CN1733090A - A kind of Flos Trollii soft capsule and preparation method thereof - Google Patents

A kind of Flos Trollii soft capsule and preparation method thereof Download PDF

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Publication number
CN1733090A
CN1733090A CN 200510044365 CN200510044365A CN1733090A CN 1733090 A CN1733090 A CN 1733090A CN 200510044365 CN200510044365 CN 200510044365 CN 200510044365 A CN200510044365 A CN 200510044365A CN 1733090 A CN1733090 A CN 1733090A
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Prior art keywords
flos trollii
content
soft capsule
extract powder
medium
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CN 200510044365
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CN100453096C (en
Inventor
仲英
刘鲁
庄建红
王菊
王姣
孙敬勇
贾志伟
左春旭
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Guangdong Luofushan Sinopharm Co Ltd
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INSTITUTE OF MATERIA MEDICA SHANDONG ACADEMY OF MEDICAL SCIENCES
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Abstract

A kind of Flos Trollii soft capsule is that adjuvants such as the medium, stabilizing agent of additional proportion amount in the Flos Trollii extract powder of producing, the aging agent of anti-softgel shell and antiseptic are made and are the thick content of brown, and quantitative filling is pressed into the Flos Trollii soft capsule in capsule shells then.This soft capsule has the advantage that soft capsule has usually: good airproof performance, and physical stability is good, is uniformly dispersed, and the bioavailability height can taste masking.

