CN102462665B - The preparation method of lyophilized excipient - Google Patents
The preparation method of lyophilized excipient Download PDFInfo
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- CN102462665B CN102462665B CN201010549097.3A CN201010549097A CN102462665B CN 102462665 B CN102462665 B CN 102462665B CN 201010549097 A CN201010549097 A CN 201010549097A CN 102462665 B CN102462665 B CN 102462665B
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Abstract
The invention discloses the preparation method of a kind of lyophilized excipient.In the preparation method of the lyophilized excipient of the present invention is utilized in mould, perfusion adds or containing the liquid of binding agent, solid or mixture, form, during lyophilization, the shape that mould is predetermined freezing, take out through knockout course after drying, be wrapped inside dress.This method is used to produce lyophilized excipient, can be by the output increased several times of lyophilized excipient, or even decades of times, solve the tradition low production capacity of lyophilized excipient, the problem of high cost, said preparation is loose porous, but there is enough hardness and toughness, be difficult to friability, multiple packaged forms such as including bottled, box-packed, blister can be used.
Description
Technical field
The present invention relates to the preparation method of a kind of lyophilized excipient, when particularly relating to a kind of packaging, be detached into pattern
The lyophilized excipient preparation method of tool.
Background technology
Lyophilizing figuration technology refers to add binding agent in flowable liquid, semisolid or solid, or described flowable
Liquid, semisolid or solid in itself containing binding agent, be then filled in mould, passed through freeze drying process
Being able to the technology of molding, the preparation prepared by lyophilizing figuration technology is referred to as lyophilized excipient.
Owing to such preparation is through freeze drying process, thermally sensitive composition can be protected not to be destroyed, pass through moisture simultaneously
Distillation produces a large amount of micropores and duct, can have disintegrate quickly and dissolution velocity, therefore suffer from extensive application, Ke Yiying
For fields such as oral cavity disintegration tablet, fast-release tablet, chewable tablet, special cosmetics.
But owing to such preparation, in freezing dry process, defines a large amount of hole traditionally, therefore formulation strengths is not
Height, easy friability, need direct in-situ packaging in mould after lyophilizing, it is impossible to take out, therefore freezing and freeze-drying process is subject to
To packer sealed characteristic and the restriction of stencil design, only with its freezing less than 1/3 and lyophilizing ability, as Xie Legong
The Dr.Das of department sums up in its open treatise " The Zydis Drug Delivery System " about Zydis, passes
System lyophilized excipient production cost remains high, and greatly limit its practical value.
The inventor of the present invention, in order to solve above-mentioned problem, has carried out in depth studying, thus has completed the present invention.
Summary of the invention
The technical problem to be solved is how to improve production capacity and the production efficiency of lyophilized excipient, thus
Reduce cost so that this kind of preparation because of the reduction of production cost, thus can be more widely used.
Traditional lyophilized excipient must use the method that lyophilizing seals in situ, and so-called lyophilizing in situ seals, and refers to
Liquid drug, semisolid or solid in packing timber parison eye after molding；Blister material after fill subsequently enters cold
Freeze and lyophilization operation；After lyophilizing completes, the packaging material that there is lyophilized excipient in bubble eye enter sealing process, will freeze
Dry figuration preparation is sealed in bubble eye.As shown in Figure 1.
On the one hand the main cause of do so is that the hardness of lyophilized excipient is not high enough, once leaves mould, holds
Easily friability, therefore take the production technology that lyophilizing seals in situ；On the one hand it is the pharmaceutical equipment level of the eighties of last century seventies, it is impossible to
The accurate careful lyophilized excipient transmitting easy friability in sealing process, thus ensure its integrity.
But, this have the consequence that: the blister material after molding can always involved in freezing and lyophilizing operation, thus
Cause and produce the low of production capacity and efficiency, and cause the huge waste of the energy.
From Fig. 2 and Fig. 3, in same area, rationally it is arranged into mould, uses the preparation technology of the demoulding at least
Can be than traditional big several times of preparation technology yield.
