CN109925296A - A kind of coating method of traditional Chinese medicine pellet - Google Patents

Abstract

The present invention provides a kind of coating method of traditional Chinese medicine pellet, wraps up one layer of powder bed on the pellet surface containing Chinese medical extract using pharmaceutically acceptable auxiliary material, is then coated again using fluidized bed coating equipment；The coating method of traditional Chinese medicine pellet of the present invention can be used for the coating of various Chinese medicine vegetable pills, it is particularly suitable for the pellet containing the biggish Chinese medical extract of stickiness, can obviously improve occur during Chinese medical extract pellet fluidized bed coating viscous stick, the bed that collapses, color difference, color spot the problems such as, have many advantages, such as that pelletization rate height, good moldability, easy to operate, production cost is low, high-efficient, is suitable for industrial mass production application.

Description

A kind of coating method of traditional Chinese medicine pellet

Technical field

The invention belongs to pharmaceutical manufacturing fields, and in particular to a kind of coating method of traditional Chinese medicine pellet.

Background technique

Traditional Chinese medicine pellet refers to diameter between 0.5-1.5mm, is usually no more than the spherical or spherical preparation of 2.5mm, tool There is a concise production process, good fluidity, attractive appearance, stability equal technology advantage by force.Belong to multi-unit drug delivery system, with Single-dose type drug delivery system is compared and is had many advantages；Each dosage usually contains tens or several hundred a pellets, and drug release behavior is The summation of each pellet；Distribution area in vivo is big, and bioavilability is high, and enteron aisle irritation is small；In gastric transit time Long, partial size is small, and transhipment is influenced the advantages that small by the food conveying rhythm and pace of moving things.

The pellet as prepared by Chinese medical concrete or Chinese drugs powder generally has stronger hygroscopicity, generallys use thin Film coating technology, to improve the sucting wet problem of its pellet.There is bad smell or containing the traditional Chinese medicine pellet of volatile oil for some, Smell can be covered by film coating or reduces the loss of volatile oil.Most common coating method is solvent coating Method, including organic solvent coating and aqueous solvent coating, but since the use of organic solvent may result in dissolvent residual, influence Drug quality, and this method has special requirement to the type selection of organic solvent, and then limits to a certain extent organic molten The application of agent coating method；Aqueous solvent coating does not need to reduce molten using organic solvent for organic solvent coating Agent remains bring quality risk, while also reducing coating cost, is increasingly becoming the mainstream selection of traditional Chinese medicine pellet packaging technique.

The coating of traditional Chinese medicine pellet generallys use coating pan or fluidized bed carries out, however due to Chinese materia medica preparation, especially Chinese medicine The extract of compound preparation is mostly medicinal extract, liquid extract or amorphous powder, these materials generally have biggish stickiness and moisture absorption Property, physicochemical property is unstable, easily occur during using fluidized bed coating it is viscous stick, the blocking of the bed that collapses, muzzle, pelletization rate it is low The problems such as, great difficulty is brought to traditional Chinese medicine pellet coating.For example, containing a large amount of soap in Chinese medicine pellet of acanthopanax senticosus extract The ingredients such as glycosides, flavones, polysaccharide, stickiness is larger, during fluidized bed coating, easily because it is viscous stick, collapse bed the problems such as cause to be coated Failure.Solution to the problems described above mainly dilutes coating solution at present, reduces the speed that coating solution sprays into, or in coating solution A certain amount of antitackiness agent, such as ethyl alcohol, talcum powder are added, but the dilution of coating solution often leads to the reduction of application rate, improved Production cost, and for the biggish traditional Chinese medicine pellet of certain stickiness, it can not reach ideal coating effect, meanwhile, it is excessive The Release Performance that the addition of antitackiness agent may cause pellet changes, and adversely affects to drug quality.

Summary of the invention

The problem to be solved in the present invention is to provide a kind of coating methods of traditional Chinese medicine pellet, for solving the above-mentioned of the prior art Problem.The purpose of the present invention is achieved through the following technical solutions:

The present invention provides a kind of coating method of traditional Chinese medicine pellet, comprising the following steps: 1) using pharmaceutically acceptable auxiliary Material wraps up one layer of powder bed on the pellet vegetable pill surface containing Chinese medical extract, obtains pellet a, and 2) use fluidized bed coating skill Art is coated pellet a；Wherein, in the powder bed Chinese pharmacology acceptable auxiliary material be selected from talcum powder, acrylic resin or Calcium stearate, preferably talcum powder or acrylic resin, most preferably talcum powder；

In the coating method of above-mentioned traditional Chinese medicine pellet, the mesh number of the talcum powder is 800 mesh or higher, preferably 1000- 2000 mesh, more preferably 1200-2000 mesh；The mesh number of the acrylic resin and/or calcium stearate is 200 mesh or higher.

Further, in the powder bed talcum powder dosage be the traditional Chinese medicine extraction amount of substance 6%-25%, preferably 8%-10%；The dosage of the acrylic resin is the 10%-25%, preferably 15%-25% of the traditional Chinese medicine extraction amount of substance.

In the coating method of traditional Chinese medicine pellet of the present invention, preferably coating weight gain is 2%-8%, more preferably 6%-8%.

The coating method of traditional Chinese medicine pellet of the present invention includes the following steps: 1) to take the pellet vegetable pill containing Chinese medical extract It is placed in fluidized bed pot, it is dry, pharmaceutically acceptable auxiliary material is added, mixes, until pellet surface forms one layer of uniform powder Last layer；2) it takes coating material that water or water-containing organic solvent is added to be configured to coating solution, sprays into fluidized bed, start to be coated, be coated Traditional Chinese medicine pellet afterwards.Wherein, the coating material can be selected from hydroxypropyl methyl cellulose E3, talcum powder, titanium dioxide, poly- sorb One of ester, Opadry 03A690067 type or Opadry 80W690000 type are a variety of；The water-containing organic solvent is preferably Ethanol water.

