CN107951989A - A kind of method moulded preparation method and prepare shenmai rehmannia pill - Google Patents

A kind of method moulded preparation method and prepare shenmai rehmannia pill Download PDF

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CN107951989A
CN107951989A CN201711054297.XA CN201711054297A CN107951989A CN 107951989 A CN107951989 A CN 107951989A CN 201711054297 A CN201711054297 A CN 201711054297A CN 107951989 A CN107951989 A CN 107951989A
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pill
shenmai
rehmannia
preparation
medicine
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杨群
张锴
林佳妮
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Shaoxing University Yuanpei College
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Shaoxing University Yuanpei College
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/88—Liliopsida (monocotyledons)
    • A61K36/896—Liliaceae (Lily family), e.g. daylily, plantain lily, Hyacinth or narcissus
    • A61K36/8968—Ophiopogon (Lilyturf)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/06—Fungi, e.g. yeasts
    • A61K36/07—Basidiomycota, e.g. Cryptococcus
    • A61K36/076—Poria
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/23—Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/65—Paeoniaceae (Peony family), e.g. Chinese peony
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/71—Ranunculaceae (Buttercup family), e.g. larkspur, hepatica, hydrastis, columbine or goldenseal
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/80—Scrophulariaceae (Figwort family)
    • A61K36/804—Rehmannia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/88—Liliopsida (monocotyledons)
    • A61K36/884—Alismataceae (Water-plantain family)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/88—Liliopsida (monocotyledons)
    • A61K36/894—Dioscoreaceae (Yam family)
    • A61K36/8945—Dioscorea, e.g. yam, Chinese yam or water yam
    • A—HUMAN NECESSITIES
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2068—Compounds of unknown constitution, e.g. material from plants or animals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing

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Abstract

The present invention relates to a kind of method moulded preparation method and prepare shenmai rehmannia pill, bulk pharmaceutical chemicals of suitable drug matching component as this method are taken by traditional Chinese patent medicine pill prescription, bulk pharmaceutical chemicals are crushed, are sieved, mix, mixed with suitable adhesive refined honey and water, refine medicine, pill bar, rub ball with the hands, spherical pill is made in whole ball, drying.This invention removes traditional human factor difference for operating bring by rule of thumb so that opportunities for contamination is reduced, and is not easy microbiological contamination, sanitary standard is easy to control；Production efficiency higher, yield bigger, yield higher, the uniformity of finished product is more preferable, and weight differential is small, and it is small to leach the time limit, so as to advantageously ensure product quality, foundation is provided for the industrialized production of shenmai rehmannia pill.