Inventor finds, the lyophilized excipient adjustment by binding agent, it is also possible to make itself and tradition lyophilizing figuration system
Agent is compared, and has higher hardness and toughness, the most broken；Meanwhile, along with level of processing and the automatization of pharmaceutical engineering equipment
The raising of controlling extent, the most can control lyophilized excipient that lyophilizing completes, fragile from leaving mould, to entering
During inner packing, will not fragmentation.
The lyophilized excipient of the demoulding simultaneously, owing to, during fill, liquid is in the surface tension of die surface, shape
Becoming to have the liquid level of acute angle, ultimately result in the preparation after lyophilizing and have acute angle, the preparation of this shape is easy the most under external force,
Lack limit to crush, the corner that upper surface is easily broken as shown in Figure 4.
In order to solve this problem, US6,224,905 propose with excessive fill, utilize the surface tension of liquid to be formed double
The sheet shape of curved surface, thus reduce the situation that corner is broken.But, the most bad control of this mode, liquid level is easily in external force
The lower deformation of effect, it is also possible to overflow, cause damage.
Inventor through long term test, finds: using upper and lower two moulds, mold is porose, upper/lower die all with contain
The liquid of active component contacts, and upper/lower die bound fraction will not ooze out medicinal liquid；Shaping upper tool shape as it is shown in figure 5,
Can make the horizontal plane corner cut with the liquid contact portion containing active component is obtuse angle, and the preparation that such lyophilizing obtains is the sharpest
The arm of angle, and owing to the shape of mould is the most fixing, the preparation obtained after lyophilizing will not deform because external force moves moulds, and also will not overflow
Go out and lose.
It addition, in addition moderate control, it can also be ensured that it is after inner packing, during until consumer uses, not transport,
During storage, occur broken, it is simple to consumer uses.
Therefore, inventor applies for a kind of preparation method using stripping means to produce lyophilized excipient, i.e. at shaping mould
Tool completes lyophilized excipient from being filled to the overall process of lyophilizing, be detached into mould afterwards, be wrapped inside dress.
Inner packing can be bottle, box, sack, soft pair of aluminum or steep the medicines such as eye sealing or food with product generation directly
Any conventional manner of packing of contact.
Realizing this production technology, fill enters the liquid of mould, semisolid or solid, it is necessary to possess one
Binding agent, be only possible to ensure lyophilized excipient be resistant to pack, transport, use during various forms of mechanical forces, tool
There is less friability.Binding agent is probably in production process interpolation, it is also possible in raw material, itself contains.
This binding agent is edible or pharmaceutically useful a kind of water-soluble high-molecular material, can be polysaccharide, polypeptide, egg
White matter, it is also possible to synthetic polymeric's macromolecule, or through the natural macromolecular material retrofited or its mixture.Conventional is viscous
Knot agent include, but are not limited to gelatin class (gelatin, isinglass, bird gelatin, gelatin hydrolysate etc.), cellulose ethers (methylcellulose,
Carboxymethyl cellulose, hydroxypropyl methyl cellulose, hydroxyethylmethyl-cellulose etc.), modified starch series (pulullan, methylol
Starch etc., sees and thanks to Le patent), hyalomitome acids, albumin, dextran, chitosan and different molecular weight product, sea
Sodium alginate, PVP, PVA, Polyethylene Glycol, arabic gum, guar gum, xanthan gum, Konjac glucomannan, carrageenan, carbomer, agar, angle
Fork dish glue, pectin or combinations thereof etc..
Detailed description of the invention
Further illustrate the present invention below by way of embodiments and comparative examples, but the present invention is not restricted to this.Following
Embodiment and comparative example in, the evaluation methodology of lyophilized excipient is as follows:
1) friability
2) outward appearance of preparation
By the oral disintegrated preparation finger of preparation from the bottom up of aluminum nest firmly, so take out preparation, then use
The exterior appearance of perusal oral disintegrated preparation, smoothness, whether there are depression, crackle etc..
3) hardness is divided into Three Estate, is expressed as: A: have the strongest hardness；B has fraction of consistency and elasticity；C:
Frangible；
Embodiment 1:
Fresh Cornu Cervi Pantotrichum, pulverizes under low temperature, is homogenized, and adds water to solid content 15%, and perfusion enters 1.2 milliliters of moulds,
In mould after lyophilizing, after rapping the taking-up of the mould back side, load in bottle.The binding agent wherein contained is gelatin, many
Sugar and hyaluronic acid.