Specifically, in the coating method of traditional Chinese medicine pellet of the present invention, the traditional Chinese medicine pellet is containing in siberian Ginseng P.E Medicine pellet；The siberian Ginseng P.E is prepared with the following method: wilsonii medicinal material taken, crushes, adds water or hydrous ethanol, Heating extraction, filtering, filtrate concentration are drying to obtain；

The capsule core of traditional Chinese medicine pellet of the present invention is that blank capsule core or pharmaceutically acceptable auxiliary material and Chinese medical extract are mixed Manufactured pellet core after conjunction；Blank capsule core of the present invention is commercially available or using conventional pelletization technology self-control, the present invention A kind of blank capsule core for enumerating is the preparation method comprises the following steps: (1) takes one of microcrystalline cellulose, starch, lactose or a variety of as figuration Agent is crossed 200 meshes, is placed in pelletization equipment, mixes；Common pill or facility for granulating may be selected in pelletization equipment, as centrifugation is made Grain machine, extrusion spheronization machine or side spray fluidized bed；(2) dextrin slurry, hydroxypropyl methyl cellulose, one of water is added or a variety of is Adhesive makes material in cotton-shaped flow regime, forms fine particle；(3) maintaining material is in cotton-shaped flow regime, and addition is assigned again Shape agent simultaneously increases adhesive simultaneously, makes particle slowly long great achievement target capsule core.

Further, traditional Chinese medicine pellet vegetable pill of the present invention can be prepared by this field routine pelletization technology, such as be squeezed Spheronization, centrifugal granulation, fluidized bed prilling method etc. out；Preferably, pharmaceutical composition of the present invention uses fluidized bed prilling legal system It is standby to obtain, specifically: recipe quantity Chinese medical extract is taken, suitable quantity of water or hydrous ethanol is added, stirs evenly, drug solns is made； It takes in capsule core investment fluidized bed pot, drug solns in penetrating obtain traditional Chinese medicine pellet.

Preferably, pharmaceutically acceptable auxiliary material can further be added in the upper drug solns, it is described pharmaceutically acceptable Auxiliary material be selected from one of talcum powder, superfine silica gel powder, lactose, chitosan, microcrystalline cellulose or a variety of.

Heretofore described traditional Chinese medicine pellet vegetable pill refers to be prepared by Chinese medical extract medicinal extract and pharmaceutically acceptable auxiliary material, And not coated traditional Chinese medicine pellet preparation.The present inventor long-term it was found that, many Chinese medicinal material extract viscositys are very big, Viscous glutinous phenomenon easily occurs during coating for the traditional Chinese medicine pellet vegetable pill being prepared, and needs for coating solution to be diluted to extremely low Concentration (is lower than 1% or 2%), or a large amount of antitackiness agents are added and are likely to complete coating reluctantly, but operation can bring many in this way Problem, such as: coating solution concentration is lower to cause coating solution volume to be multiplied, and coating efficiency is remarkably decreased；Be coated pelletization rate compared with Low, insufficient formability etc.；For the pellet preparations with special release request (slow-release controlled-release etc.), a large amount of antitackiness agent can also shadow The release profiles for ringing drug generate unpredictable influence to drug quality.

The present inventor passes through numerous studies, and discovery is wrapped in vegetable pill before fluidized bed coating using specific pharmaceutic adjuvant The problems such as wrapping up in one layer of uniform powder bed, can effectively solving glutinous ball, the bed that collapses, color spot when coating, part research experiment is as follows:

One, the preparation of traditional Chinese medicine pellet

The preparation of siberian Ginseng P.E: wilsonii medicinal material is taken (to acquire from the ferreous area of Heilongjiang Province's Yichun, through southwestern traffic University professor Song Liangke is accredited as Chinese medicine wilsonii, latin name: ACANTHOPANACIS SENTICOSI RADIX ET RHIZOMA SEU CAULIS), it is broken into 5mm particle, 8 times of deionized water amounts is added, are heated to 80 DEG C, extract 4 times, often Secondary 1.5 hours, extracting solution merged；Amalgamation liquid is concentrated under reduced pressure into relative density 1.18-1.20g/mL, obtains medicinal extract；Medicinal extract liquid is dry Dry extract powder, it is spare.

Capsule core preparation: it uses commercially available microcrystalline cellulose blank pellet (Gaocheng Biologic Nutrition Technology Co Ltd, Hangzhou), grain 750 μm -850 μm of diameter.

The preparation of wilsonii pellet: (1) siberian Ginseng P.E extract powder is added gradually in 45% ethanol solution, Bian Jia Side stirring, until solution solid content is 30%, and heating water bath is to 50 DEG C, until extract powder all dissolves；(2) complete medicine is dissolved The microcrystalline cellulose that 8% (relative to extract extract powder meter) is added in liquid stirs evenly.(3) prepared medical fluid water-bath is added Heat is stirred continuously to 50 DEG C.Capsule core is put into bottom spray or side spray fluidized bed, is higher than 45 DEG C to temperature of charge, starts to spray Enter medical fluid, until liquid medicine jet is complete, forms the spherical pellet vegetable pill containing siberian Ginseng P.E.

