CN102764311A - Xiao Jin dispensible tablet and preparation method thereof - Google Patents
Xiao Jin dispensible tablet and preparation method thereof Download PDFInfo
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- CN102764311A CN102764311A CN2012102170050A CN201210217005A CN102764311A CN 102764311 A CN102764311 A CN 102764311A CN 2012102170050 A CN2012102170050 A CN 2012102170050A CN 201210217005 A CN201210217005 A CN 201210217005A CN 102764311 A CN102764311 A CN 102764311A
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Abstract
The invention relates to a Xiao Jin dispensible tablet and a preparation method thereof. The preparation method is as follows: muskone, semen momordicae, prepared kusnezoff monkshood root, resina liquidamberis, frankincense, myrrh, trogopterus dung, alcohol processed radix angelica sinensis, lumbricus and fragrance ink are taken as raw materials to prepare raw medicine material fine powder and extract fine powder, and a proper amount of auxiliary material is added, so that a Xiao Jin dispensible tablet capable of being disintegrated within three minutes fully and achieveing a uniform dispensible state is prepared. The Xiao Jin dispensible tablet has efficacies of removing stasis and decreasing swellinging, is used for curing crewels, goiter and tumor, lump in breast which are caused by nitrogen stagnation and have the symptoms that part or a plurality of parts of skin or part or a plurality of parts of masses under the skin can be pushed to move, or the bone or bone joints are swelled, are not changed in skin color, has sclerema and is painful; and the Xiao Jin dispensible tablet has the characteristics that the Xiao Jin dispensible tablet can be disintegrated and dispersed uniformly, is easier to accept and take by patients, and is more convenient to carry and use.
Description
Technical field
The present invention relates to a kind of Xiao Jin dispersible tablet and preparation method thereof, belong to field of traditional Chinese.
Background technology
XIAOJIN WAN records in " 2010 editions one one of Chinese pharmacopoeia is prepared from the former Chinese medicine of 10 flavors such as artificial Moschus, Semen Momordicae, Radix Aconiti Kusnezoffii Preparata, Resina Liquidambaris, Olibanum, Myrrha, Oletum Trogopterori, Radix Angelicae Sinensis (processed with wine), Pheretima, XIANGMO(sic), has mass dissipating and swelling eliminating, the effect of blood-activating analgetic.Be used for scrofula, goiter, breast carcinoma, the nodules of the breast of mental disorder due to stagnating, disease is seen lump one place or number place under skin or the skin, pushes away actively, or bone and osteoarthritis, color of the leather is constant, swollen has a pain firmly.Be mainly used in goiter, benign prostatic hyperplasia, post-herpetic neuralgia, aggretion type acne, cystic hyperplasia of breast, chronic pelvic inflammatory disease enclosed mass and nodular fasciitis etc. clinically.XIAOJIN WAN is that crude drug is pulverized the back and added the paste pill that starch and the general system of starch magma form, and disintegrate and medicine stripping are slow, need smash before taking, and because of smashing the degree difference, causes the interior release difference of medicine dissolution rate and body and influences drug effect.And contain a large amount of resinae medical materials (Olibanum, Myrrha, Resina Liquidambaris) in the prescription, Yin Wendu rising resin is softening and bond in the crushing process, causes the preparation difficulty.
Summary of the invention
The purpose of this invention is to provide a kind of Xiao Jin dispersible tablet and preparation method thereof, thereby produce taking convenience, absorb the preparation fast, that bioavailability is high.
Technical scheme of the present invention is following:
The composition of Xiao Jin dispersible tablet comprises medical material powder and extract, adjuvant; Adjuvant comprises enclose material, adsorbent, filler, disintegrating agent, lubricant, and medical material fine powder and extract are processed by the following weight Chinese medicinal raw materials: artificial Moschus 28-32 part, Semen Momordicae 145-155 part, Radix Aconiti Kusnezoffii Preparata 145-155 part, Resina Liquidambaris 145-155 part, Olibanum 70-80 part, Myrrha 70-80 part, Oletum Trogopterori 145-155 part, Radix Angelicae Sinensis (processed with wine) 70-80 part, Pheretima 145-155 part, XIANGMO(sic) 10-14 part.
Each constituent weight proportion of Xiao Jin dispersible tablet is: XIAOJIN WAN crude drug powder and extract 30-50 part, enclose material 0.1-0.3 part, adsorbent 0.5-1 part, filler 40-50 part, disintegrating agent 2.5-10 part, lubricant 0-1 part.
Adsorbents adsorb is in particulate surface or granule is adsorbed in adsorbent surface can reduces granule viscosity, the adsorbent that the present invention chooses be a kind of in microcrystalline Cellulose, starch, calcium carbonate, kieselguhr and the micropowder silica gel or etc. several kinds of quality.