Description

A kind of Flos Trollii soft capsule and preparation method thereof
Technical field
The present invention relates to the field of Chinese medicines, belong to the improvement technology of Chinese medicine preparation.
Technical background
Jinlianhua pian is the Chinese patent medicine class, has the effect of heat-clearing and toxic substances removing, is used for wind-heat evil toxin and attacks lung, the upper respiratory tract infection that dominance of heat in the interior causes, pharyngitis, tonsillitis.Principal agent is a Flos Trollii, by the dried floral of cohosh Flos Trollii Trollius chinensis Bge.; Flos Trollii claims " nasturtium ", " nonirrigated farmland lotus ", " Jin Xiaorong ", " globe-flower ", " golden pimple " etc. again.Call in the supplementary Amplifications of the Compendium of Materia Medica its " bitter in the mouth. cold in nature, nontoxic ", can " control aphtha, larynx is swollen. superficial heat gingival atrophy, ear are painful. ophthalmalgia. tomorrow, separate the haze miasma ".
The Flos Trollii clinical practice is very extensive, and the dosage form of listing exploitation is also more, and tablet, granule, oral liquid are arranged; But preparation process is perfect inadequately, and tablet needs coating, complex process; The easy moisture absorption of granule; The oral liquid instability; Be developed to soft capsule, can play taste masking, protection against the tide, good stability, technology is simple, and content uniformity is little, can reduce cost.
Summary of the invention
The objective of the invention is to overcome the deficiencies in the prior art, provide a kind of easy to use, good stability, disintegration rate fast, Flos Trollii soft capsule and preparation technique thereof that bioavailability is high.
Solution of the present invention is that Flos Trollii decocting liquid is condensed into extractum, pulverizes 80~200 mesh sieves, makes extract powder, then, the extract powder additional proportion amount medium of making is made the pitchy thickness oily content of good fluidity, and quantitative filling is pressed into soft capsule in capsule shells thereafter.The constituent content of said content is by weight percentage: 10-60wt% Flos Trollii extract powder, 37-87wt% medium, 2-5wt% stabilizing agent, 0.5wt% antiseptic, the aging agent of the anti-softgel shell of 0.5-1.5wt%.The globeflower capsule preparation of so making meets following technical specification:
The form content is a pitchy thickness grease
Contain total flavones (rutin) and must not be less than 12.3%
Disintegration rate was less than 30 minutes
Flos Trollii preparation of soft capsule method of the present invention comprises following key step:
1, the preparation of extract powder:
Flos Trollii decocts with water secondary, and 1 hour for the first time, filter, merging filtrate is condensed into the thick paste shape, is dried to dry extract, pulverizes 80~200 mesh sieves, makes the Flos Trollii extract powder.
2, preparation content:
Get adjuvants such as the medium of the above extract powder additional proportion amount for preparing and stabilizing agent, antiseptic, the aging agent of anti-softgel shell, grind, mixing, make soft material, standby.The addition of medium should be adjusted according to the character of used medium and the apparent fluidity of content.Usually the Flos Trollii extract powder is 1: 4~3: 2 with the relative weight ratio of medium.
3, it is standby to make the capsule material with the method for routine with gelatin or arabic gum; Prevent that softgel shell is aging, can add 0.1~1.5% vitamin E or glycine.
4, with the content quantitative filling in the capsule material, be pressed into soft capsule.
An important feature of the present invention is that the extract powder made need add a certain amount of medium and makes soft material earlier, and fill thereafter becomes soft capsule.The selection of medium should be taken into account that medium has dispersibility preferably to extract powder, and the stability of soft material will get well, and the addition of medium should be adjusted according to the character of used medium and the viscosity of soft material.Usually extract powder is 1: 4~3: 2 with the relative weight ratio of medium.
Experiment shows: optional in Polyethylene Glycol, isopropyl alcohol, tween 80, glycerol, propylene glycol, rich mixture and vegetable oil one or more of the used medium of the present invention, here said Polyethylene Glycol is to be selected from PEG400, Macrogol 600, Macrogol 4000 and polyethylene glycol 6000, and said vegetable oil then is selected from salad oil, Oleum Glycines, Oleum Arachidis hypogaeae semen, Oleum Camelliae, Semen Maydis oil, olive oil, Oleum Sesami, Semen Allii Tuberosi wet goods.Wherein preferred medium is a kind of in salad oil, Oleum Glycines, Oleum Arachidis hypogaeae semen, Oleum Sesami, Oleum Camelliae, Semen Maydis oil, olive oil, Oleum Camelliae, PEG400, Tween 80, the isopropyl alcohol.
In the Flos Trollii content of the present invention's preparation, also be added with adjuvants such as a certain amount of stabilizing agent, the aging agent of anti-softgel shell and antiseptic, to strengthen dispersibility, the stability of content.Said stabilizing agent, it is selected from Cera Flava, insect wax, glyceryl monostearate, Tween 80, soybean lecithin, one or more in ethyl cellulose CP100, Polyethylene Glycol single-stearic, span, the Macrogol 4000-6000; The agent of wearing out of said anti-softgel shell, it is selected from vitamin E, glycine, a kind of in the glycerol; Said antiseptic, it is selected from a kind of in propylene glycol, propyl p-hydroxybenzoate, methyl parahydroxybenzoate, ethylparaben, butyl p-hydroxybenzoate, benzyl p-hydroxybenzoate, the P-hydroxybenzoic acid phenyl ester.
