CN1679901A - Compound preparation of Jianganling for liver and its making method - Google Patents
Compound preparation of Jianganling for liver and its making method Download PDFInfo
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Abstract
A Chinese medicine 'Jianganling' in the form of dispersing tablet, dripping pill and softgel for taking care of liver health and treating hepatism is prepared from the extracts of schisandra fruit, red sage root and ganoderma, and proper additive.
Description
Technical field
The present invention relates to the field of Chinese medicines, be specifically related to a kind of Schizandrol compound Chinese medicinal preparation and preparation method that has improved drug effect.
Technical background
JIANGANLING JIAONANG is the pure Chinese medicinal preparation that is used for acute, delay property, chronic hepatitis, has replenishing QI to invigorate the spleen, blood circulation promoting and blood stasis dispelling; Has the effect that reduces glutamate pyruvate transaminase.Record in 20 in Ministry of Public Health Chinese traditional patent formulation preparation.This medicine medicine source extensively is easy to get, and curative effect is reliable.But along with the continuous variation of environment and human adaptive variation for medicine, people have had higher requirement for the bioavailability of Chinese medicine and drug effect, drug quality.
Application number 93103427.2 discloses a kind of Schizandrol Chinese medicine preparation, and its prescription is different with theme of the present invention.
Summary of the invention
The object of the invention is to optimize the prescription medicinal substances extract process of Chinese medicine, and adds appropriate amount of auxiliary materials, and a kind of Schizandrol compound Chinese medicinal preparation and preparation method that has improved bioavailability and drug effect is provided.
The present invention takes following design: the component weight proportion of Schizandrol preparation of the present invention is:
Seed of Fructus Schisandrae Chinensis extractum 130～160g, Ganoderma extractum 20～45g, Radix Salviae Miltiorrhizae extractum 20～40g
Above-mentioned component cooperates the pharmaceutically alleged adjuvant or the substrate of the suitable kind of employing to make drop pill, soft capsule, dispersible tablet, pellet capsule respectively, as making soft capsule with disperse medium, suspending agent, antiseptic; Or make dispersible tablet with filler, disintegrating agent, wetting agent, lubricant; Or make drop pill with drop pill substrate.
Optimum ratio is: contain in 1000 soft capsules:
Seed of Fructus Schisandrae Chinensis extractum 150g Ganoderma extractum 50g Radix Salviae Miltiorrhizae extractum 30g
With disperse medium (80～420g), suspending agent (4～65g), (0.1～8g) makes soft capsule liquid to antiseptic; Consumption is preferred: be disperse medium 200g, suspending agent 25g, antiseptic 0.5g.
Softgel shell is made up of gelatin or Polyethylene Glycol 41.5%～68%, glycerol 1.3%, additives 0.2% and 30.5%～57.0% in water.
Contain in 1000 dispersible tablets:
It is that 50～450g, disintegrating agent are that 12～100g, lubricant are 5～15g that seed of Fructus Schisandrae Chinensis extractum 150g Ganoderma extractum 50g Radix Salviae Miltiorrhizae extractum 30g needs filler loading.Consumption is preferred: filler loading is that 240g, disintegrating agent are that 30g, lubricant are 10g.
The drop pill of 1000 parts of doses can be 3000～20000, contains:
Seed of Fructus Schisandrae Chinensis extractum 150g Ganoderma extractum 50g Radix Salviae Miltiorrhizae extractum 30g drop pill substrates quantity is 80～600g.Consumption is preferred: be 240g
Medical material all uses by the record of document specifies such as Chinese Pharmacopoeia.
Seed of Fructus Schisandrae Chinensis extractum of the present invention, Ganoderma extractum, Radix Salviae Miltiorrhizae extractum are meant through following technology and make:
Fructus Schisandrae Chinensis extrat: get seed of Fructus Schisandrae Chinensis, be crushed to 30 ~ 80 orders, can be earlier with 1～2 times of amount 95% ethanol moistening dipping, continuously filter with 7～12 times of amount 95% alcohol dipping 48 hours, filtrate is left standstill, separate oil reservoir after decompression recycling ethanol do not distinguish the flavor of to there being alcohol, promptly;
Or the improvement method for making of Fructus Schisandrae Chinensis extrat: get seed of Fructus Schisandrae Chinensis, be crushed to 30 ~ 80 orders, can continue with 7～12 times and measure 95% alcohol dipping 48 hours earlier with 1～2 times of amount 95% ethanol moistening dipping, filter, filtrate is left standstill, behind the separation oil reservoir, and weighing, what add 1/30～1/50 oil reservoir weight doubly reaches cyclodextrin, the powerful stirring makes abundant mixing 4 hours, and decompression recycling ethanol is not to there being the alcohol flavor, promptly.
This method for making gained schisandrin B content does not more add the technology that doubly reaches cyclodextrin and can significantly improve.
Ganoderma extractum: Ganoderma is got by Ganoderma extractum system, and chopping is 90% alcohol dipping 48 hours with 8 times of amount concentration, filter, decompression filtrate recycling ethanol gets ethanol extraction, medicinal residues decoct with water twice, and each 2 hours, collecting decoction, filter, filtrate is concentrated into thick paste, merges with above-mentioned ethanol extraction, add appropriate amount of starch, mixing, drying, promptly.
Radix Salviae Miltiorrhizae extractum: Radix Salviae Miltiorrhizae is got by Radix Salviae Miltiorrhizae extractum system, is ground into 20～60 purpose coarse powder, decocts with water 3 times, and each 6～12 times of amounts, each 2 hours, collecting decoction filtered, and filtrate is concentrated in right amount, drying, promptly.
Merge above-mentioned three kinds of extracts, be preparation drop pill, dispersible tablet, soft capsule,, the used medicinal substances extract of micropill.
