CN1651020A - Northern bean root soft capsule and its preparation process - Google Patents
Northern bean root soft capsule and its preparation process Download PDFInfo
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- CN1651020A CN1651020A CN 200410155506 CN200410155506A CN1651020A CN 1651020 A CN1651020 A CN 1651020A CN 200410155506 CN200410155506 CN 200410155506 CN 200410155506 A CN200410155506 A CN 200410155506A CN 1651020 A CN1651020 A CN 1651020A
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- Prior art keywords
- soft capsule
- acid
- hydroxybenzoate
- glycerol
- adjuvant
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- 239000007901 soft capsule Substances 0.000 title claims description 31
- 238000002360 preparation method Methods 0.000 title claims description 13
- 235000010627 Phaseolus vulgaris Nutrition 0.000 title claims description 12
- 244000046052 Phaseolus vulgaris Species 0.000 title claims description 12
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims description 39
- DNIAPMSPPWPWGF-UHFFFAOYSA-N Propylene glycol Chemical compound CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 claims description 18
- 239000000203 mixture Substances 0.000 claims description 14
- KFZMGEQAYNKOFK-UHFFFAOYSA-N Isopropanol Chemical compound CC(C)O KFZMGEQAYNKOFK-UHFFFAOYSA-N 0.000 claims description 12
- 239000003814 drug Substances 0.000 claims description 11
- 238000005516 engineering process Methods 0.000 claims description 11
- 238000001035 drying Methods 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
- 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
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 claims description 6
- 238000001556 precipitation Methods 0.000 claims description 6
- 229920000896 Ethulose Polymers 0.000 claims description 5
- 239000001859 Ethyl hydroxyethyl cellulose Substances 0.000 claims description 5
- 108010010803 Gelatin Proteins 0.000 claims description 5
- 239000003085 diluting agent Substances 0.000 claims description 5
- 235000019326 ethyl hydroxyethyl cellulose Nutrition 0.000 claims description 5
- 239000008273 gelatin Substances 0.000 claims description 5
- 229920000159 gelatin Polymers 0.000 claims description 5
- 235000019322 gelatine Nutrition 0.000 claims description 5
- 235000011852 gelatine desserts Nutrition 0.000 claims description 5
- 239000000375 suspending agent Substances 0.000 claims description 5
- BJEPYKJPYRNKOW-REOHCLBHSA-N (S)-malic acid Chemical compound OC(=O)[C@@H](O)CC(O)=O BJEPYKJPYRNKOW-REOHCLBHSA-N 0.000 claims description 4
- 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 4
- DHMQDGOQFOQNFH-UHFFFAOYSA-N Glycine Chemical compound NCC(O)=O DHMQDGOQFOQNFH-UHFFFAOYSA-N 0.000 claims description 4
- 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 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
- CDBYLPFSWZWCQE-UHFFFAOYSA-L Sodium Carbonate Chemical compound [Na+].[Na+].[O-]C([O-])=O CDBYLPFSWZWCQE-UHFFFAOYSA-L 0.000 claims description 4
- QAOWNCQODCNURD-UHFFFAOYSA-N Sulfuric acid Chemical compound OS(O)(=O)=O QAOWNCQODCNURD-UHFFFAOYSA-N 0.000 claims description 4
- BJEPYKJPYRNKOW-UHFFFAOYSA-N alpha-hydroxysuccinic acid Natural products OC(=O)C(O)CC(O)=O BJEPYKJPYRNKOW-UHFFFAOYSA-N 0.000 claims description 4
- WPYMKLBDIGXBTP-UHFFFAOYSA-N benzoic acid Chemical compound OC(=O)C1=CC=CC=C1 WPYMKLBDIGXBTP-UHFFFAOYSA-N 0.000 claims description 4
- -1 hydroxypropyl Chemical group 0.000 claims description 4
- 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 4
- 229960000367 inositol Drugs 0.000 claims description 4
- 239000001630 malic acid Substances 0.000 claims description 4
- 235000011090 malic acid Nutrition 0.000 claims description 4
- 239000000843 powder Substances 0.000 claims description 4
- 235000010232 propyl p-hydroxybenzoate Nutrition 0.000 claims description 4
- 239000004405 propyl p-hydroxybenzoate Substances 0.000 claims description 4
- QELSKZZBTMNZEB-UHFFFAOYSA-N propylparaben Chemical compound CCCOC(=O)C1=CC=C(O)C=C1 QELSKZZBTMNZEB-UHFFFAOYSA-N 0.000 claims description 4
- CDAISMWEOUEBRE-UHFFFAOYSA-N scyllo-inosotol Natural products OC1C(O)C(O)C(O)C(O)C1O CDAISMWEOUEBRE-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
- 239000006228 supernatant Substances 0.000 claims description 4
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 4
- 239000000654 additive Substances 0.000 claims description 3
- 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
- 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 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