The preparation of Flos Trollii extractum content selects for use the character of medium and apparent fluidity, the stability of content to adjust because of basis.When being medium with the salad oil, salad oil is 2: 1 with the relative weight ratio of Flos Trollii extract powder in the content, and adds 2wt% Cera Flava and 1wt% vitamin E; When being medium with Oleum Glycines, Oleum Glycines is 2: 1 with the relative weight ratio of Flos Trollii extract powder in the content, and adds 2wt% Cera Flava, 2wt% soybean lecithin and 0.5wt% vitamin E; When being medium with the PEG400, PEG400 is 1.5: 1 with the relative weight ratio of Flos Trollii extract powder in the content, and is added with 5-10wt% glycerol or propylene glycol.The soft capsule that so is mixed with, the content in the capsule is a grease, is difficult for the moisture absorption, good stability, dispersion of medicine, the good airproof performance of soft capsule both can be covered taste of Chinese medicine, had improved mouthfeel, had also improved medicine stability.After taking, capsule disintegrate rapidly, the content in the capsule can promptly be distributed in the body fluid, has accelerated the medicine stripping, so the performance drug effect is rapid, has improved bioavailability of medicament.
The invention will be further described with by way of example more below, provides implementation detail of the present invention, but be not to be intended to limit protection scope of the present invention.
Flos Trollii 1500g decocts with water secondary, and 1 hour for the first time, filter, merging filtrate is condensed into the thick paste shape, is dried to dry extract, pulverizes 100 orders and sieves, and makes Flos Trollii extractum.Get extract powder again and make suspended matter in an amount of medium and stabilizing agent, the aging agent of anti-softgel shell, antiseptic, then content and the 60 ℃ of gelatin solutions that make are pressed into 1000 seed lac balls with the rotating mould press, after using the solidifying by cooling in wind molding in the rotating cage again, and show oil reservoir with the ethanol flush away, dry under 24-32 ℃ of hot blast condition, get the bright and clean ellipsoid shape Flos Trollii soft capsule attractive in appearance of outward appearance.
The several examples of following reuse further specify the present invention.
Example 1: Flos Trollii 1500g, decoct with water secondary, 1 hour for the first time, filter, merging filtrate is condensed into the thick paste shape, is dried to dry extract, pulverizes 100 mesh sieves, makes the Flos Trollii extract powder.
Example 2: charge ratio: Flos Trollii extract powder 50%, salad oil 47%, Cera Flava 2%, vitamin E 0.5%, propylene glycol 0.5%, ground and mixed is even, makes the content of soft capsule; An amount of gelatin is added in the rustless steel glue pot, add 1: 1 water again, airtight, immersion is heated to 70-75 ℃, make the gelatin dissolving, in glycerol and 0.4: 1 ratio of gelatin, the glycerol of adding stirs, evacuation is removed bubble, puts into 70-80 ℃ of insulation of gelatin heat-preserving container and leaves standstill, and makes the capsule material; Make soft capsule with pressing.
Example 3: charge ratio: Flos Trollii extract powder 40%, Oleum Arachidis hypogaeae semen 54%, Cera Flava 2%, glyceryl monostearate 3%, vitamin E 0.5%, ethylparaben 0.5%, ground and mixed is even, makes the content of soft capsule; Capsule material proportioning: 1.2 times of water of adding arabic gum proportion, 0.5 times of sorbitol are made the capsule material; Make soft capsule with pressing.
Example 4: charge ratio: Flos Trollii extract powder 35%, Oleum Sesami 59%, Cera Flava 2%, the soft phosphatidase 13 % of Semen sojae atricolor, vitamin E 0.5%, propyl p-hydroxybenzoate 0.5%, ground and mixed is even, makes the content of soft capsule; Capsule material proportioning: add 1.3 times of water of arabic gum proportion, 0.5 times of glycerol and sorbitol mixture and make the capsule material; Make soft capsule with pressing.
Example 5: charge ratio: Flos Trollii extract powder 30%, Oleum Sesami 64%, Cera Flava 2%, the soft phosphatidase 13 % of Semen sojae atricolor, vitamin E 0.5%, propyl p-hydroxybenzoate 0.5%, ground and mixed is even, makes the content of soft capsule.Quantitative filling is made soft capsule with pressing in capsule shells.
Example 6: charge ratio: Flos Trollii extract powder 27%, olive oil 66%, ethyl cellulose cp1002%, the soft phosphatidase 14 % of Semen sojae atricolor, vitamin E 0.5%, butyl p-hydroxybenzoate 0.5%, ground and mixed is even, makes the content of soft capsule.Quantitative filling is made soft capsule with pressing in capsule shells.
Example 7: charge ratio: Flos Trollii extract powder 60%, PEG400 37%, glycerol 2%, vitamin E 0.5%, benzyl p-hydroxybenzoate 0.5%, ground and mixed is even, makes the content of soft capsule.Quantitative filling is made soft capsule with pressing in capsule shells.
Example 8: charge ratio: Flos Trollii extract powder 55%, isopropyl alcohol 42%, Cera Flava 2%, vitamin E 0.5%, P-hydroxybenzoic acid phenyl ester 0.5%, ground and mixed is even, makes the content of soft capsule; Capsule material proportioning.Quantitative filling is made soft capsule with pressing in capsule shells.
Example 9: charge ratio: Flos Trollii extract powder 20%, Oleum Brassicae campestris 75%, Cera Flava 2%, tween 80 2%, vitamin E 0.5%, butyl p-hydroxybenzoate 0.5%, ground and mixed is even, makes the content of soft capsule; Capsule material proportioning: 1 times of water of adding arabic gum proportion, 0.5 times of glycerol are made the capsule material; Make soft capsule with pressing.
Example 10: charge ratio: Flos Trollii extract powder 40%, PEG400 51%, the soft phosphatidase 15 % of Semen sojae atricolor, glycerol 3%, vitamin E 0.5%, butyl p-hydroxybenzoate 0.5%, ground and mixed is even, makes the content of soft capsule.Quantitative filling is made soft capsule with dropping preparation method in capsule shells.
Example 11: charge ratio: Flos Trollii extract powder 10%, salad oil 85%, Cera Flava 2%, tween 80 2%, vitamin E 0.5%, butyl p-hydroxybenzoate 0.5%, ground and mixed is even, makes the content of soft capsule; Capsule material proportioning: 1 times of water of adding arabic gum proportion, 0.5 times of glycerol are made the capsule material; Make soft capsule with pressing.

