@H]1O LKAPTZKZHMOIRE-KVTDHHQDSA-N 0.000 claims description 4
- 239000001856 Ethyl cellulose Substances 0.000 claims description 4
- 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 claims description 4
- DHMQDGOQFOQNFH-UHFFFAOYSA-N Glycine Chemical compound NCC(O)=O DHMQDGOQFOQNFH-UHFFFAOYSA-N 0.000 claims description 4
- QIGBRXMKCJKVMJ-UHFFFAOYSA-N Hydroquinone Chemical compound OC1=CC=C(O)C=C1 QIGBRXMKCJKVMJ-UHFFFAOYSA-N 0.000 claims description 4
- KWKVAGQCDSHWFK-VNKDHWASSA-N Methyl sorbate Chemical compound COC(=O)\C=C\C=C\C KWKVAGQCDSHWFK-VNKDHWASSA-N 0.000 claims description 4
- 239000000654 additive Substances 0.000 claims description 4
- 235000010323 ascorbic acid Nutrition 0.000 claims description 4
- 239000011668 ascorbic acid Substances 0.000 claims description 4
- 229960005070 ascorbic acid Drugs 0.000 claims description 4
- LKAPTZKZHMOIRE-UHFFFAOYSA-N chitose Natural products OCC1OC(C=O)C(O)C1O LKAPTZKZHMOIRE-UHFFFAOYSA-N 0.000 claims description 4
- 235000019325 ethyl cellulose Nutrition 0.000 claims description 4
- 229920001249 ethyl cellulose Polymers 0.000 claims description 4
- GJLNWLVPAHNBQN-UHFFFAOYSA-N phenyl 4-hydroxybenzoate Chemical compound C1=CC(O)=CC=C1C(=O)OC1=CC=CC=C1 GJLNWLVPAHNBQN-UHFFFAOYSA-N 0.000 claims description 4
- HRZFUMHJMZEROT-UHFFFAOYSA-L sodium disulfite Chemical compound [Na+].[Na+].[O-]S(=O)S([O-])(=O)=O HRZFUMHJMZEROT-UHFFFAOYSA-L 0.000 claims description 4
- 235000010262 sodium metabisulphite Nutrition 0.000 claims description 4
- LNAZSHAWQACDHT-XIYTZBAFSA-N (2r,3r,4s,5r,6s)-4,5-dimethoxy-2-(methoxymethyl)-3-[(2s,3r,4s,5r,6r)-3,4,5-trimethoxy-6-(methoxymethyl)oxan-2-yl]oxy-6-[(2r,3r,4s,5r,6r)-4,5,6-trimethoxy-2-(methoxymethyl)oxan-3-yl]oxyoxane Chemical compound CO[C@@H]1[C@@H](OC)[C@H](OC)[C@@H](COC)O[C@H]1O[C@H]1[C@H](OC)[C@@H](OC)[C@H](O[C@H]2[C@@H]([C@@H](OC)[C@H](OC)O[C@@H]2COC)OC)O[C@@H]1COC LNAZSHAWQACDHT-XIYTZBAFSA-N 0.000 claims description 2
- BJEPYKJPYRNKOW-REOHCLBHSA-N (S)-malic acid Chemical compound OC(=O)[C@@H](O)CC(O)=O BJEPYKJPYRNKOW-REOHCLBHSA-N 0.000 claims description 2
- IIZPXYDJLKNOIY-JXPKJXOSSA-N 1-palmitoyl-2-arachidonoyl-sn-glycero-3-phosphocholine Chemical compound CCCCCCCCCCCCCCCC(=O)OC[C@H](COP([O-])(=O)OCC[N+](C)(C)C)OC(=O)CCC\C=C/C\C=C/C\C=C/C\C=C/CCCCC IIZPXYDJLKNOIY-JXPKJXOSSA-N 0.000 claims description 2
- 229920001817 Agar Polymers 0.000 claims description 2
- MOZDKDIOPSPTBH-UHFFFAOYSA-N Benzyl parahydroxybenzoate Chemical class C1=CC(O)=CC=C1C(=O)OCC1=CC=CC=C1 MOZDKDIOPSPTBH-UHFFFAOYSA-N 0.000 claims description 2
- QFOHBWFCKVYLES-UHFFFAOYSA-N Butylparaben Chemical compound CCCCOC(=O)C1=CC=C(O)C=C1 QFOHBWFCKVYLES-UHFFFAOYSA-N 0.000 claims description 2
- 229920002134 Carboxymethyl cellulose Polymers 0.000 claims description 2
- 229920002101 Chitin Polymers 0.000 claims description 2
- 239000003109 Disodium ethylene diamine tetraacetate Substances 0.000 claims description 2
- 229920000896 Ethulose Polymers 0.000 claims description 2
- 239000001859 Ethyl hydroxyethyl cellulose Substances 0.000 claims description 2