The key of dispersible tablet is its disintegration rate in water; So the selection to disintegrating agent is extremely important, the disintegrating agent that the present invention chooses be in cross-linking sodium carboxymethyl cellulose (CCMC-Na), crospolyvinylpyrrolidone (PVPP), the pregelatinized Starch any one or etc. several kinds of quality.
Filler is in order to increase the weight and volume of dispersible tablet, to be beneficial to molding and divided dose.More because of prescription Central Plains medicated powder, molding is difficulty, needs to add a certain amount of filler and improves its mouldability.The filler that the present invention chooses be in microcrystalline Cellulose, starch, lactose, calcium sulfate, the calcium hydrogen phosphate any one or etc. several kinds of quality.
Lubricant is for feeding in raw material with slice smoothly, making the pharmaceutic adjuvant of tablet smooth and beautiful appearance.The lubricant that the present invention chooses be in magnesium stearate, micropowder silica gel, the Pulvis Talci any one or etc. several kinds of quality.
The method for preparing of Xiao Jin dispersible tablet comprises following step:
(1) preparation of enclose material: get the artificial Moschus and be dissolved in an amount of ethanol; Under 22-28 ℃; (β-CD) or HP-are (in the saturated aqueous solution of HP-β-CD) slowly to drip beta-schardinger dextrin-in artificial Moschus 6-12 times molal weight; Enclose 1 hour, clathrate with absolute ethanol washing after in 50-54 ℃ of vacuum drying, subsequent use.
(2) XIANGMO(sic) is ground into fine powder, crosses 80 mesh sieves, and is subsequent use; Semen Momordicae, Radix Aconiti Kusnezoffii Preparata, Oletum Trogopterori, Radix Angelicae Sinensis (processed with wine), Pheretima, the above five tastes add twice of the alcohol reflux of the 50%-80% of 4-5 times of quality; Each 1.5 hours, merge extractive liquid, filtered; Relative density was the clear paste of 1.00-1.10 when filtrating was concentrated into 60 ℃, and spray drying is subsequent use.
(3) Resina Liquidambaris, Olibanum, Myrrha, more than three flavors, an amount of ethanol disperses the back slowly to add above-mentioned dried clear paste; Fully stirring makes it to be uniformly dispersed, and adds the adsorbent of 1-2 times of quality of Olibanum, is uniformly dispersed; Cross sieve No. 9, drying with water bath adds artificial Moschus's clathrate and XIANGMO(sic) fine powder; Cross 80 mesh sieves, as the pastille fine powder, subsequent use.
(4) get pastille fine powder, filler, mixing, system soft material; Process granule, drying, granulate adds disintegrating agent and lubricant again, mixing, tabletting promptly gets the Xiao Jin dispersible tablet, every 1g.
The present invention makes the novel form of Xiao Jin dispersible tablet with the improvement of XIAOJIN WAN through adjuvant and technology, taking convenience, and preparation is simple, and absorption of human body is fast, bioavailability is high.
Specific embodiment
Below come the Xiao Jin dispersible tablet of further setting forth method for preparing of the present invention and processing through embodiment; But should it be interpreted as that scope of the present invention only limits to following enforcement, every technology that realizes based on foregoing of the present invention all belongs to the protection domain that the present invention requires.
Embodiment 1:
Each constituent weight proportion of Xiao Jin dispersible tablet is: 30 parts of XIAOJIN WAN crude drug powder and extracts, 0.1 part of enclose material, 0.5 part of adsorbent, 40 parts of filleies, 2.5 parts of disintegrating agents; Medical material fine powder and extract are processed by the following weight Chinese medicinal raw materials: 28 parts of artificial Moschuss, 145 parts of Semen Momordicaes, 145 parts of Radix Aconiti Kusnezoffii Preparatas, 145 parts of Resina Liquidambarises, 70 parts of Olibanums, 70 parts of Myrrhas, 145 parts of Oletum Trogopteroris, 70 parts of Radix Angelicae Sinensis (processed with wine), 145 parts of Pheretimas, 10 parts of XIANGMO(sic)s.
Wherein adsorbent is a microcrystalline Cellulose; Disintegrating agent is cross-linking sodium carboxymethyl cellulose (CCMC-Na); Filler is a calcium hydrogen phosphate.
Method for preparing comprises following step:
(1) preparation of enclose material: get the artificial Moschus and be dissolved in an amount of ethanol; Under 22 ℃, slowly drip beta-schardinger dextrin-in 6 times of molal weights of artificial Moschus (in the saturated aqueous solution of β-CD), enclose 1 hour; Clathrate with absolute ethanol washing after in 50 ℃ of vacuum dryings, subsequent use.
