CN100353954C - Antiphlogistic gallbladder-benefiting soft capsule and its prepn process - Google Patents
Antiphlogistic gallbladder-benefiting soft capsule and its prepn process Download PDFInfo
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- CN100353954C CN100353954C CNB2004100568355A CN200410056835A CN100353954C CN 100353954 C CN100353954 C CN 100353954C CN B2004100568355 A CNB2004100568355 A CN B2004100568355A CN 200410056835 A CN200410056835 A CN 200410056835A CN 100353954 C CN100353954 C CN 100353954C
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Abstract
The present invention relates to an Antiphlogistic gallbladder-benefiting soft capsule and a preparation process thereof, particularly to a new antiphlogistic gallbladder-benefiting medicine formulation. The antiphlogistic gallbladder-benefiting soft capsule is composed of medicine liquid oil and capsule wall material, wherein the medicine liquid oil is composed of an antiphlogistic gallbladder-benefiting medicine extract, a diluting agent, a suspending agent and a wetting agent. The present invention has the characteristics of high dissolution speed of active components, high bioavailability, good treating effect, high medicine liquid stability, high fluidity and homogeneous dispersion; the device has the advantages of accuracy, beautiful appearance and stable quality.
Description
Technical field
The present invention relates to the medicine novel formulation of anti-inflammatory and choleretic, be specifically related to anti-inflammatory and choleretic soft capsule and preparation technology thereof.
Background technology
Anti-inflammatory and choleretic is made up of Herba Andrographis, Herba Rabdosiae Lophanthoidis, Ramulus Et Folium Picrasmae, be mainly used in accumulate in the dampness-heat in the liver and gallbladder due to acute cholecystitis, biliary tract inflammation, the detumescence of Herba Andrographis heat-clearing and toxic substances removing, dampness is monarch drug; The Herba Rabdosiae Lophanthoidis heat clearing and damp drying is a ministerial drug; Ramulus Et Folium Picrasmae dampness function of gallbladder promoting is an adjuvant, and all medicines share, and plays the merit of heat-clearing and toxic substances removing, dampness function of gallbladder promoting altogether, for state-promulgated pharmacopoeia is recorded kind.
The oral formulations of anti-inflammatory and choleretic is the conventional tablet and the capsule of anti-inflammatory and choleretic at present, because anti-inflammatory and choleretic is become to be grouped into by plurality of Chinese, effective ingredient is comparatively complicated, therefore be made into common tablet and capsule, disintegration rate is slow, and the stripping rapidly in vivo of various effective ingredient causes bioavailability lower, onset is slower, therefore has certain technological deficiency for acute cholecystitis and the biliary tract inflammation of treatment.
Therefore, develop and a kind ofly can improve bioavailability, the novel formulation of good stability is very important, and the anti-inflammatory and choleretic soft capsule has just in time overcome above-mentioned technological deficiency.
But, those of ordinary skills know, Chinese medicinal soft capsule is different with the Western medicine soft capsule, Western medicine soft capsule content composition is more single to be easy to make oil solution, than being easier to capsuleization, and the prescription of Chinese medicine is very complicated, paste-forming rate is big, water absorption is strong, the content preparation is comparatively complicated, and this just objectively requires soft capsule content not only to want uniform and stable but also will have good stable, therefore, make good effect, the bioavailability height, the technical difficulty of steady quality soft capsule is bigger, be not those of ordinary skills adopt routine techniques can do and obtain.
Summary of the invention
The present invention is directed to above technological deficiency, a kind of new anti-inflammatory and choleretic soft capsule and preparation technology thereof are provided.
Anti-inflammatory and choleretic soft capsule of the present invention is made up of medicinal liquid oil and capsule material, and its herb liquid oil is made up of anti-inflammatory and choleretic extract, diluent, suspending agent and wetting agent.