Description

A kind of method moulded preparation method and prepare shenmai rehmannia pill
Technical field
The invention belongs to pharmaceutical technology field, is specifically related to the technique that modeling preparation method prepares shenmai rehmannia pill, especially uses The industrialized production method of pellet processing machine prepares the technique of water-honeyed pill, makes a kind of new process for preparing water-honeyed pill formulation.
Background technology
《Pharmacopoeia of People's Republic of China》Provided as follows in (version in 2015) four " 0108 pills of rules of preparations "：Pill Mean spherical made of material medicine and suitable auxiliary material or spherical solid pharmaceutical preparation, be divided into honeyed bolus, water-honeyed pill, the water-bindered pill, starched pill, The types such as condensed pill, wax-wrapped pill and dripping pill.Wherein：
Water-honeyed pill refers to medicine materical crude slice fine powder using refined honey and water as pill made of binder.Unless otherwise specified, for pill agent Medicinal powder should be fine powder or most fine powder, and auxiliary material includes at least honey or mulse mixture.
Shenmai rehmannia pill is traditional Chinese patent medicine, at present only pill (water-honeyed pill) formulation, and clinical efficacy is definite, application range Extensively, clinical common medicine is belonged to, its standard is recorded in the Sanitation Ministry medicine standard Traditional Chinese medicine historical preparation the 2nd (WS3-B-0319-90), system Preparation Method is general preparation method.
, it is necessary to undergo molding, general system makes shaping, sieves ball, capping, does layer by layer when the general preparation method of tradition prepares shenmai rehmannia pill It is dry, select ball, time length, generally require 10~15 it is small when；Preparation process is cumbersome, and labor intensity is big, molding, forming process It is middle to need manually system general in layers, screening, production efficiency is influenced, and pollute chance to increase, it is exceeded to easily cause microorganism, Make product unqualified；With medicine materical crude slice fine powder, general system forms layer by layer for general preparation method system at the same time, and the pellet sizes uniformity is poor, weight differential Greatly, tailing is more, one-pass molding rate is relatively low, compact structure, leaches the time limit and easily occurs unqualified, is unfavorable for the dissolution of active ingredient And absorption.
Shenmai rehmannia pill is prepared using modeling preparation method, is that medicine materical crude slice fine powder addition refined honey, water are mixed and made into ball in mixer Refining in block, medicine refining machine, then completes pill by pellet processing machine, then is formed through whole ball, drying, and overall process is completed by machinery, Reduce medicine to contact with the direct of people, process significantly simplifies, therefore opportunities for contamination is reduced, and is not easy microbiological contamination, sanitary standard is easily-controllable System；Pellet processing machine uses unified pelleting mould at the same time, the good evenness of finished product, and pill weight differential is small；Production efficiency higher, obtains Rate higher, yield bigger.Particularly modeling preparation process pill finished product leaches the time limit and greatly improves, and overcomes the general preparation method finished product of tradition Limit for length when leaching, influences patient's body drug absorption problem, and therefore, modeling preparation method provided by the invention prepares shenmai rehmannia pill side Method, it is big to solve shenmai rehmannia pill size heterogeneity, weight differential, limit for length when leaching, easily exceeded etc. quality problems of microorganism.
The content of the invention
The applicant has invented a kind of new work that modeling preparation method prepares shenmai rehmannia pill by the further investigation in terms of galenic pharmacy Skill, the shenmai rehmannia pill stable quality prepared by this method are curative for effect.
It is an object of the invention to provide the new process that modeling preparation method prepares shenmai rehmannia pill, wheat field is joined using traditional Chinese patent medicine Bulk pharmaceutical chemicals of the drug matching component of yellow ball prescription as this method, this method is used as using the raw material prescription proportioning of shenmai rehmannia pill Dosage, bulk drug medicine materical crude slice fine powder and suitable adhesive honey and water are mixed and made into ball block with mixer, pass through medicine refining machine Refining, pill bar is extruded in pellet processing machine, pill of uniform size is cut into by pill-making knife, then obtains finished product after whole ball, drying.
The processing step that the present invention uses covers the rings such as the mixing of medicine materical crude slice fine powder, refining medicine, pill bar, stranding ball, whole ball, drying Section.Modeling preparation method is 1.35-1.40 selected from relative density with refined honey, and water content is the refining honey of 10%-20%.
Compared with preparing shenmai rehmannia pill with general preparation method, modeling preparation method advantage of the invention is：
1. accuracy
