CN1785408A - Preparation technology of mammary healthy dispersion tablet - Google Patents

Abstract

A Chinese medicine ''Rukang dispersing tablet'' for treating mastoplasia is an improvement to ''Rukang tablet'' and is prepared from the raw materials of ''Rukang tablet'' and additional additives. Its advantages are high disintegrating and dissolving speed, good dispersed state and quickly taking its effect. Its preparing process is also disclosed.

Description

The preparation technology of mammary healthy dispersion tablet

Technical field

The present invention relates to a kind of preparation method of dispersible tablets of Chinese medicine, particularly a kind of preparation method that obtains mammary healthy dispersion tablet by RUKANG PIAN change dosage form.The mammary healthy dispersion tablet of this method preparation has fast, the rapid-action characteristics of disintegrate, swallow or eliminating cold for resuscitation blister clothes 3 minutes with interior be disintegratable, the effect of performance drug effect.

Background technology

Cyclomastopathy is commonly encountered disease, frequently-occurring disease.Patient can touch at the one or both sides breast differ in size, soft or hard differs, boundary is not clear lump, as if there is granule on the surface, does not have adhesion with skin, fascia, press...with one's finger promptly to feel pain after pressing.Simultaneously with distending pain of the breast or ache, individual patients is also to oxter and upper limb radiation.Pain and menstruation have certain relation, and symptom is more obvious before and after the menstruation, sx or disappearance during the menstrual onset.Overcast and rainy, summer-heat weather, or emotion changes, sx during as anxious, anger, melancholy, think of.Symptom is lighter when happy.Pain the lighter can not cause that patient notes, weight person can influence work and life.The a few patients nipple can flow out pale brown normal complexion crineous bloody fluid.Someone finds, facial normal chloasma and the disorderly calmness of allochromatic colour thereof of taking place of this type of patient.Show that through a large amount of study of histological morphology its continuous, progressive evolution process can cause breast carcinoma.Yet, no matter be physiological simple property breast epithelium hypertrophy or the cyst breast epithelium hypertrophy of atypism all belongs to the reversibility pathological changes.

In recent years, this disease sickness rate increases year by year, and women of child-bearing age's sickness rate is up to 28%-40%.Meanwhile, age of onset descends.This disease is more common in the women in 30-50 year, the maiden's morbidity about 20 years old is also arranged now, and symptom is apparent in view;

According to International Union Against Cancer's introduction, the women of cyclomastopathy suffers from the U.S., and the chance that in the future suffers from breast cancer is 2 times of common people, also has the scholar to be reported as 4.5 times or higher; The somebody thinks that it may be a precancerous lesion, develops into late stage, and having the canceration tendency or entreating simultaneously has early stage malignant tumor.Another part the people then think, cyclomastopathy and breast carcinoma do not have and contacts directly.Be one of multiple risk factor of breast carcinoma at the most, needn't be too nervous.However, must pay much attention to, strive for early stage inspection, early discovery, early treatment cyclomastopathy.

Above-mentioned disease is many to be caused because of the unsuccessful institute of feelings will.Theory of Chinese medical science is thought, melancholy impairing the spleen, damage of the spleen then expectorant are given birth to.Depressed rage impairing the liver, stagnation of liver-QI is the stagnation of QI then.The phlegm and qi stasis stasis of blood is amassed breast, and the stomach network is obstructed and cause nodules of the breast.If prolonged illness is multiple, the daily life imbalance injures to dash and appoints, or cloudy anemia is difficult to moisten foster less, or YANG QI deficiency is difficult warmly, can become obstinate disease.Clinical manifestation is mammary gland pain and lump, and is obvious with emotion and menstruation relation, belongs to Chinese medicine " nodules of the breast " category, the patient has then spirit depressing of stagnation of QI due to depression of the liver more, and is easily frightened, the mammary swelling mastalgia, uncomfortable in chest, irritability, QI rising in reverse order, menoxenia, and blood stasis due to qi deficiency, with liver stomach two through and appoint that to dash two arteries and veins in close relations, method of treatment is with dispersing the stagnated live-QI to relieve the stagnation of QI, blood circulation promoting and blood stasis dispelling, dissipating phlegm and resolving masses, air making-up and spleen enlivening is main.