(2) XIANGMO(sic) is ground into fine powder, crosses 80 mesh sieves, and is subsequent use; Semen Momordicae, Radix Aconiti Kusnezoffii Preparata, Oletum Trogopterori, Radix Angelicae Sinensis (processed with wine), Pheretima, the above five tastes add twice of 50% the alcohol reflux of 4 times of quality; Each 1.5 hours, merge extractive liquid, filtered; Relative density was 1.00 clear paste when filtrating was concentrated into 60 ℃, and spray drying is subsequent use.
(3) Resina Liquidambaris, Olibanum, Myrrha, more than three flavors, an amount of ethanol disperses the back slowly to add above-mentioned dried clear paste; Fully stirring makes it to be uniformly dispersed, and adds the adsorbent of 1 times of quality of Olibanum, is uniformly dispersed; Cross sieve No. 9, drying with water bath adds artificial Moschus's clathrate and XIANGMO(sic) fine powder; Cross 80 mesh sieves, as the pastille fine powder, subsequent use.
(4) get pastille fine powder, filler, mixing, system soft material; Process granule, drying, granulate adds disintegrating agent and lubricant again, mixing, tabletting promptly gets the Xiao Jin dispersible tablet, every 1g.
Embodiment 2:
Each constituent weight proportion of Xiao Jin dispersible tablet is: 40 parts of XIAOJIN WAN crude drug powder and extracts, 0.2 part of enclose material, 0.8 part of adsorbent, 45 parts of filleies, 6 parts of disintegrating agents, 0.5 part of lubricant; Medical material fine powder and extract are processed by the following weight Chinese medicinal raw materials: 30 parts of artificial Moschuss, 150 parts of Semen Momordicaes, 150 parts of Radix Aconiti Kusnezoffii Preparatas, 150 parts of Resina Liquidambarises, 75 parts of Olibanums, 75 parts of Myrrhas, 150 parts of Oletum Trogopteroris, 75 parts of Radix Angelicae Sinensis (processed with wine), 150 parts of Pheretimas, 12 parts of XIANGMO(sic)s.
Wherein adsorbent is microcrystalline Cellulose, starch, calcium carbonate, kieselguhr and the micropowder silica gel of quality; The cross-linking sodium carboxymethyl cellulose of quality such as disintegrating agent is (CCMC-Na), crospolyvinylpyrrolidone (PVPP), pregelatinized Starch; The microcrystalline Cellulose of quality such as filler is, starch, lactose, calcium sulfate, calcium hydrogen phosphate; The magnesium stearate of quality such as lubricant is, micropowder silica gel, Pulvis Talci.
Method for preparing comprises following step:
(1) preparation of enclose material: get the artificial Moschus and be dissolved in an amount of ethanol; Under 25 ℃; Slowly drip HP-(in the saturated aqueous solution of HP-β-CD) in 9 times of molal weights of artificial Moschus; Enclose 1 hour, clathrate with absolute ethanol washing after in 52 ℃ of vacuum dryings, subsequent use.
(2) XIANGMO(sic) is ground into fine powder, crosses 80 mesh sieves, and is subsequent use; Semen Momordicae, Radix Aconiti Kusnezoffii Preparata, Oletum Trogopterori, Radix Angelicae Sinensis (processed with wine), Pheretima, the above five tastes add twice of 60% the alcohol reflux of 5 times of quality; Each 1.5 hours, merge extractive liquid, filtered; Relative density was 1.05 clear paste when filtrating was concentrated into 60 ℃, and spray drying is subsequent use.
(3) Resina Liquidambaris, Olibanum, Myrrha, more than three flavors, an amount of ethanol disperses the back slowly to add above-mentioned dried clear paste; Fully stirring makes it to be uniformly dispersed, and adds the adsorbent of 1.5 times of quality of Olibanum, is uniformly dispersed; Cross sieve No. 9, drying with water bath adds artificial Moschus's clathrate and XIANGMO(sic) fine powder; Cross 80 mesh sieves, as the pastille fine powder, subsequent use.
All the other are with embodiment 1.
Embodiment 3:
Each constituent weight proportion of Xiao Jin dispersible tablet is: 50 parts of XIAOJIN WAN crude drug powder and extracts, 0.3 part of enclose material, 1 part of adsorbent, 50 parts of filleies, 10 parts of disintegrating agents, 1 part of lubricant; Medical material fine powder and extract are processed by the following weight Chinese medicinal raw materials: 32 parts of artificial Moschuss, 155 parts of Semen Momordicaes, 155 parts of Radix Aconiti Kusnezoffii Preparatas, 155 parts of Resina Liquidambarises, 80 parts of Olibanums, 80 parts of Myrrhas, 155 parts of Oletum Trogopteroris, 80 parts of Radix Angelicae Sinensis (processed with wine), 155 parts of Pheretimas, 14 parts of XIANGMO(sic)s.