- 239000004471 Glycine Substances 0.000 claims description 2
- SQUHHTBVTRBESD-UHFFFAOYSA-N Hexa-Ac-myo-Inositol Natural products CC(=O)OC1C(OC(C)=O)C(OC(C)=O)C(OC(C)=O)C(OC(C)=O)C1OC(C)=O SQUHHTBVTRBESD-UHFFFAOYSA-N 0.000 claims description 2
- KDYFGRWQOYBRFD-UHFFFAOYSA-N Succinic acid Natural products OC(=O)CCC(O)=O KDYFGRWQOYBRFD-UHFFFAOYSA-N 0.000 claims description 2
- 239000008272 agar Substances 0.000 claims description 2
- BJEPYKJPYRNKOW-UHFFFAOYSA-N alpha-hydroxysuccinic acid Natural products OC(=O)C(O)CC(O)=O BJEPYKJPYRNKOW-UHFFFAOYSA-N 0.000 claims description 2
- KDYFGRWQOYBRFD-NUQCWPJISA-N butanedioic acid Chemical compound O[14C](=O)CC[14C](O)=O KDYFGRWQOYBRFD-NUQCWPJISA-N 0.000 claims description 2
- 239000001768 carboxy methyl cellulose Substances 0.000 claims description 2
- 235000010948 carboxy methyl cellulose Nutrition 0.000 claims description 2
- 239000008112 carboxymethyl-cellulose Substances 0.000 claims description 2
- 239000007766 cera flava Substances 0.000 claims description 2
- 229960004106 citric acid Drugs 0.000 claims description 2
- 239000003086 colorant Substances 0.000 claims description 2
- UGMCXQCYOVCMTB-UHFFFAOYSA-K dihydroxy(stearato)aluminium Chemical compound CCCCCCCCCCCCCCCCCC(=O)O[Al](O)O UGMCXQCYOVCMTB-UHFFFAOYSA-K 0.000 claims description 2
- 235000019301 disodium ethylene diamine tetraacetate Nutrition 0.000 claims description 2
- BEFDCLMNVWHSGT-UHFFFAOYSA-N ethenylcyclopentane Chemical compound C=CC1CCCC1 BEFDCLMNVWHSGT-UHFFFAOYSA-N 0.000 claims description 2
- 229960001617 ethyl hydroxybenzoate Drugs 0.000 claims description 2
- 235000019326 ethyl hydroxyethyl cellulose Nutrition 0.000 claims description 2
- 235000010228 ethyl p-hydroxybenzoate Nutrition 0.000 claims description 2
- 239000004403 ethyl p-hydroxybenzoate Substances 0.000 claims description 2
- NUVBSKCKDOMJSU-UHFFFAOYSA-N ethylparaben Chemical compound CCOC(=O)C1=CC=C(O)C=C1 NUVBSKCKDOMJSU-UHFFFAOYSA-N 0.000 claims description 2
- 229960002449 glycine Drugs 0.000 claims description 2
- 229960004337 hydroquinone Drugs 0.000 claims description 2
- CDAISMWEOUEBRE-GPIVLXJGSA-N inositol Chemical compound O[C@H]1[C@H](O)[C@@H](O)[C@H](O)[C@H](O)[C@@H]1O CDAISMWEOUEBRE-GPIVLXJGSA-N 0.000 claims description 2
- 229960000367 inositol Drugs 0.000 claims description 2
- 235000010445 lecithin Nutrition 0.000 claims description 2
- 239000000787 lecithin Substances 0.000 claims description 2
- 229940067606 lecithin Drugs 0.000 claims description 2
- 239000001630 malic acid Substances 0.000 claims description 2
- 235000011090 malic acid Nutrition 0.000 claims description 2
- 229940099690 malic acid Drugs 0.000 claims description 2
- 229920000609 methyl cellulose Polymers 0.000 claims description 2
- 235000010270 methyl p-hydroxybenzoate Nutrition 0.000 claims description 2
- 239000004292 methyl p-hydroxybenzoate Substances 0.000 claims description 2
- 239000001923 methylcellulose Substances 0.000 claims description 2