Because the complexity of Chinese medicine ingredients, technological deficiencies such as the content character is inhomogeneous, easy layering often appear in Chinese medicinal soft capsule, thereby cause loading amount inaccurate, the therapeutic effect that does not reach, and suitable adjuvant can make soft capsule content have good stable and flowability, therefore selects suitable adjuvant to seem extremely important.
The present inventor finds by experimental study, and anti-inflammatory and choleretic soft capsule medicinal liquid oil of the present invention should be made up of the diluent of the anti-inflammatory and choleretic extract of 1 weight portion, 0.5-2 weight portion, the wetting agent that accounts for the suspending agent of diluent weight 1-4% and account for diluent weight 1-4%; More preferably form by the diluent of the anti-inflammatory and choleretic extract of 1 weight portion, 1.0-1.5 weight portion, the wetting agent that accounts for the suspending agent of diluent weight 2-3% and account for diluent weight 2-3%.
Diluent in the anti-inflammatory and choleretic soft capsule of the present invention can be selected the various diluent of this area routine for use, but should be prerequisite with discord active component generation chemical reaction of the present invention, diluent of the present invention be preferably one or more the vegetable oil in Oleum Sesami, Oleum Arachidis hypogaeae semen, Semen Maydis oil, soybean oil, almond oil, walnut oil, Oleum Gossypii semen, Oleum Helianthi, Oleum Ricini and the olive oil; One or more vegetable oil in Oleum Arachidis hypogaeae semen, Semen Maydis oil, the soybean oil more preferably;
Wetting agent of the present invention is Tweens or spans; Be preferably Arlacel-80; Suspending agent of the present invention is one or more in Cera Flava, aluminum monostearate, the ethyl cellulose (100CP); Be preferably Cera Flava.
Anti-inflammatory and choleretic extract of the present invention can adopt the technology of this area routine to be prepared, but the moisture in the anti-inflammatory and choleretic extract of its preparation exceeds to be no more than 3% (w/w), the yield of Herba Andrographis, Ramulus et Folium Picrasmae should be more than 5% (w/w) in the anti-inflammatory and choleretic extract, and the content of dehydrorographolide in Herba Andrographis, Ramulus et Folium Picrasmae should be more than 0.35%; The Herba Rabdosiae Lophanthoidis extract yield should be more than 7% (w/w).
The yield in the moisture of anti-inflammatory and choleretic extract and each extract and the detection of purity can adopt the detection method of various this areas routine to detect.
Anti-inflammatory and choleretic extract of the present invention preferably adopts following method to make: get 1736 weight portion Herba Andrographis, 1736 weight portion Ramulus Et Folium Picrasmaes with 80～85% ethanol (v/v) heating extraction secondary, add for the first time 8 times of amounts, extract 2h, add for the second time 6 times of amounts, extract 1h, filter merging filtrate, decompression recycling ethanol, being condensed into relative density is the thick paste of 1.25～1.28 (60 ℃ of surveys); Get 1736 weight portion Herba Rabdosiae Lophanthoidiss and decoct with water secondary, add 10 times of water gagings for the first time, decoct 2h, add for the second time 8 times of water gagings, decoct 1h, filter, collecting decoction, being concentrated into relative density is the clear paste of 1.10～1.12 (60 ℃ of surveys), adds 5 times of amount 70% ethanol, stir evenly, leave standstill 24h, filter, decompression recycling ethanol, being condensed into relative density is the thick paste of 1.25～1.28 (60 ℃ of surveys), merges above-mentioned thick paste, and drying under reduced pressure becomes dry extract.
Therefore, the prescription of capsule material seems particularly crucial in the Chinese medicinal soft capsule, not only the medicinal liquid oil quality directly influences quality of the present invention, and the quality of capsule shells also directly determines the quality of soft capsule itself, and it is having a strong impact on the disintegration of Chinese medicinal soft capsule.