Prepare soft capsule by following steps:
I) modulation capsule liquid: get one or more of seed of Fructus Schisandrae Chinensis extractum, Ganoderma extractum, Radix Salviae Miltiorrhizae extractum, adding disperse medium, antiseptic, suspending agent, emulsifying agent etc., stir, grind homogenizing, promptly get soft capsule liquid;
Ii) get gelatin, water, in heating in water bath dissolving down, mix homogeneously adds glycerol, antiseptic, additives, stirs, and after the vacuumize degassing, insulation is left standstill, and makes capsule material glue;
Iii) suppress or drip and make soft capsule: capsule liquid is encapsulated in the capsule material glue with soft capsule system of dripping or press; Promptly get the Schizandrol soft capsule.
The disperse medium of making soft capsule is: olive oil or other crude vegetals, or triglyceride oils, or oleic acid sorbitol ester, or olein: propylene glycol is 90: 10 mixture by weight, or Oleum Cocois C8/C10 monoglyceride or dibasic acid esters, or Oleum Cocois C8/C10 propylene glycol ester, or Oleum Cocois triglyceride, or the acetylizad monoglyceride of purification, or olein, or glyceryl linoleate, or the Polyethylene Glycol glyceryl laurate ester, or in the purification Oleum helianthi monoglyceride one or more, or the best peach kernel oil that uses: 1: 1 mixture of Oleum Sesami weight ratio;
The suspending agent of soft capsule is: can increase the solid matter of disperse medium viscosity, and as Cera Flava, aluminum monostearate, ethyl cellulose, carbomer etc., or the best Cera Flava that uses: 1.5: 3.5 mixture of ethyl cellulose weight ratio;
The antiseptic of soft capsule is: one or more in glycerol, propylene glycol, methyl parahydroxybenzoate, ethylparaben, propyl p-hydroxybenzoate, butyl p-hydroxybenzoate, benzyl p-hydroxybenzoate, the P-hydroxybenzoic acid phenyl ester.
Prepare dispersible tablet by following steps:
Get seed of Fructus Schisandrae Chinensis extractum, Ganoderma extractum, Radix Salviae Miltiorrhizae extractum, add filler and part disintegrating agent mix homogeneously, granulate with the wetting agent moistening, drying, granulate adds remaining disintegrating agent and lubricant, mix homogeneously tabletting, promptly get the Schizandrol dispersible tablet, or wrap again according to making coated dispersing tablet.
Its The disintegrating agents of dispersible tablets is: crospolyvinylpyrrolidone, carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose, one or more of cross-linked carboxymethyl cellulose sodium etc., or the best crospolyvinylpyrrolidone that uses: 5: 1 mixture of cross-linked carboxymethyl cellulose sodium weight ratio;
Binding agent in the dispersible tablet is: the alcoholic solution of 40% ethanol～95% alcoholic solution or starch slurry or polyvinylpyrrolidone, or best 85% alcoholic solution that uses;
Filler is in the dispersible tablet: starch, or lactose or microcrystalline Cellulose, or one or more of precoking starch, mannitol etc., or the best starch that uses: lactose: 1: 2: 1 mixture of mannitol weight ratio;
Lubricant in the dispersible tablet is a magnesium stearate, or micropowder silica gel, or one or more of Pulvis Talci etc., or bestly uses micropowder silica gel.
Prepare drop pill by following steps:
Get seed of Fructus Schisandrae Chinensis extractum, Ganoderma extractum, Radix Salviae Miltiorrhizae extractum, add in the hot drop pill substrate of melting, mix homogeneously splashes into molding in the coolant, removes coolant, promptly gets the Schizandrol drop pill.
Described drop pill substrate is: Polyethylene Glycol is meant one or both the combination of Macrogol 4000 or polyethylene glycol 6000, and the best is a Macrogol 4000: the mixture of polyethylene glycol 6000 (3: 11), consumption are 80～600g; Condensing agent in its drop pill preparation is one of dimethicone, liquid paraffin, Oleum Camelliae, vegetable oil or two or more.
The preparation pellet capsule:
Get seed of Fructus Schisandrae Chinensis extractum, Ganoderma extractum, Radix Salviae Miltiorrhizae extractum, with doubly reach mix homogeneously such as cyclodextrin, precoking starch, take a morsel earlier to place and play female ball in the full-automatic coating pelletizing machine, select the appropriate female ball of particle diameter, continue to add medicated powder, reach 16～20 orders until particle diameter, gained micropill drying, or the coating after drying, promptly;
Described weight proportion is seed of Fructus Schisandrae Chinensis extractum, Ganoderma extractum, Radix Salviae Miltiorrhizae extractum: 100 parts, doubly reach 5 parts of cyclodextrin, and 10 parts of ethyl celluloses, 8 parts of precoking starch, 10 parts of microcrystalline Cellulose, wetting agent are 85% alcoholic solution of 6% polyvinylpyrrolidone.
Effect of the present invention:
Be objective evaluation Schizandrol treatment viral hepatitis clinical efficacy and safety, take random packet, the test method of contrast, Schizandrol soft capsule group, drop pill group, each 120 examples (male 95 example of dispersible tablet group, woman's 25 examples), JIANGANLING JIAONANG group 118 examples (male 97 examples, women 21 examples).
1 clinical data
Allly meet the full infectious disease of Chinese medical and the parasite chronic hepatitis B diagnostic criteria of can national meeting formulating for the third time in May nineteen ninety-five, age is in 18-60 year, male or female, and meet following condition: (1) HBsAg and HbeAg or anti--HBe are more than positive lasting half a year.(2) preceding 3 months of treatment or above Serum ALT continue or are undesired repeatedly, (3) serum bilirubin＜30 μ mol/L.(4) Serological testing does not have acute first type, third type and hepatitis E.(5) no decompensated cirrhosis.(6) clinical and lab testing does not have autoimmune hepatitis and alcoholic liver injury.(7) half a year not used antiviral drugs and immunoregulation medicine.
Therapeutic Method
The treatment group is totally 243 examples, takes Schizandrol soft capsule, drop pill, dispersible tablet respectively, soft capsule every day 3 times, each each 2; Or 20 of drop pill, 2 of dispersible tablets (dose and former capsule are consistent), continuing for 8 weeks is 1 course of treatment.Matched group is totally 72 examples, takes JIANGANLING JIAONANG, and every day 3 times, each 3, continuing for 38 weeks is 1 course of treatment.Matched group case alternative condition is identical with the treatment group.More than remove during two groups of treatments and use general vitamin B, outside C the is aid digestion class medicine, all not reuse antiviral drugs, immunoregulation medicine and have the hepatoprotective of reducing enzyme and treating jaundice.Difference not statistically significant (P＞0.05) is analysed in aspects such as two groups of patient ages, sex, the course of disease, symptom credit by statistics.