- 239000005711 Benzoic acid Substances 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
- 239000001856 Ethyl cellulose Substances 0.000 claims description 2
- 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 2
- 239000004471 Glycine Substances 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
- 235000010323 ascorbic acid Nutrition 0.000 claims description 2
- 239000011668 ascorbic acid Substances 0.000 claims description 2
- 229960005070 ascorbic acid Drugs 0.000 claims description 2
- 235000010233 benzoic acid Nutrition 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
- LKAPTZKZHMOIRE-UHFFFAOYSA-N chitose Natural products OCC1OC(C=O)C(O)C1O LKAPTZKZHMOIRE-UHFFFAOYSA-N 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
- 235000019325 ethyl cellulose Nutrition 0.000 claims description 2
- 229920001249 ethyl cellulose Polymers 0.000 claims description 2
- 229960001617 ethyl hydroxybenzoate Drugs 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
- 239000000706 filtrate Substances 0.000 claims description 2
- 238000001914 filtration Methods 0.000 claims description 2
- 229960002449 glycine Drugs 0.000 claims description 2
- 229960004337 hydroquinone 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
- 230000002879 macerating effect Effects 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
- 239000000546 pharmaceutical excipient Substances 0.000 claims description 2
- 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 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
- 235000013772 propylene glycol Nutrition 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
- 229910000029 sodium carbonate Inorganic materials 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
- 241000245050 Menispermum Species 0.000 abstract 2
- 239000002775 capsule Substances 0.000 abstract 1
- 229920002565 Polyethylene Glycol 400 Polymers 0.000 description 8
- 239000002552 dosage form Substances 0.000 description 8
- 229940068918 polyethylene glycol 400 Drugs 0.000 description 8
- 239000000758 substrate Substances 0.000 description 8
- FJKROLUGYXJWQN-UHFFFAOYSA-N 4-hydroxybenzoic acid Chemical compound OC(=O)C1=CC=C(O)C=C1 FJKROLUGYXJWQN-UHFFFAOYSA-N 0.000 description 4
- JEIPFZHSYJVQDO-UHFFFAOYSA-N ferric oxide Chemical compound O=[Fe]O[Fe]=O JEIPFZHSYJVQDO-UHFFFAOYSA-N 0.000 description 4
- 239000007902 hard capsule Substances 0.000 description 4
- 239000011159 matrix material Substances 0.000 description 4
- 239000000047 product Substances 0.000 description 4
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 description 3
- 229920000053 polysorbate 80 Polymers 0.000 description 3
- 229940090248 4-hydroxybenzoic acid Drugs 0.000 description 2
- FBPFZTCFMRRESA-FSIIMWSLSA-N D-Glucitol Natural products OC[C@H](O)[C@H](O)[C@@H](O)[C@H](O)CO FBPFZTCFMRRESA-FSIIMWSLSA-N 0.000 description 2
- 230000000857 drug effect Effects 0.000 description 2
- 239000000428 dust Substances 0.000 description 2
- 230000000694 effects Effects 0.000 description 2
- 239000000600 sorbitol Substances 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
- 206010006458 Bronchitis chronic Diseases 0.000 description 1
- 208000002193 Pain Diseases 0.000 description 1
- 206010042674 Swelling Diseases 0.000 description 1
- 238000010521 absorption reaction Methods 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 206010006451 bronchitis Diseases 0.000 description 1
- 239000003795 chemical substances by application Substances 0.000 description 1
- 208000007451 chronic bronchitis Diseases 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
- 238000004090 dissolution Methods 0.000 description 1
- 229940079593 drug Drugs 0.000 description 1
- 238000001125 extrusion Methods 0.000 description 1
- 230000002496 gastric effect Effects 0.000 description 1
- 239000008187 granular material Substances 0.000 description 1
- 210000003026 hypopharynx Anatomy 0.000 description 1
- 238000007689 inspection Methods 0.000 description 1
- 238000011835 investigation Methods 0.000 description 1
- 230000007774 longterm Effects 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 230000000704 physical effect Effects 0.000 description 1
- 238000009495 sugar coating Methods 0.000 description 1
- 230000008961 swelling Effects 0.000 description 1
- 206010044008 tonsillitis Diseases 0.000 description 1
- 239000000080 wetting agent Substances 0.000 description 1
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- Medicinal Preparation (AREA)
Abstract
A moonseed rhizome capsule features that its core is prepared from moonseed rhizome and medical auxiliary. Its preparing process is also disclosed.
