CN106074681A - A kind of dispersible tablets of Chinese medicine of anti-hepatic fibrosis and preparation method thereof - Google Patents
A kind of dispersible tablets of Chinese medicine of anti-hepatic fibrosis and preparation method thereof Download PDFInfo
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- CN106074681A CN106074681A CN201610436888.2A CN201610436888A CN106074681A CN 106074681 A CN106074681 A CN 106074681A CN 201610436888 A CN201610436888 A CN 201610436888A CN 106074681 A CN106074681 A CN 106074681A
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- chinese medicine
- hepatic fibrosis
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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)
- A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
- A61K36/484—Glycyrrhiza (licorice)
-
- 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)
- A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
- A61K36/489—Sophora, e.g. necklacepod or mamani
-
- 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
- A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
- A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
-
- 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
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
-
- 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
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
Abstract
The invention discloses the dispersible tablets of Chinese medicine of a kind of anti-hepatic fibrosis, the raw material including following weight/mass percentage composition is made: include that the raw material of following weight/mass percentage composition is made: liquorice beverage extract 12% 20%, Radix Sophorae Flavescentis water extract 10% 18%, disintegrating agent 5% 20%, swellability adjuvant 4% 10%；Binding agent 2% 10%, lubricant 0.5% 2% and filler 32.5% 58%.The dispersible tablets of Chinese medicine taking convenience of this anti-hepatic fibrosis, good absorbing, and good stability.
Description
Technical field
The invention belongs to Chinese medicinal composition preparation technical field, be specifically related to a kind of anti-hepatic fibrosis dispersible tablets of Chinese medicine and
Its preparation method.
Background technology
Hepatic fibrosis is common clinical and frequently-occurring disease, and main pathological change is: the extracellular matrix egg based on collagen
White in liver over-deposit.The hepatic fibrosis cause of disease is sufficiently complex, can by hepatitis virus, excessive consumption of alcohol, non-alcoholic fatty liver disease and
Autoimmune diseasees etc. cause.Hepatic fibrosis is acknowledged as the cercinoma prophase pathologic change of liver cirrhosis and primary hepatocyte hepatocarcinoma.Generation
The clinical epidemiology data that boundary's health organization is announced shows, chronic hepatitis B is suffered from more than 2.4 hundred million people in the whole world, and 1.5 hundred million people suffer from
There is chronic hepatitis c.China is the district occurred frequently that viral hepatitis is popular, and chronic hepatitis patient is up to about 3,000 ten thousand；Wherein, 40%
Patient may develop into hepatic fibrosis or liver cirrhosis, and the patient of about 10% ultimately forms hepatocellular carcinoma.It addition, fatty liver
And the sickness rate of autoimmunity hepatic disease, rise the most year by year in China；Hepatic fibrosis progression becomes liver cirrhosis or hepatocyte liver
Cancer is a complicated pathological process multifactor, polygenic, lacks effective medicine at present.Although interferon, lamivudine
With adefovir ester etc., hepatitis B virus infection had certain curative effect, but its clinical effective rate also only has about 30%-40%.Find
The active drug of preventing and treating hepatic fibrosis, especially finds the prescription clinical meaning weight of effective effect of anti hepatic fibrosis from Chinese medicine
Greatly.
Radix Sophorae Flavescentis, Radix Glycyrrhizae and effective extract thereof can as treatment hepatic disease ancillary drug, but Long-term Oral its
Effective extract, patient has the serious adverse reactions such as water-sodium retention, hypertension and hypokalemia.Intravenous administration, because of the course for the treatment of too
Long, patient is difficult to accept, and because of its poorly water-soluble, bioavailability is low.
Summary of the invention
The technical problem to be solved is for above-mentioned the deficiencies in the prior art, it is provided that it is suitable that one improves patient
The dispersible tablets of Chinese medicine of the anti-hepatic fibrosis of answering property；The dispersible tablets of Chinese medicine taking convenience of this anti-hepatic fibrosis, good absorbing, biological utilisation
Degree height, and good stability.
For solving above-mentioned technical problem, the technical solution used in the present invention is, the dispersible tablets of Chinese medicine of a kind of anti-hepatic fibrosis,
Raw material including following weight/mass percentage composition is made: liquorice beverage extract 12%-20%, Radix Sophorae Flavescentis water extract 10%-18%, collapse
Solve agent 5%-20%, swellability adjuvant 4%-10%；Binding agent 2%-10%, lubricant 0.5%-2% and filler 32.5%-
58%.