1.3 observation item and index
Per two weekly check ALT before the treatment, after the treatment beginning are till A5T, total bilirubin, A/G finish to treatment; Survey inspection HBsAg before the treatment, in the treatment, when treatment finishes respectively, HBeAg, anti--HBc (enzyme is exempted from method), HBV-DNA (PCR) method; The sings and symptoms of the relevant hepatitis of per two week records; The untoward reaction of regularly filling in summary sheet and writing down medicine,
1.4 curative effect determinate standard
Produce effects: subjective symptoms disappears, and the chronic hepatitis sign alleviates, and liver function test ALT, bilirubin recover normal, among the HBV-M HBeAg or (with) HBV-DNA turns out cloudy.
Effectively: subjective symptoms disappears or takes a turn for the better, and the chronic hepatitis sign is stable, and liver function test ALT, bilirubin recover normal, HBeAg or (with) HBV-DNA do not turn out cloudy.
Invalid: the subjective symptoms no change, the chronic hepatitis sign is constant, and liver function test is still unusual, HBeAg, HBV-DNA does not all turn out cloudy:
1.5 statistical method X
2Check and definite probabilistic method, inspection level.α＝0.05。
2 results
2.1 two groups of patient's clinical symptoms Signs are improved situation analysis and are seen Table 1:
| Group | Poor appetite | Feel sick | Weak | Liver is painful | Abdominal distention | Hepatomegaly | Splenomegaly | Liver palm | ??ALT | ??SB | |
| The treatment group | Unusually | ??103 | ??72 | ??103 | ??70 | ??82 | ??46 | ??12 | ??20 | ??120 | ??29 |
| Recover | ??101 | ??72 | ??85 | ??58 | ??70 | ??38 | ??6 | ??0 | ??98 | ??24 | |
| Matched group | Unusually | ??97 | ??69 | ??99 | ??59 | ??79 | ??45 | ??11 | ??21 | ??118 | ??27 |
| Recover | ??86 | ??68 | ??81 | ??35 | ??31 | ??22 | ??5 | ??0 | ??71 | ??23 | |
| ??X 2Value | ??7.261 | ??0.000 | ??0.017 | ??16.204 | ??36.616 | ??1.515 | ??0.000 | ??0.00 | ??13.356 | ??0.00 | |
| The P value | ??0.007 | ??0.489 | ??0.896 | ??0.000 | ??0.000 | ??0.001 | ??1.000 | ??0.50 | ??0.00 | ??1.00 |
As aspect the elimination such as nauseating, weak, two groups of difference are little in common clinical symptoms and Signs, but the treatment group is better than matched group aspect the eliminations such as, abdominal distention painful at sodium error, liver, hepatomegaly, and both differences all have statistical significance (P＜0.05); Also be better than matched group (P＜0.05) in treatment group aspect the ALT normalization rate.
The situation analysis 2.2 two groups of patient's hepatitis b virus markers are turned out cloudy.
Table 2: two groups of patient's hepatitis b virus markers situation analysis (example) of turning out cloudy
| Group | ????????????HBeAg | Anti-HBC | ????????HBV-DNA | ||||||
| Positive | Turn out cloudy | Negative conversion rate | Positive | Turn out cloudy | Negative conversion rate | Positive | Turn out cloudy | Negative conversion rate | |
| The treatment group | ??96 | ??36 | ??37.5 | ??115 | ??0 | ??0 | ??101 | ????39 | ??38.6 |
| Matched group | ??95 | ??17 | ??17.9 | ??116 | ??0 | ??0 | ??103 | ????19 | ??18.4 |
| ??X 2Value | ????????????9.154 | ??????????0.000 | ????????????10.193 | ||||||
| The P value | ????????????0.002 | ???????????1.000 | ????????????0.001 | ||||||
2.3 two groups of patient treatment interpretations of result see Table 3.
| Group | The example number | Produce effects | Effectively | Invalid | Total effective rate |
| Treatment group 1 | ??120 | ??44(36.7) | ????67(55.8) | ????9(7.5) | ??92.5 |
| Treatment group 2 | ??60 | ??21(35.0) | ????29(48.3) | ????4(6.7) | ??83.3 |
| Treatment group 3 | ??63 | ??22(34.9) | ????31(49.2) | ????5(7.9) | ??84.1 |
| Matched group | ??118 | ??26(22.0) | ????49(41.5) | ????43(36.4) | ??63.5 |
Conclusion:
Chronic hepatitis B sickness rate height accounts for hepatitis B about 20%, and the course of disease is long, is difficult for radical cure, causes liver cirrhosis easily, and with primary hepatoma certain relation is arranged, and does not still have special effect medicine therapeutic at present both at home and abroad.The active drug of seeking the treatment chronic hepatitis B is the current very important problem of the world of medicine.Carry out clinical controlling by using Schizandrol, obtain satisfied effect, two groups there is no tangible untoward reaction in therapeutic process.
This paper result shows that Schizandrol treatment chronic hepatitis B curative effect in Clinical Application is satisfied, the effective percentage height, and short treating period has no adverse reaction, and is a relatively effective and safe drug.Excellent JIANGANLING JIAONANG is organized in treatment aspect the eliminations such as the Schizandrol soft capsule aches poor appetite, liver, abdominal distention, hepatomegaly, and both differences all have statistical significance (P＜0.05); Also be better than matched group (P＜0.05) in treatment group aspect the ALT normalization rate.
Advantage of the present invention is:
Drop pill: drop pill is the modern Chinese medicine novel form, belongs to solid dispersion system, and it is big to have specific surface area, and stripping is fast, the characteristics that bioavailability is high.And manufacturing cost is lower.Drops mostly is chemicals and uses, and the development of Chinese medicine dripping pills needs to test the choose reasonable substrate and make flow process by a large amount of.