Wherein adsorbent is micropowder silica gel; Disintegrating agent be crospolyvinylpyrrolidone (PVPP); Filler is a lactose; Lubricant is a Pulvis Talci.
Method for preparing comprises following step:
(1) preparation of enclose material: get the artificial Moschus and be dissolved in an amount of ethanol; Under 28 ℃; Slowly drip HP-(in the saturated aqueous solution of HP-β-CD) in 12 times of molal weights of artificial Moschus; Enclose 1 hour, clathrate with absolute ethanol washing after in 54 ℃ of vacuum dryings, subsequent use.
(2) XIANGMO(sic) is ground into fine powder, crosses 80 mesh sieves, and is subsequent use; Semen Momordicae, Radix Aconiti Kusnezoffii Preparata, Oletum Trogopterori, Radix Angelicae Sinensis (processed with wine), Pheretima, the above five tastes add twice of 80% the alcohol reflux of 5 times of quality; Each 1.5 hours, merge extractive liquid, filtered; Relative density was 1.10 clear paste when filtrating was concentrated into 60 ℃, and spray drying is subsequent use.
(3) Resina Liquidambaris, Olibanum, Myrrha, more than three flavors, an amount of ethanol disperses the back slowly to add above-mentioned dried clear paste; Fully stirring makes it to be uniformly dispersed, and adds the adsorbent of 2 times of quality of Olibanum, is uniformly dispersed; Cross sieve No. 9, drying with water bath adds artificial Moschus's clathrate and XIANGMO(sic) fine powder; Cross 80 mesh sieves, as the pastille fine powder, subsequent use.
All the other are with embodiment 1.
Embodiment 4:
Each constituent weight proportion of Xiao Jin dispersible tablet is: 35 parts of XIAOJIN WAN crude drug powder and extracts, 0.1 part of enclose material, 0.9 part of adsorbent, 47 parts of filleies, 5 parts of disintegrating agents, 0.3 part of lubricant; Medical material fine powder and extract are processed by the following weight Chinese medicinal raw materials: 28 parts of artificial Moschuss, 148 parts of Semen Momordicaes, 152 parts of Radix Aconiti Kusnezoffii Preparatas, 155 parts of Resina Liquidambarises, 77 parts of Olibanums, 75 parts of Myrrhas, 151 parts of Oletum Trogopteroris, 78 parts of Radix Angelicae Sinensis (processed with wine), 155 parts of Pheretimas, 14 parts of XIANGMO(sic)s.
Wherein adsorbent such as is at microcrystalline Cellulose, kieselguhr, the micropowder silica gel of quality; The cross-linking sodium carboxymethyl cellulose of quality such as disintegrating agent is (CCMC-Na), crospolyvinylpyrrolidone (PVPP); Filler is starch, lactose, the calcium sulfate of quality; The micropowder silica gel of quality such as lubricant is, Pulvis Talci.
Method for preparing comprises following step:
(1) preparation of enclose material: get the artificial Moschus and be dissolved in an amount of ethanol; Under 24 ℃, slowly drip beta-schardinger dextrin-in 10 times of molal weights of artificial Moschus (in the saturated aqueous solution of β-CD), enclose 1 hour; Clathrate with absolute ethanol washing after in 50 ℃ of vacuum dryings, subsequent use.
(2) XIANGMO(sic) is ground into fine powder, crosses 80 mesh sieves, and is subsequent use; Semen Momordicae, Radix Aconiti Kusnezoffii Preparata, Oletum Trogopterori, Radix Angelicae Sinensis (processed with wine), Pheretima, the above five tastes add twice of 60% the alcohol reflux of 5 times of quality; Each 1.5 hours, merge extractive liquid, filtered; Relative density was 1.02 clear paste when filtrating was concentrated into 60 ℃, and spray drying is subsequent use.
(3) Resina Liquidambaris, Olibanum, Myrrha, more than three flavors, an amount of ethanol disperses the back slowly to add above-mentioned dried clear paste; Fully stirring makes it to be uniformly dispersed, and adds the adsorbent of 2 times of quality of Olibanum, is uniformly dispersed; Cross sieve No. 9, drying with water bath adds artificial Moschus's clathrate and XIANGMO(sic) fine powder; Cross 80 mesh sieves, as the pastille fine powder, subsequent use.
All the other are with embodiment 1.
Embodiment 5:
Each constituent weight proportion of Xiao Jin dispersible tablet is: 45 parts of XIAOJIN WAN crude drug powder and extracts, 0.3 part of enclose material, 0.6 part of adsorbent, 48 parts of filleies, 7 parts of disintegrating agents, 0.8 part of lubricant; Medical material fine powder and extract are processed by the following weight Chinese medicinal raw materials: 28 parts of artificial Moschuss, 147 parts of Semen Momordicaes, 152 parts of Radix Aconiti Kusnezoffii Preparatas, 150 parts of Resina Liquidambarises, 77 parts of Olibanums, 75 parts of Myrrhas, 149 parts of Oletum Trogopteroris, 74 parts of Radix Angelicae Sinensis (processed with wine), 152 parts of Pheretimas, 13 parts of XIANGMO(sic)s.
