CN102188448A - Pilose antler freeze-dried excipient with smooth appearance and production method thereof - Google Patents
Pilose antler freeze-dried excipient with smooth appearance and production method thereof Download PDFInfo
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- CN102188448A CN102188448A CN201010127723XA CN201010127723A CN102188448A CN 102188448 A CN102188448 A CN 102188448A CN 201010127723X A CN201010127723X A CN 201010127723XA CN 201010127723 A CN201010127723 A CN 201010127723A CN 102188448 A CN102188448 A CN 102188448A
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Abstract
The invention aims to provide a pilose antler freeze-dried excipient with smooth appearance and uniform color. The pilose antler freeze-dried excipient comprises complete pilose antler ingredient, a frame proppant, an adhesive and other auxiliary materials, wherein the auxiliary materials can be essence or a flavoring agent, and the adhesive is Pullulan or gelatine. Because single adhesive, i.e. Pullulan or gelatine, is used in the freeze-dried excipient, the pilose antler freeze-dried excipient containing the complete pilose antler ingredient has uniform color, and compact and complete appearance, has no defects of pits or the like, and completely conforms to the sold-on-market standard required by the national relevant department.
Description
Technical field
The present invention relates to a kind of lyophilizing figuration preparation and production method thereof that contains active ingredient of Chinese herbs, particularly relate to a kind of lyophilized formulations and production method thereof that contains the Chinese medicine Cornu Cervi Pantotrichum.
Background technology
The medicinal Shennong's Herbal in ancient times that sees the earliest of Cornu Cervi Pantotrichum, Li Shizhen (1518-1593 A.D.) has more at large been introduced the concocting method and the medicinal efficacy of Cornu Cervi Pantotrichum in Compendium of Material Medica.
Sika deer velvet antler is the still unossified young tender antler of male Cervus nippon Temminck.The fine and soft beginning for the treatment of the preponderant disease instead of the secondary disease is answered in Cornu Cervi Pantotrichum processing.Getting fine and soft method has two kinds substantially, and the one, paste the scalp saw down with saw, claim saw fine and soft; The 2nd, connect skull band young pilose antler and cut down, claim to cut young pilose antler.The Cornu Cervi Pantotrichum that takes off will wash earlier, extracts fine and soft interior hematocele out.Cut young pilose antler and also will repair the bone shaping, make shape attractive in appearance.
The medical material Cornu Cervi Pantotrichum is divided into nascent young pilose antler and (is cylinder or taper shape, slightly crooked, five forks), two thick sticks (at first mitogenetic on trunk side shoot: make Eight characters sample separately), three troubles (mitogenetic second side shoot on trunk is three trouble shapes), regeneration fine and soft (shape is similar to two thick sticks), cut young pilose antler (two thick sticks of band skull or three branch off).Above-mentioned medical material is sturdy with body, very round, and the top is plentiful, the skin rufous, and the soft yellowish-brown that is of capillary, body the lighter is good.Sika deer velvet antler claims yellow young pilose antler again, spends young pilose antler, be in the Cornu Cervi Pantotrichum on product.Cervus elaphus linnaeus, labiad Cornu Cervi Pantotrichum, white deer young pilose antler etc. are still arranged, all can be used as medicine.
Commercially available Cornu Cervi Pantotrichum section generally is divided into level Four, and it is that Cornu Cervi Pantotrichum is cut into for vertical one section that first-class is spent fine and soft sheet, because tangent plane is level and smooth, and no sponge sample hole, color such as wax sample are bright and clean. practise title wax disk(-sc) or dough sheet, very precious.
Cornu Cervi Pantotrichum " is reported the matter of pure sun, is contained the gas of hair growth promoting ", is classified as the drug of first choice of high benefit " Yuanyang " by the traditional Chinese medical science.From the modern medicine viewpoint, " Yuanyang " has comprised basic human body physiological functions such as reproduction, growth metabolism.Cornu Cervi Pantotrichum has spermatogenesis benefit marrow, beneficial blood is supporing yang, the function of strengthening the tendons and bones, cures mainly diseases such as all are deficient, dizzy, deaf, order dark, sexual impotence, spermatorrhea, weakness of the waist and knees, deficiency and coldness leukorrhagia, metrorrhagia.Clinical usual amounts is 1.5～3g, general maximum 6g that are no more than.Modern pharmacology discovers, Cornu Cervi Pantotrichum has heart tonifying, human body immunity improving function, promote wound heal platform and gonadotropic Effect.Cornu Cervi Pantotrichum also is common in nourishing class health product, for example pantocrine, piece of antler, deer antler wine, antler gelatin, Penis et testis cervi, fine and soft tail essence or the like except that using in tcm prescription.