Soft capsule: the soft capsule introduction also claims the flexible glue pill, and it is not have a kind of preparation that forms in sealings such as the non-water-soluble liquid of dissolution or suspension and the capsule shells with oils or to the gelatin thing.Soft capsule is the tablet that continues, and a kind of novel form that grows up after the injection, its shell are to form with the gelatin compacting, the aqueous medicinal liquid of bag in the softgel shell.The invention discloses the prescription and the method for making of Schizandrol soft capsule liquid and capsule material, the gained soft capsule quality is stable.
Dispersible tablet: be a kind of solidified liquid form of administration, disintegrate fully in 3 minutes at normal temperatures, the effective ingredient stripping is rapid.But solid state is taken, but also liquid condition is taken, and makes things convenient for the patient.The development of dispersible tablets of Chinese medicine need overcome and extract the difficult point that the extractum moisture absorption influences disintegrate, and the present invention is by the screening adjuvant, thereby it is stable to reach end product quality, and disintegrate is characteristics rapidly.
The forming technique of the present micropill of pellet capsule has multiple as rolls into ball method, method of extruding and kneading to pellets centrifugal fluidized granulation method etc., the invention discloses Schizandrol is made microsphere and its preparation and adjuvant, one-tenth ball method cost of the present invention is low, mustn't special installation gained micropill outward appearance bright and clean, the granularity unanimity; Good fluidity, size evenly are easy to fill.
Original capsule extracts active ingredients in preparation process is insufficient, and the schisandrin B yield is lower in the preparation, causes the waste of herb resource.Former dosage form is rotten for preventing the extract moisture absorption, has increased more starch based adjuvant, the large size capsule of every dress 0.5g, and the patient takes inconvenience, the usually therapy discontinued because taking inconvenience, or selection other drug.Innovation dosage form of the present invention, it is convenient that the patient is taken, and the medical material utilization rate is higher, and bioavailability of medicament, drug effect also have raising comparatively significantly, thereby the patient can be followed the doctor's advice, and finish the treatment of the corresponding course of treatment.
The specific embodiment:
Experimental example 1: the preparation of Schizandrol extract
Fructus Schisandrae Chinensis extrat:
Get seed of Fructus Schisandrae Chinensis, be crushed to 80 orders, can be earlier with 1.5 times of amount 95% ethanol moistening dippings, continuously filter with 8 times of amount 95% alcohol dipping 48 hours, filtrate is left standstill, separate oil reservoir after decompression recycling ethanol do not distinguish the flavor of to there being alcohol, promptly;
Ganoderma extractum:
Ganoderma is got by Ganoderma extractum system, and chopping is 90% alcohol dipping 48 hours with 8 times of amount concentration, filter, decompression filtrate recycling ethanol gets ethanol extraction, medicinal residues decoct with water twice, and each 2 hours, collecting decoction, filter, filtrate is concentrated into thick paste, merges with above-mentioned ethanol extraction, add appropriate amount of starch, mixing, drying, promptly.
Radix Salviae Miltiorrhizae extractum:
Radix Salviae Miltiorrhizae is got by Radix Salviae Miltiorrhizae extractum system, is ground into 40 purpose coarse powder, decoct with water 3 times, and each 10 times of amounts, each 2 hours, collecting decoction filtered, and filtrate is concentrated in right amount, drying, promptly.
Merge above-mentioned three kinds of extracts, be preparation drop pill, dispersible tablet, soft capsule,, the used medicinal substances extract of micropill.
Experimental example 2: improved the preparation of the Schizandrol extract of Fructus Schisandrae Chinensis extracting method:
The improvement method for making of Fructus Schisandrae Chinensis extrat:
Get seed of Fructus Schisandrae Chinensis, be crushed to 60 orders, can continue with 10 times and measure 95% alcohol dipping 48 hours earlier with 2 times of amount 95% ethanol moistening dippings, filter, filtrate is left standstill, behind the separation oil reservoir, and weighing, what add 140 oil reservoir weight doubly reaches cyclodextrin, the powerful stirring makes abundant mixing 4 hours, and decompression recycling ethanol is not to there being the alcohol flavor, promptly.
Compare with the preparation that does not add cyclodextrin inclusion compound among the embodiment 1, schisandrin B content on average exceeds about 21%.
Ganoderma extractum:
Ganoderma is got by Ganoderma extractum system, and chopping is 90% alcohol dipping 48 hours with 8 times of amount concentration, filter, decompression filtrate recycling ethanol gets ethanol extraction, medicinal residues decoct with water twice, and each 2 hours, collecting decoction, filter, filtrate is concentrated into thick paste, merges with above-mentioned ethanol extraction, add appropriate amount of starch, mixing, drying, promptly.
Radix Salviae Miltiorrhizae extractum:
Radix Salviae Miltiorrhizae is got by Radix Salviae Miltiorrhizae extractum system, is ground into 20～60 purpose coarse powder, decoct with water 3 times, and each 6～12 times of amounts, each 2 hours, collecting decoction filtered, and filtrate is concentrated in right amount, drying, promptly.
Merge above-mentioned three kinds of extracts, be preparation drop pill, dispersible tablet, soft capsule,, the used medicinal substances extract of micropill.
Embodiment 3: the preparation of Schizandrol drop pill:
The component weight proportion:
Seed of Fructus Schisandrae Chinensis extractum 150g, Ganoderma extractum 40g, Radix Salviae Miltiorrhizae extractum 30g
Macrogol 4000 600g
Make 5000
Get the 220g medicinal substances extract, in the drop pill substrate Polyethylene Glycol 9300 that 80 ℃ of heat of adding are melted, mix homogeneously splashes into molding in the coolant, removes coolant, promptly gets the Schizandrol drop pill
Coolant: 2 ℃ of liquid paraffin are an amount of
Embodiment 4: the preparation of Schizandrol drop pill:
The component weight proportion:
Seed of Fructus Schisandrae Chinensis extractum 150g Ganoderma extractum 40g Radix Salviae Miltiorrhizae extractum 30g
Macrogol 4000: polyethylene glycol 6000 (7.5: 2.5) 120g
Poloxamer 20g
Make 10000
The preparation drop pill: medicinal substances extract is crushed to 120 orders, taking polyethylene glycol 4000: 85 ℃ of heating and melting of polyethylene glycol 6000 (7.5: 2.5) water-bath, the fine powder that adds medicinal substances extract, and poloxamer, mix homogeneously, splash into while hot in the two first class silicone oil liquid coolants, drip and make drop pill, ball heavily is controlled to be 0.045～0.055, removes liquid coolant, coating promptly gets the commodity drop pill.
