A preparation method of 'Sanjin' dispersible tablets

A technology for dispersible tablets and tablet pressing, which is applied in pharmaceutical formulations, medical preparations containing active ingredients, and plant/algae/fungus/moss components, etc. In order to achieve the effect of reasonable and feasible process, improved preparation quality and high bioavailability

Active Publication Date: 2007-08-01
SICHUAN SUNNYHOPE PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Chinese patent 200410023395 (comparative document 3) introduces the preparation method of Sanjin dispersible tablet, but does not disclose the most important auxiliary material selection and preparation in the dispersible tablet preparation process Forming process conditions, ordinary technical personnel in the field of pharmacy can not be implemented
However, there are many types of auxiliary materials used, and the amount of technology and magnesium stearate is not reasonable, and the specific variety of modified starch used is not disclosed. The prescription ratio of the dispersible tablet embodiment is also different from that of Comparative Document 2, so it cannot be prepared. into Sanjin dispersible tablets for clinical use
[0006] Chinese patent 200410073628 (comparative document 5) has introduced the preparation method of Sanjin Tablet, but its spray drying and one-step granulation process parameter scope are all very wide; Preferred The range of process parameters is also relatively wide, and the air inlet temperature and outlet air temperature of spray drying are too high, and the preferred process parameters of one-step granulation are not supported by the examples; this patent does not involve the types and quantities of auxiliary materials added to prepare dispersible tablets , and some conditions are not reasonable enough
Therefore, those of ordinary skill in the field of pharmacy cannot use it in the preparation process of Sanjin dispersible tablets
[0007] The above comparative literature also has the following deficiencies: 1. the concentration process and conditions of the raw material decoction are not optimized; The amount of water added and the internal and external addition methods of excipients in the formulation are specified; ③In the examples, there is no specific weight of raw materials, nor the amount of production
Therefore, these preparation methods either cannot be implemented specifically, or the quality of the prepared products is affected, and cannot be legally, reasonably and effectively used clinically.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] Take 2020g of golden cherry root, 1010g of smilax, 1O10g of sheep opening, 606g of golden sand vine, 606g of centella asiatica, add water to decoct twice, add 12 times of water for the first time, decoct for 2 hours; add 10 times of water for the second time, decoct 1 hour; combine the decoction, filter, and the filtrate adopts the method of three-effect decompression concentration (temperature: first effect 92°C, second effect 84°C, third effect 73°C; vacuum degree: first effect-0.03Mpa, second effect- 0.05Mpa, triple effect -0.07Mpa) concentrated to the relative density of 1.15 ~ 1.20 (60 ℃) extract, spray drying under the conditions of the inlet air temperature of 155 ~ 160 ℃, the outlet air temperature of 75 ~ 80 ℃, Obtain 265g of dry extract powder, take by weighing micropowder silica gel 213g, sodium starch glycolate 73g and mix uniformly, granulate with 70% ethanol, dry, dry granule adds magnesium stearate 2g, sodium starch glycolate 47g mixes uniformly, presses i...

Embodiment 2

[0032]Take 20.2kg of golden cherry root, 10.1kg of sarsaparilla, 10.1kg of sheep opening, 6.06g of golden sand vine, 6.06g of centella asiatica, add water to decoct three times, add 10 times the water for the first time, and decoct for 2 hours; add 8 times the water for the second and third times Double the water, decoct for 1 hour each; combine the decoction, filter, and the filtrate adopts the method of three-effect decompression concentration (temperature: first effect 90°C, second effect 80°C, third effect 70°C; vacuum degree: first effect-0.04 Mpa, second effect -0.06Mpa, third effect -0.08Mpa) concentrated to the extract with a relative density of 1.12~1.17 (60°C), use micropowder silica gel 1.21kg as the base material, spray into the extract, and the spray pressure is 0.08~ One-step granulation under the conditions of 0.09Mpa, material temperature of 70-75°C, inlet air temperature of 95-98°C, outlet air temperature of 85-86°C, and drying temperature of 65-70°C, and the o...

Embodiment 3

[0034] Take 20.2kg of golden cherry root, 10.1kg of sarsaparilla, 10.1kg of sheep opening, 6.06g of golden sand vine, 6.06g of centella asiatica, add water to decoct three times, add 9 times the water for the first time, and decoct for 2 hours; add 7 times the water for the second and third times Double the water, decoct for 1 hour each; combine the decoction, filter, and the filtrate adopts the method of three-effect decompression concentration (temperature: first effect 86°C, second effect 78°C, third effect 68°C; vacuum degree: first effect-0.05 Mpa, second effect -0.07Mpa, third effect -0.09Mpa) concentrated to the extract with a relative density of 1.18~1.20 (60°C), use micropowder silica gel 2.10kg as the base material, spray into the extract, and the spray pressure is 0.12~ Carry out one-step granulation under the conditions of 0.14Mpa, material temperature of 65-70°C, inlet air temperature of 103-105°C, outlet air temperature of 82-84°C, and drying temperature of 75-85°...

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PUM

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Abstract

The invention discloses a making method of tri-gold dispersing pill and a preparation method, which is characterized by the following: decompressing to condense the boiled raw material; spraying to dry condensate; adding fitful micro-crystal cellulose, micro-powder silica gel and sodium carboxymethylstarch through wet-method to grain or adding fitful quantity of micro-crystal cellulose to grain further; grinding the needed particle; pressing; obtaining the product. The preparation method not only can prepare tri-gold dispersing pill with characters including easy taken, fast absorption and high bioavailability, and all indexes are up to the specification in chinese pharmacopoeia; and in condition of the same crude drug amount, the amount of the effective constituent asiaticoside is much higher than the amount of tri-gold capsule.

Description

technical field [0001] The invention relates to a method for preparing Chinese patent medicine, in particular to a method for preparing Sanjin dispersible tablets. Background technique [0002] Sanjin Tablet is a kind of traditional Chinese medicine widely used clinically. It is made of 5 raw materials such as Rosa chinensis root, Smilax chinensis, Yang Kaikou, Jinsha rattan and Centella asiatica. It is used for hot stranguria, short red urination, astringent pain, frequent urination caused by damp heat in the lower Jiao; acute and chronic pyelonephritis, cystitis, and urinary tract infection see the above syndromes, and its drug standards are recorded in the People's Republic of China Pharmacopoeia one 2005 edition 326 pages (comparative literature 1). Someone has developed Sanjin Capsule and Sanjin Granule, and its standards are respectively recorded in page 83 of the National Compilation of Chinese Patent Medicine Standards Compilation of Internal Medicine and Kidney Sys...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K36/90A61K9/20A61P13/02A61P13/12
Inventor 张沛冯华祥芮旭东周道铨
Owner SICHUAN SUNNYHOPE PHARM CO LTD
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