Wherein adsorbent is starch, calcium carbonate, the kieselguhr of quality; The crospolyvinylpyrrolidone of quality such as disintegrating agent is (PVPP), pregelatinized Starch; The starch of quality such as filler is, lactose, calcium hydrogen phosphate; The magnesium stearate of quality such as lubricant is, micropowder silica gel.
Method for preparing comprises following step:
(1) preparation of enclose material: get the artificial Moschus and be dissolved in an amount of ethanol; Under 25 ℃; Slowly drip HP-(in the saturated aqueous solution of HP-β-CD) in 11 times of molal weights of artificial Moschus; Enclose 1 hour, clathrate with absolute ethanol washing after in 53 ℃ of vacuum dryings, subsequent use.
(2) XIANGMO(sic) is ground into fine powder, crosses 80 mesh sieves, and is subsequent use; Semen Momordicae, Radix Aconiti Kusnezoffii Preparata, Oletum Trogopterori, Radix Angelicae Sinensis (processed with wine), Pheretima, the above five tastes add twice of 55% the alcohol reflux of 4 times of quality; Each 1.5 hours, merge extractive liquid, filtered; Relative density was 1.03 clear paste when filtrating was concentrated into 60 ℃, and spray drying is subsequent use.
(3) Resina Liquidambaris, Olibanum, Myrrha, more than three flavors, an amount of ethanol disperses the back slowly to add above-mentioned dried clear paste; Fully stirring makes it to be uniformly dispersed, and adds the adsorbent of 1 times of quality of Olibanum, is uniformly dispersed; Cross sieve No. 9, drying with water bath adds artificial Moschus's clathrate and XIANGMO(sic) fine powder; Cross 80 mesh sieves, as the pastille fine powder, subsequent use.
All the other are with embodiment 1.
Embodiment 6:
Each constituent weight proportion of Xiao Jin dispersible tablet is: 25 parts of XIAOJIN WAN crude drug powder and extracts, 0.08 part of enclose material, 0.4 part of adsorbent, 35 parts of filleies, 2.0 parts of disintegrating agents; Medical material fine powder and extract are processed by the following weight Chinese medicinal raw materials: 25 parts of artificial Moschuss, 140 parts of Semen Momordicaes, 140 parts of Radix Aconiti Kusnezoffii Preparatas, 140 parts of Resina Liquidambarises, 65 parts of Olibanums, 65 parts of Myrrhas, 140 parts of Oletum Trogopteroris, 65 parts of Radix Angelicae Sinensis (processed with wine), 140 parts of Pheretimas, 8 parts of XIANGMO(sic)s.
Wherein adsorbent is a calcium carbonate; Disintegrating agent is pregelatinized Starch; Filler is a lactose.
Method for preparing comprises following step:
(1) preparation of enclose material: get the artificial Moschus and be dissolved in an amount of ethanol; Under 20 ℃, slowly drip beta-schardinger dextrin-in 5 times of molal weights of artificial Moschus (in the saturated aqueous solution of β-CD), enclose 1 hour; Clathrate with absolute ethanol washing after in 48 ℃ of vacuum dryings, subsequent use.
(2) XIANGMO(sic) is ground into fine powder, crosses 80 mesh sieves, and is subsequent use; Semen Momordicae, Radix Aconiti Kusnezoffii Preparata, Oletum Trogopterori, Radix Angelicae Sinensis (processed with wine), Pheretima, the above five tastes add twice of 45% the alcohol reflux of 3 times of quality; Each 1.5 hours, merge extractive liquid, filtered; Relative density was 1.00 clear paste when filtrating was concentrated into 60 ℃, and spray drying is subsequent use.
(3) Resina Liquidambaris, Olibanum, Myrrha, more than three flavors, an amount of ethanol disperses the back slowly to add above-mentioned dried clear paste; Fully stirring makes it to be uniformly dispersed, and adds the adsorbent of 1 times of quality of Olibanum, is uniformly dispersed; Cross sieve No. 9, drying with water bath adds artificial Moschus's clathrate and XIANGMO(sic) fine powder; Cross 80 mesh sieves, as the pastille fine powder, subsequent use.
All the other are with embodiment 1.