Two, the selection of powder bed supplementary product kind

Experimental material used is as follows in this experiment:

Talcum powder (1000 mesh, be purchased from the magnificent talcum development corporation, Ltd. of LONGSHENG IN GUANGXI), superfine silica gel powder (partial size 20-40nm, Purchased from Anhui Shanhe Medicinal Subsidiary Material Co., Ltd.), calcium stearate (80 mesh, purchased from upper Hydron be medical auxiliary materials technology it is limited Company), magnesium stearate (cross 200 meshes, be purchased from Anhui Shanhe Medicinal Subsidiary Material Co., Ltd.), acrylic resin (100-200 Mesh, purchased from upper Hydron be medical auxiliary materials Technology Co., Ltd.), ethyl cellulose (cross 200 meshes, purchased from upper Hydron be medicine it is auxiliary Expect Technology Co., Ltd.), microcrystalline cellulose (cross 200 meshes, be purchased from Anhui Shanhe Medicinal Subsidiary Material Co., Ltd.), neck benzene two Formic acid cellulose acetate (cross 200 meshes, be purchased from Anhui Shanhe Medicinal Subsidiary Material Co., Ltd.), povidone (cross 200 meshes, Purchased from Anhui Shanhe Medicinal Subsidiary Material Co., Ltd.), hydroxypropyl methyl cellulose (cross 200 meshes, purchased from the Anhui mountains and rivers it is medicinal Auxiliary material limited liability company).

Gained pellet in aforementioned the preparation of traditional Chinese medicine pellet " one, " is placed in fluidized bed coating pot, it is 10 minutes dry, it uses Dusting rifle is sprinkled into auxiliary material in table 1, is uniformly mixed, and so that pellet surface is wrapped up one layer of uniform fine powder, according to the amount of theoretical weight gain 5% Opadry 03A690067 type coating pre-mixing agent (Shanghai Colorcon Coating Technology Co., Ltd) is weighed, water is added to be made into solid content 7% Solution, homogeneous instrument handles 2-3 circulations, opens fluidized bed, sprays into coating solution, big after first small to adjust flow until being coated At, it is dry to get.

The screening of 1 powder bed supplementary product kind of table

Note: supplementary product consumption percentage is opposite Chinese medical extract extract powder meter.

Table 1 the result shows that, in numerous common auxiliary materials, only using talcum powder, calcium stearate and when acrylic resin, energy The different degrees of pellet that improves glues glutinous problem, and target pellet yield is higher；Use talcum powder or acrylic resin as powder When last layer, coating process is more smooth, and the coating duration is shorter, and efficiency is higher, especially best with the effect of talcum powder.

Three, the selection of powder bed auxiliary material partial size

Experimental material used is as follows in this experiment:

Talcum powder (350 mesh, 800 mesh, 1000 mesh, 1250 mesh are purchased from the magnificent talcum development corporation, Ltd. of LONGSHENG IN GUANGXI), Talcum powder (seek medical advice medicine limited liability company purchased from Beijing phoenix gift essence, and it is public to originate from Italian Yi meter Fa ratio (IMIFABI) by 2000 mesh Department), calcium stearate (be medical auxiliary materials Technology Co., Ltd. purchased from upper Hydron), acrylic resin (be medical auxiliary purchased from upper Hydron Expect Technology Co., Ltd.)

Gained pellet in aforementioned the preparation of traditional Chinese medicine pellet " one, " is placed in fluidized bed coating pot, it is 10 minutes dry, it uses Dusting rifle is sprinkled into auxiliary material in table 2, is uniformly mixed, and so that pellet surface is wrapped up one layer of uniform fine powder, according to the amount of theoretical weight gain 5% Opadry 03A690067 type coating pre-mixing agent is weighed, water is added to be made into the solution of solid content 7%, homogeneous instrument handles 2-3 circulations, Open fluidized bed, spray into coating solution, it is big after first small to adjust flow until coating is completed, it is dry to get.

The screening of 2 powder bed auxiliary material partial size of table

Note: supplementary product consumption percentage is opposite Chinese medical extract extract powder meter.

Table 2 the result shows that, talcum powder partial size be 325 mesh when, gained coating micro-pill adhesion is more, and the number that collapses is more, mesh Mark pellet yield is low, and coating process has some setbacks, and the duration is longer, when talcum powder partial size is 800 mesh or more, outside gained pellet Rounding is seen, gluing ball phenomenon improves obviously, and coating process is more smooth, and the coating duration is obviously shortened, target pellet yield It is obviously improved；When talcum powder partial size is more than 1000 mesh, when more than especially 1200 mesh, pellet not only appearance rounding, no color spot Or glutinous ball, and yield reaches 90% or more, coating process is smooth, and the coating duration greatly shortens.

In addition, coating micro-pill appearance rounding sticks ball without color spot, nothing, and coating is smooth when 200 mesh of acrylic resin or more, Yield is higher.

Four, powder bed supplementary product consumption selects

Experimental material used is as follows in this experiment:

Talcum powder (1250 mesh are purchased from the magnificent talcum development corporation, Ltd. of LONGSHENG IN GUANGXI), acrylic resin (are purchased from upper Hydron For medical auxiliary materials Technology Co., Ltd.)

Gained pellet in aforementioned the preparation of traditional Chinese medicine pellet " one, " is placed in fluidized bed coating pot, it is 10 minutes dry, it uses Dusting rifle is sprinkled into the auxiliary material of dosage shown in table 3-1, table 3-2, is uniformly mixed, and so that pellet surface is wrapped up one layer of uniform fine powder, presses Opadry 03A690067 type coating pre-mixing agent is weighed according to the amount of theoretical weight gain 5%, water is added to be made into the solution of solid content 7%, it is homogeneous 2-3 circulations of instrument processing open fluidized bed, and penetrating coating solution, the first small rear big flow that adjusts is dry up to being coated completion, i.e., ?.

The screening of table 3-1 powder bed supplementary product consumption

Note: supplementary product consumption is relative to Chinese medical extract extract powder meter.

The screening of table 3-2 powder bed supplementary product consumption

Note: supplementary product consumption is relative to Chinese medical extract extract powder meter.

According to table 3-1, table 3-2 result it is found that when amount of talc is the 6%-25% of traditional Chinese medicine extraction amount of substance, it is coated micro- Ball appearance is preferable, and target pellet yield is higher (> 80%), and coating process is more smooth, and the coating duration is shorter, especially with cunning For mountain flour dosage in 8%-10%, effect is best.When acrylic resin dosage is the 10-25% of traditional Chinese medicine extraction amount of substance, coating Pellet appearance rounding, yield is higher, and Coating times are shorter, and especially with dosage in 15-25%, effect is more preferable.

