CN102641304B - A kind of method improving granule yield of dry granulation of traditional Chinese medicine raw medicinal material powder - Google Patents
A kind of method improving granule yield of dry granulation of traditional Chinese medicine raw medicinal material powder Download PDFInfo
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Abstract
The invention discloses a kind of method improving the Chinese medicine preparation raw material dry granulation finished granule rate containing raw medicinal herbs powder in prescription, it is characterized in that adding appropriate composite auxiliary material in Chinese medicine raw medicinal herbs powder, is this composite auxiliary material by differential silica gel, plasdone? S-630 and magnesium stearate composition, dry granulation after employing mixer mix homogeneously.Advantage of the present invention is as follows: 1) the inventive method is simple, only need add a small amount of composite auxiliary material in Chinese medicine raw medicinal herbs mixed process, and operational approach is simple, substantially can not extend the production time; 2) composite auxiliary material addition is few, also reduces production cost substantially while improving the compliance of patient; 3) contained in this composite auxiliary material various adjuvants are preparation and commonly use adjuvant, take rear avirulence and untoward reaction; 4) this mixed accessories not only can improve the compact property of Chinese drugs powder, has protection against the tide simultaneously, improves the features such as Chinese medicine preparation raw material mobility, can improve Chinese medicine preparation quality.
Description
(1) technical field
The present invention relates to field of traditional Chinese, be specifically related to a kind of method utilizing medicinal composite auxiliary material to improve granule yield of dry granulation of traditional Chinese medicine raw medicinal material powder.
(2) background technology
Dry granulation technology is the new granulation technique occurred in recent years, and the gap between two rolling cylinders that this technology utilizes rotating speed identical, is rolled into tablet by pharmaceutical preparation raw material, is then made a certain size granule by granulation machine fragmentation.Its advantage is: the granulating process of (1) environment protection-type, and saving power and preventing pollution contaminates, without the need to wetting agent; (2) Explosion-Proof and the environmental issue that causes of pollution from exhaust emission that solvent granulates is solved; (3) eliminate drying process, save a large amount of energy; (4) equipment needed thereby is few, floor space is little, time and labour saving.
The compressibility of dry granulation to preparation raw material has higher requirement, the powder constituent of powder directly beaten by some Chinese medicine preparation raw material primarily of Chinese crude drug, owing to containing a large amount of cellulose crystals in medicinal powder, compressibility extreme difference, therefore in dry granulation process, often occur the plate object that suppresses and loose, granule yield is the situation of 0.
In current dry granulation production process, run into and can often adopt the method for adding a large amount of adjuvant to improve its compact property during the Chinese medicine raw medicinal herbs powder of pressure reduction, the addition of adjuvant can account for 80% of prescription sometimes.Although this method has certain effect, cost is also very large.Chinese medicine single dose is natively larger, if add a large amount of adjuvant again, be easy to occur that single is taken more than 5, tablet or taken granule 12g with the situation of first-class dosage close to the States Pharmacopoeia specifications limit, this can reduce the compliance of patient greatly.In addition, add the production cost that a large amount of adjuvant also can increase enterprise greatly, reduce economic benefit.Therefore, under being badly in need of a kind of prerequisite not changing raw medicinal herbs powdered ingredients, only adding a small amount of adjuvant and just can significantly improve preparation raw material compressibility, thus improve the method for dry granulation finished granule rate.
(3) summary of the invention
Technical problem to be solved by this invention is the dry granulation finished granule rate of the Chinese medicine preparation raw material containing raw medicinal herbs powder in the method raising prescription by adding a small amount of medicinal composite auxiliary material.
For solving the problem, technical scheme of the present invention is as follows:
Improve a method for the Chinese medicine preparation raw material dry granulation finished granule rate containing raw medicinal herbs powder in prescription, it is characterized in that adding appropriate composite auxiliary material in Chinese medicine raw medicinal herbs powder, dry granulation after employing mixer mix homogeneously.
Amount containing raw medicinal herbs powder in above-mentioned Chinese medicine preparation raw material accounts for the 79.5%-97.7% (weight ratio) of whole prescription.
The consumption of above-mentioned composite auxiliary material accounts for the 0.3%-20.5% (weight ratio) of whole granule prescription.
Above-mentioned composite auxiliary material is become to be grouped into magnesium stearate three by differential silica gel, plasdoneS-630, wherein differential silica gel (crossing 200 mesh sieves) consumption accounts for the 0.1%-15% (weight ratio) of whole granule prescription, plasdoneS-630 (crossing 120 mesh sieves) consumption accounts for the 0.1%-5% (weight ratio) of whole granule prescription, and magnesium stearate (crossing 120 orders) consumption accounts for the 0.1%-0.5% of whole granule prescription.
The mixer that above-mentioned mixed process adopts can be the conventional mixer such as double cone mixer, V-arrangement mixer, and incorporation time is 2min.