Embodiment 7:
Each constituent weight proportion of Xiao Jin dispersible tablet is: 55 parts of XIAOJIN WAN crude drug powder and extracts, 0.4 part of enclose material, 1.2 parts of adsorbents, 55 parts of filleies, 12 parts of disintegrating agents, 2 parts of lubricants; Medical material fine powder and extract are processed by the following weight Chinese medicinal raw materials: 35 parts of artificial Moschuss, 160 parts of Semen Momordicaes, 160 parts of Radix Aconiti Kusnezoffii Preparatas, 160 parts of Resina Liquidambarises, 85 parts of Olibanums, 85 parts of Myrrhas, 160 parts of Oletum Trogopteroris, 85 parts of Radix Angelicae Sinensis (processed with wine), 160 parts of Pheretimas, 15 parts of XIANGMO(sic)s.
Wherein adsorbent such as is at microcrystalline Cellulose, starch, the kieselguhr of quality; The cross-linking sodium carboxymethyl cellulose of quality such as disintegrating agent is (CCMC-Na),, pregelatinized Starch; The lactose of quality such as filler is, calcium sulfate, calcium hydrogen phosphate; The magnesium stearate of quality such as lubricant is, micropowder silica gel, Pulvis Talci.
Method for preparing comprises following step:
(1) preparation of enclose material: get the artificial Moschus and be dissolved in an amount of ethanol; Under 30 ℃; Slowly drip HP-(in the saturated aqueous solution of HP-β-CD) in 13 times of molal weights of artificial Moschus; Enclose 1 hour, clathrate with absolute ethanol washing after in 55 ℃ of vacuum dryings, subsequent use.
(2) XIANGMO(sic) is ground into fine powder, crosses 80 mesh sieves, and is subsequent use; Semen Momordicae, Radix Aconiti Kusnezoffii Preparata, Oletum Trogopterori, Radix Angelicae Sinensis (processed with wine), Pheretima, the above five tastes add twice of 90% the alcohol reflux of 6 times of quality; Each 1.5 hours, merge extractive liquid, filtered; Relative density was 1.12 clear paste when filtrating was concentrated into 60 ℃, and spray drying is subsequent use.
(3) Resina Liquidambaris, Olibanum, Myrrha, more than three flavors, an amount of ethanol disperses the back slowly to add above-mentioned dried clear paste; Fully stirring makes it to be uniformly dispersed, and adds the adsorbent of 3 times of quality of Olibanum, is uniformly dispersed; Cross sieve No. 9, drying with water bath adds artificial Moschus's clathrate and XIANGMO(sic) fine powder; Cross 80 mesh sieves, as the pastille fine powder, subsequent use.
All the other are with embodiment 1.
Comparative Examples 1:
Each constituent weight proportion of XIAOJIN WAN is: 30 parts of artificial Moschuss, 150 parts of Semen Momordicaes (shell and deoil), 150 parts of Radix Aconiti Kusnezoffii Preparatas, 150 parts of wind face creams, 75 parts of Olibanums (system), 7 parts of Myrrha (processed), 150 parts of Oletum Trogopteroris (vinegar stir-fry), 75 parts of Radix Angelicae Sinensis (processed with wine), 150 parts of Pheretimas, 12 parts of XIANGMO(sic)s.
Method for preparing is: above ten flavors, except that the artificial Moschus, nine flavors such as all the other Semen Momordicaes are ground into fine powder.With artificial Moschus's porphyrize,, sieve with above-mentioned powder facing-up.Every 100g powder adds starch 25 g, mixing, and in addition with starch 5g system magma, general ball, cold drying promptly gets.
The effectiveness study experiment:
Patient's data:
207 routine outpatient service cyclomastopathy patients are divided into 9 groups at random, age 21-58 year, average 38 years old; The course of disease 6 months-11 years; Wherein one-sided morbidity 76 examples, bilateral 131 examples of falling ill; Married 178 examples, unmarried 29 examples; Obviously can touch lump 175 examples, not touch obvious lump 32 examples.Be divided into treatment at random and organize 7 groups, 1 group of Comparative Examples, 1 group of matched group, every group 23 people.
Diagnostic criteria:
This is tested 207 routine cyclomastopathy patients and all drafts by cyclomastopathy diagnosis and efficacy assessment standard: (1) one-sided or bilateral distending pain of the breast, often aggravate premenstruum; (2) the one-sided or bilateral breast of clinical health check-up touches one or more lumps; (3) utilize mammary line molybdenum palladium to take the photograph sheet, colored exceedingly popular thermal imaging system, modern detection methods such as lump puncture smear are auxiliary diagnosis, and get rid of other good malignant changes.
Therapeutic Method:
7 groups of respectively prepared Xiao Jin dispersible tablets of oral embodiment 1-7 are organized in treatment, every day 2 times, the menstrual phase drug withdrawal, continuous 3 menstrual cycle, during do not take other analgesic; The XIAOJIN WAN that 1 group of oral contrast of contrast groups example 1 makes, every day 2 times, the menstrual phase drug withdrawal, continuous 3 menstrual cycle, during do not take other analgesic; The oral triphen chloramines of matched group sheet 10mg, every day 2 times, the 5th day begins to take medicine after the menstruation edd slack, continuous 3 menstrual cycle, drug withdrawal in menstrual period.