Further, this disintegrating agent is cross linked polyvinyl pyrrolidone (PVPP), carboxymethyl starch sodium (CMS-Na) and hands over
One or more in connection Sodium Tvlose (CCNa)；
This swellability adjuvant is one or both in sodium alginate and hydroxypropylcellulose；
This binding agent is polyvidone ethanol solution；
This lubricant is one or both in micropowder silica gel and magnesium stearate；
This filler is the mixture of microcrystalline Cellulose or microcrystalline Cellulose and calcium sulfate.
Further, this liquorice beverage extract by Licorice root, filtering drying and obtain；Described Radix Sophorae Flavescentis water extract is by hardship
Ginseng decocting liquid, filtering drying and obtain.
The invention also discloses the preparation method of the dispersible tablets of Chinese medicine of above-mentioned a kind of anti-hepatic fibrosis, the method is as follows:
Step one, weight/mass percentage composition according to each raw material, weigh above-mentioned raw materials respectively；
Step 2, by principal agent liquorice beverage extract and Radix Sophorae Flavescentis water extract and disintegrating agent, swellability adjuvant, correctives, fill out
Fill the agent method mix homogeneously with equal increments, obtain mixture；
Step 3, binding agent is added soft material processed in the mixture in step 2, cross 24 mesh sieves and pelletize, be then dried
Process, and cross 24 mesh sieve granulate；
Step 4, addition lubricant, stir, and tabletting i.e. obtains this dispersible tablet.
Further, the raw material in this step 2 before combination, the most ground 100 mesh sieves.
Further, in this step 4, the pressure size in tableting processes is 4～6Kg.
The advantage of the dispersible tablets of Chinese medicine of a kind of anti-hepatic fibrosis of the present invention and preparation method thereof is as follows:
1. being prone to absorb, dissolution is compared with the height of conventional tablet；Disintegrate dispersion in this dispersible tablet 3min in vivo, it is easy to quickly
Absorb.2., compared with venous transfusion, safety is high；In venous transfusion, medicinal liquid enters internal by blood, and danger is bigger；Adopt
Using this dispersible tablet, safety is good, reduces the untoward reaction of medicine.3. good water solubility, the swellability adjuvant of addition, have hydrophilic
Base, adds the water solublity of effective ingredient.4. it is prone to patient take, for the patient of dysphagia, or can not directly swallow
The patient of tablet, can dissolve in this dispersible tablet in water or in milk, patient take.5. the good stability of dispersible tablet, guarantees the quality
Phase is long.6. preparation method is simple, is suitable to industrialized production.
Detailed description of the invention
A kind of dispersible tablets of Chinese medicine of anti-hepatic fibrosis, each embodiment is as follows:
Table 1 embodiment form
In the various embodiments described above, when prepared by reality, adjust the amount of filler, be simultaneously introduced appropriate correctives；Taste masking
Agent is one or more in aspartame, stevioside, acesulfame potassium and Mentholum.In the various embodiments described above, made point
The gross weight of discrete piece is 100g, and the tablet weight of the dispersible tablet of preparation, based on 0.4g/ sheet, can press 250.
The preparation method of the dispersible tablets of Chinese medicine of a kind of anti-hepatic fibrosis in the various embodiments described above is as follows:
Step one, weight/mass percentage composition according to each raw material, weigh above-mentioned raw materials respectively；
Step 2, by principal agent liquorice beverage extract and Radix Sophorae Flavescentis water extract and disintegrating agent, swellability adjuvant, correctives, fill out
Fill the agent method mix homogeneously with equal increments, obtain mixture；Raw material before combination, the most ground 100 mesh sieves；
Step 3, binding agent is added soft material processed in the mixture in step 2, cross 24 mesh sieves and pelletize, be then dried
Process, and cross 24 mesh sieve granulate；
Step 4, add lubricant, stir, tabletting i.e. obtains this dispersible tablet, the pressure size in tableting processes be 4～
6Kg。
In the present invention, by the dispersible tablets of Chinese medicine of a kind of anti-hepatic fibrosis prepared in the various embodiments described above with containing this principal agent
Comparative example 1 compare with comparative example 2, wherein: comparative example 1 is conventional tablet, principal agent liquorice beverage extract and Radix Sophorae Flavescentis water extraction
The content of thing is same as in Example 5, is mixed with starch slurry, beta-schardinger dextrin-etc. by principal agent, film-making agent.Comparative example 2 is capsule, main
The content of medicine liquorice beverage extract and Radix Sophorae Flavescentis water extract is same as in Example 5, principal agent and starch mixing granulation, pours into capsule i.e.