When powder bed supplementary product consumption is lower (amount of talc < 6% is or, acrylic resin dosage < 10%)), pellet goes out Now different degrees of is viscous glutinous, and agglomeration, coating process ride comfort is poor, and easily collapse bed, or even is unable to complete successfully coating；Work as supplementary product consumption When excessive (> 25%), pellet appearance chromatic difference is obvious, yield decline.

Five, coating weight gain selects

Gained pellet in aforementioned the preparation of traditional Chinese medicine pellet " one, " is placed in fluidized bed coating pot, it is 10 minutes dry, it uses Dusting rifle is sprinkled into 10% talcum powder (1250 mesh), is uniformly mixed, and so that pellet surface is wrapped up one layer of uniform fine powder, according to table 4 Middle theoretical weight gain amount weighs Opadry 03A690067 type coating pre-mixing agent, adds water to be made into the solution of solid content 7%, at homogeneous instrument 2-3 circulations of reason open fluidized bed and start to spray into coating solution, big after first small to adjust flow until coating is completed, it is dry to get.

The detection of coating micro-pill hydroscopicity: the glass desicator that bottom fills sodium chloride supersaturated solution is set to 25 DEG C of constant temperature For 24 hours, the relative humidity in drier is 75% to constant temperature at this time in incubator.The wilsonii for weighing coating method preparation of the present invention is micro- Ball 3g is laid in the weighing bottle bottom of constant weight, in the accurately weighed above-mentioned drier of postposition (weigh the cap opening), at 25 DEG C It is more than closed placement for 24 hours, primary every measurement for 24 hours, until weight, within 5mg difference, moisture absorption is calculated as follows in precise weighing Rate the results are shown in Table 5.

Sample quality * 100% before hydroscopicity=(sample quality before sample quality-moisture absorption after moisture absorption)/moisture absorption

4 coating weight gain screening experiment of table

Coating weight gain (%)	2	4	8	16
					Pellet appearance	Appearance rounding	Appearance rounding	Appearance rounding	Pellet is viscous glutinous
Target pellet yield (%)	91.03	90.42	86.26	33.16
					It is coated duration (min)	56	94	239	372

The different coating weight gain pellet hydroscopicity data of table 5

Coating weight gain (%)	Sample weighting amount (g) before testing	Weighing bottle weight (g) before testing	6d moisture absorption rate of body weight gain/%
				2	3.0071	28.2739	12.14
4	3.0019	28.9884	8.65
				6	3.0021	28.2669	1.96
8	3.0078	28.2140	0.64
				16	3.0012	28.8743	0.23

Experimental result is shown, when coating weight gain is within the scope of 2%-8%, coating micro-pill appearance rounding is glued without color spot, nothing It is glutinous, and target pellet yield is higher, and difficulty is coated when coating weight gain is more than 8% and is gradually increased, when coating weight gain is more than 16% When pellet stick that ball phenomenon is very serious, and gained pellet color difference is larger, target pellet yield reduces obvious, and Coating times are bright It is aobvious to increase.Meanwhile pellet moisture absorption weight gain experiment display, when coating weight gain is lower than 6%, dampproof effect is poor, in experiment condition After lower storage 6 days, pellet moisture absorption weight gain is obvious, can when drawing wet weight gain less than 2% according to drug draws moist test guideline It is moist or moist without drawing to think that drug slightly draws, it is more wide in range for packaging material range of choice, have mass production potentiality.

To sum up, coating weight gain had not only been able to achieve good coating effect within the scope of 6%-8%, but also can play preferable moisture-proof Effect.

Six, conventional coating mode comparative test

Autogamy coating powder composition used in this experiment are as follows: hydroxypropyl methyl cellulose E3 (is medical auxiliary materials purchased from upper Hydron Technology Co., Ltd.) 100 parts, 4 parts of talcum powder (1250 mesh are purchased from the magnificent talcum development corporation, Ltd. of LONGSHENG IN GUANGXI), titanium dioxide 1 part of titanium (being purchased from Beijing Orient Kai Er Trade Co., Ltd.), 1 part of Tween 80 (being purchased from Chengdu Ke Long chemical reagent factory).

Conventional coating mode: according to table 6, a certain amount of coating material (with 6% note of coating of pellets weight gain) is taken, coating is added Solvent is made into certain density coating solution, stirs 45min or more with high-speed shearing machine, until coating material is completely dispersed, it is standby With wilsonii pellet obtained in aforementioned the preparation of traditional Chinese medicine pellet " one, " is put into fluidized bed, fluidized bed is opened, to object Material temperature degree is higher than 50 DEG C, starts to spray into coating solution, fast after first slow, until coating solution has sprayed, is drying to obtain.

The different coating method comparing results of table 6

According to 6 result of table it is found that under conventional coating conditions, selects commercially available Opadry coating premixing flour (containing talcum powder) or add The autogamy coating powder for adding antitackiness agent (talcum powder) can not achieve good coating effect, and pellet is viscous glutinous serious, and yield is extremely low, Coating is even caused to interrupt；After coating method of the present invention, identical coating material is selected, coating process is smooth, outside pellet Rounding, no color differnece or color spot are seen, and pellet yield is obviously improved, Coating times significantly shorten.

The present inventor has investigated simultaneously to be added a certain proportion of ethanol solution in Coating Solution and wraps as antitackiness agent Clothing, but still can not be effectively improved pellet it is viscous stick, the bed that collapses, the problems such as yield is low, be specifically shown in Table 7.

Ethyl alcohol effect expedition is added in 7 coating solution of table

The coating method of traditional Chinese medicine pellet of the present invention can be used for the coating of various traditional Chinese medicine pellets, be particularly suitable for containing stickiness compared with The pellet of big Chinese medical extract, can obviously improve occur during traditional Chinese medicine pellet fluidized bed coating viscous stick, the bed that collapses, color difference, The problems such as color spot, has many advantages, such as that pelletization rate height, good moldability, easy to operate, production cost is low, high-efficient, is suitable for industry Mass production application.