Beneficial effect of the present invention:
1. the inventive method is simple, only need add a small amount of composite auxiliary material in Chinese medicine raw medicinal herbs mixed process, and operational approach is simple, substantially can not extend the production time.
2. composite auxiliary material addition is few, also reduces production cost substantially while improving the compliance of patient.
3. various adjuvants contained in this composite auxiliary material are preparation and commonly use adjuvant, take rear avirulence and untoward reaction.
4. this mixed accessories not only can improve the compact property of Chinese drugs powder, has protection against the tide simultaneously, improves the features such as Chinese medicine preparation raw material mobility, can improve the quality of the pharmaceutical preparations.
(4) detailed description of the invention
Embodiment 1: Lignum Santali Albi raw medicinal herbs powder dry granulation
The preparation of Lignum Santali Albi granule
Get Lignum Santali Albi raw medicinal herbs powder (crossing 80 mesh sieves) directly dry granulation, obtained sample I.
Get Lignum Santali Albi raw medicinal herbs powder (crossing 80 mesh sieves), add by weight account for prescription total amount 15% micropowder silica gel (cross 200 mesh sieves), 5%plasdoneS-630 (crossing 120 mesh sieves), 0.5% magnesium stearate (crossing 120 mesh sieves), dry granulation after employing double cone mixer mixing 2min, obtained sample II.
The foundation of granulation eveluatin index:
Yield: get above-mentioned granule 30g, accurately weighed quality, put during 10 orders of regulation and 80 order medicines sieve, keep level to sieve, left and right comes and goes, and sieves while tapping 3min, accurately weighed weight, calculates 10-80 order granule yield.[granule yield (%)=10-80 order granule yield/granule gross mass * 100%]
Friability: get granule appropriate, cross 10 orders and 80 order medicines sieve, then take 10-80 order granule and be about 20g, accurately weighed, be placed in friabilator, additional about 200 average diameters are the bead of 4mm, and rotational time is 8min, and rotating speed is about 25r/min.After rotation, shift out bead, cross 45 mesh sieves, weigh the quality of remainder particulate, calculating friability [friability=(after measuring front quality-mensuration quality)/measure front quality × 100%].
Dry granulation process parameter: feeding speed: 40rpm, roller rotating speed: 4rpm, roller pressure: 16MPa
Table 1 Lignum Santali Albi raw medicinal herbs powder dry granulation yield and friability
Experimental result shows, after adding composite auxiliary material, Lignum Santali Albi raw medicinal herbs powder dry granulation finished granule rate significantly improves.
Embodiment 2: Radix Trichosanthis raw medicinal herbs powder dry granulation
The preparation of Radix Trichosanthis granule
Get Radix Trichosanthis raw medicinal herbs powder (crossing 80 mesh sieves) directly dry granulation, obtained sample I.
Get Radix Trichosanthis raw medicinal herbs powder (crossing 80 mesh sieves), add by weight account for prescription total amount 8% micropowder silica gel (cross 200 mesh sieves), 3%plasdoneS-630 (crossing 120 mesh sieves), 0.3% magnesium stearate (crossing 120 mesh sieves), dry granulation after employing double cone mixer mixing 2min, obtained sample II.
The foundation of evaluation index:
Yield: get above-mentioned granule 30g, accurately weighed quality, put during 10 orders of regulation and 80 order medicines sieve, keep level to sieve, left and right comes and goes, and sieves while tapping 3min, accurately weighed weight, calculates 10-80 order granule yield.[granule yield (%)=10-80 order granule yield/granule gross mass * 100%]
Friability: get granule appropriate, cross 10 orders and 80 order medicines sieve, then take 10-80 order granule and be about 20g, accurately weighed, be placed in friabilator, additional about 200 average diameters are the bead of 4mm, and rotational time is 8min, and rotating speed is about 25r/min.After rotation, shift out bead, cross 45 mesh sieves, weigh the quality of remainder particulate, calculating friability [friability=(after measuring front quality-mensuration quality)/measure front quality × 100%].
Dry granulation process parameter: feeding speed: 40rpm, roller rotating speed: 5rpm, roller pressure: 16MPa
Table 2 Radix Trichosanthis raw medicinal herbs powder dry granulation yield and friability
Experimental result shows, after adding composite auxiliary material, Radix Trichosanthis raw medicinal herbs powder dry granulation finished granule rate significantly improves.
Embodiment 3: Folium Sennae raw medicinal herbs powder dry granulation
Get Folium Sennae raw medicinal herbs powder (crossing 60 mesh sieves) directly dry granulation, obtained sample I.
Get Folium Sennae raw medicinal herbs powder (crossing 60 mesh sieves), add by weight account for prescription total amount 0.1% micropowder silica gel (cross 200 mesh sieves), 0.1%plasdoneS-630 (crossing 120 mesh sieves), 0.1% magnesium stearate (crossing 120 mesh sieves), dry granulation after employing double cone mixer mixing 2min, obtained sample II.