The mixture that keeps medicinal substances extract and substrate when dripping system is in 82 ℃, 90 centimetres of cooling column effective column lengths, and 5 ℃ of liquid coolants are dripped 55 on fast every part of clock, dropper mouth external diameter 2.5mm, internal diameter 2.0mm, then dripping the drop pill of making does not have the tail of taking off, and outward appearance is bright and clean shaped.
Coating solution is: polyvinylpyrrolidone 20g
Hydroxypropyl methylcellulose 5g
95% alcoholic solution 198m1
Pulvis Talci 6g
Magnesium stearate 2g
Titanium dioxide 6g
Polyethylene glycol 6000 2g
Pigment 3g
Embodiment 5: the preparation of Schizandrol drop pill:
The component weight proportion:
Seed of Fructus Schisandrae Chinensis extractum 150g, Ganoderma extractum 40g, Radix Salviae Miltiorrhizae extractum 30g
Macrogol 4000: polyethylene glycol 6000 (3: 11) 240g
Poloxamer 20g
Coolant: dimethicone is an amount of
Make 20000
Get seed of Fructus Schisandrae Chinensis extractum, Ganoderma extractum, Radix Salviae Miltiorrhizae extractum, be crushed to 100 orders or thinner, add in the hot drop pill substrate of melting, mix homogeneously splashes into molding in the coolant, removes coolant, promptly gets the Schizandrol drop pill.
Embodiment 6: the preparation of Schizandrol drop pill:
The component weight proportion:
Seed of Fructus Schisandrae Chinensis extractum 150g, Ganoderma extractum 40g, Radix Salviae Miltiorrhizae extractum 30g
Polyethylene Glycol 9300 60g
Poloxamer 20g
Make 2000
Coolant: dimethicone is an amount of
Get seed of Fructus Schisandrae Chinensis extractum, Ganoderma extractum, Radix Salviae Miltiorrhizae extractum, add in the hot drop pill substrate of melting, mix homogeneously splashes into molding in the coolant, removes coolant, promptly gets the Schizandrol drop pill.
Coolant: dimethicone is an amount of
Substrate in its drop pill is molecular weight by cured one or more of 2000～12000 Polyethylene Glycol, polyoxyethylene monostearate, sodium stearate or glycerin gelatine, poloxamer, stearic acid, glyceryl monostearate, worm.
Embodiment 7: the Schizandrol preparation of soft capsule
Seed of Fructus Schisandrae Chinensis extractum 450g Ganoderma extractum 120g Radix Salviae Miltiorrhizae extractum 90g
Cera Flava 65g;
Olive oil 420g
Propylene glycol 8g
Soybean lecithin 20
Make 1000
I) modulation capsule liquid: get seed of Fructus Schisandrae Chinensis extractum, Ganoderma extractum, Radix Salviae Miltiorrhizae extractum, adding disperse medium, antiseptic, suspending agent, emulsifying agent etc., stir, grind homogenizing, promptly get soft capsule liquid;
Ii) get gelatin, water, in heating in water bath dissolving down, mix homogeneously adds glycerol, antiseptic, additives, stirs, and after the vacuumize degassing, insulation is left standstill, and makes capsule material glue;
Iii) suppress or drip and make soft capsule: capsule liquid is encapsulated in the capsule material glue with soft capsule system of dripping or press; Control capsule grain is heavy, makes and makes 1000, promptly.
Cera Flava is a suspending agent, and the emulsifying agent soybean lecithin is an emulsifying agent in its soft capsule.
Olive oil is that the oil phase disperse medium also can be: the triglyceride oils of crude vegetal (as: soybean oil, Oleum Arachidis hypogaeae semen) or long-chain and medium-chain saturation in various degree, as: oleic acid sorbitol ester, olein: propylene glycol (90: 10), Oleum Cocois C8/C10 monoglyceride or dibasic acid esters, Oleum Cocois C8/C10 propylene glycol ester, Oleum Cocois triglyceride, the acetylizad monoglyceride of purification (Myvacet oil), olein, glyceryl linoleate, Polyethylene Glycol glyceryl laurate ester, purification Oleum helianthi monoglyceride.
Embodiment 8: the Schizandrol preparation of soft capsule
The component weight proportion:
Seed of Fructus Schisandrae Chinensis extractum 150g Ganoderma extractum 40g Radix Salviae Miltiorrhizae extractum 30g
Peach kernel oil 160g
Oleum Sesami 80g:
Cera Flava: ethyl cellulose weight ratio 1.5: 3.5 25
Ethylparaben 0.5g
Make 1000
I) modulation capsule liquid: get seed of Fructus Schisandrae Chinensis extractum, Ganoderma extractum, Radix Salviae Miltiorrhizae extractum, adding disperse medium, antiseptic, suspending agent, emulsifying agent etc., stir, grind homogenizing, promptly get soft capsule liquid;
Ii) get gelatin, water, in heating in water bath dissolving down, mix homogeneously adds glycerol, antiseptic, additives, stirs, and after the vacuumize degassing, insulation is left standstill, and makes capsule material glue;
Iii) make or drip and make soft capsule: capsule liquid is encapsulated in the capsule material glue with soft capsule system of dripping or press; Promptly get the Schizandrol soft capsule.
The suspending agent of soft capsule is: can increase the solid matter of disperse medium viscosity, as Cera Flava, aluminum monostearate, ethyl cellulose, carbomer etc. one or more.
The antiseptic of soft capsule is: one or more in glycerol, propylene glycol, methyl parahydroxybenzoate, ethylparaben, propyl p-hydroxybenzoate, butyl p-hydroxybenzoate, benzyl p-hydroxybenzoate, the P-hydroxybenzoic acid phenyl ester.