Specific embodiment

The present invention is further illustrated combined with specific embodiments below, and following embodiments are merely to illustrate the present invention It should not be construed as limiting the invention.

Embodiment 1

The preparation of siberian Ginseng P.E: wilsonii medicinal material (is acquired from Heilongjiang Province Yichun Yichun District, through southwestern traffic University professor Song Liangke is accredited as Chinese medicine wilsonii, latin name: ACANTHOPANACIS SENTICOSI RADIX ET RHIZOMA SEU CAULIS) it is ground into particle, 28% 8 times of ethyl alcohol amounts are added, is heated to boiling, extract 2 times, 1 is small every time When, extracting solution merges；It is 1.18-1.20g/ml that merging, which is concentrated under reduced pressure into relative density, obtains medicinal extract；Medicinal extract liquid it is dry medicinal extract Powder, it is spare.

The preparation of capsule core: taking appropriate cornstarch, crosses 200 meshes；Weigh the hydroxypropyl of 2% (relative to cornstarch amount) Methylcellulose E5 adds water to be made into 1% binder solution as adhesive；A part of starch is taken to put into centrifugal granulator In (Chongqing English lattice multifunctional centrifugal pelletizer, model C GC-350), adhesive is sprayed into feed bin from centrifugal granulator spray head, directly To formation fine particle；Remaining cornstarch uses plus powder rifle is slowly sprinkled into feed bin, and sprays into adhesive, until particle is slowly It grows up, is rounded, filter out the capsule core of certain partial size as carrier.

The preparation of wilsonii pellet: (1) siberian Ginseng P.E extract powder is added gradually in 35% ethanol solution, Bian Jia Side stirring, until solution solid content is 25%, and heating water bath is to 55 DEG C, until extract powder all dissolves；(2) complete medicine is dissolved The talcum powder that 5% (relative to extract extract powder meter) is added in liquid stirs evenly.(3) extremely by prepared medical fluid heating water bath 55 DEG C, and be stirred continuously.By in the bottom spray of capsule core investment or side spray fluidized bed, it is higher than 45 DEG C to temperature of charge, starts to spray into medical fluid, Until liquid medicine jet is complete, spherical pellet vegetable pill is formed.

Powder bed preparation: aforementioned spherical pellet vegetable pill is placed in drying 10 minutes in fluidized bed, is sprinkled into 8% using dusting rifle The talcum powder (1250 mesh are purchased from the magnificent talcum powder development corporation, Ltd. of LONGSHENG IN GUANGXI) of (relative to extract extract powder amount), stream Change in bed and be uniformly mixed, obtains pellet a；

Coatings preparation: (1) preparation of coating solution: E390 parts of hydroxypropyl methyl cellulose, 3 parts of talcum powder, titanium dioxide 1 Part, 1 part of polyoxyethylene sorbitan monoleate, the above material are uniformly mixed, weigh mixing coating powder according to the amount of theoretical weight gain 5%, water is added to be made into The solution of solid content 7%, homogeneous instrument handle 2-3 circulations；(2) it is higher than 48 DEG C to pellet a temperature in aforementioned fluidized bed, will matches The coating solution made sprays the bottom of from or the spray of side spray fluidized bed (the multifunctional fluidized bed granulator coater of Chongqing English lattice, WBF-3G) spray gun Enter, until coating solution all sprays into, form fine and close separation layer, it is dry to get.

Traditional Chinese medicine pellet appearance rounding after gained coating, extremely individual visible color difference；Target pellet yield: 90.32%；Pellet It is coated difficulty: whole smooth；It is coated duration 97min.

Embodiment 2

The preparation of siberian Ginseng P.E: wilsonii medicinal material (is acquired from Heilongjiang Province Yichun Yichun District, through southwestern traffic University professor Song Liangke is accredited as Chinese medicine wilsonii, latin name: ACANTHOPANACIS SENTICOSI RADIX ET RHIZOMA SEU CAULIS) it is ground into particle, 30% 8 times of ethyl alcohol amounts are added, is heated to boiling, extract 2 times, 1 is small every time When, extracting solution merges；It is 1.18-1.20g/ml that merging, which is concentrated under reduced pressure into relative density, obtains medicinal extract；Medicinal extract liquid it is dry medicinal extract Powder, it is spare.

The preparation of capsule core: taking appropriate lactose, and be sieved 200 mesh；Weigh the hydroxypropyl methyl fiber of 3% (relative to lactose yield) Plain E5 adds water to be made into 1% binder solution as adhesive；It takes a part of lactose to put into centrifugal granulator, will bond Agent sprays into feed bin from centrifugal granulator spray head, until forming fine particle；Remaining microcrystalline cellulose uses plus powder rifle is slowly sprinkled into In feed bin, and adhesive is sprayed into, until particle is slowly grown up, is rounded, filters out the capsule core of certain partial size as carrier.

The preparation of wilsonii pellet: (1) siberian Ginseng P.E extract powder is added gradually in 40% ethanol solution, Bian Jia Side stirring, until solution solid content is 30%, and heating water bath is to 60 DEG C, until extract powder all dissolves；(2) complete medicine is dissolved The talcum powder that 8% (relative to extract extract powder meter) is added in liquid stirs evenly.(3) extremely by prepared medical fluid heating water bath 55 DEG C, and be stirred continuously.By in the bottom spray of capsule core investment or side spray fluidized bed, it is higher than 45 DEG C to temperature of charge, starts to spray into medical fluid, Until liquid medicine jet is complete, spherical pellet vegetable pill is formed.

