CN1548067A - Yang-strengthening solid Xianrong prepn and its prepn process - Google Patents
Yang-strengthening solid Xianrong prepn and its prepn process Download PDFInfo
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Abstract
The Yang-strengthening solid medicine preparation, named Xianrong, is prepared with pilose antler, curculigo rhizome, epimedium, morinda root, wolfberry fruit and other three kinds of Chinese medicinal materials; and it features its supplementary material including beta-cyclodextrin, corrective stevioside or proteoglycan and plasticizer selected from mannitol, sorbic alcohol, xylitol, dextrin and lactose oligomer and the spray drying and dry pelletizing capable of maintaining the effective component completely and suitable for continuous GMP production. The medicine contains no cane sugar and preservative, is safe, without side effect, and has many other advantages.
Description
Technical field:
The present invention relates to Chinese medicine of a kind of kidney invigorating and YANG supporting, treatment body void, sexual impotence renal cold and preparation method thereof.
Background technology:
Along with the quickening of social rhythm and the increase of operating pressure, the male sexual function decline, myasthenia of limbs, pain in the low back and legs, diseases such as hypomnesis have become male's common frdquently encountered disease, for the research pay attention to day by day of such medicine, use also increasingly extensive.But lack in the modern chemistry medicine such disease of treatment safe, efficient, can be for the medicine taken for a long time, and develop the Chinese medicine traditional advantage, exploitation preparation stabilization, drug safety, dosage is accurate, quality controllable, the reliable Chinese medicine preparation of curative effect is significant.
Existing this type of Chinese medicine preparation is a liquid oral liquid at present, and stability of drug is poor; Contain antiseptic, refined honey and a large amount of sucrose, the absorption of antiseptic and too much sugar there is no benefit to human body, influences the safe handling of preparation to the part patient; Also can produce untoward reaction such as hyperglycemia to suffering from some patient who avoids sugared disease especially.
Summary of the invention:
The present invention be to solve existing problem in the prior art, provides a kind of Chinese medicine celestial fine and soft tonifying YANG solid preparation, contains the harmful effect to human body of antiseptic and a large amount of multitudinous sugar, refined honey to overcome liquid preparation, and reaches the purpose of taking convenience.Another object of the present invention provides the preparation method of the celestial fine and soft tonifying YANG solid preparation of this Chinese medicine.The technical scheme that technical solution problem of the present invention is adopted is:
The celestial fine and soft tonifying YANG solid preparation of the present invention is made of following weight portion crude drug:
12.5 parts in unhairing Cornu Cervi Pantotrichum, 25 parts of Rhizoma Curculiginises, 50 parts of Herba Epimedii, 25 parts of salt Radix Morindae Officinalis (processed), 25 parts of Herba Cistanches, 50 parts of Fructus Lycii, 10 parts of Radix Et Caulis Acanthopanacis Senticosi extractums, 50 parts of Radix Polygoni Multiflori Preparatas.
Be characterized in having in addition adjuvant: inclusion agents beta-schardinger dextrin-30-90 part, correctives 2-6 part and or forming agent 30-90 part; Described correctives is stevioside or protein sugar; Described forming agent is at least a in mannitol, sorbitol and the xylitol, or is at least a in dextrin and the oligomeric lactose.
The celestial fine and soft tonifying YANG chewable tablet of the present invention is made of following weight portion crude drug:
12.5 parts in unhairing Cornu Cervi Pantotrichum, 25 parts of Rhizoma Curculiginises, 50 parts of Herba Epimedii, 25 parts of salt Radix Morindae Officinalis (processed), 25 parts of Herba Cistanches, 50 parts of Fructus Lycii, 10 parts of Radix Et Caulis Acanthopanacis Senticosi extractums, 50 parts of Radix Polygoni Multiflori Preparatas.
Be characterized in having in addition adjuvant: inclusion agents beta-schardinger dextrin-30-90 part, forming agent 30-90 part, correctives 2-6 part; Described forming agent is at least a in mannitol, sorbitol and the xylitol, and described correctives is stevioside or protein sugar.