- LXCFILQKKLGQFO-UHFFFAOYSA-N methylparaben Chemical compound COC(=O)C1=CC=C(O)C=C1 LXCFILQKKLGQFO-UHFFFAOYSA-N 0.000 claims description 2
- 229960002216 methylparaben Drugs 0.000 claims description 2
- 239000002480 mineral oil Substances 0.000 claims description 2
- 235000010446 mineral oil Nutrition 0.000 claims description 2
- 239000003605 opacifier Substances 0.000 claims description 2
- WVDDGKGOMKODPV-ZQBYOMGUSA-N phenyl(114C)methanol Chemical compound O[14CH2]C1=CC=CC=C1 WVDDGKGOMKODPV-ZQBYOMGUSA-N 0.000 claims description 2
- 229920001223 polyethylene glycol Polymers 0.000 claims description 2
- 229920000136 polysorbate Polymers 0.000 claims description 2
- 235000010232 propyl p-hydroxybenzoate Nutrition 0.000 claims description 2
- 239000004405 propyl p-hydroxybenzoate Substances 0.000 claims description 2
- 235000013772 propylene glycol Nutrition 0.000 claims description 2
- QELSKZZBTMNZEB-UHFFFAOYSA-N propylparaben Chemical compound CCCOC(=O)C1=CC=C(O)C=C1 QELSKZZBTMNZEB-UHFFFAOYSA-N 0.000 claims description 2
- CDAISMWEOUEBRE-UHFFFAOYSA-N scyllo-inosotol Natural products OC1C(O)C(O)C(O)C(O)C1O CDAISMWEOUEBRE-UHFFFAOYSA-N 0.000 claims description 2
- 235000010378 sodium ascorbate Nutrition 0.000 claims description 2
- PPASLZSBLFJQEF-RKJRWTFHSA-M sodium ascorbate Substances [Na+].OC[C@@H](O)[C@H]1OC(=O)C(O)=C1[O-] PPASLZSBLFJQEF-RKJRWTFHSA-M 0.000 claims description 2
- 229960005055 sodium ascorbate Drugs 0.000 claims description 2
- PPASLZSBLFJQEF-RXSVEWSESA-M sodium-L-ascorbate Chemical compound [Na+].OC[C@H](O)[C@H]1OC(=O)C(O)=C1[O-] PPASLZSBLFJQEF-RXSVEWSESA-M 0.000 claims description 2
- PESXGULMKCKJCC-UHFFFAOYSA-M sodium;4-methoxycarbonylphenolate Chemical compound [Na+].COC(=O)C1=CC=C([O-])C=C1 PESXGULMKCKJCC-UHFFFAOYSA-M 0.000 claims description 2
- 235000010199 sorbic acid Nutrition 0.000 claims description 2
- 239000004334 sorbic acid Substances 0.000 claims description 2
- 229940075582 sorbic acid Drugs 0.000 claims description 2
- 239000004094 surface-active agent Substances 0.000 claims description 2
- 235000015112 vegetable and seed oil Nutrition 0.000 claims description 2
- 239000008158 vegetable oil Substances 0.000 claims description 2
- 239000000230 xanthan gum Substances 0.000 claims description 2
- 229920001285 xanthan gum Polymers 0.000 claims description 2
- 229940082509 xanthan gum Drugs 0.000 claims description 2
- 235000010493 xanthan gum Nutrition 0.000 claims description 2
- 244000132619 red sage Species 0.000 abstract 2
- WTPPRJKFRFIQKT-UHFFFAOYSA-N 1,6-dimethyl-8,9-dihydronaphtho[1,2-g][1]benzofuran-10,11-dione;1-methyl-6-methylidene-8,9-dihydro-7h-naphtho[1,2-g][1]benzofuran-10,11-dione Chemical compound O=C1C(=O)C2=C3CCCC(=C)C3=CC=C2C2=C1C(C)=CO2.O=C1C(=O)C2=C3CCC=C(C)C3=CC=C2C2=C1C(C)=CO2 WTPPRJKFRFIQKT-UHFFFAOYSA-N 0.000 abstract 1
- 235000005412 red sage Nutrition 0.000 abstract 1
- 229920002565 Polyethylene Glycol 400 Polymers 0.000 description 10
- 229940068918 polyethylene glycol 400 Drugs 0.000 description 10
- 239000002552 dosage form Substances 0.000 description 8