Powder bed preparation: aforementioned spherical pellet vegetable pill is placed in drying 10 minutes in fluidized bed, is sprinkled into using dusting rifle The talcum powder (800 mesh, the magnificent talcum development corporation, Ltd. of LONGSHENG IN GUANGXI) of 10% (relative to extract extract powder amount), fluidized bed It is interior to be uniformly mixed, obtain pellet a；

Coatings preparation: (1) preparation of coating solution, E395 parts of hydroxypropyl methyl cellulose, 5 parts of talcum powder, titanium dioxide 1.5 parts, 1.5 parts of polyoxyethylene sorbitan monoleate, the above material are uniformly mixed, weigh mixing coating powder according to the amount of theoretical weight gain 5%, add water It is made into the solution of solid content 7%, homogeneous instrument handles 2-3 circulations；(2) it is higher than 43 DEG C to pellet a temperature in aforementioned fluidized bed, Prepared coating solution is sprayed the bottom of from or side spray fluidized bed spray gun sprays into, until coating solution all sprays into, forms fine and close separation layer, It is dry to get.

Traditional Chinese medicine pellet appearance rounding after gained coating；Target pellet yield: 80.46%；Coating of pellets difficulty: smooth； It is coated duration 228min.

Embodiment 3

The preparation of siberian Ginseng P.E: wilsonii medicinal material is taken (to acquire from the ferreous area of Heilongjiang Province's Yichun, through southwestern traffic University professor Song Liangke is accredited as Chinese medicine wilsonii, latin name: ACANTHOPANACIS SENTICOSI RADIX ET RHIZOMA SEU CAULIS), it is broken into 5mm particle and 8 times of deionized water amounts is added, be heated to 80 DEG C, extract 4 times, often Secondary 1.5 hours, extracting solution merged；Amalgamation liquid is concentrated under reduced pressure into relative density 1.18-1.20g/ml, obtains medicinal extract；Medicinal extract liquid is dry Dry extract powder, it is spare.

Capsule core preparation: it uses commercially available microcrystalline cellulose blank pellet (Japanese Asahi Kasei Corporation), 750 μm of partial size- 850μm。

The preparation of wilsonii pellet: (1) siberian Ginseng P.E extract powder is added gradually in 45% ethanol solution, Bian Jia Side stirring, until solution solid content is 30%, and heating water bath is to 50 DEG C, until extract powder all dissolves；(2) complete medicine is dissolved The microcrystalline cellulose that 8% (extract powder meter) is added in liquid stirs evenly.(3) by prepared medical fluid heating water bath to 50 DEG C, and It is stirred continuously.Capsule core is put into bottom spray or side spray fluidized bed, is higher than 45 DEG C to temperature of charge, starts to spray into medical fluid, until Liquid medicine jet is complete, forms spherical pellet vegetable pill.

Powder bed preparation: aforementioned spherical pellet vegetable pill is placed in drying 10 minutes in fluidized bed, is sprinkled into using dusting rifle The talcum powder of 10% (relative to extract extract powder amount) (seek medical advice medicine limited liability company purchased from Beijing phoenix gift essence, produces by 2000 mesh From Italian Yi meter Fa ratio (IMIFABI) company), it is uniformly mixed in fluidized bed, obtains pellet a；

Coatings preparation: (1) preparation of coating solution weighs Opadry 80W690000 type packet according to the amount of theoretical weight gain 5% Clothing pre-mixing agent (Shanghai Colorcon Coating Technology Co., Ltd), adds water to be made into the solution of solid content 7%, and homogeneous instrument handles 2-3 Circulation；(2) it is higher than 45 DEG C to pellet a temperature in aforementioned fluidized bed, prepared coating solution is sprayed the bottom of from or side spray fluidized bed sprays Rifle sprays into, until coating solution all sprays into, forms fine and close separation layer, it is dry to get.

Traditional Chinese medicine pellet appearance rounding after gained coating；Target pellet yield: 91.23%；Coating of pellets difficulty: smooth； It is coated duration 92min.

Embodiment 4

The preparation of siberian Ginseng P.E: wilsonii medicinal material is taken (to acquire from the ferreous area of Heilongjiang Province's Yichun, through southwestern traffic University professor Song Liangke is accredited as Chinese medicine wilsonii, latin name: ACANTHOPANACIS SENTICOSI RADIX ET RHIZOMA SEU CAULIS), it is broken into 8mm particle and 8 times of deionized water amounts is added, be heated to 70 DEG C, extract 3 times, often Secondary 1 hour, extracting solution merged；Amalgamation liquid is concentrated under reduced pressure into relative density 1.18-1.20g/ml, obtains medicinal extract；Medicinal extract liquid is dry Extract powder is obtained, it is spare.

Capsule core preparation: market purchase sucrose blank capsule core (Shanghai Colorcon Coating Technology Co., Ltd), partial size 500 are used μm—650μm。

The preparation of wilsonii pellet: (1) siberian Ginseng P.E is added gradually in 40% ethanol solution, side edged stirs It mixes, until solution solid content is 35%, and heating water bath is dissolved to 60 DEG C until extract powder is whole；(2) complete medical fluid is dissolved to add The chitosan for entering 10% (relative to extract extract powder meter) stirs evenly.(3) by prepared medical fluid heating water bath to 60 DEG C, and be stirred continuously.Capsule core is put into bottom spray or side spray fluidized bed, is higher than 45 DEG C to temperature of charge, starts to spray into medical fluid, Until liquid medicine jet is complete, spherical pellet vegetable pill is formed.

Powder bed preparation: aforementioned spherical pellet vegetable pill is placed in drying 10 minutes in fluidized bed, is sprinkled into 7% using dusting rifle The talcum powder (1250 mesh are purchased from the magnificent talcum development corporation, Ltd. of LONGSHENG IN GUANGXI) of (relative to extract extract powder meter), stream Change in bed and be uniformly mixed, obtains pellet a；

Coatings preparation: (1) preparation of coating solution weighs Opadry 03A690067 type packet according to the amount of theoretical weight gain 4% Clothing pre-mixing agent (Shanghai Colorcon Coating Technology Co., Ltd), adds water to be made into the solution of solid content 5%, and homogeneous instrument handles 2-3 Circulation；(2) it is higher than 45 DEG C to pellet a temperature in aforementioned fluidized bed, prepared coating solution is sprayed the bottom of from or side spray fluidized bed sprays Rifle sprays into, until coating solution all sprays into, forms fine and close separation layer, it is dry to get.