Embodiment 9: the Schizandrol preparation of soft capsule
The component weight proportion:
Seed of Fructus Schisandrae Chinensis extractum 150g Ganoderma extractum 40g Radix Salviae Miltiorrhizae extractum 30g
Peach kernel oil: 1: 1 80g of Oleum Sesami:
Cera Flava: 1.5: 3.5 4g of ethyl cellulose weight ratio
Ethylparaben 0.1g
Make 1000
I) modulation capsule liquid: get seed of Fructus Schisandrae Chinensis extractum, Ganoderma extractum, Radix Salviae Miltiorrhizae extractum, adding disperse medium, antiseptic, suspending agent, emulsifying agent etc., stir, grind homogenizing, promptly get soft capsule liquid;
Ii) get gelatin, water, in heating in water bath dissolving down, mix homogeneously adds glycerol, antiseptic, additives, stirs, and after the vacuumize degassing, insulation is left standstill, and makes capsule material glue;
Iii) suppress or drip and make soft capsule: capsule liquid is encapsulated in the capsule material glue with soft capsule system of dripping or press; Promptly get the Schizandrol soft capsule.
Embodiment 10: the Schizandrol preparation of soft capsule
The component weight proportion:
Seed of Fructus Schisandrae Chinensis extractum 150g Ganoderma extractum 40g Radix Salviae Miltiorrhizae extractum 30g
Peach kernel oil: 1: 1 200g of Oleum Sesami:
Cera Flava: ethyl cellulose weight ratio 1.5: 3.5 25
Ethylparaben 0.5g
I) modulation capsule liquid: get seed of Fructus Schisandrae Chinensis extractum, Ganoderma extractum, Radix Salviae Miltiorrhizae extractum, adding disperse medium, antiseptic, suspending agent, emulsifying agent etc., stir, grind homogenizing, promptly get soft capsule liquid;
Ii) get gelatin, water, in heating in water bath dissolving down, mix homogeneously adds glycerol, antiseptic, additives, stirs, and after the vacuumize degassing, insulation is left standstill, and makes capsule material glue;
Iii) suppress or drip and make soft capsule: capsule liquid is encapsulated in the capsule material glue with soft capsule system of dripping or press; Promptly get the Schizandrol soft capsule.
Softgel shell is made up of gelatin or Polyethylene Glycol 58%, glycerol 1.3%, additives 0.2% and water 40.5%.
Embodiment 11: the preparation of Schizandrol dispersible tablet
The component weight proportion:
Seed of Fructus Schisandrae Chinensis extractum 150g Ganoderma extractum 40g Radix Salviae Miltiorrhizae extractum 30g
Filler: pregelatinized Starch 30g and lactose 20g form;
Disintegrating agent: crospolyvinylpyrrolidone 8g;
Lubricant: magnesium stearate 5g;
Correctives: xylitol 30g;
Make 1000 Schizandrol dispersible tablets.
Get seed of Fructus Schisandrae Chinensis extractum, Ganoderma extractum, Radix Salviae Miltiorrhizae extractum, with pregelatinized Starch lactose and crospolyvinylpyrrolidone mix homogeneously, dilute alcohol solution (5 parts of polyvinylpyrrolidones: moistening system soft material 80% ethanol 100ml) with the content polyvinylpyrrolidone, granulate, drying, granulate adds disintegrating agent low-substituted hydroxypropyl cellulose disintegrating agent and lubricant micropowder silica gel and xylitol 30g tabletting, the bag film-coat, promptly.
The coating solution prescription can for:
Polyvinylpyrrolidone 24g
Crospolyvinylpyrrolidone 2g
Hydroxypropyl methylcellulose 4g
95% alcoholic solution 210ml
Pulvis Talci 5g
Magnesium stearate 2g
Titanium dioxide 6g
Polyethylene glycol 6000 3g
Pigment 3g
Embodiment 12: the preparation of Schizandrol dispersible tablet
The component weight proportion:
Seed of Fructus Schisandrae Chinensis extractum 150g Ganoderma extractum 40g Radix Salviae Miltiorrhizae extractum 30g
Pregelatinized Starch 210g
Lactose 240g;
Carboxymethyl starch sodium 16g
Low-substituted hydroxypropyl cellulose 48g;
Lubricant: micropowder silica gel 15g;
Correctives: xylitol 3g;
Make 1000 Schizandrol dispersible tablets.
Get seed of Fructus Schisandrae Chinensis extractum, Ganoderma extractum, Radix Salviae Miltiorrhizae extractum, with pregelatinized Starch lactose and carboxymethyl starch sodium 16g mix homogeneously, dilute alcohol solution (5 parts of polyvinylpyrrolidones: moistening system soft material 80% ethanol 100ml) with the content polyvinylpyrrolidone, granulate, dry, granulate adds disintegrating agent low-substituted hydroxypropyl cellulose disintegrating agent and lubricant micropowder silica gel and xylitol 3g tabletting, promptly gets the Schizandrol dispersible tablet.
Embodiment 13: the preparation of Schizandrol dispersible tablet
The component weight proportion:
Seed of Fructus Schisandrae Chinensis extractum 150g Ganoderma extractum 40g Radix Salviae Miltiorrhizae extractum 30g
Starch 60g
Lactose 120g
Manna 60g
Crospolyvinylpyrrolidone 25g
Cross-linked carboxymethyl cellulose sodium 5g
Lubricant: micropowder silica gel 15g;
Make 1000 Schizandrol dispersible tablets.
Get seed of Fructus Schisandrae Chinensis extractum, Ganoderma extractum, Radix Salviae Miltiorrhizae extractum, add filler and part disintegrating agent mix homogeneously, granulate with wetting agent 85% alcoholic solution moistening, dry, granulate, add remaining disintegrating agent and lubricant, mix homogeneously tabletting, promptly get the Schizandrol dispersible tablet, or wrap again according to making coated dispersing tablet.