?.Result such as table 2:
Table 2 is the discrete piece performance parameter value corresponding with comparative example that each embodiment prepares
Dissolution Evaluation:
As shown in table 2, time in the 10min that 10min dissolution refers to, the principal agent of dissolution accounts for the percentage ratio of principal agent total amount, it is known that:
The principal agent dissolution of the dispersible tablet in the present invention is good.Adjuvant can add the dissolution of principal agent, and adjuvant itself, as carrier, promotes main
Medicine is absorbed.
Suspension ability evaluation methodology is as follows:
Taking dispersible tablet 1, put into (20 ± 1) DEG C, in 50mL water, be sufficiently stirred for, filter paper filters, and surveys immediately at 700nm
Fixed its light transmittance T0, and light transmittance when recording 0,2,4,6,8,10,15min, every kind measures 6, after taking arithmetic mean of instantaneous value, calculates
(Tt-T0)/T0, maps to time t with (Tt-T0)/T0, returns to obtain linear equation and slope k with method of least square, comment with T0, k
The suspension ability of valency various prescription dispersible tablet: T0 value is the least shows that suspension is the most muddy；Slope k is the least, shows that suspension granule sinks
Drop the slowest, the most stable.Being known by the data in table 2, the suspension ability experiment of the dispersible tablet in the present invention, slope k is little, this dispersible tablet
Suspension is more uniform, granule sedimentation is slow and stable.
Dispersing uniformity evaluation methodology is as follows:
Hanging basket is hung on support by the stainless steel shaft of upper end, immerses in 1000ml beaker, and regulate hanging basket position,
Making it drop to screen cloth during low spot is 710um away from beaker bottom 25mm, the sieve aperture internal diameter of stainless steel cloth, and water temperature is 15-25 DEG C,
Taking dispersible tablet 6, put in the glass tubing of above-mentioned hanging basket respectively, start disintegration tester and check, each all should collapse in 3min
Solve and pass through screen cloth (2015 editions pharmacopeia inspection requirements).Dispersible tablet disintegrate in the present invention is fast, dissolution is fast.
Estimation of stability:
1. hot test:
Dispersible tablet in the present invention is placed in the container of sealing clean, control temperature ± 2 DEG C, relative humidity ± 5%,
Place 10 days under the conditions of 60 DEG C, in sampling detection in 0,5,10 days.Compared with 0 day, all do not occur significantly to change.
The highest wet test:
This dispersible tablet is placed in constant humidity incubator, in 25 DEG C, place 10 days under the conditions of RH92.5% ± 5%, 0,5,
Sampling detection in 10 days, moisture absorption weightening finish is respectively less than 5%.
3. accelerated test
Take this dispersible tablet 40 ± 2 DEG C DEG C, test under the conditions of RH75% ± 5%, testing period the 0th, 1,2,3,6
Sampling detection at the individual the end of month.All do not occur significantly to change.
4. long term test:
Take the dispersible tablet in the present invention, 25 ± 2 DEG C, under the conditions of RH60% ± 10%, respectively at 0,3,6,9,12,18
Moon sampling detection, there is not significant change in this dispersible tablet.
This project is subsidized by state natural sciences fund (Grant No.: 81274171), and inventor finds in development process,
The kind of adjuvant, consumption have considerable influence to the drug effect of this dispersible tablet, to this end, carry out series of experiments, to prove work of the present invention
Skill reasonable, quality controllable, to guarantee the drug effect of medicine.Detailed process is as follows:
1. Study on Forming
Optimal moulding process is preferably gone out by single factor test and orthogonal experiment.Single factor test is mainly with disintegration, outward appearance, dispersion
Uniformity is index, has investigated the various factors that may affect dispersible tablet quality, including disintegrating agent, binding agent, swellability adjuvant
Deng.Each index requires detection according to the Pharmacopoeia of the People's Republic of China (four, 2015 editions).