Traditional Chinese medicine pellet appearance rounding after gained coating, the visible color spot of minute quantity；Target pellet yield: 88.75%；Pellet It is coated difficulty: smooth；It is coated duration 114min.

Embodiment 5

The preparation of siberian Ginseng P.E: wilsonii medicinal material is taken (to acquire from the ferreous area of Heilongjiang Province's Yichun, through southwestern traffic University professor Song Liangke is accredited as Chinese medicine wilsonii, latin name: ACANTHOPANACIS SENTICOSI RADIX ET RHIZOMA SEU CAULIS), it is broken into 5mm particle, 8 times of deionized water amounts are added, are heated to boiling, extraction 2 times, often Secondary 0.5 hour, extracting solution merged；Amalgamation liquid is concentrated under reduced pressure into relative density 1.18-1.20g/ml, obtains medicinal extract；Medicinal extract liquid is dry Dry extract powder, it is spare.

Capsule core preparation: taking appropriate microcrystalline cellulose, is sieved, obtains the satisfactory material of granularity；Weigh 2% (relative to Microcrystalline cellulose amount) dextrin as adhesive, add water to be made into 10% binder solution, be heated to 85 DEG C, gelatinization to get； A part of microcrystalline cellulose is taken to put into side spray fluidized bed, by adhesive, spray head sprays into feed bin from side spray fluidized bed, until Form fine particle；Remaining microcrystalline cellulose uses plus powder rifle is slowly sprinkled into feed bin, and sprays into adhesive, until particle is slowly It grows up, is rounded, filter out the capsule core of certain partial size as carrier.

The preparation of wilsonii pellet: (1) siberian Ginseng P.E extract powder is added gradually in 45% ethanol solution, Bian Jia Side stirring, until solution solid content is 30%, and heating water bath is to 55 DEG C, until extract powder all dissolves；(2) complete medicine is dissolved The microcrystalline cellulose that 5% (relative to extract extract powder meter) is added in liquid is mixed uniformly.(3) by prepared medical fluid heating water bath To 55 DEG C, and it is stirred continuously.Capsule core is put into bottom spray or side spray fluidized bed, is higher than 45 DEG C to temperature of charge, starts to spray into Medical fluid forms spherical pellet vegetable pill until liquid medicine jet is complete.

Powder bed preparation: aforementioned spherical pellet vegetable pill is placed in drying 10 minutes in fluidized bed, is sprinkled into 8% using dusting rifle The talcum powder (1250 mesh, be purchased from the magnificent talcum development corporation, Ltd. of LONGSHENG IN GUANGXI) of (extract powder amount) is uniformly mixed in fluidized bed, Obtain pellet a；

Coatings preparation: (1) preparation of coating solution weighs Opadry 03A690067 type packet according to the amount of theoretical weight gain 5% Clothing pre-mixing agent, adds water to be made into the solution of solid content 7%, and homogeneous instrument handles 2-3 circulations；(2) to pellet a in aforementioned fluidized bed Temperature is higher than 45 DEG C, and prepared coating solution is sprayed the bottom of from or side spray fluidized bed spray gun sprays into, until coating solution all sprays into, shape At fine and close separation layer, it is dry to get.

Traditional Chinese medicine pellet appearance rounding after gained coating, no color spot；Target pellet yield: 90.32%；Coating of pellets is difficult Degree: smooth；It is coated duration 97min.

Embodiment 6

Siberian Ginseng P.E preparation: taking wilsonii medicinal material, (acquisition is big through southwestern traffic from the ferreous area of Heilongjiang Province's Yichun Xue Songliang section professor is accredited as Chinese medicine wilsonii, latin name: ACANTHOPANACIS SENTICOSI RADIX ET RHIZOMA SEU CAULIS), it is broken into 8mm particle, 8 times of deionized water amounts are added, are heated to boiling, extraction 2 times, 1 hour every time, Extracting solution merges；Amalgamation liquid is concentrated under reduced pressure into relative density 1.18-1.20g/ml, obtains medicinal extract；Medicinal extract liquid it is dry extract powder, It is spare.

Blank capsule core preparation: taking appropriate microcrystalline cellulose, is sieved, obtains the satisfactory material of granularity；Weigh 1.5% The hydroxypropyl methyl cellulose E of (relative to microcrystalline cellulose amount)₃(Shanghai Colorcon Coating Technology Co., Ltd) is as bonding Agent adds water to be made into 2% binder solution, sufficiently swelling 12 hours or more to get；A part of microcrystalline cellulose is taken to put into side It sprays in fluidized bed, by adhesive, spray head sprays into feed bin from side spray fluidized bed, until forming fine particle；Remaining microcrystalline cellulose Using adding powder rifle to be slowly sprinkled into feed bin, and adhesive is sprayed into, until particle is slowly grown up, is rounded, filters out certain partial size Capsule core is as carrier.

The preparation of wilsonii pellet: (1) siberian Ginseng P.E extract powder is added gradually in 45% ethanol solution, Bian Jia Side stirring, until solution solid content is 30%, and heating water bath is to 50 DEG C, until extract powder all dissolves；(2) complete medicine is dissolved The talcum powder (1250 mesh, the magnificent talcum development corporation, Ltd. of LONGSHENG IN GUANGXI) that 5% (extract powder meter) is added in liquid is mixed uniformly.(3) By prepared medical fluid heating water bath to 50 DEG C, and it is stirred continuously.Capsule core is put into bottom spray or side spray fluidized bed, to material Temperature is higher than 45 DEG C, starts to spray into medical fluid, until liquid medicine jet is complete, forms spherical pellet vegetable pill.