The main purpose of Cornu Cervi Pantotrichum processing is dehydration, dry, anticorrosion, sterilization, conformal, guarantor's color, improves the quality, and is beneficial to preservation.For a long time, the processing of China Cornu Cervi Pantotrichum adopts boiling water to boil fried and high-temperature baking technology always, adds Chinese liquor and also can make protein denaturation, cause fine and soft in the effective ingredient active substance suffer in various degree loss and destruction.
Antler freeze-dried method is to adopt modern food and biological product freeze preservation and dry technology theory, organizational structure and biological characteristics in conjunction with Cornu Cervi Pantotrichum, manage to make fine and soft intravital free water and constitution water to be easy to separate out, make bright young pilose antler after quick-freezing, the dehydrate that directly distils under the cryogenic vacuum condition becomes the new technology of best buy young pilose antler.Avoided existing " decocting in water, baking " processing method destruction to temperature-sensitive active component enzyme, hormone, aminoacid etc. in the Cornu Cervi Pantotrichum; Can keep shape, color and luster, the taste of bright Cornu Cervi Pantotrichum constant substantially; And keep the nutritional labeling of Cornu Cervi Pantotrichum and physiologically active ingredient not to run off, do not destroy to greatest extent, improved the product quality and the appearance property of Cornu Cervi Pantotrichum; And rehydration is good, immerse in the water after, can very fast suction restore, like bright product.
Oral disintegrated preparation, refer to can be in the oral cavity disintegrate or dissolved preparation rapidly, this type of preparation runs into saliva disintegrate and most of dissolving rapidly in the oral cavity, need not water and just can take.The freeze-dry orally disintegrating preparations belongs to lyophilizing figuration preparation, comes across the later stage seventies 20th century, and employing Freeze Drying Techniques such as Gregory have been made the pharmaceutical carrier of high porosity, the disintegrate after the oral cavity runs into saliva of this carrier.Oral disintegrated preparation more and more is subjected to liking of patient with its unique advantages.This preparation does not need water delivery service, runs into the rapid disintegrate of saliva in the oral cavity, takes medicine to some function of deglutition patient bad and water intaking inconvenience convenience is provided.
According to pointing out in first to file prior art 200510090503.3, when preparation contains the freeze-dry orally disintegrating tablet of medicine, if use single adjuvant Pullulan to prepare oral disintegrated preparation as binding agent, the outward appearance of the oral disintegrated preparation of preparation is more coarse, and lack necessary hardness, make in the transportation surface very easily be oppressed and be out of shape, and then influence disintegration of tablet.Should use Pullulan and dextran to use as composite adhesive with proper proportion, like this Zhi Bei oral cavity disintegration tablet appearance luster evenly, fine and close, complete, no any defective such as subside meets the listing criteria of national departments concerned requirement fully.But when inventor of the present invention prepares the lyophilizing figuration preparation that contains Cartialgenous all-component of the present invention, but find when using the composite adhesive of Pullulan and dextran composition, the freeze-dry orally disintegrating tablet that obtains still outward appearance is more coarse, and lack necessary hardness, make in the transportation surface very easily be oppressed and be out of shape.
Inventor of the present invention is in order to overcome above-mentioned defective, carried out research in depth, find that the lyophilizing figuration preparation appearance luster that contains Cartialgenous all-component of using single binding agent Pullulan or gelatin can make preparation is even, fine and close, complete, no any defective such as subside, meet the listing criteria that national departments concerned requires fully, thereby finished the present invention.
Summary of the invention
The object of the invention is to provide a kind of lyophilizing figuration preparation that contains Cartialgenous all-component; Another purpose of the present invention is to provide the preparation method of this lyophilizing figuration preparation that contains Cartialgenous all-component.