The capsule material of anti-inflammatory and choleretic soft capsule of the present invention is made up of the sizing material of 1 weight portion, the plasticizer of 0.5 weight portion and the distilled water of 1 weight portion and an amount of opacifier, sizing material is gelatin or arabic gum, be preferably gelatin, the power value of freezing of gelatin should be greater than 180g among the present invention, moisture should be between 40%～50%, and the viscosity of glue should be controlled at 2700～3000mPa.s; Plasticizer is glycerol or sorbitol or both combinations, is preferably glycerol; Opacifier can be selected the opacifier of this area routine for use, as curcumin, milk chocolate palm fibre, ferrum oxide etc., is preferably the milk chocolate palm fibre.
Preparation of soft capsule technology of the present invention can adopt this area routine techniques to be prepared, and in order to reach better technique effect, the present invention preferably adopts and is prepared as follows technology: cancel scorching function of gallbladder promoting extract, pulverizing is also crossed 100 mesh sieves, and is standby; Get suspending agent, wetting agent melts in 60 ℃ of heating in water bath, adds in the diluent stirring and evenly mixing; Said extracted thing fine powder is added in the diluent, and stirring and evenly mixing is regulated the colloid mill fineness between 5～15 μ m, adds the medicinal liquid circulation and mills 0.5 hour, and fully mixing filters (crossing 100 mesh sieves), makes soft capsule content; It is an amount of to get sizing material, plasticizer, distilled water, opacifier, makes rubber after changing glue, the embedding pelleting, and drying, ethanol is washed ball, drying, is chosen ball, promptly.
In the anti-inflammatory and choleretic soft capsule preparation technology of the present invention, when adopting colloid mill to grind, should guarantee that particle diameter is between 70-90 μ m.
Anti-inflammatory and choleretic extract preparation technology of the present invention has kept the active component in the crude drug to the full extent, stable yield, lighter color, character homogeneous, water content is below 2.5%, overcome the long high temperature heat drying of clear paste in the traditional handicraft and problems such as complexion changed and ingredient heat loss have taken place, shortened man-hour, improve work efficiency, reduced germ contamination, quick, easy.
Anti-inflammatory and choleretic soft capsule of the present invention is compared with tablet, capsule, and the active component dissolution rate is fast, the bioavailability height, therapeutic effect is good, and soft capsule medicinal liquid of the present invention is stable, good fluidity, be uniformly dispersed, loading amount is accurate, good looking appearance, steady quality.
The specific embodiment
The present invention further sets forth the present invention by following examples and test example, but is not limited to this.
The preparation of embodiment 1 anti-inflammatory and choleretic extract
Get 1 736g Herba Andrographis, 1736g Ramulus Et Folium Picrasmae with 80～85% ethanol heating extraction secondaries, add 8 times of amounts for the first time, extract 2h, add for the second time 6 times of amounts, extract 1h, filter, merging filtrate, decompression recycling ethanol, being condensed into relative density is the thick paste of 1.25～1.28 (60 ℃ of surveys); Get the 1736g Herba Rabdosiae Lophanthoidis and decoct with water secondary, add 10 times of water gagings for the first time, decoct 2h, add for the second time 8 times of water gagings, decoct 1h, filter, collecting decoction, being concentrated into relative density is the clear paste of 1.10～1.12 (60 ℃ of surveys), adds 5 times of amount 70% ethanol, stir evenly, leave standstill 24h, filter, decompression recycling ethanol, being condensed into relative density is the thick paste of 1.25～1.28 (60 ℃ of surveys), merges above-mentioned thick paste, and drying under reduced pressure becomes dry extract.
