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A method for improving the yield of dry granulation granules of traditional Chinese medicine raw medicinal materials powder

A technology for dry granulation and raw medicinal materials, applied in the directions of inorganic inactive ingredients, bulk delivery, etc., can solve the problems of reducing patient compliance, large single dose, reducing economic benefits, etc., to improve fluidity and simple methods. , the effect of prolonging the production time

Active Publication Date: 2016-01-20
SHANGHAI UNIV OF T C M
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The single dose of traditional Chinese medicine is relatively large, if a large amount of excipients are added, it is easy to cause a single dose of more than 5 tablets or more than 12g of granules to approach the limit specified in the Pharmacopoeia, which will greatly reduce the compliance of patients
In addition, adding a large amount of auxiliary materials will greatly increase the production cost of the enterprise and reduce the economic benefits.

Method used

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  • A method for improving the yield of dry granulation granules of traditional Chinese medicine raw medicinal materials powder
  • A method for improving the yield of dry granulation granules of traditional Chinese medicine raw medicinal materials powder
  • A method for improving the yield of dry granulation granules of traditional Chinese medicine raw medicinal materials powder

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0017] Embodiment 1: dry granulation of raw material powder of sandalwood

[0018] Preparation of Sandalwood Granules

[0019] Take sandalwood crude drug powder (passed through 80 mesh sieve) and directly dry granulate to obtain sample I.

[0020] Get sandalwood raw medicinal material powder (crossing 80 mesh sieves), add micropowder silica gel (crossing 200 mesh sieves), 5% plasdoneS-630 (crossing 120 mesh sieves), 0.5% magnesium stearate ( pass through a 120-mesh sieve), use a double-cone mixer to mix for 2 minutes, and then dry granulate to obtain sample II.

[0021] The establishment of particle evaluation index:

[0022] Yield: Take 30g of the above-mentioned granules, accurately weigh the mass, put them in the prescribed 10-mesh and 80-mesh medicine sieves, sieve them in a horizontal state, go back and forth from left to right, tap gently for 3 minutes while sieving, accurately weigh the weight, and calculate 10- 80 mesh particle yield. [Granule yield (%)=10-80 mesh ...

Embodiment 2

[0028] Embodiment 2: Trichosanthes crude medicinal material powder dry granulation

[0029] Preparation of trichosanthes granules

[0030] Sample Ⅰ was obtained by direct dry granulation of the raw medicinal material powder of Trichosanthum pollen (passed through a 80-mesh sieve).

[0031] Get the crude medicinal material powder of Trichosanthes officinalis (passes 80 mesh sieves), adds by weight the micropowder silica gel (passes 200 mesh sieves) that accounts for prescription total amount 8%, 3% plasdoneS-630 (passes 120 mesh sieves), 0.3% magnesium stearate (through a 120-mesh sieve), mixed for 2 minutes with a double-cone mixer, and then dry-granulated to obtain sample II.

[0032] The establishment of evaluation indicators:

[0033] Yield: Take 30g of the above-mentioned granules, accurately weigh the mass, put them in the prescribed 10-mesh and 80-mesh medicine sieves, sieve in a horizontal state, go back and forth, tap 3 minutes while sieving, accurately weigh the wei...

Embodiment 3

[0040] Embodiment 3: dry granulation of senna raw medicinal material powder

[0041] The raw senna powder (passed through a 60-mesh sieve) was directly dry-granulated to obtain sample I.

[0042] Get the raw senna powder (cross 60 mesh sieve), add 0.1% micropowder silica gel (cross 200 mesh sieve), 0.1% plasdoneS-630 (cross 120 mesh sieve), 0.1% stearin by weight Magnesium acid (through a 120-mesh sieve), mixed with a double-cone mixer for 2 minutes, and then dry-granulated to obtain sample II.

[0043] The establishment of evaluation indicators:

[0044] Yield: Take 30g of the above-mentioned granules, accurately weigh the mass, put them in the prescribed 10-mesh and 80-mesh medicine sieves, sieve in a horizontal state, go back and forth, tap 3 minutes while sieving, accurately weigh the weight, and calculate 10- 80 mesh particle yield. [Granule yield (%)=10-80 mesh grain yield / grain total mass*100%]

[0045] Friability: Take an appropriate amount of granules, pass throug...

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Abstract

The invention discloses a method for improving the granule yield of dry granulation of traditional Chinese medicine preparation raw materials containing raw medicinal material powder in a prescription, and is characterized in that a proper amount of composite auxiliary materials are added into traditional Chinese medicine raw medicinal material powder; the composite auxiliary materials comprise micro-silica, plasdone S-630, and magnesium stearate; and dry granulation is performed after well mixing by a mixer. The advantages of the invention are that: 1) the method of the invention is simple; only a few composite auxiliary materials are added during the mixing process of the traditional Chinese medicine raw medicinal materials; the operation methods are simple; and the production time is not prolonged basically; 2) the adding amount of the composite auxiliary materials is low; patient compliance is improved and the production cost is reduced to the maximal extent; 3) various auxiliary materials contained in the composite auxiliary materials are all auxiliary materials commonly-used in preparations, and have no toxicity or adverse reactions after administration; 4) the composite auxiliary materials not only improve compression formability of the traditional Chinese medicine powder, but also have the characteristics of moisture resistance and fluidity improvement of traditional Chinese medicine preparation raw materials, and can improve the quality of the traditional Chinese medicine preparation.

Description

(1) Technical field [0001] The invention relates to the field of traditional Chinese medicine preparations, in particular to a method for improving the yield of dry granulated granules of raw medicinal materials of traditional Chinese medicine by using a medicinal compound auxiliary material. (2) Background technology [0002] Dry granulation technology is a new granulation technology that has emerged in recent years. This technology uses the gap between two rolling cylinders with the same speed to roll the raw materials of pharmaceutical preparations into tablets, and then crush them into tablets of a certain size through a granulator. particles. Its advantages are: (1) Environmentally friendly granulation process, energy-saving and pollution-free, without wetting agent; (2) Solved the explosion-proof problem of solvent granulation and environmental protection problems caused by exhaust pollution; (3) Eliminated The drying process saves a lot of energy; (4) less equipment ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K47/02A61K9/16
Inventor 杜若飞冯怡阮克锋李洁曹韩韩
Owner SHANGHAI UNIV OF T C M
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