CN1919214A - Monascus soft capsule and its preparation method - Google Patents
Monascus soft capsule and its preparation method Download PDFInfo
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- CN1919214A CN1919214A CNA2005100215216A CN200510021521A CN1919214A CN 1919214 A CN1919214 A CN 1919214A CN A2005100215216 A CNA2005100215216 A CN A2005100215216A CN 200510021521 A CN200510021521 A CN 200510021521A CN 1919214 A CN1919214 A CN 1919214A
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Abstract
The invention discloses a soft capsule agent and preparing method based on red monascus as raw material, which is characterized by the following: adopting new agent and craft to improve dust utility and sealing degree, displaying pretty appearance and content.
Description
Technical field
The present invention relates to a kind of Chinese patent medicine novel formulation and preparation method thereof, particularly a kind of is the soft capsule preparation and preparation method thereof of raw material with the Monas cuspurpureus Went, belongs to medical technical field.
Background technology
Monas cuspurpureus Went is to be raw material with the rice, and through a kind of aubergine rice-koji that the Monascus ruber breeding forms, medicine-food two-purpose is in the history in existing more than 1,000 year of China.Early it has been widely used in food color, wine brewing, fermentation, Chinese medicine aspect in ancient times.Monas cuspurpureus Went beginning is stated from the principle of Correct Diet in the Yuan Dynasty, has put down in writing its medical value in the Compendium of Material Medica---and " help digestion and invigorate blood circulation, the dry stomach of spleen invigorating, control water paddy under the dysentery with red and white feces.Wine brewing, the capable medicine gesture of removing blood stasis is killed epidemic pathogenic factors from mountains, control to beat and pounce on wound, the public security human blood, gas is logical be puerperal stagnant blood not to the utmost, it is good to beat beverage ".In recent years, along with filtering out potent component for reducing blood fat lovastatin (Monacolin K) afterwards in the tunning of Monas cuspurpureus Went, the research of Monas cuspurpureus Went is just causing the very big concern of Chinese scholars.The scholar of various countries has carried out deeply and extensive studies it, find that Monas cuspurpureus Went can produce many useful secondary metabolites, as monascorubin, Cholesterol Inhibitor lovastatin, and has a composition of physiologically actives such as blood pressure lowering, antibiotic, antitumor, blood sugar lowering, make traditional Monas cuspurpureus Went increase new intension, the new function of therefore developing Monas cuspurpureus Went has become the focus of various countries' research.(Lei Ping, Jin Zonglian. bioactive substance progress in the Monas cuspurpureus Went. food industry science and technology, 2003,24 (9): 86～88)
At present domestic is that the pharmaceutical preparation of main material production has two kinds with the Monas cuspurpureus Went, i.e. the XUEZHIKANG JIAONANG of Beijing University's dimension letter and the zhibituo sheet of Chengdu Diao Pharmaceutical Group.Also have the compound recipe fat of forming by Monas cuspurpureus Went and other drug matching of Chengdu Diao Pharmaceutical Group exploitation must safe capsule in addition.The patent No. is that the Chinese patent of CN 1061537C discloses " a kind of hyperlipidemia and cardiovascular and cerebrovascular diseases associated monascus preparation for the treatment of "; Publication number is that the Chinese patent of CN 1513451A discloses " being the Chinese medicine Monas cuspurpureus Went and the preparation thereof of main active with lovastatin salt "; Publication number is that the Chinese patent of CN 1605347A discloses " a kind of preparation of red yeast tablet and application thereof ", and the monascus preparation application is more extensive clinically, but tablet and capsule are only arranged at present.