Pill weight differential compares, and moulds preparation method weight differential≤2.4%, general preparation method weight differential≤5.9%, the two phase Than there were significant differences, illustrate that moulding preparation method accuracy compared with general preparation method improves.
2. batch production deadline
Complete same batch shenmai rehmannia pill (by taking 300kg as an example), general preparation method need about 12~15 it is small when, modeling preparation method warp When needing 8-10 small, production efficiency greatly improves.Eliminate at the same time it is traditional operate the human factor difference brought by rule of thumb, make Obtain opportunities for contamination to reduce, be not easy microbiological contamination, sanitary standard is easy to control.
3. leach the time limit
According to version in 2015《Chinese Pharmacopoeia》Method under four general rule 0921 disintegration time limited inspection technique tablet items adds baffle Checked, water-honeyed pill leaches the time limit should：≤ 1 it is small when.
Modeling preparation method leaches the time limit：Within 30 minutes
General preparation method leaches the time limit：30-56 minutes
Pill prepared by modeling preparation method leaches the time limit and has clear improvement than general preparation method.
4. can the degree of automation
General preparation method preparation process is cumbersome, and labor intensity is big, and artificial system general in layers, mistake are needed in molding, forming process Sieve, influences production efficiency.
Modeling preparation method preparation process flow is smooth, is produced using the mixer, medicine refining machine, pellet processing machine of automation, and output is big, Production time is short.
To reach above-mentioned purpose, the method that the present invention prepares shenmai rehmannia pill for modeling preparation method, is by the following technical programs Realize：
Step：
(1) pulverizing medicinal materials：Prepared rhizome of rehmannia, Fructus Corni, Chinese yam, rhizoma alismatis, Poria cocos, moutan bark, north sand are weighed respectively by a certain amount of Ginseng and ophiopogon, are uniformly mixed, are placed in pulverizer and crush, and sieve, and mix, spare；
(2) auxiliary material is handled：Honey sieving is filtered out into impurity, when refining to 105~115 DEG C, relative density is 1.35 or so, is contained Water is 14-20%；Or at 116-118 DEG C, relative density is 1.37 or so, and water content is in 14%-16%；Or 119-122 DEG C When, relative density is 1.4 or so, and water content is below 10%.
(3) pill block：Obtained medicine materical crude slice fine powder will be crushed in step (1) in stirrer for mixing certain time, addition step Suddenly the refined honey in (2) and a small amount of water, stir evenly, up to ball block；
(4) medicine is refined：Obtained ball block in step (3) is placed in medicine refining machine, repeats refining for several times；
(5) pill grain：The medicinal strip refined in step (4) is placed in extrusion pill bar in Chinese medicinal pills preparing machine, pill-making knife cutting Pill is made；
(6) whole ball：Pill is put a small amount of diluted mulse is sprayed into general ball pot, and be sprinkled into a small amount of fine drug powder, counted repeatedly It is secondary, make pill appearance rounding consistent.
(7) it is dry：Wet ball is placed in baking oven and is dried, obtains shenmai rehmannia pill.
Shenmai rehmannia pill made from the step (7) is placed in the medicine sieve of suitable size and screens the pill being sized for.
The granularity that step (1) Chinese medicine crushes is 80-120 mesh.
The incorporation time of pill block is 20-40min in the step (3), and pill block amount of water is 10-20mL/100g medicines Material medicine materical crude slice fine powder.
Refining medicine number in the step (4) is 1-4 times.
Whole ball in the step (6) adds powder amount to be 1-2%.
Drying temperature in the step (7) is 60-80 DEG C, drying time 4-6h.
In conclusion beneficial effects of the present invention are as follows：
The present invention prepares a kind of new process of shenmai rehmannia pill for modeling preparation method, eliminates what traditional operation by rule of thumb was brought Human factor difference so that opportunities for contamination is reduced, and is not easy microbiological contamination, sanitary standard is easy to control；Production efficiency higher, yield bigger, Yield higher, the uniformity of finished product is more preferable, and weight differential is small, is shenmai rehmannia pill so as to advantageously ensure product quality Industrialized production provides foundation.
Brief description of the drawings
Fig. 1 is Paeonol maximum absorption wavelength；
Fig. 2 is Paeonol standard curve；
Fig. 3 is amylum body microscopical characters；
Fig. 4 is Poria cocos mycelia microscopical characters；
Fig. 5 is calcium oxalate cluster crystal microscopical characters；
Fig. 6 is rhizoma alismatis TLC identification results, wherein, it is left：Test solution is right：Rhizoma alismatis control medicinal material；
Fig. 7 is Paeonol TLC identification results, wherein, it is left：Paeonol reference substance solution is right：Test solution.
Embodiment
With reference to specific embodiment, the present invention is further illustrated, but protection scope of the present invention is not limited to This.
It is prepared by 1 shenmai rehmannia pill
1.1 prescription