The screening of 1.1 disintegrating agents
Adding filler microcrystalline Cellulose, each disintegrating agent consumption is tablet weight 10%, principal agent and each adjuvant and all crosses 100 mesh sieves
After mixing, add 5% polyvidone (PVP) 50% ethanol, make soft material, cross 24 mesh sieve wet granulations.Granule is dried at 50 DEG C, mistake
24 mesh sieve granulate, additional magnesium stearate lubricant, tabletting after mix homogeneously, tablet weight is 0.4g.Other conditions are constant, result such as table
3。
The screening of table 3 disintegrating agent kind
As known from Table 3, select respectively above-mentioned four kinds of disintegrating agents dispersible tablet can disintegrate within 3min, result shows to gather
Ethylene ratio pyrrolidone (PVPP), Sodium Tvlose (CCNa) and PVP (CMS-Na) disintegrate effect are preferable,
Optimal disintegrating agent can be filtered out by screening further.
1.2 disintegrating agent use in conjunction are investigated
When single disintegrating agent effect is not so good, if with two or more disintegrating agent compatibilities, effect can be better than single
Disintegrating agent, can reduce the cost of film-making simultaneously.By PVP (PVPP), Sodium Tvlose (CCNa) and poly-
Ethylene ratio pyrrolidone (CMS-Na) combination of two is investigated.Add filler microcrystalline Cellulose auxiliary materials and mixing, principal agent and each auxiliary
After 100 mesh sieve mixings all crossed by material, add 2% polyvidone (PVP) 50% ethanol, make soft material, cross 24 mesh sieve wet granulations.Granule
Dried at 50 DEG C, to cross 24 mesh sieve granulate, add tabletting after magnesium stearate mix homogeneously, tablet weight is 0.4g, result such as table 4.
The screening of table 4 disintegrating agent use in conjunction
As seen from the results in Table 4, disintegrating agent PVP (PVPP) is combined with PVP (CMS-Na)
Application disintegrate effect is relatively.
The screening of 1.3 filleies
In basic prescription ratio, it is separately added into microcrystalline Cellulose (MCC), starch, calcium sulfate and lactose, coughs up with polyethylene ratio
Alkanone (PVPP) and PVP (CMS-Na) are disintegrating agent (accounting for tablet weight 10%), and 100 mesh all crossed by principal agent and each adjuvant
After sieve mixing, add 50% ethanol of 5%PVP, make soft material, cross 24 mesh sieve wet granulations.Granule is dried at 50 DEG C, crosses 24
Mesh sieve granulate, additional magnesium stearate lubricant, tabletting after mix homogeneously, tablet weight is 0.4g.Other conditions are constant, and screening is filled
Agent.Result such as table 5.
The screening of table 5 filler
As known from Table 5, the slice, thin piece that starch, lactose and calcium sulfate are suppressed as filler, its dispersing uniformity is the most defective,
And microcrystalline Cellulose is as filler, tablet character and disintegrate are relatively good, so finally selecting microcrystalline Cellulose as filling
Agent.
1.4 swellability adjuvant screenings
With hardness, disintegration time and suspension ability as inspection target, according to basic prescription, add filler microcrystalline Cellulose,
Other adjuvants such as disintegrating agent PVP (PVPP) and PVP (CMS-Na).Principal agent and each adjuvant all mistakes
After 100 mesh sieve mixings, add 2% polyvidone (PVP) 50% ethanol, make soft material, cross 24 mesh sieve wet granulations.Granule is at 50 DEG C
After drying, crossing 24 mesh sieve granulate, add tabletting after the magnesium stearate mix homogeneously of 1%, tablet weight is 0.4g, result such as table 6.
The screening of table 6 swellability adjuvant
As shown in Table 6, swellability adjuvant sodium alginate and hydroxypropylcellulose effect are preferable.
Claims (6)
1. the dispersible tablets of Chinese medicine of an anti-hepatic fibrosis, it is characterised in that include that the raw material of following weight/mass percentage composition is made: sweet
Grass water extract 12%-20%, Radix Sophorae Flavescentis water extract 10%-18%, disintegrating agent 5%-20%, swellability adjuvant 4%-10%；
Binding agent 2%-10%, lubricant 0.5%-2% and filler 32.5%-58%.