- 229940079593 drug Drugs 0.000 description 6
- JEIPFZHSYJVQDO-UHFFFAOYSA-N ferric oxide Chemical compound O=[Fe]O[Fe]=O JEIPFZHSYJVQDO-UHFFFAOYSA-N 0.000 description 5
- 239000011159 matrix material Substances 0.000 description 5
- 239000000758 substrate Substances 0.000 description 5
- 229920002584 Polyethylene Glycol 6000 Polymers 0.000 description 4
- 229940093429 polyethylene glycol 6000 Drugs 0.000 description 4
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 description 4
- 229920000053 polysorbate 80 Polymers 0.000 description 4
- 239000000047 product Substances 0.000 description 4
- 208000024172 Cardiovascular disease Diseases 0.000 description 3
- 239000000428 dust Substances 0.000 description 3
- 230000000694 effects Effects 0.000 description 3
- 108010010803 Gelatin Proteins 0.000 description 2
- 229920003091 Methocel™ Polymers 0.000 description 2
- 201000010099 disease Diseases 0.000 description 2
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 2
- 230000000857 drug effect Effects 0.000 description 2
- 230000002526 effect on cardiovascular system Effects 0.000 description 2
- 239000008273 gelatin Substances 0.000 description 2
- 229920000159 gelatin Polymers 0.000 description 2
- 235000019322 gelatine Nutrition 0.000 description 2
- 235000011852 gelatine desserts Nutrition 0.000 description 2
- 125000001436 propyl group Chemical group [H]C([*])([H])C([H])([H])C([H])([H])[H] 0.000 description 2
- 238000003860 storage Methods 0.000 description 2
- RZVAJINKPMORJF-UHFFFAOYSA-N Acetaminophen Chemical compound CC(=O)NC1=CC=C(O)C=C1 RZVAJINKPMORJF-UHFFFAOYSA-N 0.000 description 1
- 206010002383 Angina Pectoris Diseases 0.000 description 1
- 206010028980 Neoplasm Diseases 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 208000026106 cerebrovascular disease Diseases 0.000 description 1
- 239000003795 chemical substances by application Substances 0.000 description 1
- 239000011248 coating agent Substances 0.000 description 1
- 238000000576 coating method Methods 0.000 description 1
- 239000000470 constituent Substances 0.000 description 1
- 208000029078 coronary artery disease Diseases 0.000 description 1
- 230000007423 decrease Effects 0.000 description 1
- 230000002950 deficient Effects 0.000 description 1
- 238000001125 extrusion Methods 0.000 description 1
- 239000008187 granular material Substances 0.000 description 1
- 238000011835 investigation Methods 0.000 description 1
- 230000002045 lasting effect Effects 0.000 description 1
- 230000007774 longterm Effects 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 239000002994 raw material Substances 0.000 description 1
- 238000009495 sugar coating Methods 0.000 description 1
- 239000000080 wetting agent Substances 0.000 description 1
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- Medicinal Preparation (AREA)
Abstract
A Danshen capsule features that its core is prepared from the extract of red sage root and the medical auxiliary. Its preparing process is also disclosed.