The raw material prescription of the present embodiment modeling preparation method preparation shenmai rehmannia pill, which matches, is：Radix Glehniae 200g, prepared rhizome of rehmannia 400g, wheat Winter 150g, moutan bark 150g, Chinese yam 200g, Fructus Corni (steaming) 200g, Poria cocos 150g, rhizoma alismatis 150g.
1.2 prepare
The present embodiment modeling preparation method prepares the orthogonal of shenmai rehmannia pill：Modeling preparation method easily goes out during preparing pill The problem of existing, which predominantly leaches the time limit, transfinites, splits ball etc..It is the grinding particle size of medicinal material, binder dosage, the mixing pill block time, dry Dry temperature and drying time etc. have a certain impact to leaching time limit and pill appearance.Therefore, to leach outside time limit and pill Roundness is seen as evaluation index, with pulverizing medicinal materials granularity, pill block amount of water, mixing pill block time, refining medicine number, whole ball It is factor to add powder amount, drying temperature, drying time, and each factor drafts 3 levels, and factor level table is shown in Table 1, carries out L18 (37) orthogonal test.
Table 1：Factor level table
The method that the present embodiment modeling preparation method prepares shenmai rehmannia pill includes the following steps：
1.2.1 pulverizing medicinal materials：Weigh prepared rhizome of rehmannia, Fructus Corni (steaming), Chinese yam, rhizoma alismatis, Poria cocos, tree peony respectively by recipe quantity Skin, Radix Glehniae and ophiopogon medicine materical crude slice, are uniformly mixed, put in pulverizer and crush, and sieve, and mix, spare.
1.2.2 mix pill block：Medicine materical crude slice fine powder through crushing is uniformly mixed in mixer, it is (every to add refined honey 100g powder adds refined honey 35g) and suitable water, it is stirred, pill block.
1.2.3 refine medicine shaping：Obtained ball block is put in medicine refining machine, is extruded ball block by mechanical force, repeats refining for several times, refining Synthetic tissue is uniform, soft or hard identical material.
1.2.4 pill：The medicine refined is put into extrusion pill bar in pellet processing machine, it is desirable to which even thickness is consistent, not easily broken, viscosity Good, surface is smooth, and inner face enriches tight；Ball is rubbed with the hands by the pill-making knife on pellet processing machine again pill is made.To prevent pill adhesion, system A small amount of ethanol can be added in ball, and a small amount of fine drug powder is added in pill in making.
1.2.5 whole ball：Pill will be made to put in general ball pot, spray into a small amount of diluted refined honey, and be sprinkled into a small amount of fine drug powder, It is repeated several times, makes pill appearance rounding consistent.Pay attention to adding medicinal powder preferably carefully, less, the whole ball time is preferably short.
It is 1.2.6 dry：Wet ball is immediately placed in baking oven and is dried, obtains shenmai rehmannia pill.
1.2.7 ball is selected：Put in the sieve of suitable size or select and rounding, pill of uniform size are screened to obtain in ball machine.
Orthogonal experiments comprehensive grading explanation：
Take the observation of 100 shenmai rehmannia pills, appearance rounding is without cracking, size, uniform color, no adhesion for 100 points.Go out Existing 5 percent split ball for 95 points, occur 10 split ball situation for 90, and so on.Leach the time limit using 30min as 100 points, in 30min the time often reduce 1min and add 1 point, often increase 1min more than 30min and detain 1 point.Appearance and point for leaching the time limit Value respectively accounts for 50%.It the results are shown in Table 2.
Table 2：L18(37) orthogonal experiments
(1) analysis directly perceived
As can be seen from Table 2, in 18 experiments of progress, using the 13rd scheme to be best, specific testing program is A2B1C2D3E1F2G3, comprehensive grading is 98 points.
By the size of very poor R, it is known that A is main factor, and F is most secondary cause.Factor primary-slave relation is：
Main → secondary A ＞ D ＞ B ＞ C ＞ E ＞ G ＞ F
Optimum process condition is：A2B3C2D3E1F3G2, i.e., 100 mesh of medicine grinding particle size, mixing pill block when amount of water 10ml/ is per 100g fine drug powders, pill block incorporation time 30min, refining medicine 3 times, whole ball add powder amount 1%, 80 DEG C of drying temperature, Drying time 5h.
The horizontal combination is not present in 18 orthogonal tests, is done again by the technological parameter and is repeated to test three times, as a result It is shown in Table 3.
Table 3：Repeat result of the test
As can be seen from Table 3：The shenmai rehmannia pill appearance circle that the optimum process condition screened with this experiment is produced Whole, size, uniform color, no adhesion, leaches time limit, moisture and meets version in 2015《Chinese Pharmacopoeia》Four requirements.Appearance and The average aggregate scoring for leaching the time limit is 102.2 points, better than No. 13 testing program, it is thus determined that optimization process is A2B3C2D3E1F3G2。
I.e. optimised process is：100 mesh of pulverizing medicinal materials granularity, mixing pill block amount of water 10ml/ per 100g fine drug powders, The incorporation time 30min of pill block, refining medicine 3 times, whole ball add powder amount 1%, 80 DEG C of drying temperature, drying time 5h.
(2) variance analysis
Table 4：Analysis of variance table