The present invention also aims to provide a kind of product appearance of preparation smooth smooth, color and luster contains the lyophilizing figuration preparation of Cartialgenous all-component uniformly.
The present invention contains in the lyophilizing figuration preparation of Cartialgenous all-component and comprises Cartialgenous all-component, skeleton proppant, binding agent and other adjuvant, and other adjuvant can be essence or correctives.
The implication of lyophilizing figuration preparation is that the preparation that obtains behind the figuration is carried out in the sample lyophilization.
Described Cartialgenous all-component is the material that the Cornu Cervi Pantotrichum of Cervus nippon Temminck or Cervus elaphus linnaeus or other suitable deer obtains after lyophilization.The content range of the dry thing of described Cornu Cervi Pantotrichum in lyophilizing figuration preparation is 1-98%, and preferred 5-95% is more preferably 10-90%, preferred especially 20-90%, most preferably 30-90%.
Described skeleton proppant is: have 2 amino acid whose one or more mixture to 12 carbon atoms; Described aminoacid is: glycine, serine, arginine, proline, alanine, aspartic acid, glutamic acid, hydroxyproline, isoleucine, leucine or phenylalanine.Be preferably glycine.The content range of described skeleton proppant in lyophilizing figuration preparation is 1-50%, and preferred 2-40% is more preferably 3-30%, preferred especially 4-30%, most preferably 5-30%.
Wherein said binding agent is Pullulan or gelatin, and the content range of described binding agent in lyophilizing figuration preparation is 1-50%, and preferred 2-40% is more preferably 3-30%, preferred especially 4-30%, most preferably 5-30%.。
Wherein said essence or correctives include but not limited to mint flavored, the jasmine flavor, the Arillus Longan flavor, the Flos Chrysanthemi flavor, the Fructus Fragariae Ananssae flavor, the Fructus Musae flavor, chocolate flavoured, the Semen arachidis hypogaeae flavor, the Fructus Crataegi flavor, the Fructus Mangifera Indicae flavor, the Fructus Jujubae flavor, the Fructus Pruni flavor, the Flos Osmanthi Fragrantis flavor, the Fructus Ananadis comosi flavor, the Herba Passiflorae Caeruleae flavor, the Punica granatum L. flavor, the Fructus psidii guajavae immaturus flavor, the Fructus Fici flavor, the Semen Sesami flavor, egg yolk flavor, the Fructus Lycopersici esculenti flavor, the corn flavor, creamy taste, the black currant flavor, blue berry flavor, the Radix Glycyrrhizae flavor, the orange flavor, the Fructus Vitis viniferae flavor, lemon, the Fructus actinidiae chinensis flavor, caramel, vanilla flavored, cherry-flavored, the hami melon flavor, the Fructus Chaenomelis flavor, the Fructus Mali pumilae flavor, the Fructus Caricae flavor, the Fructus Litchi flavor, the pears flavor, the peach flavor, caf, tea flavour, the essence of milk flavor etc. or the mixture of above one or more fragrance; Its content can be 0.1-5%.
The preparation method that the present invention contains the lyophilizing figuration preparation of the dry thing of Cornu Cervi Pantotrichum may further comprise the steps (those skilled in the art can suitably add other step again under the prerequisite that does not deviate from essence of the present invention):
1. fresh Cornu Cervi Pantotrichum is freezing below 0 degree centigrade;
2. refrigerated Cornu Cervi Pantotrichum is ground into refrigerated granule below 40 degrees centigrade, about described particle grain size 20 orders;
3. add an amount of saccharide, an amount of skeleton proppant, suitable amount of adhesive in the purified water, mixed dissolution is cooled to below 40 ℃ after disperseing;
4. the 2nd go on foot frozen particle homogenizing below 40 ℃ or the homogenate formation suspendible preparation liquid that obtains, or the 2nd frozen particle that obtains of step is dispensed in solution, suspension or the emulsion that purified water or the 3rd step obtain, homogenizing or homogenate below 40 ℃ form suspendible preparation liquid;
5. the 4th go on foot the suspendible preparation liquid that obtains, divide the mould that is filled to suitable volumes, behind pre-freeze and two processing steps of lyophilization, obtain Cartialgenous all-component uniform freeze-dried figuration preparation.