Description
[technical field] the present invention relates to salvia miltiorrhiza soft capsule and preparation technology thereof.
[background technology] cardiovascular diseases seizes 1,200 ten thousand people's life every year, near world population total dead 1/4, become the No.1 formidable enemy of human health, today in the world, cardiovascular disease is killed more people than other any diseases, and millions upon millions of people are disabled.Although the most countries of cardiovascular death rate except that East Bloc all has decline in various degree over nearly 30 years, but it is still majority state primary cause of death of male more than 45 years old, in the women then is second cause of the death that is only second to tumor, is having a strong impact on human life expectancy and life quality.
The medicine of existing multiple treatment cardiovascular and cerebrovascular disease, we are folk prescription soft capsule preparations of Radix Salviae Miltiorrhizae, select for use Radix Salviae Miltiorrhizae as raw material, the active constituent content height,, curative effect remarkable to treatment of diseases effects such as coronary heart disease, angina pectoriss rapidly, stable lasting.
Radix Salviae Miltiorrhizae Tabellae is a conventional medicament, and in blocks by pressed powder that contains medicine or granule compacting, sugar coating or film-coat form, and exist the common problem of tablet, and dust-producing amount is big during coating; Sliver, variable color, quality instability in the storage life; Disintegrate, absorb slowly, curative effect is affected; And existing fairly simpleization of dosage form quality standard; Simultaneously, coated tablet is unfavorable for that diabetics takes.Our then overcome the shortcoming of conventional dosage forms.
[summary of the invention] the present invention seeks to avoid having now the weak point that exists in dosage form and the technology, a kind of salvia miltiorrhiza soft capsule and preparation technology thereof are provided, preparation process by the advanced person, on the basis that keeps good drug effect, original technology and preparation are improved, make salvia miltiorrhiza soft capsule, further to improve the quality of products and technology content.Salvia miltiorrhiza soft capsule can overcome the shortcoming of existing dosage form, constant product quality, carry taking convenience, effectively stripping is fast, the bioavailability height satisfies the standard of such dosage form aspect outward appearance, hardness, disintegration etc. and physicochemical property, its steady quality, easy to use effective.
Salvia miltiorrhiza soft capsule of the present invention is made up of content in softgel shell and the softgel shell, and its technical scheme is:
Get Radix Salviae Miltiorrhizae 1000g, add 90% alcohol reflux 1.5 hours, filter filtrate recycling ethanol; Medicinal residues decoct with water 1 hour, filter; Merge above-mentioned filtrate, be evaporated to an amount of after drying and pulverize, medicated powder and an amount of pharmaceutic adjuvant mixing are wrapped in and form soft capsule in the soft capsule shell, promptly.
Adjuvant comprises diluent, suspending agent, surfactant, antiseptic, one or more in antioxidant and the additives.Wherein diluent is one or more in polyethylene glycols, isopropyl alcohol, tween, span, glycerol, propylene glycol, water, mineral oil and the vegetable oil; Suspending agent is one or more in oily wax mixture, Cera Flava, ethylhydroxyethylcellulose, chitin, chitose, methylcellulose, carboxymethyl cellulose, agar, hydroxypropyl emthylcellulose, xanthan gum, aluminum monostearate, the ethyl cellulose; Antioxidant is one or more in ethylenediaminetetraacetic acid, disodium EDTA, dibenzylatiooluene, glycine, inositol, ascorbic acid, sodium ascorbate, lecithin, malic acid, hydroquinone, citric acid, succinic acid, the sodium pyrosulfite; Antiseptic is one or more in sorbic acid, sorbic acid methyl ester, methyl parahydroxybenzoate, ethylparaben, propyl p-hydroxybenzoate, butyl p-hydroxybenzoate, P-hydroxybenzoic acid phenyl ester, benzyl p-hydroxybenzoate class, Sodium Methyl Hydroxybenzoate, benzoic acid, benzyl alcohol, propylene glycol, the glycerol; Described additives are one or more in antiseptic, antioxidant, coloring agent, the opacifier.
