CN1682885A - Hemostatic preparation for gynecology department - Google Patents
Hemostatic preparation for gynecology department Download PDFInfo
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- CN1682885A CN1682885A CN 200510033584 CN200510033584A CN1682885A CN 1682885 A CN1682885 A CN 1682885A CN 200510033584 CN200510033584 CN 200510033584 CN 200510033584 A CN200510033584 A CN 200510033584A CN 1682885 A CN1682885 A CN 1682885A
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Abstract
The gynecological hemostasis preparation is prepared with effective medicine material and through decoction and other steps to extract the effective components, and the extracted effective components and supplementary material are then prepared into dispersed tablet, coated dispersed tablet, dripping pill, soft capsule, micro pill, coated micro pill or other preparation form. The present invention has high effective content in the preparation and raised medicinal effect, and the preparation may contain no sugar for sugar avoiding patient.
Description
Technical field
The present invention relates to field of medicaments, be specifically related to a kind of preparation of Herba Clinopodii preparation and the extracting method of said preparation raw material.
Background technology
Herba Clinopodii is to spread the various hemorrhage hemorrhage of application of treatment in several thousand of going through among the people, and Herba Clinopodii and extractum sheet thereof are that 90 editions, 95 editions, 2000 editions Chinese Pharmacopoeias record.Be the labiate Clinopodium Polycephalum Herba Clinopodii (Herba Clinopodii Polycephali)
Clinopodium polycephalum (Vaniot) C.Y.Wu et Hsuanex Hsuan or Herba Clinopodii Polycephali
The dry aerial parts of Clinopodium chinense (Benth.) O.Kuntze, crude drug source is extensive.
The various gynecological bleeding that dysfunctional uterine hemorrhage, menorrhagia, metrorrhagia, family planning advice etc. cause, very common clinically, account for gynecological's outpatient service, inpatient's 1/3.Because multiple factors such as gynecological bleeding and endocrine function are relevant, therefore, Western medicine is used hemorrhage merely can not stop its hemorrhage situation.
The present invention's prescription is that raw material is formed with Herba Clinopodii styptic activity position clinopodium polycephalum Saponin.The invention solves existing Herba Clinopodii and slightly obtain through refining problems such as the agent dose is big, impurity is many, poor controllability, the bioavailability height, stripping is rapid.
Summary of the invention
The object of the present invention is to provide preparation based on Herba Clinopodii extract make drop pill or the method for oral formulations such as dispersible tablet or soft capsule or effervescent tablet or oral cavity disintegration tablet or micropill.
Process route of the present invention is succinctly convenient, and the gained quality of the pharmaceutical preparations is stable, and drug bioavailability, drug effect are significantly increased.
The present invention is achieved in that
Herba Clinopodii extract of the present invention is made like this:
Get Herba Clinopodii, cutting decocts with water secondary, and each 1.0～2.0 hours, collecting decoction, filter, it is 1.15 (6080 ℃) that filtrate is concentrated into relative density, adds the ethanol of 1.7 times of amounts, fully stirs, and leaves standstill 24 hours, get the supernatant concentrating under reduced pressure and become the thick paste shape, be dried to dry extract, pulverize, promptly;
Also can make the Herba Clinopodii general glycoside as follows:
Get Herba Clinopodii, cutting decocts with water secondary, each 1.0～2.0 hours, collecting decoction filtered, it is 1.15 (80 ℃) that filtrate is concentrated into relative density, and 6000-12000rpm is centrifugal, gets supernatant by D101 macroporous resin fat post, flow velocity is 1～6 times of resin bed volume per hour, washes resin column with water, reuse 50～90% ethanol elutions, flow velocity is 2～6 times of resin bed volumes per hour, collects ethanol elution, reclaims ethanol, be condensed into thick paste, or be dried to fine powder, standby;
Herba Clinopodii drop pill of the present invention is made like this:
Taking polyethylene glycol 6000 heating and melting add Herba Clinopodii extract, and mix homogeneously is incubated under 50 ℃～90 ℃ conditions, and mix homogeneously splashes in the coolant and is shaped, and remove liquid coolant and promptly get drop pill, or coated again technology is made coated drop pill;
0.5～5.0 part of 1 part of proportioning substrate of the extract of Herba Clinopodii form; Or 1 part of Herba Clinopodii general glycoside is formed with 0.5～20 part of substrate;
Substrate in its drop pill is except that polyethylene glycol 6000, can also for molecular weight by cured etc. one or more of 2000～12000 Polyethylene Glycol or polyoxyethylene monostearate or sodium stearate or glycerin gelatine or poloxamer or stearic acid or glyceryl monostearate or worm, or the best polyethylene glycol 6000 that uses; Coolant in the drop pill is a dimethicone, or liquid paraffin, or Oleum Camelliae, or one or more of vegetable oil etc.