Prior art is taught in preparation and contains the freeze-dry orally disintegrating tablet of medicine when (belonging to lyophilizing figuration preparation), should use Pullulan and dextran to use as composite adhesive with proper proportion, Zhi Bei oral cavity disintegration tablet appearance luster is even, fine and close, complete like this, no any subsiding opposes to use single binding agent.Yet inventor of the present invention discovers, exceed the expectation of prior art, when the preparation lyophilizing figuration preparation that contains Cartialgenous all-component of the present invention, when using the composite adhesive of Pullulan and dextran composition, effect is bad on the contrary, the lyophilizing figuration preparation outward appearance for preparing is more coarse, and lacks necessary hardness, makes in the transportation surface very easily be oppressed and be out of shape.In contrast to this, when single binding agent Pullulan that uses prior art not recommend to use or gelatin, the lyophilizing figuration preparation appearance luster that contains Cartialgenous all-component that can make preparation evenly, fine and close, complete, no any defective such as subside meets the listing criteria that national departments concerned requires fully.Inventor of the present invention infers the composite adhesive that this may form with Pullulan and dextran and is not suitable for as the binding agent in the lyophilizing figuration preparation that contains a large amount of animal protein class medicines relevant, inventor of the present invention in addition infer the part animal protein colloidality composition in the Cartialgenous all-component may be in lyophilizing figuration preparation of the present invention also part play the effect of binding agent, remedied single with Pullulan or gelatin deficiency as binding agent.Although inventor of the present invention has carried out the deciphering of some theoretical properties to the present invention, these theories should not be used for limiting the present invention.
Description of drawings
Fig. 1 is the scanning electron microscope image according to the lyophilizing figuration dosage surface of the method preparation of embodiment 1 and comparative example 1.
Fig. 2 is the scanning electron microscope image according to the lyophilizing figuration dosage surface of the method preparation of embodiment 3 and comparative example 3.
The specific embodiment
With comparative example the present invention is described in further detail by the following examples, but these embodiment are of the present invention giving an example, the present invention is not restricted to this.
Prepare lyophilizing figuration preparation according to composition shown in the table 1 and quantity thereof, its concrete grammar is as follows:
1. fresh Cornu Cervi Pantotrichum is freezing below 0 degree centigrade;
2. refrigerated Cornu Cervi Pantotrichum is ground into refrigerated granule below 40 degrees centigrade, about described particle grain size 20 orders;
3. add an amount of saccharide, an amount of skeleton proppant, suitable amount of adhesive in the purified water, mixed dissolution is cooled to below 40 ℃ after disperseing;
4. the 2nd go on foot frozen particle homogenizing below 40 ℃ or the homogenate formation suspendible preparation liquid that obtains, or the 2nd frozen particle that obtains of step is dispensed in solution, suspension or the emulsion that purified water or the 3rd step obtain, homogenizing or homogenate below 40 ℃ form suspendible preparation liquid;
5. the 4th go on foot the suspendible preparation liquid that obtains, divide the mould that is filled to suitable volumes, behind pre-freeze and two processing steps of lyophilization, obtain Cartialgenous all-component uniform freeze-dried figuration preparation.
Table 1
Annotate: glycine: Beijing essence is asked chemical industry Co., Ltd,
Mannitol: Beijing essence is asked chemical industry Co., Ltd
Menthol: standing grain field, Suzhou spice company limited
An Saimi: Zhangjiagang Haobo Chemical Product Co., Ltd.
Macrodex: Wanda Mountain, Heilungkiang pharmaceutical factory
Fig. 1, the 2nd, according to the scanning electron microscope image of the lyophilizing figuration dosage surface of the method for embodiment 1-3 and comparative example 1-3 preparation, its amplification multiple is respectively 25 times, 100 times and 500 times.Shooting part, position (25 times, 100 times, 500 times).