Embodiment 2:
Fresh sea cucumber, pulverizes under low temperature, is homogenized, and adds water to solid content 15%, and perfusion enters 1.2 milliliters of moulds,
In mould after lyophilizing, rapping after the mould back side takes out, load in bottle, the binding agent wherein contained is gelatin, many
Sugar and hyaluronic acid.
Embodiment 3:
Sldenafil 25g, is crushed to less than 50 microns, adds isinglass 25g and mannitol 25g, is configured to 400ml suspendible
After liquid, fill enters mould, 0.4 milliliter of solution of fill in each mould, takes out after lyophilizing, packs to the double aluminum bag of hatchback
In dress, become sldenafil oral cavity disintegration tablet.
Embodiment 4
EGF stock solution, adds gelatin, gelatin hydrolysate and mannitol, is configured to solution after defrosting, fill enters mould,
In each mould, fill contains 5,0.15 milliliter of solution of 000 unit EGF, takes out after lyophilizing, packs to hatchback double aluminum packaging
In, become modern biotechnology cosmetics.
Embodiment 5
After vitamin C mixes according to the ratio of 5: 1 with Pullulan, 60mg mixture is divided into two parts, and 80% with powder
Form fill enter 0.4 milliliter of mould, 20% with after 0.3ml water dissolution in the form of a solution fill enter same a molding
Tool, takes out after lyophilizing, packs to hatchback double aluminum packaging, becomes modern biotechnology cosmetics.
Embodiment 6
Risperidone 2g, gelatin 3g, dextran 2g, mannitol 5g, add water and be made into 200ml suspension, accurate fill mould
To 0.2ml, take out after lyophilizing, pack to hatchback double aluminum packaging, become risperidone orally disintegrating tablets.
Embodiment 7
Desmopressin acetate 0.1g, gelatin 2g, dextran 1 g, mannitol 2.5g, add water and be made into 100ml suspension,
Accurately fill mould is to 0.1ml, takes out after lyophilizing, packs to hatchback double aluminum packaging, becomes desmopressin acetate oral cavity
Disintegrating tablet.
Embodiment 8
Various plants pollen, such as ladder forage spp plant pollen, extract at low temperature water-soluble macromolecule, purification obtains molecular weight
The proteantigen of 1000-30000 1000 parts (10ml), contains the molten of 2%PVA, 1% dextran and 2.5% mannitol with 90ml
Liquid disperses, and accurate fill mould, to 0.1ml, takes out after lyophilizing, packs to hatchback double aluminum packaging, becomes sublingual administration treatment
The vaccine of Hay Fever.
Embodiment 9
Selegiline 1.25g, gelatin 1g, gelatin hydrolysate 1g, dextran 1 g, mannitol 2.5g, adding water, it is mixed to be made into 100ml
Suspension, accurate fill mould, to 0.1ml, takes out after lyophilizing, packs to hatchback double aluminum packaging, becomes selegiline oral cavity and collapse
Solve sheet.
Embodiment 10
Radix Salviae Miltiorrhizae 255g, Radix Notoginseng 50g, Borneolum Syntheticum 2.85g, Radix Salviae Miltiorrhizae, Radix Notoginseng decoct 3 times, each 1 hour, merge decoction liquor, filter
Cross, filtrate concentrates, and adds 2 times amount ethanol, stands 24 hours, filters, and reclaims ethanol, is concentrated into when 55-80 degree Celsius the closeest
Degree is the thick paste of 1.33-1.35, adds Pullulan 4g, PVA4g, mannitol 8g, and after mix homogeneously, add water 350ml, injects
0.4ml in mould, lyophilization；It is heated to 60 degrees Celsius with Polyethylene Glycol 10g, mixes with 2.85g Borneolum Syntheticum, with accurately insulation
Spray gun tablet surface spraying 12.85mg Borneolum Syntheticum-melt and dissolved liquid of Polyethylene Glycol after lyophilizing, seals after cooling, obtains 1000 again
Fang Dancan lyophilized excipient
Table 1: test result
| Embodiment 1 | Embodiment 2 | Embodiment 3 | Embodiment 4 | Embodiment 5 | Embodiment 6 | |
| Disintegration time (s) | 30 seconds | 30 seconds | 8 seconds | 1 second | 5 seconds | 3 seconds |
| Outward appearance | Flat smooth | Flat smooth | Flat smooth | Flat smooth | Flat smooth | Flat smooth |
| Hardness | 400g | 500g | 100g | 30g | 50g | 150g |
| Embodiment 7 | Embodiment 8 | Embodiment 9 | Embodiment 10 | |
| Disintegration time (s) | 1 second | 3 seconds | 5 seconds | 25 seconds |
| Outward appearance | Flat smooth | Flat smooth | Flat smooth | Flat smooth |
| Hardness | 100g | 120g | 150g | 500g |
It should be noted that the various details for the present invention can be revised arbitrarily, but certainly, these are repaiied
Change within falling within protection scope of the present invention.