Herba Clinopodii soft capsule of the present invention is made like this:
(1), the preparation of capsule liquid: get adjuvants such as suspending agent and be dissolved in mixing in the disperse medium; Add Herba Clinopodii extract or Herba Clinopodii general glycoside, stir, grind evenly, be capsule liquid;
(2), the preparation of softgel shell solution: get gelatin, glycerol, water, put the vessel in heating dissolving, filter, add additives, mixing gets softgel shell solution;
(3), get above-mentioned (1) capsule liquid and (2) softgel shell solution, make soft capsule with the soft capsule production equipment, promptly.Making the used disperse medium of soft capsule is oiliness disperse medium or aqueous dispersion medium;
Used oiliness disperse medium, available: olive oil, or other crude vegetals, as soybean oil, or Oleum Arachidis hypogaeae semen, or triglyceride oils, or the oleic acid sorbitol ester, or olein: propylene glycol (90: 10), or Oleum Cocois C8/C10 monoglyceride or dibasic acid esters, or Oleum Cocois C8/C10 propylene glycol ester, or the Oleum Cocois triglyceride, or the acetylizad monoglyceride of purification, or olein, or glyceryl linoleate, or the Polyethylene Glycol glyceryl laurate ester, or one or more of purification Oleum helianthi monoglyceride etc., or best operating weight set of dispense ratio is 5: 1 olive oil and Oleum Arachidis hypogaeae semen;
Used water-soluble medium is: molecular weight is 200 to 800 Polyethylene Glycol, or isopropyl alcohol, or glycerol, or propylene glycol, or one or more of water etc.;
Suspending agent in the soft capsule is for increasing the solid matter of dispersion medium viscosity, as Cera Flava, or aluminum monostearate, or one or more of ethyl cellulose etc., or best operating weight set of dispense ratio is 3: 2 Cera Flava and ethyl cellulose;
Supplementary product consumption is: 1 part of Herba Clinopodii extract or Herba Clinopodii general glycoside and 0.5～4.8 part of disperse medium, 0.02～0.5 part of suspending agent.
Blood flow cutting off dispersing tablet of the present invention is made like this:
Get Herba Clinopodii extract or Herba Clinopodii general glycoside, add filler and part disintegrating agent mix homogeneously, granulate with wetting agent or adhesive, drying, granulate adds residue disintegrating agent, lubricant etc., mix homogeneously, tabletting promptly gets dispersible tablet; Or coating behind the tabletting, promptly get coated dispersing tablet.
5～280 parts of 100 parts of proportioning filleies of Herba Clinopodii extract or Herba Clinopodii general glycoside, 3～150 parts of disintegrating agents, 0.1～8 part of lubricant, binding agent is an amount of.
Filler in the dispersible tablet is: starch, or lactose, or microcrystalline Cellulose, or precoking starch, or one or more of mannitol etc.; Or the best is a starch: the mixture of lactose=33: 26;
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: the mixture of carboxymethyl starch sodium=7: 2;
Binding agent in the dispersible tablet is: Different concentrations of alcohol solution, or starch slurry, or the alcoholic solution of polyvinylpyrrolidone; Or best 65% alcoholic solution that uses 7% polyvinylpyrrolidone;
Lubricant in the dispersible tablet is a magnesium stearate, or micropowder silica gel, or one or more of Pulvis Talci etc.; Or the best differential silica gel that uses: the mixture of Pulvis Talci=15: 1.
Herba Clinopodii effervescent tablet of the present invention is made like this:
Get Herba Clinopodii extract or Herba Clinopodii general glycoside, add filler, disintegrating agent, effervescent mixing granulation, add adjuvants such as lubricant again, mixing, tabletting promptly gets effervescent tablet, or coating is made coated tablet again.
1 part of Herba Clinopodii extract or Herba Clinopodii general glycoside and 0.1～3.0 part of filler, 0.02～1.0 part of effervescent, 0.03～1.0 part of composition of disintegrating agent;
Be preferably Herba Clinopodii extract 100g and 70g filler, 35g effervescent acid-base pair, 25g disintegrating agent composition.
Effervescent is that sodium bicarbonate is formed with citric acid or tartaric acid;
Filler is a lactose: mannitol: 3: 3: 1 mixture of precoking starch;
Disintegrating agent 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: the mixture of low-substituted hydroxypropyl cellulose=1: 2.
Herba Clinopodii micropill of the present invention is made like this:
(1) preparation of micropill: get Herba Clinopodii extract or Herba Clinopodii general glycoside, and doubly reach mix homogeneously such as cyclodextrin, precoking starch, make the micropill of diameter less than 2.5mm;
(2) with gained micropill drying, or the coating after drying, promptly.
100 parts of the extract of Herba Clinopodii or Herba Clinopodii general glycosides, doubly to reach cyclodextrin 5-45 part, precoking starch 2-30 part, wetting agent be the 30-95% alcoholic solution of 2-13% polyvinylpyrrolidone;
Best proportioning is: 100 parts of the extracts of Herba Clinopodii, doubly to reach 15 parts of cyclodextrin, 10 parts of precoking starch, wetting agent be 75% alcoholic solution of 6% polyvinylpyrrolidone.
Herba Clinopodii oral cavity disintegration tablet of the present invention is made like this:
Get Herba Clinopodii extract or Herba Clinopodii general glycoside, with filler, disintegrating agent, fluidizer, correctives mix homogeneously, directly low-pressure promptly, or coating is made coated tablet again.