For the medicine of the existing treatment of above-mentioned disease, its dosage form is a RUKANG PIAN, records in the 12 in " the Sanitation Ministry medicine standard " Chinese traditional patent formulation preparation, standard No.: WS at present ₃-B-2356-97.RUKANG PIAN is that raw material is made by Chinese medicines such as Concha Ostreae, Bulbus Fritillariae Thunbergii, Sargassum, Fructus Trichosanthis, Radix Salviae Miltiorrhizae, rhizoma sparganic, Rhizoma Curcumae, Olibanum, Myrrha, Radix Asparagi, Radix Scrophulariae, Spica Prunellae, Endothelium Corneum Gigeriae Galli, the Radix Astragali, the Rhizoma Atractylodis Macrocephalaes, through zoopery and clinical practice, confirmation has the hypothalamic-pituitary-ovarian of adjusting function, the effect of regulating immunity-neuroendocrine net.The estradiol of inhibition, the excretory effect of estriol are arranged, thereby remove, promote the normal physiological function of its restore cycle property hypertrophy-restoration of old ways mammary gland tissue pessimal stimulation factor.Have dispersing the stagnated live-QI to relieve the stagnation of QI, regulating QI to relieve pain, promoting blood circulation and breaking stagnation, removing food stagnancy reduces phlegm, hard masses softening and resolving, air making-up and spleen enlivening effect.Be used for cyclomastopathy.

Radix Astragali tonifying Qi and lifting yang is a monarch drug in the prescription, the Radix Salviae Miltiorrhizae blood circulation promoting and blood stasis dispelling, and the removing heat from blood eliminating carbuncle, the Spica Prunellae clearing away liver-fire, Disperse hepatic depression, the Sargassum eliminating phlegm and softening indurated mass, the Concha Ostreae suppressing the hyperactive liver and subsiding YANG, hard masses softening and resolving is restrained astringent or styptic treatment for spontaneous sweating; The Fructus Trichosanthis removing heat from the lung and dissipating phlegm, the promoting the circulation of QI the chest stuffiness relieving; The Radix Scrophulariae heat clearing away, detoxifcation, yin nourishing is ministerial drug altogether; Rhizoma sparganic, removing blood stasis, promoting the circulation of QI to relieve pain; The Rhizoma Curcumae removing blood stasis, promoting the circulation of QI to relieve pain; The Myrrha promoting blood circulation and stopping pain, detumescence and promoting granulation is adjuvant drug; Bulbus Fritillariae Thunbergii heat clearing away eliminating stagnation is messenger drug.All medicines share, and are total to long memorial liver resolving depression, regulating QI to relieve pain, and promoting blood circulation and breaking stagnation, removing food stagnancy reduces phlegm, hard masses softening and resolving, the function of air making-up and spleen enlivening.