The characteristics of the preparation method of the celestial fine and soft tonifying YANG chewable tablet of the present invention are to have following steps:
A, get Radix Polygoni Multiflori, Herba Epimedii, Radix Morindae Officinalis, Fructus Lycii, Herba Cistanches, Rhizoma Curculiginis with 8 times of amount 35% alcohol reflux secondaries, merge extractive liquid, filters, add ethanol after the concentrating filter liquor, stir, leave standstill, filter, reclaim ethanol, the relative density under 50 ℃ is 1.06～1.12 concentrated solution A;
B, Cornu Cervi Pantotrichum put in the pot steamed 30～40 minutes, take out section, with 10 times of amount 40% ethanol warm macerating more than 12 hours, 8 times of amounts of reuse, 40% alcohol reflux 4 times, merge extractive liquid,, filtration; Add ethanol in the filtrate after concentrating, stir, leave standstill, filter, reclaim ethanol, precipitation is washed till colourless with 60% ethanol, and washing liquid leaves standstill, reclaim ethanol, the relative density under 50 ℃ is 1.06～1.12 concentrated solution B, with Radix Et Caulis Acanthopanacis Senticosi extractum, concentrated solution A, concentrated solution B mixing;
C, get inclusion agents beta-schardinger dextrin-30-90 part, add forming agent 30-90 part, correctives 2-6 part, fully stir, filter, under atomize, feed hot-air, carry out spray drying, 170-180 ℃ of hot-air inlet temperature, leaving air temp 70-80 ℃, material is dry granulation under≤60 ℃ of temperature, granulate, tabletting promptly gets chewable tablet.
The celestial fine and soft tonifying YANG tablet of the present invention, capsule or granule are made of following weight portion crude drug:
12.5 parts in unhairing Cornu Cervi Pantotrichum, 25 parts of Rhizoma Curculiginises, 50 parts of Herba Epimedii, 25 parts of salt Radix Morindae Officinalis (processed), 25 parts of Herba Cistanches, 50 parts of Fructus Lycii, 10 parts of Radix Et Caulis Acanthopanacis Senticosi extractums, 50 parts of Radix Polygoni Multiflori Preparatas.
Be characterized in forming agent 30-90 part, described forming agent is at least a in dextrin and the oligomeric lactose.The characteristics of the preparation method of the celestial fine and soft tonifying YANG tablet of the present invention, capsule or granule have following steps:
A, get Radix Polygoni Multiflori, Herba Epimedii, Radix Morindae Officinalis, Fructus Lycii, Herba Cistanches, Rhizoma Curculiginis with 8 times of amount 35% alcohol reflux secondaries, merge extractive liquid, filters, add ethanol after the concentrating filter liquor, stir, leave standstill, filter, reclaim ethanol, the relative density under 50 ℃ is 1.06～1.12 concentrated solution A;
B, Cornu Cervi Pantotrichum put in the pot steamed 30～40 minutes, take out section, with 10 times of amount 40% ethanol warm macerating more than 12 hours, 8 times of amounts of reuse, 40% alcohol reflux 4 times, merge extractive liquid,, filtration; Add ethanol in the filtrate after concentrating, stir, leave standstill, filter, reclaim ethanol, precipitation is washed till colourless with 60% ethanol, and washing liquid leaves standstill, reclaim ethanol, the relative density under 50 ℃ is 1.06～1.12 concentrated solution B, with Radix Et Caulis Acanthopanacis Senticosi extractum, concentrated solution A, concentrated solution B mixing;
C, add-on type agent 30-90 part stir, and filter, and feed hot-air under atomize, carry out spray drying, 170-180 ℃ of hot-air inlet temperature, and leaving air temp 70-80 ℃, material is dry granulation under≤60 ℃ of temperature, and granulate promptly gets granule; Granule gets tablet through tabletting, and the encapsulating capsule promptly gets capsule.