Claims (10)

1, a kind of Flos Trollii soft capsule, its drug component is the extract powder of Flos Trollii water extraction, it is characterized in that said Flos Trollii soft capsule preparation is to add the medium of proportional quantity and stabilizing agent, the aging agent of anti-softgel shell, antiseptic in extract powder, make content earlier, then quantitative filling is pressed into the Flos Trollii soft capsule in capsule shells.
2, according to the described Flos Trollii soft capsule of claim 1, it is characterized in that the constituent content of said content, be by weight percentage: 10-60wt% Flos Trollii extract powder, the 37-87wt% medium, the 2-5wt% stabilizing agent, the aging agent of the anti-softgel shell of 0.5-1.5wt%, 0.5wt% antiseptic.
3, according to the described Flos Trollii preparation of soft capsule of claim 1 method, it is characterized in that comprising following key step:
3-1 prepares the Flos Trollii extract powder:
The depletion Flos Nelumbinis decocts with water, and filters, and merging filtrate is condensed into the thick paste shape, is dried to dry extract, pulverizes 80~200 mesh sieves, makes the Flos Trollii extract powder;
3-2 preparation Flos Trollii content:
The medium of depletion Flos Nelumbinis extract powder additional proportion amount and stabilizing agent, antiseptic, the aging agent of anti-softgel shell are ground evenly, make content, and be standby;
3-3 is with the stable capsule material of conventional method preparation performance, and is standby;
3-4 in the capsule material, is pressed into soft capsule with the content quantitative perfusion.
4, according to the described Flos Trollii preparation of soft capsule of claim 3 method, the preparation of said Flos Trollii content is characterized in that wherein the relative weight ratio of Flos Trollii extractum and medium is 1: 4-3: 2; Said medium is selected from one or more mixture in PEG400-600, isopropyl alcohol, Tween 80, glycerol, propylene glycol, rich mixture and the vegetable oil.
5, according to the described Flos Trollii soft capsule of claim 2, said content, it is characterized in that said stabilizing agent, it is selected from Cera Flava, insect wax, glyceryl monostearate, Tween 80, soybean lecithin, one or more in aluminum monostearate, ethyl cellulose CP100, polyethyleneglycol tristearin, span, the Macrogol 4000-6000;
The aging agent of anti-softgel shell, it is selected from vitamin E, glycine, glycerol;
Antiseptic, it is selected from glycerol, propylene glycol, methyl parahydroxybenzoate, para hydroxybenzene methyl acid ethyl ester, propyl p-hydroxybenzoate, butyl p-hydroxybenzoate, benzyl p-hydroxybenzoate, P-hydroxybenzoic acid phenyl ester.
6,, it is characterized in that said vegetable oil is selected from a kind of in salad oil, Oleum Arachidis hypogaeae semen, Oleum Sesami, Oleum Glycines, Oleum Camelliae, Semen Maydis oil, olive oil, the Oleum Brassicae campestris according to the described preparation method of claim 3.
7,, it is characterized in that said medium is selected from a kind of in salad oil, Oleum Arachidis hypogaeae semen, Oleum Sesami, Oleum Glycines, Oleum Camelliae, Semen Maydis oil, olive oil, Oleum Brassicae campestris, PEG400, Tween 80, the isopropyl alcohol according to the described preparation method of claim 3.
8, according to the described preparation method of claim 4, when it is characterized in that being medium with the salad oil, salad oil is 2: 1 with the relative weight ratio of Flos Trollii extract powder in the content, and adds 2wt% Cera Flava and 1wt% vitamin E.
9, according to the described preparation method of claim 4, when it is characterized in that being medium with the PEG400, PEG400 is 1.5: 1 with the relative weight ratio of Flos Trollii extract powder in the content, and contains glycerol or the propylene glycol of 5%~10wt%.
10, according to the described preparation method of claim 4, when it is characterized in that being medium with Oleum Glycines, Oleum Glycines is 2: 1 with the relative weight ratio of Flos Trollii extract powder in the content, and adds 2wt% Cera Flava, 2wt% soybean lecithin and 0.5wt% vitamin E.
CNB2005100443655A 2005-08-03 2005-08-03 Chinese globeflower soft capsule and its preparation method Expired - Fee Related CN100453096C (en)

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101606989B (en) * 2009-04-21 2012-03-21 王平 Novel preparation method of trollius chinensis granular preparation
CN106723037A (en) * 2016-12-24 2017-05-31 山东建筑大学 The preparation method and products obtained therefrom of a kind of sterculia seed throat-clearing throat-moistening fermentation capsule

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101606989B (en) * 2009-04-21 2012-03-21 王平 Novel preparation method of trollius chinensis granular preparation
CN106723037A (en) * 2016-12-24 2017-05-31 山东建筑大学 The preparation method and products obtained therefrom of a kind of sterculia seed throat-clearing throat-moistening fermentation capsule

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