Efficacy assessment standard:
Curative effect determinate standard by the thematic group formulation of Chinese national Chinese medicine association's surgery gland.Recovery from illness: lump and pain disappear, and do not recur in 3 months after the drug withdrawal; Produce effects: the lump maximum gauge dwindles more than 1/2 and mastalgia disappears; Effectively: the lump maximum gauge dwindles less than 1/2, but mastalgia alleviates; Invalid: lump does not have and dwindles or increase hardening on the contrary, or simple mastalgia alleviates, and lump does not dwindle.
Each organizes patient's clinical efficacy relatively
Can find out that from effectiveness study experiment the therapeutic effect of the Xiao Jin dispersible tablet that the present invention makes obviously is superior to Xiao Jin dispersible tablet and the effect of XIAOJIN WAN outside process parameters range, taking convenience, preparation is simple, and absorption of human body is fast, bioavailability is high.
Claims (9)
1. Xiao Jin dispersible tablet is characterized by: composition comprises the corresponding medical material powder of XIAOJIN WAN and extract, adjuvant; Adjuvant comprises enclose material, adsorbent, filler, disintegrating agent, lubricant.
2. Xiao Jin dispersible tablet as claimed in claim 1 is characterized by: medical material fine powder and extract are processed by the following weight Chinese medicinal raw materials: artificial Moschus 28-32 part, Semen Momordicae 145-155 part, Radix Aconiti Kusnezoffii Preparata 145-155 part, Resina Liquidambaris 145-155 part, Olibanum 70-80 part, Myrrha 70-80 part, Oletum Trogopterori 145-155 part, Radix Angelicae Sinensis (processed with wine) 70-80 part, Pheretima 145-155 part, XIANGMO(sic) 10-14 part.
3. Xiao Jin dispersible tablet as claimed in claim 1 is characterized by: XIAOJIN WAN crude drug powder and extract 30-50 part, enclose material 0.1-0.3 part, adsorbent 0.5-1 part, filler 40-50 part, disintegrating agent 2.5-10 part, lubricant 0-1 part.
4. like claim 1 or 3 described Xiao Jin dispersible tablets, it is characterized by: adsorbent is one or more in microcrystalline Cellulose, starch, calcium carbonate, kieselguhr and the micropowder silica gel; Disintegrating agent is any one or a few in cross-linking sodium carboxymethyl cellulose, crospolyvinylpyrrolidone, the pregelatinized Starch; Filler is any one or a few in microcrystalline Cellulose, starch, lactose, calcium sulfate, the calcium hydrogen phosphate; Lubricant is any one or a few in magnesium stearate, micropowder silica gel, the Pulvis Talci.
5. Xiao Jin dispersible tablet as claimed in claim 1, it is characterized by: method for preparing is following:
(1) preparation of enclose material: get the artificial Moschus and be dissolved in an amount of ethanol; Under 22-28 ℃; (β-CD) or HP-are (in the saturated aqueous solution of HP-β-CD) slowly to drip beta-schardinger dextrin-in artificial Moschus 6-12 times molal weight; Enclose 1 hour, clathrate with absolute ethanol washing after in 50-54 ℃ of vacuum drying, subsequent use;
(2) XIANGMO(sic) is ground into fine powder, crosses 80 mesh sieves, and is subsequent use; Semen Momordicae, Radix Aconiti Kusnezoffii Preparata, Oletum Trogopterori, Radix Angelicae Sinensis (processed with wine), Pheretima, the above five tastes add twice of the alcohol reflux of the 50%-80% of 4-5 times of quality; Each 1.5 hours, merge extractive liquid, filtered; Relative density was the clear paste of 1.00-1.10 when filtrating was concentrated into 60 ℃, and spray drying is subsequent use;
(3) Resina Liquidambaris, Olibanum, Myrrha, more than three flavors, an amount of ethanol disperses the back slowly to add above-mentioned dried clear paste; Fully stirring makes it to be uniformly dispersed, and adds the adsorbent of 1-2 times of quality of Olibanum, is uniformly dispersed; Cross sieve No. 9, drying with water bath adds artificial Moschus's clathrate and XIANGMO(sic) fine powder; Cross 80 mesh sieves, as the pastille fine powder, subsequent use;
(4) get pastille fine powder, filler, mixing, system soft material; Process granule, drying, granulate adds disintegrating agent and lubricant again, mixing, tabletting promptly gets the Xiao Jin dispersible tablet, every 1g.