Powder bed preparation: aforementioned spherical pellet vegetable pill is placed in drying 10 minutes in fluidized bed, is sprinkled into using dusting rifle The acrylic resin (German rom, Utech E100 cross 200 meshes) of 15% (relative to extract extract powder amount), fluidized bed It is interior to be uniformly mixed, obtain pellet a；

Coatings preparation: (1) preparation of coating solution weighs Opadry 80W690000 type packet according to the amount of theoretical weight gain 4% Clothing pre-mixing agent, adds water to be made into the solution of solid content 5%, and homogeneous instrument handles 2-3 circulations；(2) to pellet a in aforementioned fluidized bed Temperature is higher than 45 DEG C, and prepared coating solution is sprayed the bottom of from or side spray fluidized bed spray gun sprays into, until coating solution all sprays into, shape At fine and close separation layer, it is dry to get.

Traditional Chinese medicine pellet appearance rounding after gained coating has a small amount of white color spot；Target pellet yield: 90.16%；Pellet It is coated difficulty: smooth；It is coated duration 125min.

Claims (10)

1. a kind of coating method of traditional Chinese medicine pellet, comprising the following steps: 1) use pharmaceutically acceptable auxiliary material, containing Chinese medicine One layer of powder bed is wrapped up on the pellet vegetable pill surface of extract, obtains pellet a, and 2) pellet a is carried out using fluidized bed coating equipment Coating, the traditional Chinese medicine pellet after being coated；Wherein, acceptable auxiliary material is selected from talcum powder, propylene in the powder bed Chinese pharmacology Acid resin or calcium stearate, preferably talcum powder or acrylic resin, most preferably talcum powder.

2. the coating method of traditional Chinese medicine pellet according to claim 1, it is characterised in that the mesh number of the talcum powder is 800 mesh Or higher, preferably 1000-2000 mesh, more preferably 1200-2000 mesh；The mesh of the acrylic resin and/or calcium stearate Number is 200 mesh or higher.

3. the coating method of traditional Chinese medicine pellet according to claim 1, it is characterised in that the use of talcum powder in the powder bed Amount is the 6%-25%, preferably 8%-10% of the traditional Chinese medicine extraction amount of substance；The dosage of the acrylic resin is in described The 10%-25% of medicament extract quality, preferably 15%-25%.

4. the coating method of traditional Chinese medicine pellet described in any one of -3 according to claim 1, it is characterised in that preferred coating weight gain is 2%-8%, more preferably 6%-8%.

5. the coating method of traditional Chinese medicine pellet described in any one of -4 according to claim 1, which is characterized in that the coating method packet It includes following steps: 1) the pellet vegetable pill containing Chinese medical extract being taken to be placed in fluidized bed pot, it is dry, it is added pharmaceutically acceptable Auxiliary material mixes, until pellet surface forms one layer of uniform powder bed；2) take coating material that water or water-containing organic solvent is added to configure At coating solution, fluidized bed is sprayed into, starts to be coated, the traditional Chinese medicine pellet after being coated.

6. the coating method of traditional Chinese medicine pellet according to claim 5, which is characterized in that the coating material can be selected from hydroxypropyl Ylmethyl cellulose E3, talcum powder, titanium dioxide, polysorbate, Opadry 03A690067 type or Opadry 80W690000 type One of or it is a variety of；The water-containing organic solvent is preferably ethanol water.

7. the coating method of traditional Chinese medicine pellet according to claim 1 to 6, which is characterized in that the traditional Chinese medicine pellet It is the traditional Chinese medicine pellet containing siberian Ginseng P.E；Preferably, the siberian Ginseng P.E is prepared with the following method: taking thorn Slender acanthopanax medicinal material crushes, and adds water or hydrous ethanol, and heating extraction filters, and filtrate concentration is drying to obtain.

8. the coating method of traditional Chinese medicine pellet according to claim 1 to 6, which is characterized in that the traditional Chinese medicine pellet Capsule core be manufactured pellet core after blank capsule core or pharmaceutically acceptable auxiliary material are mixed with Chinese medical extract；Wherein, institute It is commercially available or using conventional pelletization technology self-control to state blank capsule core, the blank capsule core is the preparation method comprises the following steps: (1) takes crystallite fine Tie up one of element, starch, lactose or a variety of as excipient, 200 meshes of mistake are placed in pelletization equipment, mix；Pelletization equipment Common pill or facility for granulating may be selected, such as centrifugal granulator, extrusion spheronization machine or side spray fluidized bed；(2) be added dextrin slurry, One of hydroxypropyl methyl cellulose, water or it is a variety of be adhesive, make material in cotton-shaped flow regime, form fine particle； (3) maintaining material is in cotton-shaped flow regime, adds excipient again and increases adhesive simultaneously, makes particle slowly long great achievement target Capsule core.

9. the coating method of traditional Chinese medicine pellet according to claim 7, which is characterized in that the traditional Chinese medicine pellet uses extrusion spheronization Method, centrifugal granulation or fluidized bed prilling method are prepared；Preferably, the traditional Chinese medicine pellet is prepared into using fluidized bed prilling method It arrives, specifically: recipe quantity Chinese medical extract is taken, suitable quantity of water or hydrous ethanol is added, stirs evenly, drug solns is made；Take ball Core is put into fluidized bed pot, and drug solns in penetrating obtain traditional Chinese medicine pellet.

10. the coating method of traditional Chinese medicine pellet according to claim 9, which is characterized in that can be into one in the upper drug solns Pharmaceutically acceptable auxiliary material is added in step, and it is poly- that the pharmaceutically acceptable auxiliary material is selected from talcum powder, superfine silica gel powder, lactose, shell One of sugar, microcrystalline cellulose are a variety of.