Soft capsule is a kind of novel medicament dosage form, is made up of softgel shell and medicinal liquid two parts.The capsule material of forming softgel shell mainly is sizing material, plasticizer, additives and water.Sizing material is generally gelatin, arabic gum; Plasticizer is used glycerol, sorbitol always, is used alone or as a mixture; Additives comprise 4 parts of antiseptic methyl parahydroxybenzoate commonly used, and the mixture that propyl p-hydroxybenzoate is 1 part is 0.2～0.3% of gelatin amount; The water-soluble dye of pigment edible specification commonly used; The bourbonal,ethyl vanillin of spice commonly used 0.1% or 2% essence; Opacifier is used titanium dioxide always, and per kilogram gelatin raw material often adds 2～12g, also can add 1% fumaric acid to increase capsular dissolubility.The disperse medium of capsule liquid vegetable oil commonly used or PEG400 also should contain suspending agent in the capsule liquid.For the normally used suspending agent of oily substrate is 10～30% oily wax mixtures, and it consists of: 1 part of oil with hydrogenated soybean, 1 part in Cera Flava, 4 parts of short chain vegetable oil; For non-oily substrate, then use 1～15% PEG4000 or PEG6000 always.Sometimes also can add antioxidant, surfactant and improve the stability and the bioavailability of soft capsule.(Fan Biting chief editor, pharmacy of Chinese materia medica .1997, Shanghai science tech publishing house, 355 pages), but be not that any raw material is all applicable to being prepared into soft capsule, because the character of raw material itself and the indication of raw material have determined whether this raw material can be prepared into soft capsule, up to now, Shang Weijian is the report that primary raw material prepares soft capsule with the Monas cuspurpureus Went.
Summary of the invention
Technical scheme of the present invention has provided a kind of monascus soft capsule, and the present invention also provides this preparation of soft capsule method.
The invention provides a kind of monascus soft capsule, it is to be prepared from by following weight proportion raw material and substrate adjuvant: 80～120 parts in Monas cuspurpureus Went, and 80～120 parts of adjuvants, preferably, the weight ratio of Monas cuspurpureus Went and substrate adjuvant is: 1: (0.8～1.2).
Wherein, described substrate adjuvant is one or more in Colla Corii Asini, salad oil, soybean phospholipid, vitamin E, Cera Flava, safflower oil, low-substituted hydroxypropyl cellulose, methylcellulose, ethyl cellulose, Polyethylene Glycol, sodium carboxymethyl cellulose, microcrystalline Cellulose, micropowder silica gel, Pulvis Talci, the polyvinylpyrrolidone.
Further, described substrate adjuvant is soybean oil, Cera Flava.
Soft capsule of the present invention is to be prepared from by following weight proportion raw material and substrate adjuvant: 80～120 parts in Monas cuspurpureus Went, 80～117 parts of soybean oils, 1～3 part in Cera Flava.
Further, it is to be prepared from by following weight proportion raw material and substrate adjuvant: 100 parts in Monas cuspurpureus Went, 117 parts of soybean oils, 3 parts in Cera Flava.
The present invention also provides the preparation method of this monascus soft capsule, and it comprises the steps:
A, preparation capsule material glue: take by weighing and contain the following weight proportion raw material and prepare the capsule material: the weight proportion of dried plasticizer and dry gelatin is (0.3～0.6): 1.0, and the weight proportion of water and dry gelatin is 1: 1;
B, take by weighing Monas cuspurpureus Went, drying is pulverized, and crosses 60～200 mesh sieves;
C, Monas cuspurpureus Went is added soybean oil and Cera Flava, mixing adopts pressing to prepare soft capsule.
Wherein, the described dried plasticizer of step a is: glycerol, methyl hydroxybenzoate, ethyl hydroxybenzoate.
Further, the described capsule material of step a glue is to contain the preparation of following weight proportion raw material:
50 parts in gelatin, 15～30 parts of glycerol, 50 parts in water, 0.05 part of methyl hydroxybenzoate, 0.1 part of ethyl hydroxybenzoate.
Further, the described capsule material of step a glue is to contain the preparation of following weight proportion raw material:
50 parts in gelatin, 20 parts of glycerol, 50 parts in water, 0.05 part of methyl hydroxybenzoate, 0.1 part of ethyl hydroxybenzoate.
Monascus soft capsule of the present invention is compared with common Monas cuspurpureus Went dosage form, bioavailability height, good seal, accurate, the good looking appearance of content, hydrophobic drug for the bioavailability difference is very suitable, and the main effective medicinal components Monacolin of 3 classes K, monascorubin, etembonate alcohols material that Monas cuspurpureus Went contains are lyophobic dust, poorly water-soluble, the gastrointestinal absorption degree is low and bioavailability is poor, so with itself and the soft capsule of packing into after carrier mixes, can improve its bioavailability greatly, provide a kind of new selection for clinical.
Obviously, according to foregoing of the present invention,,, can also make modification, replacement or the change of other various ways not breaking away under the above-mentioned basic fundamental thought of the present invention prerequisite according to the ordinary skill knowledge and the customary means of this area.