Fig. 1 is traditional lyophilized excipient mode of production figure；
Fig. 2 is the mould figure of traditional lyophilized excipient；
Fig. 3 is the mould figure of the demoulding lyophilized excipient of the present invention；
Fig. 4 is demoulding lyophilized excipient picture figure；
Fig. 5 is upper/lower die and preparation shape graph；
Fig. 6 is shaping upper tool and the horizontal plane corner cut of liquid contact portion containing active component is obtuse angle schematic diagram.
Claims (4)
1. a production technology for lyophilized excipient, it is made up of following operation:
A) containing active substance and the liquid of binding agent, accurate quantification fill enters mould；Mould after fill is through supercool
Lyophilizing drying process, makes lyophilized excipient；
B) lyophilized excipient made is detached into mould, enters inner packing operation；
It is characterized in that, described binding agent one or many in Pullulan, mannitol, dextran, PVA and hyaluronic acid
Kind；Described mould is made up of mold and lower mold two parts, and mold is porose, upper/lower die all with containing active component
Liquid contact, mold and the horizontal plane corner cut of the liquid contact portion containing active component are obtuse angle and upper/lower die is combined
Part will not ooze out fill liquid.
2. a production technology for lyophilized excipient, is made up of following operation:
A) containing active substance and the semisolid of binding agent or solid, accurate quantification fill enters mould；After fill
Mould, through lyophilization operation, makes lyophilized excipient；
B) lyophilized excipient made is detached into mould, enters inner packing operation；
It is characterized in that, described binding agent one or many in Pullulan, mannitol, dextran, PVA and hyaluronic acid
Kind；Described mould is made up of mold and lower mold two parts, and mold is porose, upper/lower die all with containing active component
Liquid contact, mold and the horizontal plane corner cut of the liquid contact portion containing active component are obtuse angle and upper/lower die is combined
Part will not ooze out fill liquid.
3. the production technology as described in claim 1-2 any one, it is characterised in that the consumption of described binding agent or content
For binding agent gross weight: the gross weight of liquid, semisolid or solid during fill entrance mould, scope is at 1%-10%
Between.
4. production technology as claimed in claim 3, it is characterised in that the consumption of described binding agent or content are that binding agent is total
Weight: the gross weight of liquid, semisolid or solid during fill entrance mould, scope is between 2%-8%.
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| CN110656361A (en) * | 2018-06-28 | 2020-01-07 | 山东坦途农业科技有限公司 | Freeze-drying excipient forming die and preparation method |
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| CN101757030A (en) * | 2010-03-19 | 2010-06-30 | 董玲 | Cartialgenous all-component uniform freeze-dried preparation and production method thereof |
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| SK282868B6 (en) * | 1996-06-17 | 2003-01-09 | Janssen Pharmaceutica N. V. | Biconvex rapidly disintegrating dosage forms |
| CN1431021A (en) * | 2003-01-21 | 2003-07-23 | 周赤 | Biologic spongy body used for treating gynaecology disease and produing method thereof |
| JP5386157B2 (en) * | 2007-11-30 | 2014-01-15 | 日本エフディ株式会社 | Manufacturing method of freeze-dried molded products |
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