(wherein gelatin, glycerol proportioning are difficult to grasp salvia miltiorrhiza soft capsule of the present invention to the prescription of various conditions (as temperature, humidity etc.), softgel shell in the kind of soft capsule adjuvant and principal agent and proportioning dosage, the preparation process on the basis of conventional soft capsule preparation method.The amount of glycerol is too many, and softgel shell is softer, than being easier to extrusion; The amount of glycerol very little, softgel shell is harder, crisp, influences the quality stability and the disintegration time of soft capsule.) grope, preferred through test of many times research and long-term investigation, obtained proportioning preferably at last.Have the advantages that reasonable mixture ratio, technology are simple, be easy to control.
The best proportioning of medicine and adjuvant is 1: 0.5-1: between 2, the best prescription proportioning is:
Form content (percentage by weight)
Medicine 30%-60%
Diluent 40%-70%
Wetting agent 1%-5%
Suspending agent 1%-5%
Other (as antioxidant, antiseptic) 0%-5%
The best proportioning of gelatin and glycerol is 2 in the softgel shell: 1-4: between 1.
Compared with the prior art, beneficial effect of the present invention is embodied in:
The present invention is wrapped in medicine and adjuvant mixture to make soft capsule in the soft capsule shell.On the basis that keeps the good drug effect of tablet, original technology and dosage form are improved the soft capsule soft or hard appropriateness after the improvement, be imbued with flexibility and toughness, improved content of effective in the dry extract, Determination on content and qualitative easy operating make the quality standard of this medicine that new raising arranged.Constant product quality, disintegrate is fast, bioavailability is high, rapid-action.Simultaneously, overcome the shortcoming of existing dosage form, reduced the dust-producing amount when producing, shortened the production cycle, improved the hygiology standard.Overcome coated tablet defective such as sliver, variable color in the storage life.
[specific embodiment]
The present invention will be further described below in conjunction with example, and following each example only is used to illustrate the present invention, but the protection authority of the present patent application is not limited in this.
Embodiment 1:
Form (by the total medicated powder amount of last gained) umber (by weight)
5 parts of medicines
Polyethylene Glycol-400 2.79 part
0.1 part of Polyethylene Glycol-6000
0.05 part of citric acid
0.06 part of tween 80
The preparation of substrate: taking polyethylene glycol-400 558g, add Polyethylene Glycol-6000 20g, citric acid 10g, tween 80 12g, mix homogeneously gets soft capsule matrix 600g altogether.
Preparation of soft capsule: get Radix Salviae Miltiorrhizae 1000g, add 90% alcohol reflux 1.5 hours, filter filtrate recycling ethanol; Medicinal residues decoct with water 1 hour, filter; Merge above-mentioned filtrate, be evaporated to an amount of after drying and pulverize, medicated powder and an amount of pharmaceutic adjuvant mixing are wrapped in and form soft capsule in the soft capsule shell, promptly.
Embodiment 2:
Component umber (by weight)
5 parts of medicines
Polyethylene Glycol-400 3 part
1.5 parts of glycerol
0.25 part of span
0.15 part of sorbic acid methyl ester
0.1 part of ethylenediaminetetraacetic acid
The preparation of substrate: taking polyethylene glycol-400 600g, add glycerol 300g, span 50g, sorbic acid methyl ester 30g, ethylenediaminetetraacetic acid 20g, mix homogeneously gets soft capsule matrix 1000g.
Preparation of soft capsule: preparation of soft capsule: get Radix Salviae Miltiorrhizae 1000g, add 90% alcohol reflux 1.5 hours, filter filtrate recycling ethanol; Medicinal residues decoct with water 1 hour, filter; Merge above-mentioned filtrate, be evaporated to an amount of after drying and pulverize, medicated powder and an amount of pharmaceutic adjuvant mixing are wrapped in and form soft capsule in the soft capsule shell, promptly.