The specific embodiment of form is described in further detail foregoing of the present invention again by the following examples.But this should be interpreted as that the scope of the above-mentioned theme of the present invention only limits to following example.All technology that realizes based on foregoing of the present invention all belong to scope of the present invention.
The specific embodiment
Embodiment 1 different degree of grinding to lovastatin Effect of Drying Incineration of Plant in the Monas cuspurpureus Went
Detected level (the unit: mg/g) of lovastatin in the different degree of grinding Monas cuspurpureus Went of table 1
| Lot number | 020423 | 011205 | 020312 |
| A B C D E | 7.95 5.38 4.82 3.98 2.78 | 6.04 5.52 4.91 4.02 3.37 | 4.94 5.00 3.77 3.17 2.58 |
Annotate: A can pass through 200 mesh sieves; B can pass through 150 mesh sieves; C can pass through 120 mesh sieves; D can pass through 80 mesh sieves; E can not pass through 80 mesh sieves;
As can be seen from Table 1, degree of grinding has tangible influence to lovastatin detected level in the Monas cuspurpureus Went, and the former medicine of crossing 200 mesh sieves can not improve more than 1 times by the detected level of 80 its lovastatins of purpose raw material.
The selection of embodiment 2 supplementary product kinds
The adjuvant that soft capsule is commonly used has edible vegetable oil and PEG400.With the gelatin is the soft capsule of softgel shell, because the hydrophilic of gelatin, therefore the medicinal liquid to soft capsule has special requirement, be that moisture in the soft capsule medicinal liquid prescription must be less than 3%, the quality of soft capsule be could guarantee, distortion and seepage caused to prevent soft capsule because of the moisture that absorbs in the medicinal liquid, so the substrate of soft capsule selects aqueous hardly oleaginous base soybean oil better, it can be with the medicated powder mixing, and good fluidity.If add a little Cera Flava, stability is also fine, and therefore, selecting soybean oil, Cera Flava is the substrate adjuvant.
The selection of embodiment 3 supplementary product consumptions
For guaranteeing that content (medicinal liquid) is pressed into qualified soft capsule, promptly when the fill soft capsule, be easy to fill (medicinal liquid good fluidity), the soft capsule of fill is stablized (uniformity), so be necessary content stability, flowability are investigated.
Table 2 content stability, flowability
| Numbering | Medicated powder consumption (g) | Soybean oil consumption (g) | Cera Flava consumption (g) | Stability | Mobile |
| 1 2 3 4 5 6 7 8 9 | 100 100 100 100 100 100 100 100 100 | 78.80 98.50 118.20 78.00 97.50 117.00 77.20 96.50 115.80 | 1.20 1.50 1.80 2.00 2.50 3.00 2.80 3.50 4.20 | Relatively poor relatively poor carefully | Carefully relatively poor relatively poor |
As shown in Table 2,1～No. 3 good fluidity, but less stable are so can not select for use; 7～No. 9 good stabilities, but mobile relatively poor, so can not select for use; 4～No. 6 flowabilities and stability are all better, so all can select for use, promptly supplementary product consumption is that 1 ± 20% of Hongqu powder (red colouring agent) consumption reaches stable purpose with the interior medicinal liquid that makes.
The screening and the preparation of embodiment 4 soft capsule glues prescription
The screening of table 3 glue prescription
| Numbering | Gelatin | Glycerol | Water | Mud pool tortoise beetle ester | Mud moor gold ethyl ester | Food coloring |
| 1 2 3 4 | 50g 50g 50g 50g | 30g 25g 20g 15g | 50g 50g 50g 50g | 50mg 50mg 50mg 50mg | 100mg 100mg 100mg 100mg | 200mg 200mg 200mg 200mg |
The prescription screening index is: the hardness of A soft capsule; The disintegration of B soft capsule;
(1) compound method of capsule material glue: after the gelatin that takes by weighing recipe quantity is put and made its abundant swelling in the purified water, add glycerol and other adjuvant, add water to full dose, heating, 55 ℃ of insulations, evacuation stirs, and it is standby to survey moisture qualified back insulation.