F0.05(2,3)=9.55, F0.01(2,3)=34.12
SSe=SSAlways-SSA-SSB-SSC-SSD-SSE-SSF-SSG
(formula：Free degree fCause=factor level number -1；Total free degree fAlways=n-1=18-1=17；By mistake Poor free degree fe=fAlways-∑fCause=17-2 × 7=3, variance=SS of factorCause/fCause；Variance=SS of errore/fe；F is examined：)
As can be seen from Table 4：FA>34.12, therefore factors A effect is extremely notable, should select A2； FB、FC、FD、FE>9.55 Therefore factor B, C, D, E effect are significantly, should select B3、C2、 D3、E1；FF、FGEqual ＜ 9.55, therefore the effect of factor F, G is not notable, it is contemplated that Improve production efficiency, reduce production cost, select F3、G2。
Optimum process scheme：A2B3C2D3E1F3G2, it is consistent with analysis result directly perceived.
Performance test
The shenmai rehmannia pill prepared respectively to embodiment 1 and commercially available general preparation method carries out appearance, weight differential and leaches the time limit Comparative studies.
1 visual examination：Each three batches, every batch of 9g, shenmai rehmannia pill sample for taking modeling preparation method and commercially available general preparation method to prepare, range estimation Check its appearance.It the results are shown in Table 5：
Table 5：Visual examination result table
2 weight differential inspections：Difference estimation (version in 2015 by weight《Chinese Pharmacopoeia》Four general rules 0108) measure：With 10 balls are portion, take 10 parts of test sample, respectively weighed weight, then indicate weight (every ball labelled amount × weigh ball number) phase with every part Compare, according to the form below regulation, 2 parts must not be more than beyond limit test of weight variation, and there must not be a 1 times of overrun.The result is shown in Table 6.
Table 6：Weight differential result
As shown in Table 6, compared with the shenmai rehmannia pill prepared with commercially available general preparation method, the ginseng wheat field of modeling preparation method of the invention preparation Yellow ball weight differential is bigger than shenmai rehmannia pill (weight differential is within 5.9%) prepared by commercially available general preparation method within 2.4% It is small evenly, weight differential smaller, taking dose evenly, is more advantageous to the performance of curative effect.
3 leach time limit measure：According to disintegration time limited inspection technique (version in 2015《Chinese Pharmacopoeia》Four general rules 0921) tablet item Under method add baffle to be checked, water-honeyed pill interior whole should be leached when 1 is small.As test sample sticks baffle harm in operating process When hindering inspection, 6 ball of test sample should be separately taken, inspection Check is carried out to be not added with baffle.Above-mentioned inspection Check, should all pass through at the appointed time Sieve.If any fine particle shape thing not by sieve, but soften and can be by meeting regulation opinion without hard-core person.It the results are shown in Table 7.
Table 7：Leach time limit table
As shown in Table 7, compared with the shenmai rehmannia pill prepared with commercially available general preparation method, the ginseng wheat field of modeling preparation method of the invention preparation Yellow ball leaches the time limit within 30 minutes, leaches time limit 30-56 minute smaller than general preparation method, is more advantageous to active ingredient Dissolution and absorption, bioavilability higher.Modeling preparation method leaches the time limit：
The production process that traditional general preparation method prepares shenmai rehmannia pill is various, and product quality is difficult to control.This experiment uses Mould preparation process and prepare shenmai rehmannia pill, and devise L18(37) optimization of orthogonal test modeling preparation process, it is determined that optimised process Parameter, definite optimum process condition are：100 mesh of medicine grinding particle size, mixing pill block amount of water 10ml/100g medicines are thin Powder, the incorporation time 30min of pill block, refining medicine number 3 times, whole ball add powder amount 1%, 80 DEG C of drying temperature, drying time 5h, most Shenmai rehmannia pill appearance rounding prepared by good technique, size, uniform color, no adhesion, is limited within 27min, weight when leaching Difference is within 2.4%, obtained shenmai rehmannia pill appearance, weight differential and leaches the time limit and meets version in 2015《Middle traditional Chinese medicines Allusion quotation》Regulation.
Present invention modeling preparation method prepare shenmai rehmannia pill new process eliminate it is traditional operate by rule of thumb bring it is artificial because Plain difference so that opportunities for contamination is reduced, and is not easy microbiological contamination, sanitary standard is easy to control；Production efficiency higher, yield bigger；Finished product The uniformity is more preferable, weight differential smaller, so as to advantageously ensure product quality, is provided for the industrialized production of shenmai rehmannia pill Foundation.
Above-described embodiment is only used for illustrating the inventive concept of the present invention, rather than the restriction to rights protection of the present invention, All changes for carrying out unsubstantiality to the present invention using this design, should all fall into protection scope of the present invention.