Compared with the prior art, beneficial effect of the present invention is embodied in:
1, solid preparation of the present invention, medicine stability is good, easily storage.
2, the present invention adopts the beta-cyclodextrin inclusion compound technology, and effective ingredient is uniformly dispersed, suitable chewing, and mouthfeel is good, the suitable chewable tablet of making.
3, product taking convenience of the present invention, dosage are accurate, do not contain antiseptic and sucrose, take safety and have no side effect.4, preparation of the present invention also is prepared from by the new technique of spray drying, dry granulation.Spray drying technology is by nebulizer medicinal liquid to be sprayed into droplet, be dispersed in the thermal current, make moisture flash evapn drying, and the loose powdered granule of formation, effective ingredient is not destroyed and reservation fully, overcome present oral liquid and be aqueous solution state, effective ingredient is easily degraded and unsettled drawback.Dry granulation is that mechanical compaction, one-tenth under the medicine dry powder convection drying state are put in order and formed, and makes effective ingredient constant.The said method operating process is simple, is convenient to large-scale production under the seriality GMP condition.
The specific embodiment:
Embodiment 1:
The preparation of celestial fine and soft tonifying YANG chewable tablet
1, takes by weighing raw material Cornu Cervi Pantotrichum (unhairing) 12.5g, Rhizoma Curculiginis 25g, Herba Epimedii 50g, Radix Morindae Officinalis (processed with salt) 25g, Herba Cistanches 25g, Fructus Lycii 50g, Radix Et Caulis Acanthopanacis Senticosi extractum 10g, Radix Polygoni Multiflori (system) 50g.
2, above eight flavors, get Radix Polygoni Multiflori, Herba Epimedii, Radix Morindae Officinalis, Fructus Lycii, Herba Cistanches, Rhizoma Curculiginis with 8 times of amount 35% alcohol reflux secondaries, 6 hours for the first time, 4 hours for the second time, merge extractive liquid,, filter, filtrate adds ethanol after being concentrated in right amount, stirs, leave standstill, filter, reclaim ethanol, the relative density under 50 ℃ is 1.06～1.12 concentrated solution A;
3, Cornu Cervi Pantotrichum is put the interior steaming of pot 30～40 minutes, taken out section, more than 12 hours, reuse is measured 40% alcohol reflux 4 times for 8 times with 10 times of an amount of warm macerating of amount 40% ethanol, is followed successively by merge extractive liquid,, filtration 3,3,2,2 hours; It is an amount of to add ethanol in concentrated solution, stirs, and leaves standstill, and filters, filtrate recycling ethanol, precipitation is washed till colourless with 60% ethanol, and washing liquid leaves standstill, and reclaims ethanol, concentrate the concentrated solution B of 50 ℃ of relative densities to 1.10 down, adding Radix Et Caulis Acanthopanacis Senticosi extractum, concentrated solution A, concentrated solution B mixing; 4, add inclusion agents beta-schardinger dextrin-60g, correctives stevioside 4g stirs, add forming agent mannitol 60g, stir, filter, carry out spray drying, 170 ℃ of hot-air inlet temperature, 70 ℃ of leaving air temps, material is dry granulation under≤60 ℃ of temperature, granulate, get brown yellow granule 120g, 100 of tablettings.
Embodiment 2: the preparation of celestial fine and soft tonifying YANG sheet
Preparation process is with embodiment one, different is in above-mentioned steps 4, add just as the dextrin 60g of forming agent.Stir, filter, under atomize, feed hot-air, carry out spray drying, 170-180 ℃ of hot-air inlet temperature, leaving air temp 70-80 ℃, material is dry granulation under≤60 ℃ of temperature, and granulate gets brown yellow granule 70g, 200 of tablettings.
Embodiment 3: the preparation of celestial fine and soft yang-strengthening capsule
Preparation process is with embodiment 2, and different is with granule encapsulating capsule, gets 200 of capsules.