Described filler is: one or more of microcrystalline Cellulose, mannitol, glucose, lactose, galactose, cyclodextrin, sorbitol etc.; The preferred microcrystalline Cellulose that uses: mannitol 1: 1;
Described disintegrating agent is: crospolyvinylpyrrolidone, carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose, one or more of cross-linked carboxymethyl cellulose sodium etc.;
Described fluidizer is: micropowder silica gel, or one or more of magnesium stearate etc.;
Described correctives is: A Basi is sweet, stevioside, sucrose, maltose alcohol, citric acid etc. are edible or one or more of medicinal correctives; Preferably use A Basi sweet with citric acid 1: 1.
100g Herba Clinopodii extract or Herba Clinopodii general glycoside cooperate filler 5～200g, disintegrating agent 3～50g, fluidizer 0.3～15g, correctives an amount of, and the best is preferably:
The 100g Herba Clinopodii extract cooperates filler 80g, disintegrating agent 35g, fluidizer 5g agent, correctives an amount of.
Described a kind of gynecological hemostasis drop pill, dispersible tablet, effervescent tablet, oral cavity disintegration tablet, micropill etc. can coatedly be made coated dispersing tablet, coated drop pill, coating effervescent tablet, coating oral cavity disintegration tablet, coated micropill; The coating solution prescription can for:
Polyvinylpyrrolidone 20g
Hydroxypropyl methylcellulose 5～7g
95% alcoholic solution 198ml
Pulvis Talci 4～6g
Magnesium stearate 2g
Titanium dioxide 4～6g
Polyethylene glycol 6000 2g
Pigment 1～3g
Herba Clinopodii novel formulation by above technology preparation has the unexistent outstanding advantage of former dosage form, is described in detail as follows:
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.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 is than tablet, capsule, and granule is rapid-action.More easy to carry than oral liquid.Because the optimization of soft capsule liquid prescription of the present invention, thereby bioavailability height.Reduced patient's dose, made that compliance was higher when the patient used this medicine.But because the soft capsule complicated process of preparation has higher requirements to preparations shaping technology, need screening appropriate supplementary product kind, proportioning, just might make stay-in-grade finished product soft capsule.
Dispersible tablet is a kind of solidified liquid form of administration, disintegrate fully in 3 minutes at normal temperatures, and 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.
Oral cavity disintegration tablet, micropill have absorption soon equally, the characteristics that bioavailability is high.Its production method need be screened appropriate supplementary product kind, proportioning, just might make.
The situation of relevant experimentation is described in detail as follows: Herba Clinopodii treatment married woman metrorrhagia clinical observation
Metrorrhagia is a common gynecological disease, and women Duo Yin feelings will is hindered, and causes depression of liver-QI, and the stagnation of QI is blood stasis then, heat-transformation fire-transformation with the passing of time, and the venation of burning makes blood from through excessive, does not follow normal orbit, blood circulating out of vessels, gathering is condensed, and satisfies into blood stasis, and causes metrorrhagia.
Herba Clinopodii styptic activity position clinopodium polycephalum Saponin is that raw material is main.With the Herba Clinopodii is main treatment, and utilization Herba Clinopodii preparation for treating married woman metrorrhagia has obtained curative effect preferably.
The I clinical data
All case is the out-patient, and order is divided into four groups at random during by prescription on individual diagnosis, and patient age, course of disease situation see Table 1.
Table 1: patient age, course of disease comparison sheet
| Group | Total routine number | Age (year) | The course of disease (my god) |
| Drop pill group soft capsule group dispersible tablet group micropill group oral cavity disintegration tablet group matched group | ??42 ??40 ??44 ??41 ??42 ??42 | ????42.2±9.4 ????41.2±8.6 ????43.8±3.3 ????42.8±2.4 ????42.4±4.6 ????42.1±6.7 | ????14.3±3.2 ????13.7±4.6 ????14.2±5.6 ????15.1±3.2 ????14.5±6.2 ????13.8±3.8 |
Each group is learned check by statistics with the matched group data, and patient's difference on age, the course of disease does not have significance (P＞0.05).
1.1 diagnostic criteria with reference to metrorrhagia disease in " disease of tcm diagnostic criteria " diagnostic criteria, formulate in conjunction with clinical practice.
(1) the confusion of the menstrual cycle; (2) many through measuring, more than paper 3 bags, bleeding continued more than 7 days, or both alternately occur; (3) get rid of hematopathy.
Therapeutic Method
The drop pill group: take the Herba Clinopodii drop pill, one time 3,3 times on the one, every menstrual cycle clothes 15-20 days serve on 3 cycles.
The soft capsule group: take the Herba Clinopodii soft capsule, one time 3,3 times on the one, every menstrual cycle clothes 15-20 days serve on 3 cycles.
The dispersible tablet group: take blood flow cutting off dispersing tablet, one time 3,3 times on the one, every menstrual cycle clothes 15-20 days serve on 3 cycles.
The oral cavity disintegration tablet group: take the Herba Clinopodii oral cavity disintegration tablet, one time 3,3 times on the one, every menstrual cycle clothes 15-20 days serve on 3 cycles.
The pellet tablet group: take the Herba Clinopodii pellet tablet, one time 20 piller, 3 times on the one, every menstrual cycle clothes 15-20 days serve on 3 cycles.