Preparation of soft capsule
Embodiment 2
Prescription: anti-inflammatory and choleretic extract 250g; Soybean salad oil 250g, Cera Flava 7.5g, Arlacel-80 5.0g, water 200ml, glycerol 100g, gelatin 200g, milk chocolate palm fibre 0.6g,
Preparation technology: get recipe quantity anti-inflammatory and choleretic extract, pulverize, 100 orders sieve, and are standby; Get recipe quantity Cera Flava, span,, add in the soybean salad oil stirring and evenly mixing in 60 ℃ of heating in water bath fusings; Said extracted thing fine powder is added in the fluid, and stirring and evenly mixing is regulated the colloid mill fineness between 5～15 μ m, adds the medicinal liquid circulation and mills 0.5 hour, and fully mixing filters (crossing 100 mesh sieves), makes soft capsule content; Get gelatin, glycerol, distilled water, milk chocolate palm fibre, make rubber after changing glue, the embedding pelleting is made soft capsule, and dry 12 hours, ethanol was washed ball, drying, chosen ball, promptly.
Embodiment 3
Prescription: anti-inflammatory and choleretic extract 250g, Oleum Arachidis hypogaeae semen 380g, Cera Flava 10g, Arlacel-80 10g, water 200ml, glycerol 100g, gelatin 200g, milk chocolate palm fibre 0.6g,
Preparation technology: get recipe quantity anti-inflammatory and choleretic extract, pulverize, 100 orders sieve, and are standby; Get recipe quantity Cera Flava, Arlacel-80,, add in the Oleum Arachidis hypogaeae semen stirring and evenly mixing in 60 ℃ of heating in water bath fusings; Said extracted thing fine powder is added in the fluid, and stirring and evenly mixing is regulated the colloid mill fineness between 5～15 μ m, adds the medicinal liquid circulation and mills 0.5 hour, and fully mixing filters (crossing 100 mesh sieves), makes soft capsule content; Get gelatin, glycerol, distilled water, milk chocolate palm fibre, make rubber after changing glue, the embedding pelleting is made soft capsule, and dry 12 hours, ethanol was washed ball, drying, chosen ball, promptly.
Embodiment 4 anti-inflammatory and choleretic preparation of soft capsule
Prescription: anti-inflammatory and choleretic extract 250g; Semen Maydis oil 280g, Cera Flava 5.5g, Arlacel-80 5.5g, water 200ml, glycerol 100g, gelatin 200g, milk chocolate palm fibre 0.6g,
Preparation technology: get recipe quantity anti-inflammatory and choleretic extract, pulverize, 100 orders sieve, and are standby; Get the recipe quantity Cera Flava, span is an amount of, in the fusing of 60 ℃ of heating in water bath, adds in the Semen Maydis oil oil stirring and evenly mixing; Said extracted thing fine powder is added in the fluid, and stirring and evenly mixing is regulated the colloid mill fineness between 5～15 μ m, adds the medicinal liquid circulation and mills 0.5 hour, and fully mixing filters (crossing 100 Mu Sieve), makes soft capsule content; Get gelatin, glycerol, distilled water, milk chocolate palm fibre, make rubber after changing glue, the embedding pelleting is made soft capsule, and dry 12 hours, ethanol was washed ball, drying, chosen ball, promptly.
Embodiment 5
Prescription: anti-inflammatory and choleretic extract 250g; Soybean salad oil 350g, aluminum monostearate 7.0g, tween 80 7.0g, water 200ml, glycerol 100g, gelatin 200g, milk chocolate palm fibre 0.6g,
Preparation technology: get recipe quantity anti-inflammatory and choleretic extract, pulverize, 100 orders sieve, and are standby; Get the recipe quantity aluminum monostearate, tween melts in 60 ℃ of heating in water bath, adds in the soybean salad oil stirring and evenly mixing; Said extracted thing fine powder is added in the fluid, and stirring and evenly mixing is regulated the colloid mill fineness between 5～15 μ m, adds the medicinal liquid circulation and mills 0.5 hour, and fully mixing filters (crossing 100 Mu Sieve), makes soft capsule content; Get gelatin, glycerol, distilled water, milk chocolate palm fibre, make rubber after changing glue, the embedding pelleting is made 1000 of soft capsules, and dry 12 hours, ethanol was washed ball, drying, chosen ball, promptly.