RUKANG PIAN is as the pure Chinese medicinal preparation of this disease of treatment, and by many people in the industry are approved, and a line medicine of cyclomastopathy is treated in conduct.Ceng Wenjun etc. have carried out overall assessment to RUKANG PIAN treatment cyclomastopathy curative effect, select case 237 examples altogether, 26 examples of fully recovering (accounting for 10.97%); Produce effects 149 examples (accounting for 62.87%); 6 examples that take a turn for the better (accounting for 26.16%); Invalid 12 examples (accounting for 5.06%).Total effective rate is 94.09%.Lei Qiumo] use RUKANG PIAN, 1365 examples after diagnosing clearly for the cyclomastopathy patient treats, have been obtained promising result.RUKANG PIAN medication onset time the shortest two weeks, the longest 1 first quarter moon, except that to modal cyclomastopathy effectively, long to the course of disease, fibroadenosis type curative effect, it is fast especially male's hypertrophy lump to be disappeared, and observation at a specified future date is recurred few, to the treatment and the preventive effect preferably of having of companion's tuberosity, the easy canceration of capsule, but the pain effect of dispelling is slower.Organize with this that total effective rate is 86.2% in valuable 1365 examples, obvious effective rate is 529%, to the fibrosis type, tumorization, the higher patient of canceration probability has clinical effectiveness preferably: especially the patient to some masculine mastoplasias is more remarkable, this has has not only reduced or remitted the hardship of many patients' operation, and to the having one's own knack of Breast Cancer Prevention, is the good medicine that doctor and patient trust.Observe this group case, all do not have obvious toxicity, 2 examples take medicine back stomach discomfort, upper gastrointestinal hemorrhage only occur, take a turn for the better through the drug withdrawal anti symptom treatment.Analyzing in the RUKANG PIAN composition still has resolving the hard mass and so on medicine except that the medicine of liver-smoothing, qi-regulating, this is also just to the fibrosis type, the effective main cause of tumor sample tuberosity (adenopathy type) pathological changes, in the clinical use to suffering from the use of serious gastritis, Peptic Ulcers patient Ying Shen.The research report of the clinical research unit of three tame RUKANG PIAN such as Shuguang Hospital clinical pharmacology base is pointed out: be the curative effect of checking RUKANG PIAN (being made up of the Radix Astragali, Radix Salviae Miltiorrhizae, Olibanum, Myrrha, Bulbus Fritillariae Thunbergii, Endothelium Corneum Gigeriae Galli etc.) treatment cyclomastopathy, include standard in according to case, selected 105 routine patients to carry out clinical observation.The oral RUKANG PIAN of patient (0.3g/ sheet) every day 3 times, each 3, menstrual phase is withdrawn.20 days is a course of treatment, adds up curative effect after serveing on 2 courses of treatment.Result: analgesic effect: clinical recovery 45 examples, produce effects 33 examples, effective 23 examples, invalid 4 examples, total effective rate 962%; The piece effect disappears: clinical recovery 24 examples, produce effects 36 examples, effective 34 examples, invalid 11 examples, total effective rate 89.5%; Comprehensive therapeutic effect: clinical recovery 37 examples, produce effects 33 examples, effective 28 examples, invalid 7 examples, total effective rate 93.3%.Chen Xilin etc. have carried out clinical observation to RUKANG PIAN treatment cyclomastopathy 150 examples, and the result shows: clinical cure 57 examples account for 36.55%; Produce effects 66 examples account for 42.3%; Effective 18 examples account for 11.54%; Invalid 15 examples account for 9.61%.Total effective rate 90.39%.Difference has utmost point significance (P＜0.01) effectively and between the invalid case.Zhang Jianguo is observed RUKANG PIAN treatment cyclomastopathy 280 routine curative effects, and the result shows: this organizes 280 examples, and clinical recovery 102 examples account for 36.4%; Produce effects 118 examples account for 42.1%; Effective 45 examples account for 16%; Invalid 15 examples account for 5.4%, and total effective rate is 94.6%.Side effect: observing this group case does not all have obvious toxicity, and only nauseating gastrointestinal reaction, the transference cure behind the one after each meal of waiting appears in 3 examples.Qiao Jian etc. treat cyclomastopathy 90 examples with RUKANG PIAN, and total effective rate is 95.5%.Hao Yanhui estimates total effective rate 95% to RUKANG PIAN treatment cyclomastopathy 136 routine clinical efficacies.Official spring and autumn etc. have been to having done clinical observation with RUKANG PIAN treatment cyclomastopathy, 106 routine cases, total effectively green 71.6%.

In a word, the RUKANG PIAN pathogenesis that hits, curative effect is reliable, and taking convenience is economic, and clinical can being extensive use of is the comparatively ideal medicine of treatment cyclomastopathy.

But also there is certain defective in above-mentioned RUKANG PIAN, is the ordinary glazes tablet as this dosage form, and disintegration time is long, and onset is slower, and coated tablet contains sugar, is unfavorable for that sugar avoiding patient takes.