Matched group: take Herba Clinopodii Tabellae, one time 3,3 times on the one, every menstrual cycle clothes 15-20 days serve on 3 cycles.
3 efficacy assessment standards
Cure: after the control over bleeding, continuous 3 menstrual cycle, menstrual period, blood volume are all normal, and subjective symptoms disappears, and hemoglobin can be recovered normal ovulation more than 100g/L, be no less than 12 days luteal phase, or climacteric women blood only after menopause person.Produce effects: after the control over bleeding, menstrual cycle, blood volume are normal substantially, but menstrual period still long (more than 7 days below 10 days), subjective symptoms disappears substantially, the above person of hemoglobin 100g/L.Effectively: menstrual cycle, menstrual period, the part subjective symptoms be improved significantly.Oligemia, the above person of hemoglobin 80g/L.Invalid: above every improver that all do not have.
4 results
1 liang of group curative effect
Table 4 case curative effect of disease relatively
| Group | Total routine number | Recovery from illness | Produce effects | Progressive | Invalid | Total effective rate (%) |
| Drop pill group soft capsule group dispersible tablet group micropill group oral cavity disintegration tablet group matched group | ??42 ??40 ??44 ??41 ??42 ??42 | ??15 ??14 ??16 ??15 ??14 ??12 | ??12 ??12 ??14 ??11 ??13 ??9 | ??10 ??11 ??12 ??12 ??11 ??13 | ??5 ??3 ??2 ??3 ??4 ??8 | ??88.09 ??92.50 ??95.45 ??92.68 ??90.48 ??80.95 |
Each group compares in curative effect and matched group, learns check by statistics, and Ridit analyzes: P＜0.05, and difference has significance, and novel form is respectively organized curative effect and all is better than matched group.
Specific embodiment
The preparation of embodiment 1 Herba Clinopodii extract:
Get Herba Clinopodii, cutting decocts with water secondary, and each 1.5 hours, collecting decoction, filter, it is 1.15 (80 ℃) that filtrate is concentrated into relative density, adds the ethanol of 1.7 times of amounts, fully stirs, and leaves standstill 24 hours, get the supernatant concentrating under reduced pressure and become the thick paste shape, be dried to dry extract, pulverize, promptly.
The preparation of embodiment 2 Herba Clinopodii extracts:
Get Herba Clinopodii, cutting decocts with water secondary, and each 1.5 hours, collecting decoction, filter, it is 1.15 (60 ℃) that filtrate is concentrated into relative density, adds the ethanol of 1.7 times of amounts, fully stirs, and leaves standstill 24 hours, get the supernatant concentrating under reduced pressure and become the thick paste shape, be dried to dry extract, pulverize, promptly.
The preparation of embodiment 3 Herba Clinopodii extracts:
Get Herba Clinopodii, cutting decocts with water secondary, each 1.5 hours, collecting decoction filtered, filtrate is concentrated into relative density and is 1.15 (80 ℃), and is centrifugal with 10000rpm, gets supernatant by D101 macroporous resin fat post, flow velocity is 1.5 times of resin bed volumes per hour, washes resin column with water, reuse 85% ethanol elution, flow velocity is 2.5 times of resin bed volumes per hour, collects ethanol elution, reclaims ethanol, be condensed into thick paste, or be dried to fine powder, standby.
The preparation of embodiment 4 Herba Clinopodii extracts:
Get Herba Clinopodii, cutting decocts with water secondary, each 2.0 hours, collecting decoction filtered, filtrate is concentrated into relative density and is 1.15 (60 ℃), and is centrifugal with 8000rpm, gets supernatant by D101 macroporous resin fat post, flow velocity is 4.5 times of resin bed volumes per hour, washes resin column with water, reuse 95% ethanol elution, flow velocity is 3.0 times of resin bed volumes per hour, collects ethanol elution, reclaims ethanol, be condensed into thick paste, or be dried to fine powder, standby.This method total saponins yield is about 25% of embodiment 1 or 2 yields.
The preparation of embodiment 5 Herba Clinopodii drop pill
1 part of the extract of Herba Clinopodii
2.6 parts of polyethylene glycol 6000s
Taking polyethylene glycol 6000 heating and melting add Herba Clinopodii extract, and mix homogeneously is incubated under 90 ℃ of conditions, and mix homogeneously splashes in the coolant and is shaped, and remove liquid coolant and promptly get drop pill, or coated again technology is made coated drop pill;
Substrate in its drop pill is except that polyethylene glycol 6000, can also for molecular weight by cured etc. one or more of 2000～12000 Polyethylene Glycol or polyoxyethylene monostearate or sodium stearate or glycerin gelatine or poloxamer or stearic acid or glyceryl monostearate or worm, or the best polyethylene glycol 6000 that uses; Coolant in the drop pill is a dimethicone, or liquid paraffin, or Oleum Camelliae, or one or more of vegetable oil etc.