Its The disintegrating agents of dispersible tablets is: crospolyvinylpyrrolidone, carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose, one or more of cross-linked carboxymethyl cellulose sodium etc., or the best crospolyvinylpyrrolidone that uses: 5: 1 mixture of cross-linked carboxymethyl cellulose sodium weight ratio;
Binding agent in the dispersible tablet is: the alcoholic solution of 40% ethanol～95% alcoholic solution or starch slurry or polyvinylpyrrolidone, or best 85% alcoholic solution that uses;
Filler is in the dispersible tablet: starch, or lactose or microcrystalline Cellulose, or one or more of precoking starch, mannitol etc., or the best starch that uses: lactose: 1: 2: 1 mixture of mannitol weight ratio;
Lubricant in the dispersible tablet is a magnesium stearate, or micropowder silica gel, or one or more of Pulvis Talci etc., or bestly uses micropowder silica gel.
Embodiment 14: the preparation of Schizandrol pellet capsule
Seed of Fructus Schisandrae Chinensis extractum 150g Ganoderma extractum 50g Radix Salviae Miltiorrhizae extractum 30g
Doubly reach cyclodextrin 11g
Ethyl cellulose 22g
Precoking starch 16g
Microcrystalline Cellulose 22g
85% alcoholic solution 60ml of wetting agent (or claiming adhesive) 6% polyvinylpyrrolidone
Get seed of Fructus Schisandrae Chinensis extractum, Ganoderma extractum, Radix Salviae Miltiorrhizae extractum and be crushed to 100 orders or thinner, with doubly reach mix homogeneously such as cyclodextrin, precoking starch, take a morsel earlier to place and play female ball in the full-automatic coating pelletizing machine, select the appropriate female ball of particle diameter, continue to add medicated powder, reach 16～20 orders until particle diameter, with gained micropill drying, capsular 1000 of packing;
Embodiment 15: the preparation of Schizandrol pellet capsule
Seed of Fructus Schisandrae Chinensis extractum 150g Ganoderma extractum 50g Radix Salviae Miltiorrhizae extractum 30g
Doubly reach cyclodextrin 15g
Ethyl cellulose 24g
Precoking starch 10g
Microcrystalline Cellulose 15g
85% alcoholic solution 80ml of wetting agent (or claiming adhesive) 11% polyvinylpyrrolidone
The coated formula of micropill is:
Polyvinylpyrrolidone 20g
Hydroxypropyl methylcellulose 6g
95% alcoholic solution 198ml
Pulvis Talci 5g
Magnesium stearate 2g
Titanium dioxide 4g
Polyethylene glycol 6000 2g
Pigment 1g
With Fructus Schisandrae Chinensis by embodiment 2 become the seed of Fructus Schisandrae Chinensis extractum, be crushed to 100 orders or thinner by said ratio and Ganoderma extractum, Radix Salviae Miltiorrhizae extractum; with mix homogeneously such as second class cellulose element, precoking starch; take a morsel earlier to place and play female ball in the full-automatic coating pelletizing machine; select the appropriate female ball of particle diameter; continue to add medicated powder, reach 16～20 orders until particle diameter, gained micropill drying; coating, drying are distributed into capsular 1000 of every 0.3g.
Compare with the preparation that does not add cyclodextrin inclusion compound in the Fructus Schisandrae Chinensis extraction, schisandrin B content on average exceeds 21%.
Claims (10)
1, a kind of Schizandrol compound preparation, it is characterized by: used medicinal raw material is:
Seed of Fructus Schisandrae Chinensis extractum 130～170g Ganoderma extractum 20～65g ginseng extractum 20～40g
The medicinal substances extract of above-mentioned component cooperates pharmaceutically alleged adjuvant that adopts suitable kind or soft capsule, dispersible tablet, the drop pill that substrate is made; As making soft capsule with disperse medium, suspending agent, antiseptic; Or make dispersible tablet with filler, disintegrating agent, wetting agent, lubricant; Or make drop pill with drop pill substrate.
2, a kind of Schizandrol soft capsule is characterized in that the best proportioning of 1000 its used medicinal substances extracts of soft capsule is: seed of Fructus Schisandrae Chinensis extractum 150g, Ganoderma extractum 50g, Radix Salviae Miltiorrhizae extractum 30g and disperse medium (80～420g), suspending agent (4～65g), (0.1～8g) makes soft capsule liquid to antiseptic;
Softgel shell is made up of gelatin or Polyethylene Glycol 41.5%～68%, glycerol 1.3%, additives 0.2% and 30.5%～57.0% in water.
3, according to the described a kind of Schizandrol compound preparation that has improved bioavailability and drug effect of claim 2, it is characterized in that can be made into soft capsule by following steps:
I) modulation capsule liquid: get one or more of seed of Fructus Schisandrae Chinensis extractum, Ganoderma extractum, Radix Salviae Miltiorrhizae extractum, adding disperse medium, antiseptic, suspending agent, emulsifying agent etc., stir, grind homogenizing, promptly get soft capsule liquid;
Ii) get gelatin, water, in heating in water bath dissolving down, mix homogeneously adds glycerol, antiseptic, additives, stirs, and after the vacuumize degassing, insulation is left standstill, and makes capsule material glue;
Iii) suppress or drip and make soft capsule: capsule liquid is encapsulated in the capsule material glue with soft capsule system of dripping or press; Promptly get the Schizandrol soft capsule.
4, according to the described a kind of Schizandrol compound preparation that has improved bioavailability and drug effect of claim 1, it is characterized in that making dispersible tablet by following steps:
Get seed of Fructus Schisandrae Chinensis extractum, Ganoderma extractum, Radix Salviae Miltiorrhizae extractum, add filler and part disintegrating agent mix homogeneously, granulate with the wetting agent moistening, drying, granulate adds remaining disintegrating agent and lubricant, mix homogeneously tabletting, promptly gets the Schizandrol dispersible tablet.
5, according to the described a kind of Schizandrol compound preparation that has improved bioavailability and drug effect of claim 1, it is characterized in that can be made into drop pill by following steps:
Get seed of Fructus Schisandrae Chinensis extractum, Ganoderma extractum, Radix Salviae Miltiorrhizae extractum, add in the hot drop pill substrate of melting, mix homogeneously splashes into molding in the coolant, removes coolant, promptly gets the Schizandrol drop pill.