6. Xiao Jin dispersible tablet as claimed in claim 2 is characterized by: medical material fine powder and extract are processed by the following weight Chinese medicinal raw materials: 30 parts of artificial Moschuss, 150 parts of Semen Momordicaes, 150 parts of Radix Aconiti Kusnezoffii Preparatas, 150 parts of Resina Liquidambarises, 75 parts of Olibanums, 75 parts of Myrrhas, 150 parts of Oletum Trogopteroris, 75 parts of Radix Angelicae Sinensis (processed with wine), 150 parts of Pheretimas, 12 parts of XIANGMO(sic)s.
7. Xiao Jin dispersible tablet as claimed in claim 3 is characterized by: each constituent weight proportion of Xiao Jin dispersible tablet is: 40 parts of XIAOJIN WAN crude drug powder and extracts, 0.2 part of enclose material, 0.8 part of adsorbent, 45 parts of filleies, 6 parts of disintegrating agents, 0.5 part of lubricant.
8. Xiao Jin dispersible tablet as claimed in claim 4 is characterized by: adsorbent is microcrystalline Cellulose, starch, calcium carbonate, kieselguhr and the micropowder silica gel of quality; The cross-linking sodium carboxymethyl cellulose of quality such as disintegrating agent is (CCMC-Na), crospolyvinylpyrrolidone (PVPP), pregelatinized Starch; The microcrystalline Cellulose of quality such as filler is, starch, lactose, calcium sulfate, calcium hydrogen phosphate; The magnesium stearate of quality such as lubricant is, micropowder silica gel, Pulvis Talci.
9. the method for preparing of Xiao Jin dispersible tablet as claimed in claim 5 is characterized by:
(1) preparation of enclose material: get the artificial Moschus and be dissolved in an amount of ethanol; Under 25 ℃; Slowly drip HP-(in the saturated aqueous solution of HP-β-CD) in 9 times of molal weights of artificial Moschus; Enclose 1 hour, clathrate with absolute ethanol washing after in 52 ℃ of vacuum dryings, subsequent use;
(2) XIANGMO(sic) is ground into fine powder, crosses 80 mesh sieves, and is subsequent use; Semen Momordicae, Radix Aconiti Kusnezoffii Preparata, Oletum Trogopterori, Radix Angelicae Sinensis (processed with wine), Pheretima, the above five tastes add twice of 60% the alcohol reflux of 5 times of quality; Each 1.5 hours, merge extractive liquid, filtered; Relative density was 1.05 clear paste when filtrating was concentrated into 60 ℃, and spray drying is subsequent use;
(3) Resina Liquidambaris, Olibanum, Myrrha, more than three flavors, an amount of ethanol disperses the back slowly to add above-mentioned dried clear paste; Fully stirring makes it to be uniformly dispersed, and adds the adsorbent of 1.5 times of quality of Olibanum, is uniformly dispersed; Cross sieve No. 9, drying with water bath adds artificial Moschus's clathrate and XIANGMO(sic) fine powder; Cross 80 mesh sieves, as the pastille fine powder, subsequent use;
Get pastille fine powder, filler, mixing, system soft material; Process granule, drying, granulate adds disintegrating agent and lubricant again, mixing, tabletting promptly gets the Xiao Jin dispersible tablet, every 1g.
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| CN104306474A (en) * | 2014-10-29 | 2015-01-28 | 成都中医药大学 | Process for preparing xiaojin pill |
| CN104739956A (en) * | 2015-02-27 | 2015-07-01 | 武汉健民药业集团股份有限公司 | Use of traditional Chinese medicine composition in preparing antiandrogen drug |
| CN104825771A (en) * | 2014-02-11 | 2015-08-12 | 杭州美誉医药有限公司 | Traditional Chinese medicine composition for eliminating swelling and relieving pain and preparation method thereof |
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Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103110707A (en) * | 2013-02-07 | 2013-05-22 | 江苏七○七天然制药有限公司 | Traditional Chinese medicine babu (Chinese character) paste for removing swelling and clearing away toxin |
| CN103110707B (en) * | 2013-02-07 | 2014-11-19 | 江苏七○七天然制药有限公司 | Traditional Chinese medicine babu (Chinese character) paste for removing swelling and clearing away toxin |
| CN104825771A (en) * | 2014-02-11 | 2015-08-12 | 杭州美誉医药有限公司 | Traditional Chinese medicine composition for eliminating swelling and relieving pain and preparation method thereof |
| CN104306474A (en) * | 2014-10-29 | 2015-01-28 | 成都中医药大学 | Process for preparing xiaojin pill |
| CN104306474B (en) * | 2014-10-29 | 2017-05-17 | 成都中医药大学 | Process for preparing xiaojin pill |
| CN104739956A (en) * | 2015-02-27 | 2015-07-01 | 武汉健民药业集团股份有限公司 | Use of traditional Chinese medicine composition in preparing antiandrogen drug |
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Application publication date: 20121107 |