The preparation of embodiment 6 Herba Clinopodii drop pill
1 part of the extract of Herba Clinopodii
4.8 parts of polyethylene glycol 6000s
0.2 part of poloxamer
Taking polyethylene glycol 6000, poloxamer heating and melting add Herba Clinopodii extract, and mix homogeneously is incubated under 90 ℃ of conditions, and mix homogeneously splashes in the coolant and is shaped, and remove liquid coolant and promptly get drop pill, or coated again technology is made coated drop pill;
The preparation of embodiment 7 Herba Clinopodii drop pill
1 part of Herba Clinopodii total saponins
2.4 parts of polyethylene glycol 6000s
0.1 part of poloxamer
Taking polyethylene glycol 6000, poloxamer heating and melting add Herba Clinopodii extract, mix homogeneously, be incubated under 90 ℃ of conditions, mix homogeneously splashes in the coolant and is shaped, remove in the liquid coolant-6 ℃ liquid paraffin, promptly get drop pill, or coated again technology is made coated drop pill.
The mixture that keeps medicinal substances extract and substrate when dripping system is in 90 ℃, 90 centimetres of cooling column effective column lengths, and 6 ℃ of liquid coolants are dripped 55 on fast every part of clock, dropper mouth external diameter 2.4mm, 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.
The preparation of embodiment 8 Herba Clinopodii drop pill
1 part of Herba Clinopodii total saponins
15 parts of polyethylene glycol 6000s
0.15 part of poloxamer
Taking polyethylene glycol 6000, poloxamer heating and melting add Herba Clinopodii extract, and mix homogeneously is incubated under 90 ℃ of conditions, mix homogeneously splashes in the coolant and is shaped, and removes in the liquid coolant-6 ℃ liquid paraffin, promptly gets drop pill, remove liquid coolant, coating, drying, promptly.Coating solution is:
Polyvinylpyrrolidone 20g
Hydroxypropyl methylcellulose 5.5g
95% alcoholic solution 198ml
Pulvis Talci 4.0g
Magnesium stearate 2g
Titanium dioxide 4.5g
Polyethylene glycol 6000 2g
Pigment 1.2g
Embodiment 9 Herba Clinopodii preparation of soft capsule
1 part of Herba Clinopodii extract
4.8 parts in olive oil,
0.5 part in Cera Flava.
Making the soft capsule specification is: every contains the dried cream 0.45g of Herba Clinopodii extract.
(1), the preparation of capsule liquid: get adjuvants such as suspending agent and be dissolved in mixing in the disperse medium; Add Herba Clinopodii extract or Herba Clinopodii general glycoside, stir, grind evenly, be capsule liquid;
(2), the preparation of softgel shell solution: get gelatin, glycerol, water, put the vessel in heating dissolving, filter, add additives, mixing gets softgel shell solution;
(3), get above-mentioned (1) capsule liquid and (2) softgel shell solution, make soft capsule with the soft capsule production equipment, promptly.
Embodiment 10 Herba Clinopodii preparation of soft capsule
1 part of Herba Clinopodii total saponins
0.5 part of 5: 1 olive oil and Oleum Arachidis hypogaeae semen,
0.3 part in Cera Flava
0.2 part of second class cellulose
Liquid egg phosphatidase 10 .4 part
Making the soft capsule specification is: every contains Herba Clinopodii general glycoside 0.30g.
Method for making is with embodiment 9.
Softgel shell is by gelatin 41.5%, water 38%, and glycerol 20%, antiseptic 0.35%, pigment 0.15% is formed
Embodiment 11 Herba Clinopodii preparation of soft capsule
1 part of Herba Clinopodii total saponins
1.5 parts of 5: 1 olive oil and Oleum Arachidis hypogaeae semen,
0.3 part in Cera Flava
0.2 part of second class cellulose
Liquid egg phosphatidase 10 .4 part
Making the soft capsule specification is: every contains Herba Clinopodii general glycoside 0.30g.
Method for making is with embodiment 9.
Softgel shell is by gelatin 37.5%, water 38%, and glycerol 24%, antiseptic 0.35%, pigment 0.15% is formed
The preparation of embodiment 12 blood flow cutting off dispersing tablet
Herba Clinopodii 1000g
(keeping within bounds the powder 60g that gets dry extract)
Pregelatinized Starch 75g
Lactose 15g
Crospolyvinylpyrrolidone 20g;
Magnesium stearate 1g;
Xylitol 0.5g
Get dried powder, pregelatinized Starch, lactose, and the disintegrating agent 12g mix homogeneously of soaking of the medicinal substances extract that obtains by embodiment 1 or embodiment 2, granulate with binder content 95% alcoholic acid alcoholic solution moistening, dry, granulate, add stearic magnesium 1g of calculation of disintegrating agent 8g and lubricant and xylitol 0.5g tabletting, promptly get 200 of dispersible tablets.
The preparation of embodiment 13 blood flow cutting off dispersing tablet
Herba Clinopodii 10000g
(making total Saponin 150g approximately)
Pregelatinized Starch 66g
Lactose 52g
Mannitol 12g
Crospolyvinylpyrrolidone 20g;
Magnesium stearate 0.05g;
Sodium lauryl sulphate: 0.25g
Xylitol 0.75g
Get the medicinal substances extract total saponins that obtains by embodiment 3 or embodiment 4, pregelatinized Starch, lactose, mannitol, and disintegrating agent 12g mix homogeneously, 95% alcoholic solution moistening with binding agent-9% polyvinylpyrrolidone is granulated, dry, granulate, add stearic magnesium and sodium lauryl sulphate and the xylitol 0.75g tabletting calculated of disintegrating agent 8g and lubricant, promptly get 1000 of dispersible tablets.