The foundation of evaluation index:
Yield: get above-mentioned granule 30g, accurately weighed quality, put during 10 orders of regulation and 80 order medicines sieve, keep level to sieve, left and right comes and goes, and sieves while tapping 3min, accurately weighed weight, calculates 10-80 order granule yield.[granule yield (%)=10-80 order granule yield/granule gross mass * 100%]
Friability: get granule appropriate, cross 10 orders and 80 order medicines sieve, then take 10-80 order granule and be about 20g, accurately weighed, be placed in friabilator, additional about 200 average diameters are the bead of 4mm, and rotational time is 8min, and rotating speed is about 25r/min.After rotation, shift out bead, cross 45 mesh sieves, weigh the quality of remainder particulate, calculating friability [friability=(after measuring front quality-mensuration quality)/measure front quality × 100%].
Dry granulation process parameter: feeding speed: 40rpm, roller rotating speed: 4rpm, roller pressure: 16MPa
Table 3 Folium Sennae raw medicinal herbs powder dry granulation yield and friability
Experimental result shows, after adding composite auxiliary material, Folium Sennae raw medicinal herbs powder dry granulation finished granule rate significantly improves.
Claims (3)
1. improve a method for the Chinese medicine preparation raw material dry granulation finished granule rate containing raw medicinal herbs powder in prescription, it is characterized in that: in Chinese medicine raw medicinal herbs powder, add appropriate composite auxiliary material, dry granulation after employing mixer mix homogeneously; The weight ratio that the consumption of above-mentioned composite auxiliary material accounts for whole granule prescription is 0.3%-20.5%; Above-mentioned composite auxiliary material is become to be grouped into magnesium stearate three by micropowder silica gel, plasdoneS-630, wherein micropowder silica gel consumption accounts for the weight ratio of whole granule prescription is 0.1%-15%, the weight ratio that plasdoneS-630 consumption accounts for whole granule prescription is 0.1%-5%, and the weight ratio that magnesium stearate consumption accounts for whole granule prescription is 0.1%-0.5%.
2. a kind of method improving the Chinese medicine preparation raw material dry granulation finished granule rate containing raw medicinal herbs powder in prescription according to claim 1, is characterized in that: the weight ratio that the amount containing raw medicinal herbs powder in above-mentioned Chinese medicine preparation raw material accounts for whole prescription is 79.5%-97.7%.
3. a kind of method improving the Chinese medicine preparation raw material dry granulation finished granule rate containing raw medicinal herbs powder in prescription according to claim 1, is characterized in that: the mixer that above-mentioned mixed process adopts is double cone mixer or V-arrangement mixer.
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Citations (4)
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| WO2003086343A2 (en) * | 2002-04-05 | 2003-10-23 | Cadila Healthcare Limited | Fast disintegrating oral dosage forms |
| CN1814093A (en) * | 2005-11-30 | 2006-08-09 | 王衡新 | Chinese medicine preparation for activating blood-circulation and diminishing congestion, and preparing method |
| CN1823959A (en) * | 2005-12-12 | 2006-08-30 | 湛江市国基药业有限公司 | Heart vessel free flowing dispersion tablet and its preparation method |
| CN1850206A (en) * | 2006-02-21 | 2006-10-25 | 彭滢 | Medicine for treating women's climateric syndrome and preparing method |
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Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2003086343A2 (en) * | 2002-04-05 | 2003-10-23 | Cadila Healthcare Limited | Fast disintegrating oral dosage forms |
| CN1814093A (en) * | 2005-11-30 | 2006-08-09 | 王衡新 | Chinese medicine preparation for activating blood-circulation and diminishing congestion, and preparing method |
| CN1823959A (en) * | 2005-12-12 | 2006-08-30 | 湛江市国基药业有限公司 | Heart vessel free flowing dispersion tablet and its preparation method |
| CN1850206A (en) * | 2006-02-21 | 2006-10-25 | 彭滢 | Medicine for treating women's climateric syndrome and preparing method |
Non-Patent Citations (1)
| Title |
|---|
| 现代中药制剂开发中药用心辅料的应用概况;林华庆等;《药品评价》;20060228;第3卷(第1期);第70页左栏倒数第1段 * |
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Inventor after: Du Ruofei Inventor after: Feng Yi Inventor after: Ruan Kefeng Inventor after: Li Jie Inventor after: Cao Hanhan Inventor before: Du Ruofei Inventor before: Feng Yi Inventor before: Ruan Kefeng Inventor before: Li Jie |
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Effective date of registration: 20200102 Address after: 201203 Shanghai city Pudong New Area Cailun Road No. 1200 Patentee after: Shanghai University of Traditional Chinese Medicine Address before: 201203 Shanghai Cailun Road, room 423 No. 781 Patentee before: Shanghai Zhangjiang Traditional Chinese Medicine Modern Pharmaceutical Preparation Technology Engineering Research Center |
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