CN1634427A - Soft capsule containing rhubarb, goldthread root and scutellaria root and preparation technique thereof - Google Patents
Soft capsule containing rhubarb, goldthread root and scutellaria root and preparation technique thereof Download PDFInfo
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- CN1634427A CN1634427A CN 200410087854 CN200410087854A CN1634427A CN 1634427 A CN1634427 A CN 1634427A CN 200410087854 CN200410087854 CN 200410087854 CN 200410087854 A CN200410087854 A CN 200410087854A CN 1634427 A CN1634427 A CN 1634427A
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Abstract
The disclosed soft capsule is prepared from rhubarb horsetails, goldthread root, baikal skullcap root and right amount of medicinal adjuvant, which form the content and coated into capsule shell of the soft capsule. The advantages of the capsule include convenient administration, quick action, high biological availability, and less side effects.
Description
[technical field]
The present invention relates to SANHUANG soft capsule and preparation technology thereof.
[background technology]
The prescription of SANHUANG soft capsule derives from " XIEXIN TANG " that medical science monograph " Medical Treasures of the Golden Chamber " records.SANHUANG in the side, Radix Et Rhizoma Rhei, Rhizoma Coptidis, Radix Scutellariae are the product in big bitter Great Cold, bitter can dampness letting out clearly, cold energy clearing away heat-fire.Its wide clinical application is in the three warmers intenseness of heat, conjunctival congestion and swelling pain, and mouth and nose are given birth to skin ulcer, laryngopharynx swelling and pain, gingival hemorrhage, restlessness and thirst, dark coloured urine constipation; Also be used for acute gastroenteritis, dysentery, department of eye acute inflammation such as pharyngolaryngitis, acute pulmonary infection, inflammatory lesion as the abdominal cavity is all, the sore swollen toxin of surgery, chronic pelvic inflammatory disease, vaginitis etc.
Mainly contain effective constituent Radix Et Rhizoma Rhei anthraquinone analog derivative, baicalin, berberine hydrochloride in the SANHUANG, be poorly water soluble drugs, bioavailability is lower.Existing quality standard only has the content inspection item of Radix Et Rhizoma Rhei, and the Radix Scutellariae in the prescription is lacked corresponding content controlling index.We improve extraction process on the extraction of original SANHUANG PIAN, preparation technology basis, adopt the soft capsule dosage form technology of preparing to solve the problems referred to above.The characteristics of soft capsule dosage form are that medicine disperses in gastrointestinal soon, good absorbing, and than the bioavailability height of tablet, 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.Therefore select the dosage form of soft capsule for use as this product.
[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 SANHUANG 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 the SANHUANG soft capsule, further to improve the quality of products and technology content.The SANHUANG 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, content, disintegration etc. and physicochemical property, its steady quality, easy to use effective.
SANHUANG 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 Et Rhizoma Rhei 300g, be ground into coarse powder, add 50% alcohol reflux three times, filter, merging filtrate reclaims ethanol and concentrating under reduced pressure, and the spray-dried fine powder that gets of concentrated solution is measured content, and is standby.It is an amount of to get Radix Scutellariae, decocts with water 1.5 hours for the first time three times, 1 hour for the second time, 40 minutes for the third time, collecting decoction, filter, filtrate adds hydrochloric acid and regulates pH value to 1～2, leaves standstill 1 hour, gets precipitation, wash with water and make pH value to 5～7, the spray-dried fine powder that gets of gained suspension is measured content, and is standby.Get berberine hydrochloride 5g and above-mentioned extractum rhei fine powder, Radix Scutellariae extractum fine powder by equivalent dilution method mix homogeneously, add in right amount in the substrate of forming by pharmaceutic adjuvant and stir, gained suspendible liquid and gelatin (being offset plate or the adhesive tape made from behind gelatin and glycerol, the water dissolution) are under 25 ± 2 ℃ of room temperatures, relative humidity 40% condition, be pressed into 1000 of the soft capsules of regulation content of dispersion through automatic rotation rolling capsule machine, under 28 ± 2 ℃, relative humidity 40% condition with dry 20 hours of capsule, 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 SANHUANG 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 1.7, the best prescription proportioning is:
Form content (percentage by weight)
Medicine 30%-70%
Diluent 30%-70%
Wetting agent 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 that the mixture with medicine and adjuvant is wrapped in and makes soft capsule in the soft capsule shell.Keep on the basis of the good drug effect of tablet, original technology and dosage form are improved, improve bioavailability and quality standard, again on the extraction of original SANHUANG PIAN, preparation technology basis, improve extraction process, adopt the soft capsule dosage form technology of preparing to solve the problems referred to above.Soft capsule soft or hard appropriateness after improvement is imbued with flexibility and toughness, has improved content of effective in the dry extract, and the discriminating of composition and Determination on content etc. are simple to operation, 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 umber (by weight)
1 part in medicated powder (by the total medicated powder amount of last gained)
0.6 part of glycerol
0.2 part in water
0.1 part of Polyethylene Glycol-6000
0.1 part in Cera Flava
Make medicated powder according to technique scheme recipe quantity and method thereof, it is added in the substrate that this ratio makes, stir, gained suspendible liquid and gelatin (being offset plate or the adhesive tape made from behind gelatin and glycerol, the water dissolution) are under 25 ± 2 ℃ of room temperatures, relative humidity 40% condition, through rotating the soft capsule that rolling capsule machine is pressed into the regulation content of dispersion automatically, under 28 ± 2 ℃, relative humidity 40% condition with dry 20 hours of capsule, promptly.
Embodiment 2:
Form umber (by weight)
1 part in medicated powder (by the total medicated powder amount of last gained)
0.34 part of isopropyl alcohol
0.5 part of propylene glycol
0.2 part in agar
0.06 part of inositol
0.09 part of malic acid
0.001 part of sorbitol
Making medicated powder according to technique scheme recipe quantity and method thereof adds in the substrate that this ratio makes, stir, gained suspendible liquid and gelatin (being offset plate or the adhesive tape made from behind gelatin and glycerol, the water dissolution) are under 25 ± 2 ℃ of room temperatures, relative humidity 40% condition, through rotating the soft capsule that rolling capsule machine is pressed into the regulation content of dispersion automatically, under 28 ± 2 ℃, relative humidity 40% condition with dry 20 hours of capsule, promptly.
Embodiment 3:
Form umber (by weight)
1 part in medicated powder (by the total medicated powder amount of last gained)
1.3 parts of soybean oils
0.148 part of tween 80
0.4 part of oil wax mixture
0.148 part of dibenzylatiooluene
0.004 part of P-hydroxybenzoic acid
Making medicated powder according to technique scheme recipe quantity and method thereof adds in the substrate that this ratio makes, stir, gained suspendible liquid and gelatin (being offset plate or the adhesive tape made from behind gelatin and glycerol, the water dissolution) are under 25 ± 2 ℃ of room temperatures, relative humidity 40% condition, through rotating the soft capsule that rolling capsule machine is pressed into the regulation content of dispersion automatically, under 28 ± 2 ℃, relative humidity 40% condition with dry 20 hours of capsule, promptly.
Embodiment 4:
Form umber (by weight)
1 part of medicine (by the total medicated powder amount of last gained)
Polyethylene Glycol-400 1.2 part
1.27 parts of soybean oils
0.1 part of ethylenediaminetetraacetic acid
0.1 part of sodium pyrosulfite
0.3 part of propylene glycol
0.03 part of sorbic acid methyl ester
Making medicated powder according to technique scheme recipe quantity and method thereof adds in the substrate that this ratio makes, stir, gained suspendible liquid and gelatin (being offset plate or the adhesive tape made from behind gelatin and glycerol, the water dissolution) are under 25 ± 2 ℃ of room temperatures, relative humidity 40% condition, through rotating the soft capsule that rolling capsule machine is pressed into the regulation content of dispersion automatically, under 28 ± 2 ℃, relative humidity 40% condition with dry 20 hours of capsule, promptly.
According to the soft capsule that the method for the foregoing description makes, appoint and get wherein qualified six and measure disintegration, all disintegrates in 15 minutes, than tablet, disintegration time obviously shortens.Its stripping active substance percentage rate in 45 minutes of stripping time limit measuring is significantly improved than tablet under the same terms.