The preparation of embodiment 14 blood flow cutting off dispersing tablet
Herba Clinopodii 1000g
(keeping within bounds the powder 60g that gets dry extract)
Pregelatinized Starch 66g
Lactose 52g
Crospolyvinylpyrrolidone 20g;
Magnesium stearate 1g;
Xylitol 0.5g
Get dried powder, pregelatinized Starch, lactose, and the disintegrating agent 12g mix homogeneously of soaking of the medicinal substances extract that obtains by embodiment 1 or embodiment 2, granulate with binder content 95% alcoholic acid alcoholic solution moistening, dry, granulate, add stearic magnesium 1g of calculation of disintegrating agent 8g and lubricant and xylitol 0.5g tabletting, promptly get 200 of dispersible tablets, coating, promptly.Coating solution is:
Polyvinylpyrrolidone 20g
Hydroxypropyl methylcellulose 7g
95% alcoholic solution 198ml
Pulvis Talci 6g
Magnesium stearate 2g
Titanium dioxide 6g
Polyethylene glycol 6000 2g
Pigment 1g
The preparation of embodiment 15 Herba Clinopodii oral cavity disintegration tablets
Form by following raw material and adjuvant for 1000:
Herba Clinopodii 2000g
(making total Saponin 120g approximately)
Filler: microcrystalline Cellulose 45g,
Mannitol 45g
Disintegrating agent: crospolyvinylpyrrolidone 10g
Low-substituted hydroxypropyl cellulose 20g
The sweet 8g of correctives A Basi
Citric acid 6g
Lubricant: micropowder silica gel 4g
Get Herba Clinopodii extract or Herba Clinopodii general glycoside, with filler, disintegrating agent, fluidizer, correctives mix homogeneously, directly low-pressure promptly, or coating is made coated tablet again.
Described filler is: one or more of microcrystalline Cellulose, mannitol, glucose, lactose, galactose, cyclodextrin, sorbitol etc.; The preferred microcrystalline Cellulose that uses: mannitol 1: 1;
Described disintegrating agent is: crospolyvinylpyrrolidone, carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose, one or more of cross-linked carboxymethyl cellulose sodium etc.;
Described fluidizer is: micropowder silica gel, or one or more of magnesium stearate etc.;
Described correctives is: A Basi is sweet, stevioside, sucrose, maltose alcohol, citric acid etc. are edible or one or more of medicinal correctives; Preferably use A Basi sweet with citric acid 1: 1.
100g Herba Clinopodii extract or Herba Clinopodii general glycoside cooperate filler 5～200g, disintegrating agent 3～50g, fluidizer 0.3～15g, correctives an amount of, and the best is preferably:
The 100g Herba Clinopodii extract cooperates filler 80g, disintegrating agent 35g, fluidizer 5g agent, correctives an amount of.
The preparation of embodiment 16 Herba Clinopodii oral cavity disintegration tablets
Form by following raw material and adjuvant for 1000:
Herba Clinopodii 10000g
(making total Saponin 150g approximately)
Filler: lactose 55g,
Microcrystalline Cellulose 20g
Mannitol 55g
Disintegrating agent: crospolyvinylpyrrolidone 5g
Low-substituted hydroxypropyl cellulose 20g
The sweet 8g of correctives A Basi
Citric acid 10g
Lubricant: micropowder silica gel 7.5g
Get Herba Clinopodii extract or Herba Clinopodii general glycoside, with filler, disintegrating agent, fluidizer, correctives mix homogeneously, direct low-pressure tabletting, coating, promptly.
The preparation of embodiment 17 Herba Clinopodii effervescent tablets
Form by following raw material and adjuvant for 1000:
Herba Clinopodii 2000g
(making extract 120g approximately)
Filler: lactose 45g,
Mannitol 45g
Give coking starch 15g
Effervescent: sodium bicarbonate 30g
Tartaric acid 40g
Citric acid 5g
Disintegrating agent: crospolyvinylpyrrolidone 10g
Low-substituted hydroxypropyl cellulose 20g
Lubricant: micropowder silica gel 4g
Get Herba Clinopodii Herba Clinopodii general glycoside, add filler, disintegrating agent, effervescent mixing granulation, add adjuvants such as lubricant again, mixing, tabletting promptly gets effervescent tablet, or coating is made coated tablet again.
Effervescent is that sodium bicarbonate is formed with citric acid or tartaric acid;
Disintegrating agent is: crospolyvinylpyrrolidone, carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose, one or more of cross-linked carboxymethyl cellulose sodium etc.