Also have at present RUKANG PIAN is carried out the improved mammary healthy dispersion tablet of dosage form, Chinese patent discloses a kind of mammary healthy dispersion tablet and preparation method thereof, application number: 200410045008.6, and publication number: CN1593604A, open day: on March 16th, 2005; This mammary healthy dispersion tablet has adopted the prescription of RUKANG PIAN fully, and its preparation method is also identical with former RUKANG PIAN, only is the different of dosage form with the difference of RUKANG PIAN.Adopt any/multiple mixed use in receiving of micropowder silica gel, starch, dextrin, magnesium stearate, essence, Pulvis Talci, sucrose, microcrystalline Cellulose, carboxymethyl starch though also mentioned the adjuvant of preparation mammary healthy dispersion tablet in the description.Do not add above-mentioned ratio and parameter but provide, also proof does not add the good effect that adjuvant brings, and those skilled in the art can't obtain fast, the rapid-action characteristics of the said disintegrate truly of description from the technical scheme of this application.

Summary of the invention

The objective of the invention is to, provide a kind of RUKANG PIAN is prepared the technology of mammary healthy dispersion tablet, the mammary healthy dispersion tablet of this prepared, good dispersing state, disintegration time is short, the medicine stripping is rapid; It is various that taking convenience, dispersible tablet are taken mode, can swallow, chew to contain and suck or with taking after the aqueous dispersion, especially is fit to the old man and the patient of the difficulty of swallowing takes; The production technology of dispersible tablet is identical substantially with the conventional tablet production technology, need not specific (special) requirements, need not to add again equipment, and production cost is low.

In order to realize above-mentioned task, the present invention takes following technical scheme:

A kind of preparation technology of mammary healthy dispersion tablet is characterized in that, this technology may further comprise the steps:

1) per 1000 tablet recipes of mammary healthy dispersion tablet

Raw material of Chinese medicine: Concha Ostreae 75g, Olibanum 30g, Fructus Trichosanthis 75g, Sargassum 60g, Radix Astragali 120g, Myrrha 30g, Radix Asparagi 60g, Spica Prunellae 75g, rhizoma sparganic 30g, Radix Scrophulariae 60g, Rhizoma Atractylodis Macrocephalae 60g, Bulbus Fritillariae Thunbergii 30g, Rhizoma Curcumae 30g, Radix Salviae Miltiorrhizae 75g Endothelium Corneum Gigeriae Galli (parched) 30g;

Adjuvant: cross-linked pvp 50g～180g, CMS-Na 40g～180g, microcrystalline Cellulose 30g～140g, magnesium stearate 2g～10g, micropowder silica gel 3g～25g, aspartame 2g～15g;

2) preparation technology

With above ten Chinese medicine of the five flavours raw materials, Endothelium Corneum Gigeriae Galli (parched) wherein, Bulbus Fritillariae Thunbergii, Olibanum, Myrrha four flavors are ground into fine powder, and all the other ten decoct with water secondary simply, add for the first time 12 times of amounts of water, add 10 times of amounts of water for the second time, decocted 2 hours at every turn, collecting decoction filters, and filtrate is cooled to below 40 ℃, add natural clarifying agent, stir, left standstill 4 hours, filter, under 60 ℃ of conditions, filtrate is concentrated into relative density 1.10, spray drying;

Add adjuvant cross-linked pvp, carboxymethylstach sodium (CMS-Na), microcrystalline Cellulose, aspartame in above-mentioned four Chinese medicine powder and the prescription then, mixing is granulated with 95% ethanol, 14 mesh sieves, drying, 16 mesh sieve granulate add magnesium stearate, micropowder silica gel, mixing is pressed into 1000, promptly.

Sweeting agents such as the also available cyclamate of above-mentioned Aspartane, steviosin replace, and also can add correctivess such as suitable flavoring orange essence or citric acid in addition in the adjuvant and regulate mouthfeel.Natural clarifying agent of the present invention is a Tianjin ZTC II type clarifier, and using method sees the operation instructions of this product for details.