2. according to the dispersible tablets of Chinese medicine of a kind of anti-hepatic fibrosis described in claim 1, it is characterised in that described disintegrating agent is for handing over
The one in (CCNa) received by connection PVP (PVPP), carboxymethyl starch sodium (CMS-Na) and cross-linked carboxymethyl cellulose
Or it is multiple；
Described swellability adjuvant is one or both in sodium alginate and hydroxypropylcellulose；
Described binding agent is polyvidone ethanol solution；
Described lubricant is one or both in micropowder silica gel and magnesium stearate；
Described filler is the mixture of microcrystalline Cellulose or microcrystalline Cellulose and calcium sulfate.
3. according to the dispersible tablets of Chinese medicine of a kind of anti-hepatic fibrosis described in claim 2, it is characterised in that described liquorice beverage extracts
Thing by Licorice root, filtering drying and obtain；Described Radix Sophorae Flavescentis water extract by Radix Sophorae Flavescentis decocting liquid, filtering drying and obtain.
4., according to the preparation method of the dispersible tablets of Chinese medicine of a kind of anti-hepatic fibrosis described in claim 1,2 or 3, its feature exists
In, the method is as follows:
Step one, weight/mass percentage composition according to each raw material, weigh above-mentioned raw materials respectively；
Step 2, by principal agent liquorice beverage extract and Radix Sophorae Flavescentis water extract and disintegrating agent, swellability adjuvant, correctives, filler
With the method mix homogeneously of equal increments, obtain mixture；
Step 3, binding agent is added soft material processed in the mixture in step 2, cross 24 mesh sieves and pelletize, be then dried place
Reason, and cross 24 mesh sieve granulate；
Step 4, addition lubricant, stir, and tabletting i.e. obtains this dispersible tablet.
5. according to the preparation method of dispersible tablets of Chinese medicine of a kind of anti-hepatic fibrosis described in claim 4, it is characterised in that described
Raw material in step 2 before combination, the most ground 100 mesh sieves.
6. according to the preparation method of dispersible tablets of Chinese medicine of a kind of anti-hepatic fibrosis described in claim 4, it is characterised in that described
In step 4, the pressure size in tableting processes is 4～6Kg.
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108743656A (en) * | 2018-09-17 | 2018-11-06 | 石磊 | Kuh-seng Radix Glycyrrhizae prescription for treating non-alcohol fatty liver |
| WO2018201920A1 (en) * | 2017-05-02 | 2018-11-08 | 上海中华药业有限公司 | Use of dragon tiger panacea in preparation of drug for preventing and/or treating hepatic fibrosis |
| CN111603501A (en) * | 2020-05-11 | 2020-09-01 | 中国中医科学院中医临床基础医学研究所 | Traditional Chinese medicine composition for primary liver cancer and application thereof |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1312077A (en) * | 2001-01-04 | 2001-09-12 | 贺平 | Composite component comprising the effective extracts of licorice and lightyellow sophora and its application |
| CN102772455A (en) * | 2012-07-10 | 2012-11-14 | 石河子大学医学院第一附属医院 | Seabuckthorn flavone dispersible tablets |
-
2016
- 2016-06-17 CN CN201610436888.2A patent/CN106074681A/en active Pending
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1312077A (en) * | 2001-01-04 | 2001-09-12 | 贺平 | Composite component comprising the effective extracts of licorice and lightyellow sophora and its application |
| CN102772455A (en) * | 2012-07-10 | 2012-11-14 | 石河子大学医学院第一附属医院 | Seabuckthorn flavone dispersible tablets |
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2018201920A1 (en) * | 2017-05-02 | 2018-11-08 | 上海中华药业有限公司 | Use of dragon tiger panacea in preparation of drug for preventing and/or treating hepatic fibrosis |
| CN108743656A (en) * | 2018-09-17 | 2018-11-06 | 石磊 | Kuh-seng Radix Glycyrrhizae prescription for treating non-alcohol fatty liver |
| CN111603501A (en) * | 2020-05-11 | 2020-09-01 | 中国中医科学院中医临床基础医学研究所 | Traditional Chinese medicine composition for primary liver cancer and application thereof |
| CN111603501B (en) * | 2020-05-11 | 2022-03-25 | 中国中医科学院中医临床基础医学研究所 | Traditional Chinese medicine composition for primary liver cancer and application thereof |
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Application publication date: 20161109 |