The preparation of embodiment 18 Herba Clinopodii effervescent tablets
Form by following raw material and adjuvant for 1000:
Herba Clinopodii 10000g
(making total Saponin 150g approximately)
Filler: lactose 45g,
Mannitol 45g
Give coking starch 15g
Effervescent: sodium bicarbonate 15g
Tartaric acid 20g
Disintegrating agent: crospolyvinylpyrrolidone 7.5g
Low-substituted hydroxypropyl cellulose 20g
Lubricant; Micropowder silica gel 4g
Get Herba Clinopodii Herba Clinopodii general glycoside, add filler, disintegrating agent, effervescent mixing granulation, add adjuvants such as lubricant again, mixing, tabletting promptly gets effervescent tablet, and coating is made coated tablet again.Coating solution: polyvinylpyrrolidone 20g
Hydroxypropyl methylcellulose 6.5g
95% alcoholic solution 198ml
Pulvis Talci 5g
Magnesium stearate 2g
Titanium dioxide 5g
Polyethylene glycol 6000 2g
Pigment 2g
The preparation of embodiment 19 Herba Clinopodii micropills
100 parts of Herba Clinopodii extracts
Doubly reach cyclodextrin 45
30 parts of precoking starch
95% alcoholic solution of 11% polyvinylpyrrolidone is an amount of
(1) preparation of micropill: get Herba Clinopodii extract or Herba Clinopodii general glycoside, and doubly reach mix homogeneously such as cyclodextrin, precoking starch, make the micropill of diameter less than 2.5mm;
(2) with gained micropill drying, the coating after drying, promptly.
Coating solution is: polyvinylpyrrolidone 20g
Hydroxypropyl methylcellulose 6.5g
95% alcoholic solution 198ml
Pulvis Talci 5g
Magnesium stearate 2g
Titanium dioxide 5g
Polyethylene glycol 6000 2g
Pigment 2g
The preparation of embodiment 20 Herba Clinopodii micropills
100 parts of Herba Clinopodii extracts
Doubly reach cyclodextrin 15
10 parts of precoking starch
75% alcoholic solution of 6% polyvinylpyrrolidone is an amount of
(1) preparation of micropill: get Herba Clinopodii extract or Herba Clinopodii general glycoside, and doubly reach mix homogeneously such as cyclodextrin, precoking starch, make the micropill of diameter less than 2.5mm;
(2) with gained micropill drying, or the coating after drying, promptly.
Claims (17)
1, a kind of hemostatic preparation for gynecology department, it is characterized in that: the dry aerial parts of the labiate Clinopodium Polycephalum Herba Clinopodii (Herba Clinopodii Polycephali) or Herba Clinopodii Polycephali are made Herba Clinopodii extract or Herba Clinopodii general glycoside through extraction, cooperate drop pill or the preparations of making such as dispersible tablet or soft capsule or effervescent tablet or oral cavity disintegration tablet or micropill with pharmaceutically alleged adjuvant or substrate.
2, the preparation method of a kind of gynecological hemostasis drop pill is characterized in that may further comprise the steps:
Taking polyethylene glycol 6000 heating and melting add Herba Clinopodii extract, and mix homogeneously is incubated under 50 ℃～90 ℃ conditions, and mix homogeneously splashes in the coolant and is shaped, and remove liquid coolant and promptly get drop pill, or coated again technology is made coated drop pill.
3, a kind of gynecological according to claim 2 hemostasis drop pill, it is characterized in that: used principal agent is: the extract of Herba Clinopodii or Herba Clinopodii general glycoside; Substrate weight proportion when making drop pill by: 1 part of proportioning substrate of the extract of Herba Clinopodii is formed for 0.5～5.0 part; Or 1 part of Herba Clinopodii general glycoside forms with 0.5～20 part of substrate,
Substrate in its drop pill is except that polyethylene glycol 6000, can also for molecular weight by cured etc. one or more of 2000～12000 Polyethylene Glycol or polyoxyethylene monostearate or sodium stearate or glycerin gelatine or poloxamer or stearic acid or glyceryl monostearate or worm, or the best polyethylene glycol 6000 that uses; Coolant in the drop pill is a dimethicone, or liquid paraffin, or Oleum Camelliae, or one or more of vegetable oil etc.
4, a kind of gynecological hemostasis preparation of soft capsule method is characterized in that may further comprise the steps:
(1), the preparation of capsule liquid: get suspending agent and be dissolved in mixing in the disperse medium; Add Herba Clinopodii extract or Herba Clinopodii general glycoside, stir, grind evenly, be capsule liquid;
(2), the preparation of softgel shell solution: get gelatin, glycerol, water, put the vessel in heating dissolving, filter, add additives, mixing gets softgel shell solution;
(3), get above-mentioned (1) capsule liquid and (2) softgel shell solution, make soft capsule with the soft capsule production equipment, promptly.
5, a kind of gynecological according to claim 4 hemostasis soft capsule, it is characterized in that: making the used disperse medium of soft capsule is oiliness disperse medium or aqueous dispersion medium;
Used oiliness disperse medium, available: olive oil, or other crude vegetals, as soybean oil, or Oleum Arachidis hypogaeae semen, or triglyceride oils, or the oleic acid sorbitol ester, or olein: propylene glycol (90: 10), or Oleum Cocois C8/C10 monoglyceride or dibasic acid esters, or Oleum Cocois C8/C10 propylene glycol ester, or the Oleum Cocois triglyceride, or the acetylizad monoglyceride of purification, or olein, or glyceryl linoleate, or the Polyethylene Glycol glyceryl laurate ester, or one or more of purification Oleum helianthi monoglyceride etc., or best operating weight set of dispense ratio is 5: 1 olive oil and Oleum Arachidis hypogaeae semen;
Used water-soluble medium is: molecular weight is 200 to 800 Polyethylene Glycol, or isopropyl alcohol, or glycerol, or propylene glycol, or one or more of water etc.;
Suspending agent in the soft capsule is for increasing the solid matter of dispersion medium viscosity, as Cera Flava, or aluminum monostearate, or one or more of ethyl cellulose etc., or best operating weight set of dispense ratio is 3: 2 Cera Flava and ethyl cellulose;
Supplementary product consumption is: 1 part of Herba Clinopodii extract or Herba Clinopodii general glycoside and 0.5～4.8 part of disperse medium, 0.02～0.5 part of suspending agent.