(2) preparation of soft capsule: machine revolving die compacting soft capsule on the medicinal liquid that makes by embodiment 2 described content Monas cuspurpureus Went medicinal liquid preparing process and the 50 ℃ of gelatin solutions, after in rotating cage, using the solidifying by cooling in wind molding, with ethanol flush away surface oil reservoir, in 20～30 ℃ of hot air dryings, promptly.
(3) mensuration of disintegration: by " an appendix X of Chinese pharmacopoeia version in 2000 D measures, and is medium with 37 ℃ of water, checks the disintegration of soft capsule.
Compare by the prescription screening index, the results are shown in Table 4.
The The selection result of table 4 glue prescription
| Numbering | Hardness | Disintegration | Analysis-by-synthesis |
| 1 2 3 4 | Soft partially soft partially well too hard | 28 26 21 23 | General good general |
The comprehensive table analysis of going up determines that the glue prescription is prescription 3, that is:
Gelatin: 50Kg
Glycerol: 20Kg
Purified water: 50Kg
Mud pool tortoise beetle ester: 50g
Mud moor gold ethyl ester: 100g
Food coloring: 200g
The preparation technology of capsule material glue: purified water 50Kg, the gelatin 50Kg and the glycerol 20Kg that take by weighing recipe quantity, swelling 30min, heat temperature raising to 65～70 ℃, insulation half an hour, add mud pool tortoise beetle ester 50g, mud moor gold ethyl ester 100g and food coloring 200g, evacuation also stirs mix homogeneously, moisture is surveyed in sampling, when the scope of moisture, stop to stir and evacuation 55 ℃ of insulation stand for standby use 27～30%.
Embodiment 5 preparation of soft capsule of the present invention
Monas cuspurpureus Went 273g
Soybean oil 320g
Cera Flava 7g
Get Monas cuspurpureus Went, pulverized 80 mesh sieves, add soybean oil and Cera Flava, mixing prepares capsule material glue by the method for embodiment 3, adopts pressing to make soft capsule, makes 1000 altogether.
Embodiment 6 preparation of soft capsule of the present invention
Monas cuspurpureus Went 240g
Soybean oil 240g
Cera Flava 3g
Get Monas cuspurpureus Went, pulverized 100 mesh sieves, add soybean oil and Cera Flava, mixing prepares capsule material glue by the method for embodiment 3, adopts pressing to make soft capsule, makes 1000 altogether.
Embodiment 7 preparation of soft capsule of the present invention
Monas cuspurpureus Went 240g
Soybean oil 226g
Cera Flava 9g
Get Monas cuspurpureus Went, pulverized 120 mesh sieves, add soybean oil and Cera Flava, mixing prepares capsule material glue by the method for embodiment 3, adopts pressing to make soft capsule, makes 1000 altogether.
Embodiment 8 preparation of soft capsule of the present invention
Monas cuspurpureus Went 240g
Soybean oil 234g
Cera Flava 6g
Get Monas cuspurpureus Went, pulverized 150 mesh sieves, add soybean oil and Cera Flava, mixing prepares capsule material glue by the method for embodiment 3, adopts pressing to make soft capsule, makes 1000 altogether.
Embodiment 9 preparation of soft capsule of the present invention
Monas cuspurpureus Went 300g
Soybean oil 270g
Cera Flava 6g
Get Monas cuspurpureus Went, pulverized 200 mesh sieves, add soybean oil and Cera Flava, mixing prepares capsule material glue by the method for embodiment 3, adopts pressing to make soft capsule, makes 1000 altogether.
Claims (11)
1, a kind of monascus soft capsule is characterized in that: it is the soft capsule that is prepared from by following weight proportion raw material and substrate adjuvant: 80～120 parts in Monas cuspurpureus Went, 80～120 parts of substrate adjuvants.
2, monascus soft capsule according to claim 1 is characterized in that: the weight ratio of Monas cuspurpureus Went and substrate adjuvant is: 1: (0.8～1.2).
3. monascus pellet according to claim 1 and 2 is characterized in that: described Monas cuspurpureus Went is to pulverize the powder of back by 60～200 mesh sieves.
4, monascus soft capsule according to claim 1 is characterized in that: described substrate adjuvant is one or more in Colla Corii Asini, salad oil, soybean phospholipid, vitamin E, Cera Flava, safflower oil, low-substituted hydroxypropyl cellulose, methylcellulose, ethyl cellulose, Polyethylene Glycol, sodium carboxymethyl cellulose, microcrystalline Cellulose, micropowder silica gel, Pulvis Talci, the polyvinylpyrrolidone.