Embodiment 4: the preparation of celestial fine and soft tonifying YANG granule
Preparation process is with embodiment 2, and different is that the direct fill of prepared granule is become bag, and every bag of 1.5g gets 100 bags of granules.
About the influence of spray drying powder to effective ingredient:
Carry out spray drying under suitable condition, effective ingredient is kept fully and be not destroyed, spray drying is also very important to grain forming, before and after the spray drying and the spray drying under the different condition influence of active constituent content and moisture be the results are shown in Table 1.
The variation of effective ingredient (icariin) before and after table 1 spray drying
Advance/leaving air temp icariin retention rate (%) moisture
Spray drying is preceding 100.0-
170℃/70℃ 99.2 5.8
180℃/80℃ 98.7 4.4
190℃/90℃ 89.8 3.6
Result of the test shows, selects 170-180 ℃ of air intake, and spray drying is carried out in 70-80 ℃ of air-out, and to the influence of several nothings of effective ingredient content Determination of Icariin, and water content is 4.0～6.0%, can directly make granularity, granule that hardness is suitable.
About stability study to the fine and soft invigorating Yang oral liquid of celestial being, celestial fine and soft tonifying YANG chewable tablet
The fine and soft invigorating Yang oral liquid of celestial being, celestial fine and soft tonifying YANG chewable tablet being carried out stable contrast test, adopt the room temperature test that keeps sample, is index with icariin content, experimental result such as table 2.
The stable contrast test of the celestial fine and soft invigorating Yang oral liquid of table 2, celestial fine and soft tonifying YANG chewable tablet
The celestial fine and soft tonifying YANG chewable tablet of celestial fine and soft invigorating Yang oral liquid of time (moon) (mg/ml) (mg/ sheet)
0 0.52 0.51
3 0.47 0.50
6 0.39 0.52
12 0.33 0.49
About the influence of beta-cyclodextrin inclusion compound to the chewable tablet taste
Contain hardship, puckery, fishy smell medical material among the present invention in the used prescription, adopt the beta-cyclodextrin inclusion compound technology above-mentioned taste can be covered effectively, be convenient to take, as investigating index, carry out enclose and test, the results are shown in Table 3 with bitter, puckery, fishy smell.
The influence that table 3 beta-cyclodextrin inclusion compound is suited one's taste
Beta-schardinger dextrin-amount bitterness astringent taste
0 3.8 2.9
0.5 1.5 1.2
1 0.1 0.0
Score is definite according to the degree of medicinal liquid taste, be divided into 5 the most bitter, puckery, successively decrease successively be divided into 4 fens, 3 minutes, 2 minutes, 1 minute, 0 minute totally six grades, measure the average score value again by 10 people.The result shows that the beta-cyclodextrin inclusion compound technology of 1 times of amount can be covered disagreeable taste effectively.
About content Determination of Icariin is measured
This preparation is measured according to high performance liquid chromatography (" 2000 editions one appendix VI D of Chinese pharmacopoeia).Chromatographic condition and system suitability test: with octadecylsilane chemically bonded silica is filler, acetonitrile: trifluoroacetic acid aqueous solution (25: 75) is a mobile phase, and the detection wavelength is 270nm, and number of theoretical plate calculates by the icariin peak should be not less than 3000;
The preparation of reference substance solution: precision takes by weighing in 60 ℃ of peoniflorin reference substances that are dried to constant weight an amount of, makes the solution that every 1ml contains 0.2mg with mobile phase, promptly;
The preparation of need testing solution: get in this product 1g to 100ml measuring bottle, add mobile phase and be diluted to scale, shake up, membrane filtration, promptly;
Measure: accurate respectively reference substance solution and each 10 μ l of need testing solution of drawing, inject chromatograph of liquid, measure, calculate with external standard method, that is, every of this product contains icariin and is no less than 0.20mg.
This celestial fine and soft tonifying YANG chewable tablet adopts the mensuration icariin to carry out quality control, compare with the national standard of the existing quality control of the fine and soft invigorating Yang oral liquid of celestial being, quality standard of the present invention has had significant raising, has controlled the quality of product effectively, guarantees stability of drug and curative effect.