6, according to claim 2 or the 3 described disperse medium of making soft capsule be: olive oil or other crude vegetals, or triglyceride oils, or oleic acid sorbitol ester, or olein: propylene glycol is 90: 10 mixture by weight, or Oleum Cocois C8/C10 monoglyceride or dibasic acid esters, or Oleum Cocois C8/C10 propylene glycol ester, or Oleum Cocois triglyceride, or the acetylizad monoglyceride of purification, or olein, or glyceryl linoleate, or the Polyethylene Glycol glyceryl laurate ester, or in the purification Oleum helianthi monoglyceride one or more, or the best peach kernel oil that uses: 1: 1 mixture of Oleum Sesami weight ratio;
The suspending agent of soft capsule is: can increase the solid matter of disperse medium viscosity, and as Cera Flava, aluminum monostearate, ethyl cellulose, carbomer etc., or the best Cera Flava that uses: 1.5: 3.5 mixture of ethyl cellulose weight ratio;
The antiseptic of soft capsule is: one or more in glycerol, propylene glycol, methyl parahydroxybenzoate, ethylparaben, propyl p-hydroxybenzoate, butyl p-hydroxybenzoate, benzyl p-hydroxybenzoate, the P-hydroxybenzoic acid phenyl ester.
7, a kind of Schizandrol compound preparation dispersible tablet preparation method according to claim 4 is characterized in that:
Its The disintegrating agents of dispersible tablets is: crospolyvinylpyrrolidone, carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose, one or more of cross-linked carboxymethyl cellulose sodium etc., or the best crospolyvinylpyrrolidone that uses: 5: 1 mixture of cross-linked carboxymethyl cellulose sodium weight ratio;
Binding agent in the dispersible tablet is: the alcoholic solution of 40% ethanol～95% alcoholic solution or starch slurry or polyvinylpyrrolidone, or best 85% alcoholic solution that uses;
Filler is in the dispersible tablet: starch, or lactose or microcrystalline Cellulose, or one or more of precoking starch, mannitol etc., or the best starch that uses: lactose: 1: 2: 1 mixture of mannitol weight ratio;
Lubricant in the dispersible tablet is a magnesium stearate, or micropowder silica gel, or one or more of Pulvis Talci etc., or bestly uses micropowder silica gel.
8, a kind of Schizandrol compound preparation dispersible tablet preparation method according to claim 4 is characterized in that: making 1000 need filler loading be that 50～450g, disintegrating agent are that 12～100g, lubricant are 5～15g.
9, drop pill substrate according to claim 5 is: Polyethylene Glycol is meant one or both the combination of Macrogol 4000 or polyethylene glycol 6000, and the best is a Macrogol 4000: the mixture of polyethylene glycol 6000 (3: 11), consumption are 80～600g; Condensing agent in its drop pill preparation is one of dimethicone, liquid paraffin, Oleum Camelliae, vegetable oil or two or more.
10, according to claim 4 or 5 a kind of Schizandrol compound preparation dispersible tablets or drop pill, can coatedly make coated dispersing tablet, coated drop pill; The coating solution prescription can for:
Polyvinylpyrrolidone 24g
Crospolyvinylpyrrolidone 2g
Hydroxypropyl methylcellulose 3～5g
95% alcoholic solution 210ml
Pulvis Talci 4～6g
Magnesium stearate 2g
Titanium dioxide 4～6g
Polyethylene glycol 6000 3g
Pigment 1～3g.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2005100328040A CN1320881C (en) | 2005-01-21 | 2005-01-21 | Compound preparation of Jianganling for liver and its making method |
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| Application Number | Priority Date | Filing Date | Title |
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| CNB2005100328040A CN1320881C (en) | 2005-01-21 | 2005-01-21 | Compound preparation of Jianganling for liver and its making method |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1977888B (en) * | 2005-12-05 | 2012-03-07 | 山东轩竹医药科技有限公司 | Medicinal composition of baicalin, ganoderma lucidum and salvia miltrorrhiza |
| CN103494897A (en) * | 2013-09-30 | 2014-01-08 | 秦福玉 | Traditional Chinese medicine for treating chronic hepatitis |
| CN113577178A (en) * | 2021-09-07 | 2021-11-02 | 香河县人民医院 | Traditional Chinese medicine composition and medical application thereof |
Families Citing this family (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104173443A (en) * | 2014-08-16 | 2014-12-03 | 黑龙江江恒医药科技有限公司 | Liver invigorating tablet and preparation method thereof |
-
2005
- 2005-01-21 CN CNB2005100328040A patent/CN1320881C/en active Active
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1977888B (en) * | 2005-12-05 | 2012-03-07 | 山东轩竹医药科技有限公司 | Medicinal composition of baicalin, ganoderma lucidum and salvia miltrorrhiza |
| CN103494897A (en) * | 2013-09-30 | 2014-01-08 | 秦福玉 | Traditional Chinese medicine for treating chronic hepatitis |
| CN113577178A (en) * | 2021-09-07 | 2021-11-02 | 香河县人民医院 | Traditional Chinese medicine composition and medical application thereof |
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| Publication number | Publication date |
|---|---|
| CN1320881C (en) | 2007-06-13 |
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Assignee: Guangdong Luofushan Sinopharm Co., Ltd. Assignor: Ye Yaoliang Contract record no.: 2010440001149 Denomination of invention: Compound preparation of Jianganling for liver and its making method Granted publication date: 20070613 License type: Exclusive License Open date: 20051012 Record date: 20100813 |
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Effective date of registration: 20190214 Address after: 516133 Bianling Pai Industrial Zone of Guangshan Highway, Changning Town, Boluo County, Huizhou City, Guangdong Province (Luofushan Pharmaceutical City) Patentee after: Guangdong Luofushan Sinopharm Co., Ltd. Address before: 516100 No. 36 Qiaodong three road, Luoyang Town, Boluo County, Huizhou, Guangdong Patentee before: Ye Yaoliang |
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