From Fig. 1,2 as can be seen, when adopting Pullulan and dextran to prepare lyophilizing figuration preparation as composite adhesive, lace can appear, broken limit, the top layer be full of cracks, defectives (seeing the comparative example 1-3 of Fig. 1) such as slight atrophy, because these defectives, thereby the enforcement that the lyophilizing figuration preparation that make to adopt the prescription preparation of comparative example 1-3 is taken in transportation or consumer suffers damage easily and makes that the dosage of taking is not enough, therefore must carry out extra packing to these two kinds of products and make it avoid being subjected to extraneous infringement, and this can increase the cost of product undoubtedly greatly.And when adopting Pullulan to use as independent binding agent, the lyophilizing figuration preparation appearance luster of preparation evenly, fine and close, complete, no any defective such as subside meets the listing criteria of national departments concerned requirement fully.
With the Pullulan among the gelatin alternate embodiment 1-3, all the other are constant.Prepare after corresponding product compares, can obtain essentially identical result with Fig. 1.
It should be noted, can revise arbitrarily, but undoubtedly, these modifications all will fall within protection scope of the present invention for various details of the present invention.
Claims (7)
1. a lyophilizing figuration preparation that contains Cartialgenous all-component comprises Cartialgenous all-component, skeleton proppant, binding agent, it is characterized in that described binding agent is Pullulan or gelatin.
2. lyophilizing lyophilizing figuration preparation as claimed in claim 1 is characterized in that described skeleton proppant is to have 2 amino acid whose one or more mixture to 12 carbon atoms.
3. lyophilizing figuration preparation as claimed in claim 2, it is characterized in that described aminoacid be glycine, arginine, serine, proline, alanine, aspartic acid, glutamic acid, hydroxyproline, isoleucine, leucine or phenylalanine one of or more than one mixture.
4. as claim 2 or 3 described lyophilizing figuration preparations, it is characterized in that described aminoacid is glycine.
5. as any described lyophilizing figuration preparation of claim 1-6, the content that it is characterized in that Cartialgenous all-component is that the content of 1-90%, skeleton proppant is that the content of 1-50%, binding agent is 1-50%.
6. as any described lyophilizing figuration preparation of claim 1-7, it is characterized in that also containing essence or the correctives of 0.1-5%.
7. as the preparation method of any described lyophilizing figuration preparation of claim 1-8, may further comprise the steps:
(1) fresh Cornu Cervi Pantotrichum is freezing below 0 degree centigrade;
(2) refrigerated Cornu Cervi Pantotrichum is ground into refrigerated granule below 40 degrees centigrade, about described particle grain size 20 orders;
(3) add an amount of saccharide, an amount of skeleton proppant, suitable amount of adhesive in the purified water, mixed dissolution is cooled to below 40 ℃ after disperseing;
Frozen particle homogenizing below 40 ℃ that (4) the 2nd steps obtained or homogenate form suspendible preparation liquid, or the 2nd frozen particle that obtains of step is dispensed in solution, suspension or the emulsion that purified water or the 3rd step obtain, homogenizing or homogenate below 40 ℃ form suspendible preparation liquid;
The suspendible preparation liquid that (5) the 4th steps obtained divides the mould that is filled to suitable volumes, obtains Cartialgenous all-component uniform freeze-dried figuration preparation behind pre-freeze and two processing steps of lyophilization.
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| Application Number | Priority Date | Filing Date | Title |
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| CN201010127723XA CN102188448A (en) | 2010-03-19 | 2010-03-19 | Pilose antler freeze-dried excipient with smooth appearance and production method thereof |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108066152A (en) * | 2016-11-18 | 2018-05-25 | 董玲 | A kind of preparation method of lyophilized excipient |
| CN109078004A (en) * | 2017-06-13 | 2018-12-25 | 量子高科（北京）研究院有限公司 | A kind of freeze-drying oral disnitegration tablet and preparation method thereof |
-
2010
- 2010-03-19 CN CN201010127723XA patent/CN102188448A/en active Pending
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108066152A (en) * | 2016-11-18 | 2018-05-25 | 董玲 | A kind of preparation method of lyophilized excipient |
| CN109078004A (en) * | 2017-06-13 | 2018-12-25 | 量子高科（北京）研究院有限公司 | A kind of freeze-drying oral disnitegration tablet and preparation method thereof |
| CN109078004B (en) * | 2017-06-13 | 2021-05-04 | 北京量子高科制药科技有限公司 | Freeze-dried orally disintegrating tablet and preparation method thereof |
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Application publication date: 20110921 |