Claims (5)
1, celestial fine and soft tonifying YANG solid preparation is made of following weight portion crude drug: 12.5 parts in unhairing Cornu Cervi Pantotrichum, 25 parts of Rhizoma Curculiginises, 50 parts of Herba Epimedii, 25 parts of salt Radix Morindae Officinalis (processed), 25 parts of Herba Cistanches, 50 parts of Fructus Lycii, 10 parts of Radix Et Caulis Acanthopanacis Senticosi extractums, 50 parts of Radix Polygoni Multiflori Preparatas; It is characterized in that having in addition adjuvant: inclusion agents beta-schardinger dextrin-30-90 part, correctives 2-6 part and or forming agent 30-90 part; Described correctives is stevioside or protein sugar; Described forming agent is at least a in mannitol, sorbitol and the xylitol, or is at least a in dextrin and the oligomeric lactose.
2, celestial fine and soft tonifying YANG chewable tablet is made of following weight portion crude drug: 12.5 parts in unhairing Cornu Cervi Pantotrichum, 25 parts of Rhizoma Curculiginises, 50 parts of Herba Epimedii, 25 parts of salt Radix Morindae Officinalis (processed), 25 parts of Herba Cistanches, 50 parts of Fructus Lycii, 10 parts of Radix Et Caulis Acanthopanacis Senticosi extractums, 50 parts of Radix Polygoni Multiflori Preparatas; It is characterized in that adjuvant is arranged: inclusion agents beta-schardinger dextrin-30-90 part, forming agent 30-90 part, correctives 2-6 part; Described forming agent is at least a in mannitol, sorbitol and the xylitol, and described correctives is stevioside or protein sugar.
3, the preparation method of the fine and soft tonifying YANG chewable tablet of the described celestial being of a kind of claim 2 is characterized in that step is as follows:
A, get Radix Polygoni Multiflori, Herba Epimedii, Radix Morindae Officinalis, Fructus Lycii, Herba Cistanches, Rhizoma Curculiginis with 8 times of amount 35% alcohol reflux secondaries, merge extractive liquid, filters, add ethanol after the concentrating filter liquor, stir, leave standstill, filter, reclaim ethanol, the relative density under 50 ℃ is 1.06～1.12 concentrated solution A;
B, Cornu Cervi Pantotrichum put in the pot steamed 30～40 minutes, take out section, with 10 times of amount 40% ethanol warm macerating more than 12 hours, 8 times of amounts of reuse, 40% alcohol reflux 4 times, merge extractive liquid,, filtration; Add ethanol in the filtrate after concentrating, stir, leave standstill, filter, reclaim ethanol, precipitation is washed till colourless with 60% ethanol, and washing liquid leaves standstill, reclaim ethanol, the relative density under 50 ℃ is 1.06～1.12 concentrated solution B, with Radix Et Caulis Acanthopanacis Senticosi extractum, concentrated solution A, concentrated solution B mixing;
C, get the inclusion agents beta-schardinger dextrin-, add forming agent, correctives, fully stir, filter, under atomize, feed hot-air, carry out spray drying, 170-180 ℃ of hot-air inlet temperature, leaving air temp 70-80 ℃, material is dry granulation under≤60 ℃ of temperature, granulate, and tabletting promptly gets chewable tablet.
4, celestial fine and soft tonifying YANG tablet, capsule or granule are made of following weight portion crude drug: 12.5 parts in unhairing Cornu Cervi Pantotrichum, 25 parts of Rhizoma Curculiginises, 50 parts of Herba Epimedii, 25 parts of salt Radix Morindae Officinalis (processed), 25 parts of Herba Cistanches, 50 parts of Fructus Lycii, 10 parts of Radix Et Caulis Acanthopanacis Senticosi extractums, 50 parts of Radix Polygoni Multiflori Preparatas; It is characterized in that adjuvant is arranged: forming agent 30-90 part, described forming agent are at least a in dextrin and the oligomeric lactose.