5, monascus soft capsule according to claim 4 is characterized in that: described adjuvant is soybean oil, Cera Flava.
6, monascus soft capsule according to claim 5 is characterized in that: it is to be prepared from by following weight proportion raw material and substrate adjuvant: 80～120 parts in Monas cuspurpureus Went, 80～117 parts of soybean oils, 1～3 part in Cera Flava.
7, monascus soft capsule according to claim 6 is characterized in that: it is to be prepared from by following weight proportion raw material and substrate adjuvant: 100 parts in Monas cuspurpureus Went, 117 parts of soybean oils, 3 parts in Cera Flava.
8, a kind of method for preparing claim 1 or 2 described monascus soft capsules, it comprises the steps:
A, preparation capsule material glue:
Take by weighing and contain the following weight proportion raw material and prepare the capsule material: the weight proportion of dried plasticizer and dry gelatin is 0.3～0.6: 1.0, and the weight proportion of water and dry gelatin is 1: 1;
B, take by weighing Monas cuspurpureus Went, drying is pulverized, and crosses 60～200 mesh sieves;
C, Monas cuspurpureus Went is added soybean oil and Cera Flava, mixing;
D, employing pressing prepare soft capsule.
9, the preparation method of monascus soft capsule according to claim 8 is characterized in that: the described dried plasticizer of step a is: glycerol, methyl hydroxybenzoate, ethyl hydroxybenzoate.
10, the preparation method of monascus soft capsule according to claim 9 is characterized in that: the described capsule material of step a glue is to contain the preparation of following weight proportion raw material: 50 parts in gelatin, 15～30 parts of glycerol, 50 parts in water, 0.05 part of methyl hydroxybenzoate, 0.1 part of ethyl hydroxybenzoate.
11, the preparation method of monascus soft capsule according to claim 10 is characterized in that: the described capsule material of step a glue is to contain the preparation of following weight proportion raw material: 50 parts in gelatin, 20 parts of glycerol, 50 parts in water, 0.05 part of methyl hydroxybenzoate, 0.1 part of ethyl hydroxybenzoate.
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN104172145A (en) * | 2013-05-20 | 2014-12-03 | 山东东阿阿胶股份有限公司 | Compound donkey-hide gelatin composition promoting blood health, and preparation method and application thereof |
| CN105285978A (en) * | 2015-09-23 | 2016-02-03 | 威海紫光金奥力生物技术有限公司 | Auxiliarily blood lipid lowering seal oil and purple perilla seed oil soft capsule |
Family Cites Families (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1183935C (en) * | 2002-05-27 | 2005-01-12 | 云大科技股份有限公司 | Notoginseng and fermented red rice composition for preventing and treating cardiac and cerebral vascular diseases |
| CN1248700C (en) * | 2003-04-14 | 2006-04-05 | 李朝晖 | Health-care food for preventing and treating hyperlipoidemia |
| CN1293874C (en) * | 2003-08-18 | 2007-01-10 | 李朝晖 | Traditional chinese medicine Monascus purpureus went using Lovastatin salt as main active and its preparation component |
| CN1290441C (en) * | 2004-07-19 | 2006-12-20 | 薛春生 | Rye-red yeast vinegar soft capsule and its preparing method |
| CN1650981A (en) * | 2004-12-10 | 2005-08-10 | 北京阜康仁生物制药科技有限公司 | Compound red leaven extract medicinal preparation and its application |
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2005
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104172145A (en) * | 2013-05-20 | 2014-12-03 | 山东东阿阿胶股份有限公司 | Compound donkey-hide gelatin composition promoting blood health, and preparation method and application thereof |
| CN104172145B (en) * | 2013-05-20 | 2016-08-31 | 山东东阿阿胶股份有限公司 | Promote compound ass-hide gelatin compositions of blood health and its preparation method and application |
| CN105285978A (en) * | 2015-09-23 | 2016-02-03 | 威海紫光金奥力生物技术有限公司 | Auxiliarily blood lipid lowering seal oil and purple perilla seed oil soft capsule |
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| CN1919214B (en) | 2010-05-05 |
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