The present invention has possessed the advantage of tablet and granule simultaneously, has fast, the rapid-action characteristics of disintegrate.Both but eliminating cold for resuscitation blister clothes (3 minutes with interior disintegrate) also can be swallowed.Not only have and carry with easy to use, advantage such as curative effect is reliable, and can significantly treat cyclomastopathy, and along with growth in the living standard, it is more extensive that the product of this prepared is suitable for the crowd, and market prospect is wide.

The specific embodiment

Below be the specific embodiment that the inventor provides, these embodiment can amplify production, are not limited to these embodiment.

Embodiment 1:

Per 1000 tablet recipes of mammary healthy dispersion tablet:

Raw material of Chinese medicine: Concha Ostreae 75g, Olibanum 30g, Fructus Trichosanthis 75g, Sargassum 60g, Radix Astragali 120g, Myrrha 30g, Radix Asparagi 60g, Spica Prunellae 75g, rhizoma sparganic 30g, Radix Scrophulariae 60g, Rhizoma Atractylodis Macrocephalae 60g, Bulbus Fritillariae Thunbergii 30g, Rhizoma Curcumae 30g, Radix Salviae Miltiorrhizae 75g, Endothelium Corneum Gigeriae Galli (parched) 30g;

Adjuvant: cross-linked pvp 100g, CMS-Na 100g, microcrystalline Cellulose 140g, magnesium stearate 4g, micropowder silica gel 4g, aspartame 10g;

Preparation technology comprises the following steps:

With above ten Chinese medicine of the five flavours raw materials, Endothelium Corneum Gigeriae Galli (parched) wherein, Bulbus Fritillariae Thunbergii, Olibanum, Myrrha four flavors are ground into fine powder, and all the other ten decoct with water secondary simply, for the first time adding water is 12 times of amounts of raw material of Chinese medicine, and adding water for the second time is 10 times of amounts of raw material of Chinese medicine, decocts 2 hours at every turn, collecting decoction filters, and filtrate is cooled to below 40 ℃, add natural clarifying agent, stir, left standstill 4 hours, filter, under 60 ℃ of conditions, filtrate is concentrated into relative density 1.10, drying is ground into fine powder.

Add adjuvant cross-linked pvp, carboxymethylstach sodium, microcrystalline Cellulose, aspartame in above-mentioned four Chinese medicine powder and the prescription then, mixing is granulated with 95% ethanol, 14 mesh sieves, drying, 16 mesh sieve granulate add magnesium stearate, micropowder silica gel, mixing is pressed into 1000, promptly.

Can add flavoring orange essence or citric acid or other correctives in the adjuvant and regulate taste.

Aspartane can replace with cyclamate or steviosin or other sweeting agent.

Embodiment 2:

Per 1000 tablet recipes of healthy dispersion tablet: raw material of Chinese medicine is with embodiment 1.Adjuvant: cross-linked pvp 50g, CMS-Na 180g, microcrystalline Cellulose 110g, magnesium stearate 2g, micropowder silica gel 8g, aspartame 4g, steviosin 6g; Flavoring orange essence is an amount of.Preparation technology is with embodiment 1.

Embodiment 3:

Per 1000 tablet recipes of mammary healthy dispersion tablet: raw material of Chinese medicine is with embodiment 1.Adjuvant: cross-linked pvp 160g, CMS-Na 60g, microcrystalline Cellulose 120g, magnesium stearate 6g, micropowder silica gel 25g, aspartame 13g; Citric acid 6g, strawberry essence is an amount of.Preparation technology is with embodiment 1.

1, prescription source

The mammary healthy dispersion tablet prescription of the present invention's preparation derives from the 12 in " the Sanitation Ministry medicine standard " Chinese traditional patent formulation preparation, standard No.: WS ₃The RUKANG PIAN prescription of-B-2356-97.The present invention is the new drug kind that is improved to dispersible tablet from tablet, better brings into play the performance of medicine, is convenient to more patient and takes, and also increases a new selection for clinical application simultaneously.