Description
[technical field]
The present invention relates to northern bean root soft capsule and preparation technology thereof.
[background technology]
Rhizoma Menispermi is traditional heat-clearing and detoxifying herb, the formal name used at school Caulis menispermi, and it is widely used clinically, is used for the treatment of laryngopharynx swelling and pain, tonsillitis and chronic bronchitis etc., acts on safe and effective.
The effective constituent that mainly contains in the Rhizoma Menispermi is a Rhizoma Menispermi total bases, and tablet, hard capsule are common dosage forms, still, the Rhizoma Menispermi sheet is 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; Simultaneously, coated tablet is unfavorable for that diabetics takes.The characteristics of soft capsule dosage form are that medicine disperses in gastrointestinal soon, good absorbing, and than the bioavailability height of tablet, hard capsule, and its dissolution is much superior with the kind tablet, can be absorbed by the body rapidly after taking and bring into play curative effect.
[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 northern bean root 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 northern bean root soft capsule, further to improve the quality of products and technology content.Northern bean root 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.
Northern bean root soft capsule of the present invention is made up of content in softgel shell and the softgel shell, and its technical scheme is:
Get Rhizoma Menispermi coarse powder 1000g, add the aqueous sulfuric acid (PH1-2) of 8 times of amounts, twice of warm macerating (55-60 ℃), each 24 hours, filter merging filtrate, leave standstill, get supernatant after precipitation is complete and add sodium carbonate adjusting pH value to 9, leave standstill, precipitation is the back abandoning supernatant fully, get the precipitation sucking filtration, be washed till neutrality with low amounts of water, 50-60 ℃ of drying promptly gets Rhizoma Menispermi extract.With itself and pharmaceutic adjuvant mix homogeneously, be pressed into soft capsule, drying, 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 northern bean root 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.) 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: 0.6-1: between 2, the best prescription proportioning is:
Form content (percentage by weight)
Medicine 30%-70%
Diluent 30%-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 tablet, the good drug effect of hard capsule, original technology and dosage form are improved, 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 quality and hygiology standard.Overcome tablet shortcoming 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 umber (by weight)
1 part of medicine
0.05 part of glycerol
0.02 part of tween 80
Polyethylene Glycol-400 0.92 part
0.01 part of propyl p-hydroxybenzoate
The preparation of substrate: taking polyethylene glycol-400 920g, add glycerol 50g, polysorbas20 g, propyl p-hydroxybenzoate 10g mix homogeneously gets soft capsule matrix 1000g altogether.
Rhizoma Menispermi extract and above-mentioned substrate mix homogeneously are pressed into soft capsule, drying, promptly.
Embodiment 2:
Form umber (by weight)
1 part of medicine
0.308 part of isopropyl alcohol
Polyethylene Glycol-400 0.86 part
0.015 part of inositol
0.015 part of malic acid
0.002 part of sorbitol
The preparation of substrate: taking polyethylene glycol-400 860g, add isopropyl alcohol 308g, inositol 15g, malic acid 15g, sorbitol 2g, mix homogeneously gets soft capsule matrix 1200g altogether.
Rhizoma Menispermi extract and above-mentioned substrate mix homogeneously are pressed into soft capsule, drying, promptly.
Embodiment 3:
Form umber (by weight)
1 part of medicine
Polyethylene Glycol-400 1.38 part
0.05 part of tween 80
0.02 part of ethylhydroxyethylcellulose
0.045 part of dibenzylatiooluene
0.005 part of P-hydroxybenzoic acid
The preparation ethylhydroxyethylcellulose of substrate: taking polyethylene glycol-400 1380g, add tween 80 50g, ethylhydroxyethylcellulose 20g, dibenzylatiooluene 45g, P-hydroxybenzoic acid 5g, mix homogeneously gets soft capsule matrix 1500g altogether.
Rhizoma Menispermi extract and above-mentioned substrate mix homogeneously are pressed into soft capsule, drying, promptly.