Embodiment 3:
Component umber (by weight)
5 parts of medicines
Polyethylene Glycol-400 6.7 part
0.25 part of Polyethylene Glycol-6000
0.2 part of tween 80
0.15 part of ethyl cellulose
0.12 part of dibenzylatiooluene
0.08 part in benzoic acid
The preparation of substrate: taking polyethylene glycol-400 1340g, add Polyethylene Glycol-6000 50g, tween 80 40g, ethyl cellulose 30g, dibenzylatiooluene 24g, benzoic acid 16g, mix homogeneously gets soft capsule matrix 1500g.
Preparation of soft capsule: preparation of soft capsule: preparation of soft capsule: get Radix Salviae Miltiorrhizae 1000g, add 90% alcohol reflux 1.5 hours, filter filtrate recycling ethanol; Medicinal residues decoct with water 1 hour, filter; Merge above-mentioned filtrate, be evaporated to an amount of after drying, pulverize, medicated powder and an amount of pharmaceutic adjuvant mixing are wrapped in and form soft capsule in the soft capsule shell, promptly.
Embodiment 4:
Component umber (by weight)
5 parts of medicines
Polyethylene Glycol-400 5.45 part
3.5 parts of propylene glycol
0.5 part of hydroxypropyl emthylcellulose
0.3 part in ascorbic acid
0.25 part of P-hydroxybenzoic acid phenyl ester
The preparation of substrate: taking polyethylene glycol-400 1090g, propylene glycol 700g adds hydroxypropyl emthylcellulose 100g, ascorbic acid 60g, P-hydroxybenzoic acid phenyl ester 50g, mix homogeneously gets soft capsule matrix 2000g.
Preparation of soft capsule: preparation of soft capsule: preparation of soft capsule: get Radix Salviae Miltiorrhizae 1000g, add 90% alcohol reflux 1.5 hours, filter filtrate recycling ethanol; Medicinal residues decoct with water 1 hour, filter; Merge above-mentioned filtrate, be evaporated to an amount of after drying and pulverize, medicated powder and an amount of pharmaceutic adjuvant mixing are wrapped in and form soft capsule in the soft capsule shell, promptly.
Embodiment 5:
Component umber (by weight)
5 parts of medicines
Polyethylene Glycol-400 5.7 part
3.5 parts of isopropyl alcohols
0.55 part of carboxylic propyl methocel
0.15 part of chitose
0.05 part of sodium pyrosulfite
0.05 part in benzoic acid
The preparation of substrate: taking polyethylene glycol-400 1140g, isopropyl alcohol 700g adds carboxylic propyl methocel 110g, chitose 30g, sodium pyrosulfite 10g, benzoic acid 10g, mix homogeneously gets soft capsule matrix 2000g.
Preparation of soft capsule: get Radix Salviae Miltiorrhizae 1000g, add 90% alcohol reflux 1.5 hours, filter filtrate recycling ethanol; Medicinal residues decoct with water 1 hour, filter; Merge above-mentioned filtrate, be evaporated to an amount of after drying and pulverize, medicated powder and an amount of pharmaceutic adjuvant mixing are wrapped in and form soft capsule in the soft capsule shell, promptly.
Overcome by the salvia miltiorrhiza soft capsule of as above specifically implementing the example gained that the tablet dust was big in the past, the tabletting condition is difficult for shortcomings such as grasp, and soft capsule dosage form has relative high bioavailability, and has proved technology simple possible of the present invention, product safety is effective, steady quality.
The protection authority of the present patent application is not limited in this; and the present invention also can embody by other concrete form under the condition that does not deviate from its basic feature; therefore we think that specific embodiments of the present invention and enforcement example generally speaking are illustrative rather than restrictive; protection domain is determined according to appended claims rather than according to above-mentioned explanation, so all implication and the variations in the equivalency range thereof in claim all should be included in the scope of the invention.
Claims (5)
1. a salvia miltiorrhiza soft capsule is characterized in that content comprises Radix Salviae Miltiorrhizae extract and an amount of adjuvant.