2. the recipe quantity of mammary healthy dispersion tablet and usage and dosage

Mammary healthy dispersion tablet, the medication amount of prescription is identical with former tablet formulation amount, and every is equivalent to primary crude drug 0.84g.Its usage and dosage is: oral or in hot water, disperse after take, one time 2～3,2 times on the one.One after each meal, 20 days is a course of treatment.5～7 days at interval, continue second course of treatment, but also continuous use.

3. preparations shaping technical study

3.1 the selection of adjuvant

Dispersible tablet claims water dispersion tablet again, mean meet water rapidly disintegrate form the tablet of even viscosity suspension.Therefore selecting for use with use amount of adjuvant directly influences disintegrate, the dispersed uniform of tablet and the suspension ability that disperses the back suspension.Used adjuvant mainly comprises in the general prescription: disintegrating agent or chance water form full-bodied swellability adjuvant, diluent, wetting agent or binding agent, lubricant, correctives etc.

As dispersible tablets of Chinese medicine, the disintegrate and the dispersive adjuvant that directly influence dispersible tablet mainly are disintegrating agent or swellability adjuvant, diluent, wetting agent or binding agent.This product disintegrating agent selects for use bulk density little, and specific surface area is big, and good fluidity is easy to homodisperse in prescription, the PVPP (cross-linked pvp) and the CMS-Na that use always in dispersible tablet; Diluent selects for use plasticity good, and disintegrative is good, the microcrystalline Cellulose of good fluidity; Wetting agent is selected ethanol for use.

This test designs different prescriptions and carries out the prescription screening test to prepare 500 consumptions.

Experimental technique: 5 times of amounts by prescription take by weighing medical material, and Endothelium Corneum Gigeriae Galli, Bulbus Fritillariae Thunbergii, Olibanum, Myrrha are ground into fine powder, and all the other 11 flavors add 10 times of amounts of water (adding 2 times of water gagings first) respectively, decoct secondary; Each 2 hours, filter, filtrate is cooled to below 40 ℃, add commercially available ZTC II type natural clarifying agent, the method of its adding is, press earlier 3% spray of decocting liquid amount and stir to add B component solution (1%), and per 30 minutes between left and right every stirring once, after 2 hours, with the A component solution (1%) of quadrat method adding decocting liquid amount 1.5%, restir once left standstill 4 hours after 50 minutes, filter, it is 1.10 (60 ℃) that filtrate decompression is concentrated into relative density, and spray drying adds above-mentioned medicated powder, mixing, standby.

Get the above-mentioned medicated powder that makes of 500 amounts, with the cross-linked pvp of recipe quantity (in add), carboxymethyl starch sodium, microcrystalline Cellulose mixing, with Different concentrations of alcohol system soft material, 14 mesh sieves are granulated, vacuum drying, 16 mesh sieve granulate add magnesium stearate, micropowder silica gel, mixing, tabletting, measure its disintegration time, observe its dispersing uniformity

The dispersing uniformity test: get 2 of different dispersible tablets of writing out a prescription, put respectively in the hot water, jolting 3 minutes, all disintegrate is also by No. two sieves.

Mouthfeel: get dispersible tablet, 5 of every prescriptions after disperseing in 200ml water respectively, allow 5 healthy volunteers taste, and choose the score value of each prescription respectively, and total points is 10 minutes.Make judge with the accumulative total score value, accumulative total score value≤20 are divided into very poor; 20 minutes＜accumulative total score value≤40 are divided into generally; Accumulative total score value＞40 are divided into better.

Experimental design with the results are shown in Table 1.

