CN1318060C - Preparation process of Chinese medicine soft capsule - Google Patents

Preparation process of Chinese medicine soft capsule Download PDF

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Publication number
CN1318060C
CN1318060C CNB2004101555051A CN200410155505A CN1318060C CN 1318060 C CN1318060 C CN 1318060C CN B2004101555051 A CNB2004101555051 A CN B2004101555051A CN 200410155505 A CN200410155505 A CN 200410155505A CN 1318060 C CN1318060 C CN 1318060C
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China
Prior art keywords
preparation
soft capsule
hours
suspending agent
filtrate
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Expired - Fee Related
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CNB2004101555051A
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CN1781525A (en
Inventor
杨文龙
曾雄辉
刘云
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RENHE DEVELOPMENT GROUP Co Ltd
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RENHE DEVELOPMENT GROUP Co Ltd
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Priority to CNB2004101555051A priority Critical patent/CN1318060C/en
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Publication of CN1318060C publication Critical patent/CN1318060C/en
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Abstract

The present invention discloses a preparation method of a traditional Chinese medicine soft capsule. On the basis of an original formula, the process of water extract and alcohol deposition is adopted, an amount of dispersing agents and suspending agents are added so that the product obtains uniform and stable quality.

Description

A kind of preparation method of Chinese medicinal soft capsule
Technical field
The invention discloses a kind of preparation method of Chinese medicinal soft capsule, belong to the field of Chinese medicines.
Background technology
Existing market a kind of Chinese medicine on sale " KANGGONGYAN PIAN " is used for chest and abdomen swelling and pain, the QI rising in reverse order dyspnea with rapid respiration, and deficiency-cold in the urinary bladder, enuresis frequent micturition, xenon, the treatment of diseases such as dysmenorrhea has clinical application effect preferably.But because but the acceptance of tablet in the middle of the patient is poor, so comparatively seriously influenced of the popularization of this medicine in market; And on the other hand, the patient wishes to have a kind of therapeutic equivalence and the more advanced medicine of dosage form to satisfy the demands again very much, will contain the huge market space so develop new product.
Soft capsule is the emerging developing direction of the field of Chinese medicines, it with good looking appearance, stable in properties, content medicine accurately, can cover advantage such as bad smell and approved by patient and market gradually.But, only carry out the purpose that suitable process modification just can reach the preparation soft capsule because the soft capsule content must be made the non-solid-state system of stable homogeneous, thereby can't continue to use the technology of traditional solid preparation or liquid preparation fully.A kind of preparation method of " KANGGONGYAN PIAN " is disclosed in CN1092983A, but wherein not about preparing the useful prompting of soft capsule.
Summary of the invention
Make qualified soft capsule, must carry out the improvement of technology again, the inventor studies at this point, and has realized the purpose of preparation soft capsule by the following method:
Get Callicarpa kwangtungensis Chun 5511 weight portions, Herba Leonuri 616 weight portions and the Radix Linderae 702 weight portions, add 10~16 times in water, decoct 2~3 times, each 1~2 hour, collecting decoction filtered, filtrate is condensed into extractum, adds ethanol and makes and contain alcohol amount and reach 40~60%, leaves standstill 12~24 hours, filter, filtrate recycling ethanol, the extractum that obtains is spray dried to fine powder, adds dispersant and suspending agent, its addition is enough to make this mixed system energy suspendible even, makes soft capsule behind the mixing.
Further preferred each technological parameter, it is as follows to obtain processing step:
Get Callicarpa kwangtungensis Chun 5511 weight portions, Herba Leonuri 616 weight portions and the Radix Linderae 702 weight portions, decoct with water three times, each amount of water is respectively 16,12,12 times, decocting time was respectively 2 hours, 1.5 hours, 1 hour, collecting decoction filters, and relative density was 1.10 when filtrate was concentrated into 60 ℃, cooling, add ethanol and make and contain the alcohol amount and reach 50%, stir evenly, left standstill 24 hours, filter, relative density is the clear paste of 1.15-1.20 during filtrate recycling ethanol to 60 ℃, is spray dried to fine powder, adds the dispersant and the suspending agent of proper proportion, make suspendible even, make soft capsule.
In the above-mentioned technology, dispersant can use polyethylene glycols (english abbreviation: PEG), as PEG-400 and PEG-6000; Also can use the consumption vegetable oil, as one or more mixture of soybean oil, Oleum Arachidis hypogaeae semen, Oleum sesami, Semen Allii Tuberosi wet goods.After preferred, it is more stable than the product that obtains with polyethylene glycols with vegetable oil that the inventor thinks, so select vegetable oil for use; And in the vegetable oil, because of soybean oil source is wide, quality better, price are low, so be defined as the optimal choice of dispersant.
Be beneficial to the uniform and stable of content, also in dispersant, add a certain amount of outstanding agent, one or more the mixture as in Cera Flava, lecithin, aluminum monostearate, the ethyl cellulose etc. can both be effective.After preferred, the inventor has selected the mixture of Cera Flava and lecithin.
On above research basis, the inventor has determined that further the optimum weight proportioning of medicated powder and soybean oil, Cera Flava, lecithin is 1: 0.94: 0.04: 0.02, and the needs of preparation can be fully satisfied in so both material savings again.
Further illustrate the feasibility of invention preparation method by the following examples.
Embodiment 1: get Callicarpa kwangtungensis Chun 5511g, Herba Leonuri 616g and Radix Linderae 702g, add 12 times of amounts of water, decoct 2 times, each 1.5 hours, collecting decoction, filter, relative density was 1.05~1.10 extractum when filtrate was condensed into 60 ℃, put cold, adding ethanol makes and contains alcohol amount and reach 50%, left standstill 12 hours, and filtered filtrate recycling ethanol, and relative density is the extractum of 1.15-1.20 when continuing to be concentrated into 60 ℃, be spray dried to fine powder, add the PEG-400 of 1.1 times of amounts and the Cera Flava of 0.05 times of amount, after colloid mill grinds well, make soft capsule.
Embodiment 2: get Callicarpa kwangtungensis Chun 5511g, Herba Leonuri 616g and Radix Linderae 702g, add 10 times of amounts of water, decoct 2 times, each 1 hour, collecting decoction, filter, relative density was 1.05~1.10 extractum when filtrate was condensed into 60 ℃, put cold, adding ethanol makes and contains alcohol amount and reach 40%, left standstill 12 hours, and filtered filtrate recycling ethanol, and relative density is the extractum of 1.15-1.20 when continuing to be concentrated into 60 ℃, be spray dried to fine powder, add the soybean oil of 1 times of amount and the Cera Flava of 0.05 times of amount, after colloid mill grinds well, make soft capsule.
Embodiment 3: get Callicarpa kwangtungensis Chun 5511g, Herba Leonuri 616g and Radix Linderae 702g, add 16 times in water, decoct 3 times, each 2 hours, collecting decoction, filter, relative density was 1.10~1.15 extractum when filtrate was condensed into 60 ℃, added ethanol and made and contain the alcohol amount and reach 60%, left standstill 24 hours, filter, filtrate recycling ethanol, and relative density is the extractum of 1.15-1.20 when continuing to be concentrated into 60 ℃, be spray dried to fine powder, by 1: 0.92: 0.03: 0.02 weight ratio added Oleum Arachidis hypogaeae semen, Cera Flava and lecithin, and colloid mill grinds well, and makes soft capsule.
Embodiment 4: get Callicarpa kwangtungensis Chun 5511g, Herba Leonuri 616g and Radix Linderae 702g, decoct with water three times, each amount of water is respectively 16,12,12 times, decocting time was respectively 2 hours, 1.5 hour, 1 hour, collecting decoction filters, and relative density was 1.10 when filtrate was concentrated into 60 ℃, cooling, add ethanol and make and contain the alcohol amount and reach 50%, stir evenly, left standstill 24 hours, filter, relative density is the clear paste of 1.15-1.20 during filtrate recycling ethanol to 60 ℃, is spray dried to fine powder, and by 1: 0.94: 0.04: 0.02 weight ratio added soybean oil, Cera Flava and lecithin, grind well through colloid mill, make soft capsule.