2. content Chinese medicine according to claim 1 accounts for 30%-60%, and adjuvant accounts for 40%-70%.Its best ratio range is 1: 0.5-1: 2.
3. the preparation technology of the salvia miltiorrhiza soft capsule described in claim 1, its feature may further comprise the steps: get Radix Salviae Miltiorrhizae 1000g, add 90% alcohol reflux 1.5 hours, filter filtrate recycling ethanol; Medicinal residues decoct with water 1 hour, filter; Merge above-mentioned filtrate, be evaporated to an amount of after drying and pulverize, medicated powder and an amount of pharmaceutic adjuvant mixing are wrapped in and form soft capsule in the soft capsule shell, promptly.
4. it is characterized in that according to claim 1 and 2 described salvia miltiorrhiza soft capsules adjuvant can be diluent, suspending agent, surfactant, antiseptic, one or more in antioxidant and the additives.
5. according to claim 4, it is characterized in that described diluent is one or more in polyethylene glycols, isopropyl alcohol, tween, span, glycerol, propylene glycol, water, mineral oil and the vegetable oil; Suspending agent is one or more in oily wax mixture, Cera Flava, ethylhydroxyethylcellulose, chitin, chitose, methylcellulose, carboxymethyl cellulose, agar, hydroxypropyl emthylcellulose, xanthan gum, aluminum monostearate, the ethyl cellulose; Antioxidant is one or more in ethylenediaminetetraacetic acid, disodium EDTA, dibenzylatiooluene, glycine, inositol, ascorbic acid, sodium ascorbate, lecithin, malic acid, hydroquinone, citric acid, succinic acid, the sodium pyrosulfite; Antiseptic is sorbic acid, sorbic acid methyl ester, methyl parahydroxybenzoate, ethylparaben, propyl p-hydroxybenzoate, butyl p-hydroxybenzoate, P-hydroxybenzoic acid phenyl ester, benzyl p-hydroxybenzoate class, Sodium Methyl Hydroxybenzoate, benzoic acid, benzyl alcohol, propylene glycol, [one or more in the glycerol; Described additives are one or more in antiseptic, antioxidant, coloring agent, the opacifier.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200410155513 CN1651024A (en) | 2004-12-07 | 2004-12-07 | Salvia root capsule and its preparation technology |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200410155513 CN1651024A (en) | 2004-12-07 | 2004-12-07 | Salvia root capsule and its preparation technology |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN1651024A true CN1651024A (en) | 2005-08-10 |
Family
ID=34869737
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 200410155513 Pending CN1651024A (en) | 2004-12-07 | 2004-12-07 | Salvia root capsule and its preparation technology |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN1651024A (en) |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101732409B (en) * | 2010-02-22 | 2011-11-16 | 辽宁盛生医药集团有限公司 | Salvia miltiorrhiza soft capsule and preparation method thereof |
| CN107582627A (en) * | 2016-07-06 | 2018-01-16 | 东莞暨南大学研究院 | A kind of red sage root oil droplet ball and preparation method thereof |
| CN108210559A (en) * | 2016-12-22 | 2018-06-29 | 东莞暨南大学研究院 | A kind of ganoderma lucidum spore oil agaricus blazei oil and salvia miltiorrhiza oil soft capsule and its preparation method |
-
2004
- 2004-12-07 CN CN 200410155513 patent/CN1651024A/en active Pending
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101732409B (en) * | 2010-02-22 | 2011-11-16 | 辽宁盛生医药集团有限公司 | Salvia miltiorrhiza soft capsule and preparation method thereof |
| CN107582627A (en) * | 2016-07-06 | 2018-01-16 | 东莞暨南大学研究院 | A kind of red sage root oil droplet ball and preparation method thereof |
| CN108210559A (en) * | 2016-12-22 | 2018-06-29 | 东莞暨南大学研究院 | A kind of ganoderma lucidum spore oil agaricus blazei oil and salvia miltiorrhiza oil soft capsule and its preparation method |
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