Claims (10)

  1. A kind of 1. method moulded preparation method and prepare shenmai rehmannia pill, it is characterised in that：Taken by traditional Chinese patent medicine pill prescription suitable Bulk pharmaceutical chemicals of the drug matching component as this method, bulk pharmaceutical chemicals are crushed, are sieved, and are mixed, with suitable adhesive refined honey and water Mixing, refines medicine, and pill bar rubs ball with the hands, and spherical pill is made in whole ball, drying.
  2. 2. the method that modeling preparation method prepares shenmai rehmannia pill as claimed in claim 1, it is characterised in that：Wherein described traditional Chinese patent medicine Pill is Chinese medicine water-honeyed pill made from general preparation method.
  3. 3. the method that modeling preparation method prepares shenmai rehmannia pill as claimed in claim 1, it is characterised in that：Wherein described drug matching group It is divided into：Radix Glehniae 200g, prepared rhizome of rehmannia 400g, ophiopogon 150g, moutan bark 150g, Chinese yam 200g, Fructus Corni (steaming) 200g, Poria cocos 150g, rhizoma alismatis 150g.
  4. 4. as claimed in claim 1 modeling preparation method prepare shenmai rehmannia pill method, it is characterised in that the pelletizing process include with Lower step：
    Refined honey and water are used as adhesive, in terms of 100g medicinal powder, adds that refined honey amount is 35g and water is 5-100ml, is mixed and made into ball block It is placed in medicine refining machine and repeats 1-20 times；The ball block refined is placed in extrusion diameter 4-10mm ball bars in Chinese medicinal pills preparing machine, then by pill Pill, pellet diameters 4-10mm is made in the cutting of machine mould, and average ball weight is every 100 weights 5g-20g, hardness 2-8kg.
  5. 5. the method that modeling preparation method prepares shenmai rehmannia pill as claimed in claim 1, it is characterised in that：It is described in terms of 100g medicinal powder It is 35g that pelletizing process, which adds honey to measure, and water is 5-100ml.
  6. 6. the method that modeling preparation method prepares shenmai rehmannia pill as claimed in claim 1, it is characterised in that：What all components medicine crushed Granularity is 80-120 mesh.
  7. 7. the method that modeling preparation method prepares shenmai rehmannia pill as claimed in claim 1, it is characterised in that：Pill block in the step Incorporation time is 10-50min.
  8. 8. the method that modeling preparation method prepares shenmai rehmannia pill as claimed in claim 1, it is characterised in that：The refining medicine number is 1-6 It is secondary.
  9. 9. the method that modeling preparation method prepares shenmai rehmannia pill as claimed in claim 1, it is characterised in that：Dry temperature in the step Spend for 60-100 DEG C, drying time 2-6h.
  10. 10. the method that modeling preparation method prepares shenmai rehmannia pill as claimed in claim 1, it is characterised in that：Pill in the step It is 1-2% to add powder amount, and pill block amount of water is 10-20mL per 100g medicine materical crude slice fine powder.
CN201711054297.XA 2017-11-01 2017-11-01 A kind of method moulded preparation method and prepare shenmai rehmannia pill Pending CN107951989A (en)

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN108514551A (en) * 2018-05-18 2018-09-11 北京同仁堂制药有限公司 A kind of preparation method of medicine pill

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CN1583124A (en) * 2004-06-11 2005-02-23 北京同仁堂股份有限公司 Preparation of pills by pressing process

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CN1583124A (en) * 2004-06-11 2005-02-23 北京同仁堂股份有限公司 Preparation of pills by pressing process

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN108514551A (en) * 2018-05-18 2018-09-11 北京同仁堂制药有限公司 A kind of preparation method of medicine pill

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Application publication date: 20180424