Adjuvant The selection result in table 1 prescription

The prescription numbering		1	2	3	4	5	6
								Prescription is formed (500)	Medicated powder (120 orders, g)	146	146	146	146	146	146
PVPP (120 orders, g)	10	20	20	30	40	50
							CMS-Na (120 orders, g)		-	-	-	20	40	50
Microcrystalline Cellulose (120 orders, g)	-	10	20	30	60	70
							Aspartame (120 orders, g)		-	3	3	4	5	5
Magnesium stearate (120 orders, g)	-	1	1	1.5	2	2
							Micropowder silica gel (120 orders, g)		-	1	1	1.5	2	2
Concentration of alcohol (%)	70	85	95	95	95	95

Evaluation of result	The shaping situation	Difficult the granulation is shaped	Granule is tighter, it is bad to be shaped, and the tablet face is coarse	Tablet is harder, and the tablet face is coarse	Tablet hardness is good, and the tablet face is brighter and cleaner	Tablet hardness is good, and the tablet face is bright and clean	Tablet hardness is good, and the tablet face is bright and clean
								Disintegration time (branch)	Do not detect	4 minutes 37 seconds	3 minutes 55 seconds	2 minutes 54 seconds	2 minutes 25 seconds	1 minute 44 seconds
	Dispersing uniformity	Do not detect	Part is passed through	Do not pass through on a small quantity	Do not pass through on a small quantity	All pass through	All pass through
								Mouthfeel	Very poor	Very poor	Generally	Generally	Better	Better

No. 6 prescriptions are optimum prescription as shown in Table 1, and the midbody particle degree of tightness is moderate, and is better mobile, and institute's pressing disintegration time, dispersing uniformity and suspendible stability all can reach requirement, therefore, determine that the adjuvant prescription is No. 6 prescriptions.The supplementary product consumption of producing 1000 this product is: cross-linked pvp 100g, CMS-Na100g, microcrystalline Cellulose 140g, aspartame 10g, magnesium stearate 4g, micropowder silica gel 4g.

4. the pilot scale demonstration test of production technology

By above definite prescription and preparation technology, middle trial production three batch samples, production scale are 10 times of recipe quantity.As a result, the sample yield is more stable, and all greater than 95%, and it is all up to specification by the check of this product quality standard to produce the gained sample.Show the production technology basic feasible solution, scalable production.

5, quality standard research

The dispersible tablet of this method preparation has been formulated the thin layer discrimination method to Bulbus Fritillariae Thunbergii, Radix Salviae Miltiorrhizae, Spica Prunellae, Radix Astragali four Chinese medicine in its quality standard, and adopts high performance liquid chromatography that the content of danshensu in the finished product has been carried out quantitative control.With octadecylsilane chemically bonded silica is filler; Methanol-water-glacial acetic acid (8: 91: 1) is a mobile phase; The detection wavelength is 281nm.Number of theoretical plate calculates by the danshensu peak should be not less than 4000.Danshensu peak and other composition peak energy reach baseline separation under this condition, and baseline is steady.Through tests such as specificity, linearity and the range of linearity, precision, stability, repeatability, the response rate, the result shows that this method specificity is strong, highly sensitive, precision is high, the response rate meets the quantitative assay requirement.

6, stability study

The present invention produces three batch samples as a trial and adopts simulation listing packing, and room temperature kept sample 18 months, investigated the situation of change of indexs such as sample character, discriminating, dispersing uniformity, microbial limit, content respectively.The result shows, sample is through the test that keeps sample of 18 months room temperatures, its steady quality, and every index all meets the requirements.。

7, the selection of immediate packaging materials and foundation

The dispersible tablet of the present invention's preparation is a Chinese medicine preparation, should note sealing, damp proof insulation when storing, and has therefore selected the plastic-aluminum bubble-cap as its packaging material.This material light weight is transparent, the steam good barrier property, and stable in properties is difficult for and medicine generation chemical reaction, is easy to processing, and easily reclaims compliance with environmental protection requirements.Advantages such as in addition, this packaging material also have, and are elegant in appearance, easy to carry, and cost is lower.

After adopting aluminium-plastic bubble plate packing, can reach sealing, damp proof insulation, that can ensure drug quality is stable.Through 18 months long term test, the result showed: this product quality is basicly stable.