Embodiment 4:
Form umber (by weight)
1 part of medicine (by the total medicated powder amount of last gained)
Polyethylene Glycol-400 1.275 part
0.025 part of ethylenediaminetetraacetic acid
0.07 part of sodium pyrosulfite
0.6 part of propylene glycol
0.03 part of sorbic acid methyl ester
The preparation of substrate: taking polyethylene glycol-400 1275g, add ethylenediaminetetraacetic acid 25g, sodium pyrosulfite 70g, propylene glycol 600g, sorbic acid methyl ester 30g mix homogeneously gets soft capsule matrix 2000g altogether.
Rhizoma Menispermi extract and above-mentioned substrate mix homogeneously are pressed into soft capsule, drying, promptly.
Embodiment 5:
Because the difference of soft capsule content character is also different to the proportioning that makes its softgel shell, so we have carried out detailed experimental study to gelatin, the glycerol proportioning of softgel shell:
| Inspection item | Gelatin and glycerol proportioning | |||||
| The outward appearance of softgel shell and physical property | 5∶1 | 4.5∶1 | 4∶1 | 3～3.8∶1 | 2∶1 | 1.5∶1 |
| Too firmly, easily crisp | Too firmly, more crisp | More suitable | Suitable | More suitable | Too soft, the easy moisture absorption | |
Overcome shortcoming such as tablet, hard capsule in the past by the northern bean root soft capsule of as above specifically implementing the example gained, soft capsule dosage form has relative high bioavailability, and has proved technology simple possible of the present invention, and 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 it is 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 northern bean root soft capsule comprises the content in softgel shell and the softgel shell, it is characterized in that content is Rhizoma Menispermi extract and an amount of adjuvant.
2. the preparation technology of the northern bean root soft capsule described in claim 1, its feature may further comprise the steps: get Rhizoma Menispermi coarse powder 1000g, add the aqueous sulfuric acid (PH1-2) of 8 times of amounts, warm macerating (55-60 ℃) twice each 24 hours, filters, merging filtrate leaves standstill, and gets supernatant after precipitation is complete and adds sodium carbonate adjusting pH value to 9, leave standstill, precipitation is the back abandoning supernatant fully, gets the precipitation sucking filtration, is washed till neutrality with low amounts of water, 50-60 ℃ of drying promptly gets Rhizoma Menispermi extract.With itself and pharmaceutic adjuvant mix homogeneously, be pressed into soft capsule, drying, promptly.
3. content Chinese medicine according to claim 1 accounts for 30%-70%, and adjuvant accounts for 30%-70%.
Its best ratio range is 1: 0.6-1: 2.The best ratio range of gelatin and glycerol is 2 in the softgel shell: 1-4: 1.
4. require 1 described northern bean root soft capsule to it is characterized in that adjuvant can be one or more in diluent, suspending agent, antioxidant, surfactant and the antiseptic.
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 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.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200410155506 CN1651020A (en) | 2004-12-06 | 2004-12-06 | Northern bean root soft capsule and its preparation process |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200410155506 CN1651020A (en) | 2004-12-06 | 2004-12-06 | Northern bean root soft capsule and its preparation process |
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| Publication Number | Publication Date |
|---|---|
| CN1651020A true CN1651020A (en) | 2005-08-10 |
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|---|---|---|---|
| CN 200410155506 Pending CN1651020A (en) | 2004-12-06 | 2004-12-06 | Northern bean root soft capsule and its preparation process |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1939417B (en) * | 2005-09-26 | 2011-02-09 | 山东轩竹医药科技有限公司 | Medicinal composition of douricine, tinosporae or its extract |
| CN101040899B (en) * | 2006-03-20 | 2013-06-19 | 周亚伟 | Antineoplastic Chinese traditional compound and the preparation and the method for producing the same |
| CN103479727A (en) * | 2013-09-16 | 2014-01-01 | 湖北诺克特药业有限公司 | Improved processing method for extracting rhizoma menispermi |
-
2004
- 2004-12-06 CN CN 200410155506 patent/CN1651020A/en active Pending
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1939417B (en) * | 2005-09-26 | 2011-02-09 | 山东轩竹医药科技有限公司 | Medicinal composition of douricine, tinosporae or its extract |
| CN101040899B (en) * | 2006-03-20 | 2013-06-19 | 周亚伟 | Antineoplastic Chinese traditional compound and the preparation and the method for producing the same |
| CN103479727A (en) * | 2013-09-16 | 2014-01-01 | 湖北诺克特药业有限公司 | Improved processing method for extracting rhizoma menispermi |
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