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 by the SANHUANG 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, by making this dosage form have relative high bioavailability after the extraction process improvement, and 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 kind of SANHUANG soft capsule comprises the content in softgel shell and the softgel shell, it is characterized in that content comprises 300 parts of (by weight) Radix Et Rhizoma Rhei, 21 parts of Radix Scutellariae extractums, 5 parts of berberine hydrochloride and an amount of adjuvant.
2, preparation technology according to claim 1, its feature may further comprise the steps: get Radix Et Rhizoma Rhei, be ground into coarse powder, add 50% alcohol reflux three times, filter, merging filtrate reclaims ethanol and concentrating under reduced pressure, the spray-dried fine powder that gets of concentrated solution is measured content, and is standby.Get Radix Scutellariae, decoct with water three times, 1.5 hours for the first time, 1 hour for the second time, 40 minutes for the third time, collecting decoction filters, and filtrate adds hydrochloric acid and regulates pH value to 1～2, leaves standstill 1 hour, gets precipitation, wash with water and make pH value to 5～7, the spray-dried fine powder that gets of gained suspension is measured content, and is standby.Get berberine hydrochloride and above-mentioned extractum rhei fine powder, Radix Scutellariae extractum fine powder by equivalent dilution method mix homogeneously, add an amount of pharmaceutic adjuvant, mixing is wrapped in and forms soft capsule in the soft capsule shell.
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: 1.5.The best ratio range of gelatin and glycerol is 2 in the softgel shell: 1-4: 1.
4, it is characterized in that according to claim 1 and 2 described SANHUANG soft capsules 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 200410087854 CN1634427A (en) | 2004-11-01 | 2004-11-01 | Soft capsule containing rhubarb, goldthread root and scutellaria root and preparation technique thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200410087854 CN1634427A (en) | 2004-11-01 | 2004-11-01 | Soft capsule containing rhubarb, goldthread root and scutellaria root and preparation technique thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN1634427A true CN1634427A (en) | 2005-07-06 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 200410087854 Pending CN1634427A (en) | 2004-11-01 | 2004-11-01 | Soft capsule containing rhubarb, goldthread root and scutellaria root and preparation technique thereof |
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100370993C (en) * | 2006-01-11 | 2008-02-27 | 四川省中药研究所 | Medicinal composition with heat-clearing, fire-draining and detoxification function |
| CN101711808B (en) * | 2009-09-11 | 2011-08-24 | 海南海神同洲制药有限公司 | Soft capsule used for clearing away heat and toxic materials and preparation method thereof |
| CN103285121A (en) * | 2013-06-26 | 2013-09-11 | 重庆邮电大学 | Chinese medicine soft capsule for treating upper respiratory infection and preparation method as well as quality detection method thereof |
| JP2020055766A (en) * | 2018-10-01 | 2020-04-09 | 東洋カプセル株式会社 | Soft capsule agent containing dutasteride |
| CN116965546A (en) * | 2023-08-03 | 2023-10-31 | 重庆深山生物科技有限公司 | Health food for regulating and lowering blood pressure and preparation method thereof |
-
2004
- 2004-11-01 CN CN 200410087854 patent/CN1634427A/en active Pending
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100370993C (en) * | 2006-01-11 | 2008-02-27 | 四川省中药研究所 | Medicinal composition with heat-clearing, fire-draining and detoxification function |
| CN101711808B (en) * | 2009-09-11 | 2011-08-24 | 海南海神同洲制药有限公司 | Soft capsule used for clearing away heat and toxic materials and preparation method thereof |
| CN103285121A (en) * | 2013-06-26 | 2013-09-11 | 重庆邮电大学 | Chinese medicine soft capsule for treating upper respiratory infection and preparation method as well as quality detection method thereof |
| JP2020055766A (en) * | 2018-10-01 | 2020-04-09 | 東洋カプセル株式会社 | Soft capsule agent containing dutasteride |
| CN116965546A (en) * | 2023-08-03 | 2023-10-31 | 重庆深山生物科技有限公司 | Health food for regulating and lowering blood pressure and preparation method thereof |
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