In sum, the mammary healthy dispersion tablet of method preparation of the present invention also has some advantages of self outside the advantage of inheriting tablet:

1, mammary healthy dispersion tablet oral after, rapidly disintegration of medicine is conducive to fully absorb and the performance curative effect, has overcome the slow deficiency of traditional Chinese medicine onset, the characteristics that tool is quick-acting.

2, mammary healthy dispersion tablet is because adopt superfine silica gel powder etc. as glidant; the flowability of particle or powder can be in pelletizing press sheet or direct powder compression, effectively improved, disintegration and the dissolution rate of insoluble drug can be significantly improved behind the simultaneously silanol base of the Silica Surface absorption medicine.

3, mammary healthy dispersion tablet is uniformly dispersed in medium, and single dose is more accurate.

4, mammary healthy dispersion tablet has the advantage of tablet and granule simultaneously, taking convenience, and it is various to take mode, can swallow, chew to contain and suck or with taking after the aqueous dispersion, especially is fit to the old man and the patient of the difficulty of swallowing takes.

5, mammary healthy dispersion tablet can cover the bitter taste of Rukang granules, makes medicine can bring into play rapidly curative effect, reduces patient's misery.

6, the production technology of mammary healthy dispersion tablet is identical with conventional tablet, need not specific (special) requirements, need not again to add equipment, and production cost is low.

Based on advantage and the characteristics of above-mentioned mammary healthy dispersion tablet, believe that it necessarily can satisfy the demand of extensive patients, benefit society.

Claims (4)

1. the preparation technology of a mammary healthy dispersion tablet is characterized in that, this technology may further comprise the steps:

1) per 1000 tablet recipes of mammary healthy dispersion tablet

Raw material of Chinese medicine: Concha Ostreae 75g, Olibanum 30g, Fructus Trichosanthis 75g, Sargassum 60g, Radix Astragali 120g, Myrrha 30g, Radix Asparagi 60g, Spica Prunellae 75g, rhizoma sparganic 30g, Radix Scrophulariae 60g, Rhizoma Atractylodis Macrocephalae 60g, Bulbus Fritillariae Thunbergii 30g, Rhizoma Curcumae 30g, Radix Salviae Miltiorrhizae 75g, Endothelium Corneum Gigeriae Galli (parched) 30g;

Adjuvant: cross-linked pvp 50g～180g, CMS-Na 40g～180g, microcrystalline Cellulose 30g～140g, magnesium stearate 2g～10g, micropowder silica gel 3g～25g, aspartame 2g～15g;

2) preparation technology

With above ten Chinese medicine of the five flavours raw materials, Endothelium Corneum Gigeriae Galli (parched) wherein, Bulbus Fritillariae Thunbergii, Olibanum, Myrrha four flavor is ground into fine powder, and all the other ten decoct with water secondary simply, for the first time adding water is 12 times of amounts of raw material of Chinese medicine, and adding water for the second time is 10 times of amounts of raw material of Chinese medicine, decocts 2 hours at every turn, collecting decoction, filter, the filtrate cooling adds natural clarifying agent, stir, left standstill 4 hours, and filtered, under 60 ℃ of conditions, filtrate is concentrated into relative density 1.10, drying is ground into fine powder, adds the adjuvant cross-linked pvp in above-mentioned four Chinese medicine powder and the prescription, carboxymethylstach sodium, microcrystalline Cellulose, aspartame, mixing, with 80～95% alcohol granulations, drying, granulate, add magnesium stearate, micropowder silica gel, mixing is pressed into 1000, promptly.

2. preparation technology as claimed in claim 1, it is characterized in that, described natural clarifying agent adding method is, at first press 3% of decocting liquid amount and stir the B component solution of adding 1%, stirred once in 30 minutes at every interval, after 2 hours, add 1% A component solution of decocting liquid amount 1.5% with quadrat method, restir once gets final product after 50 minutes.

3. preparation technology as claimed in claim 1 is characterized in that, also adds flavoring orange essence or citric acid or other correctives in the described adjuvant.

4. preparation technology as claimed in claim 2 is characterized in that, described Aspartane replaces with cyclamate or steviosin or other sweeting agent.