Embodiment 6
Prescription: anti-inflammatory and choleretic extract 250g; Soybean salad oil 350g, Cera Flava 10.5g, Arlacel-80 7.0g, water 200ml, sorbitol 100g, arabic gum 200g, curcumin 0.6g,
Preparation technology: get recipe quantity anti-inflammatory and choleretic extract, pulverize, 100 orders sieve, and are standby; Get recipe quantity Cera Flava, span,, add in the soybean salad oil stirring and evenly mixing in 60 ℃ of heating in water bath fusings; Said extracted thing fine powder is added in the fluid, and stirring and evenly mixing is regulated the colloid mill fineness between 5～15 μ m, adds the medicinal liquid circulation and mills 0.5 hour, and fully mixing filters (crossing 100 Mu Sieve), makes soft capsule content; Get arabic gum, sorbitol, distilled water, curcumin, make rubber after changing glue, the embedding pelleting is made soft capsule, and dry 12 hours, ethanol was washed ball, drying, chosen ball, promptly.
Test example 1 anti-inflammatory and choleretic soft capsule study on the stability
Investigation method: get this product (embodiment of the invention 1 and 2 preparations, the plastic-aluminum bubble-cap, 12/plate, 0.5g/ grain) place under the room temperature condition respectively and constant temperature and humidity (37 ℃ of temperature, humidity 75%) preserve under the condition, of that month examination was once examined once in later every month, three totally months, examination once (2004.1～2004.7) again in six months.
Investigation project:, the examination project of this product is decided to be five of character, discriminating, disintegration, assay, limit test of microbe etc. by the stability test requirement content of " soft capsule ".
Conclusion: from investigating the result as can be seen: " anti-inflammatory and choleretic soft capsule " be 0～6 month preliminarily stabilised investigation of relaxing the bowels with purgatives of warm nature and constant temperature and humidity (37 ℃ of temperature often, humidity 75%) 0～6 month accelerated stability is investigated under the condition, every index was compared there was no significant difference with 0 month, all meet preparation quality standard (draft) regulation, show this product steady quality, preparation technology is rationally feasible.(specifically seeing Table 1 table 2).
Table 1 preparation preliminarily stabilised investigation report
Sample title: anti-inflammatory and choleretic soft capsule lot number 040105
Table 2 preparation accelerated stability investigation report
(constant temperature and humidity: 37 ℃ of temperature, humidity 75%)
Sample title: anti-inflammatory and choleretic soft capsule lot number 040105
Claims (7)
1, a kind of anti-inflammatory and choleretic soft capsule, it is characterized in that being made up of medicinal liquid oil and capsule material, its herb liquid oil is made up of the diluent of the anti-inflammatory and choleretic extract of 1 weight portion, 1.0-1.5 weight portion, the wetting agent that accounts for the suspending agent of diluent weight 2-3% and account for diluent weight 2-3%; The anti-inflammatory and choleretic extract adopts following method to make: get 1736 weight portion Herba Andrographis and 1736 weight portion Ramulus Et Folium Picrasmaes with 80～85% ethanol heating extraction secondaries, add for the first time 8 times of amounts, extract 2h, add for the second time 6 times of amounts, extract 1h, filter merging filtrate, decompression recycling ethanol, being condensed into 60 ℃, to survey relative densities be 1.25～1.28 thick paste; Get 1736 weight portion Herba Rabdosiae Lophanthoidiss and decoct with water secondary, add 10 times of water gagings for the first time, decoct 2h, add for the second time 8 times of water gagings, decoct 1h, filter, collecting decoction, being concentrated into 60 ℃, to survey relative densities be 1.10～1.12 clear paste, adds 5 times of amount 70% ethanol, stir evenly, leave standstill 24h, filter, decompression recycling ethanol, being condensed into 60 ℃, to survey relative densities be 1.25～1.28 thick paste, merges above-mentioned thick paste, drying under reduced pressure becomes dry extract, is ground into fine powder.