Claims (5)

1. the preparation method of a Chinese medicinal soft capsule, the prescription of this Chinese medicine consists of Callicarpa kwangtungensis Chun 5511 weight portions, Herba Leonuri 616 weight portions and the Radix Linderae 702 weight portions, it is characterized in that this method comprises following processing step:
Get three flavor medicines, add 10~16 times in water, decoct 2~3 times, each 1~2 hour, collecting decoction filtered, filtrate is condensed into extractum, adds ethanol and makes and contain alcohol amount and reach 40~60%, leaves standstill 12~24 hours, filter, filtrate recycling ethanol, the extractum that obtains is spray dried to fine powder, adds the dispersant and the suspending agent of proper proportion, make suspendible even, make soft capsule.
2. preparation method according to claim 1 is characterized in that this method comprises following processing step:
Get three flavor medicines, decoct with water three times, each amount of water is respectively 16,12,12 times, decocting time was respectively 2 hours, 1.5 hours, 1 hour, and collecting decoction filters, relative density was 1.10 when filtrate was concentrated into 60 ℃, and cooling adds ethanol and makes and contain the alcohol amount and reach 50%, stir evenly, left standstill 24 hours, filter, relative density is the clear paste of 1.15-1.20 during filtrate recycling ethanol to 60 ℃, is spray dried to fine powder, adds the dispersant and the suspending agent of proper proportion, make suspendible even, make soft capsule.
3. preparation method as claimed in claim 2 is characterized in that used dispersant is polyethylene glycols or consumption vegetable oil; Used suspending agent can be one or more the mixture in Cera Flava, lecithin, aluminum monostearate, the ethyl cellulose etc.
4. preparation method as claimed in claim 3 is characterized in that used vegetable oil is one or more a mixture of Oleum Arachidis hypogaeae semen, Oleum sesami, Oleum Brassicae campestris or other edible vegetable oils; Used suspending agent is Cera Flava and lecithin and mixture.
5. preparation method as claimed in claim 4, the weight proportion that it is characterized in that medicated powder and soybean oil, Cera Flava, lecithin is 1: 0.94: 0.04: 0.02.
CNB2004101555051A 2004-12-03 2004-12-03 Preparation process of Chinese medicine soft capsule Expired - Fee Related CN1318060C (en)

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CNB2004101555051A CN1318060C (en) 2004-12-03 2004-12-03 Preparation process of Chinese medicine soft capsule

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CNB2004101555051A CN1318060C (en) 2004-12-03 2004-12-03 Preparation process of Chinese medicine soft capsule

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CN1781525A CN1781525A (en) 2006-06-07
CN1318060C true CN1318060C (en) 2007-05-30

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Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1092983A (en) * 1993-03-26 1994-10-05 萍乡市中药厂 A kind of manufacture method of anti-inflammation tablet for metritis
CN1368123A (en) * 2001-02-02 2002-09-11 杨孟君 Nano medicine 'Kanggongyan' and its preparing process

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1092983A (en) * 1993-03-26 1994-10-05 萍乡市中药厂 A kind of manufacture method of anti-inflammation tablet for metritis
CN1368123A (en) * 2001-02-02 2002-09-11 杨孟君 Nano medicine 'Kanggongyan' and its preparing process

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Granted publication date: 20070530

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