5, the preparation method of the fine and soft tonifying YANG tablet of the described celestial being of a kind of claim 4, capsule or granule is characterized in that step is as follows:
A, get Radix Polygoni Multiflori, Herba Epimedii, Radix Morindae Officinalis, Fructus Lycii, Herba Cistanches, Rhizoma Curculiginis with 8 times of amount 35% alcohol reflux secondaries, merge extractive liquid, filters, add ethanol after the concentrating filter liquor, stir, leave standstill, filter, reclaim ethanol, 50 ℃ of following relative densities are 1.06～1.12 concentrated solution A;
B, Cornu Cervi Pantotrichum put in the pot steamed 30～40 minutes, take out section, with 10 times of amount 40% ethanol warm macerating more than 12 hours, 8 times of amounts of reuse, 40% alcohol reflux 4 times, merge extractive liquid,, filtration; Add ethanol in the filtrate after concentrating, stir, leave standstill, filter, reclaim ethanol, precipitation is washed till colourless with 60% ethanol, and washing liquid leaves standstill, reclaim ethanol, 50 ℃ of following relative densities are 1.06～1.12 concentrated solution B, with Radix Et Caulis Acanthopanacis Senticosi extractum, concentrated solution A, concentrated solution B mixing;
C, add-on type agent stir, and filter, and feed hot-air under atomize, carry out spray drying, 170-180 ℃ of hot-air inlet temperature, and leaving air temp 70-80 ℃, material is dry granulation under≤60 ℃ of temperature, and granulate promptly gets granule; Granule gets tablet through tabletting, and the encapsulating capsule promptly gets capsule.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB03113498XA CN100536827C (en) | 2003-05-15 | 2003-05-15 | Yang-strengthening solid Xianrong reparation and its preparation process |
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| Application Number | Priority Date | Filing Date | Title |
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| CNB03113498XA CN100536827C (en) | 2003-05-15 | 2003-05-15 | Yang-strengthening solid Xianrong reparation and its preparation process |
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| Publication Number | Publication Date |
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| CN1548067A true CN1548067A (en) | 2004-11-24 |
| CN100536827C CN100536827C (en) | 2009-09-09 |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100457168C (en) * | 2006-11-23 | 2009-02-04 | 姚素英 | A traditional Chinese medicine for treating prostate diseases |
| CN103784754A (en) * | 2014-01-22 | 2014-05-14 | 安徽思康生物科技有限公司 | Capsules with effects of tonifying kidney and strengthening yang and preparation method thereof |
| CN108310119A (en) * | 2018-04-25 | 2018-07-24 | 殷元龙 | A kind of Herba Cistanches chewable tablets and preparation method thereof |
| CN108652004A (en) * | 2018-03-29 | 2018-10-16 | 李昀芊 | A kind of Desert Herba Cistanches electuary of high-content and preparation method thereof |
-
2003
- 2003-05-15 CN CNB03113498XA patent/CN100536827C/en not_active Expired - Lifetime
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100457168C (en) * | 2006-11-23 | 2009-02-04 | 姚素英 | A traditional Chinese medicine for treating prostate diseases |
| CN103784754A (en) * | 2014-01-22 | 2014-05-14 | 安徽思康生物科技有限公司 | Capsules with effects of tonifying kidney and strengthening yang and preparation method thereof |
| CN108652004A (en) * | 2018-03-29 | 2018-10-16 | 李昀芊 | A kind of Desert Herba Cistanches electuary of high-content and preparation method thereof |
| CN108652004B (en) * | 2018-03-29 | 2022-08-05 | 李昀芊 | Desert cistanche granule |
| CN108310119A (en) * | 2018-04-25 | 2018-07-24 | 殷元龙 | A kind of Herba Cistanches chewable tablets and preparation method thereof |
Also Published As
| Publication number | Publication date |
|---|---|
| CN100536827C (en) | 2009-09-09 |
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Granted publication date: 20090909 |