2, anti-inflammatory and choleretic soft capsule according to claim 1 is characterized in that diluent is a kind of in Oleum Sesami, Oleum Arachidis hypogaeae semen, Semen Maydis oil, soybean oil, almond oil, walnut oil, Oleum Gossypii semen, Oleum Helianthi, Oleum Ricini and the olive oil; Suspending agent is a kind of among Cera Flava, aluminum monostearate and the ethyl cellulose 100CP; Wetting agent is Tweens or spans.
3, anti-inflammatory and choleretic soft capsule according to claim 2 is characterized in that diluent is a kind of in Oleum Arachidis hypogaeae semen, Semen Maydis oil, the soybean oil; Suspending agent is a Cera Flava; Wetting agent is an Arlacel-80.
4, anti-inflammatory and choleretic soft capsule according to claim 1 is characterized in that the capsule material is by the sizing material of 1 weight fraction, plasticizer and the distilled water of 1 weight portion and an amount of opacifier of 0.5 weight portion.
5, anti-inflammatory and choleretic soft capsule according to claim 4 is characterized in that sizing material is gelatin or arabic gum; Plasticizer is glycerol or sorbitol or both combinations; Opacifier is the milk chocolate palm fibre.
6, anti-inflammatory and choleretic soft capsule according to claim 1, the moisture that it is characterized in that the anti-inflammatory and choleretic extract exceeds to be no more than percentage by weight 3%, the yield of Herba Andrographis, Ramulus et Folium Picrasmae should be at percentage by weight more than 5% in the anti-inflammatory and choleretic extract, and the content of dehydrorographolide in Herba Andrographis, Ramulus Et Folium Picrasmae should be more than 0.35%; The yield of Herba Rabdosiae Lophanthoidis extract should be at percentage by weight more than 7%.
7, claim 1 or 4 described anti-inflammatory and choleretic preparation of soft capsule technologies is characterized in that: cancel scorching function of gallbladder promoting extract, pulverize, cross 100 mesh sieves, and standby; Get suspending agent, wetting agent melts in 60 ℃ of heating in water bath, adds in the diluent stirring and evenly mixing; Said extracted thing fine powder is added in the diluent, and stirring and evenly mixing is regulated the colloid mill fineness between 5～15 μ m, adds the medicinal liquid circulation and mills 0.5 hour, and fully mixing is crossed 100 mesh sieves, makes soft capsule content; It is an amount of to get sizing material, plasticizer, distilled water, opacifier, makes rubber embedding pelleting after changing glue, make soft capsule, drying, wash ball, drier, choose ball, promptly.
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| CN103006764A (en) * | 2012-12-27 | 2013-04-03 | 上海海虹实业(集团)巢湖今辰药业有限公司 | Method for preparing anti-inflammation cholagogue soft capsule |
| CN106377579A (en) * | 2015-08-05 | 2017-02-08 | 北京海吉星医疗科技有限公司 | Glossy privet fruit-astragalus root body resistance-strengthening soft capsule and preparation method thereof |
| CN108524599A (en) * | 2018-06-29 | 2018-09-14 | 广东万年青制药有限公司 | A kind of purposes of Chinese medicine composition in the drug for preparing treatment enteritis |
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| CN1490041A (en) * | 2003-07-22 | 2004-04-21 | 浙江天一堂集团有限公司 | Cottonrose hibiscus leaf and magnolia bark containing medicines against catch-cold and preparation thereof |
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| CN1490041A (en) * | 2003-07-22 | 2004-04-21 | 浙江天一堂集团有限公司 | Cottonrose hibiscus leaf and magnolia bark containing medicines against catch-cold and preparation thereof |
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| Title |
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| 中华人民共和国药典委员会编 中华人民共和国药品标准中药成方制剂，第十卷 1995 * |
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