6, the preparation method of a kind of gynecological hemostasis dispersible tablet is characterized in that may further comprise the steps:
Get Herba Clinopodii extract or Herba Clinopodii general glycoside, add filler and part disintegrating agent mix homogeneously, granulate with wetting agent or adhesive, drying, granulate adds residue disintegrating agent, lubricant etc., mix homogeneously, tabletting promptly gets dispersible tablet; Or coating behind the tabletting, promptly get coated dispersing tablet.
7, according to the described a kind of gynecological of claim 6 hemostasis dispersible tablet, it is characterized in that forming by the following stated part by weight material:
5～280 parts of 100 parts of proportioning filleies of Herba Clinopodii extract or Herba Clinopodii general glycoside, 3～150 parts of disintegrating agents, 0.1～8 part of lubricant, binding agent is an amount of.
8, a kind of gynecological according to claim 6 hemostasis dispersible tablet is characterized in that:
Filler in the dispersible tablet is: starch, or lactose, or microcrystalline Cellulose, or precoking starch, or one or more of mannitol etc.; Or the best is a precoking starch: the mixture of lactose=33: 26;
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: the mixture of carboxymethyl starch sodium=7: 2;
Binding agent in the dispersible tablet is: Different concentrations of alcohol solution, or starch slurry, or the alcoholic solution of polyvinylpyrrolidone; Or best 65% alcoholic solution that uses 7% polyvinylpyrrolidone;
Lubricant in the dispersible tablet is a magnesium stearate, or micropowder silica gel, or one or more of Pulvis Talci etc.; Or the best differential silica gel that uses: the mixture of Pulvis Talci=15: 1.
9, the preparation method of a kind of gynecological hemostasis effervescent tablet is characterized in that may further comprise the steps:
Get Herba Clinopodii extract or Herba Clinopodii general glycoside, add filler, disintegrating agent, effervescent mixing granulation, add adjuvants such as lubricant again, mixing, tabletting promptly gets effervescent tablet, or coating is made coated tablet again.
10, a kind of gynecological according to claim 9 hemostasis effervescent tablet, it is characterized in that: the required adjuvant part by weight of preparation effervescent tablet consists of:
1 part of Herba Clinopodii extract or Herba Clinopodii general glycoside and 0.1～3.0 part of filler, 0.02～1.0 part of effervescent, 0.03～1.0 part of composition of disintegrating agent;
Be preferably Herba Clinopodii extract 100g and 70g filler, 35g effervescent acid-base pair, 25g disintegrating agent composition.
11, according to the described a kind of gynecological of claim 9 hemostasis effervescent tablet, it is characterized in that:
Effervescent is that sodium bicarbonate is formed with citric acid or tartaric acid;
Filler is a lactose: mannitol: 3: 3: 1 mixture of precoking starch;
Disintegrating agent 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: the mixture of low-substituted hydroxypropyl cellulose=1: 2.
12, the preparation method of a kind of gynecological hemostasis micropill is characterized in that may further comprise the steps:
(1) preparation of micropill: get Herba Clinopodii extract or Herba Clinopodii general glycoside, and doubly reach mix homogeneously such as cyclodextrin, precoking starch, make the micropill of diameter less than 2.5mm;
(2) with gained micropill drying, or the coating after drying, promptly.
13, according to the described a kind of gynecological of claim 11 hemostasis micropill, it is characterized in that: the required adjuvant part by weight of preparation micropill consists of:
100 parts of the extract of Herba Clinopodii or Herba Clinopodii general glycosides, doubly to reach cyclodextrin 5-45 part, precoking starch 2-30 part, wetting agent be the 30-95% alcoholic solution of 2-13% polyvinylpyrrolidone;
Best proportioning is: 100 parts of the extracts of Herba Clinopodii, doubly to reach 15 parts of cyclodextrin, 10 parts of precoking starch, wetting agent be 75% alcoholic solution of 6% polyvinylpyrrolidone.
14, the preparation method of a kind of gynecological hemostatic port cavity disintegrating tablet is characterized in that:
Get Herba Clinopodii extract or Herba Clinopodii general glycoside, with filler, disintegrating agent, fluidizer, correctives mix homogeneously, directly low-pressure promptly, or coating is made coated tablet again.
15, according to the described a kind of gynecological of claim 13 hemostatic port cavity disintegrating tablet, it is characterized in that:
Described filler is: one or more of microcrystalline Cellulose, mannitol, glucose, lactose, galactose, cyclodextrin, sorbitol etc.; The preferred microcrystalline Cellulose that uses: mannitol 1: 1;
Described disintegrating agent is: crospolyvinylpyrrolidone, carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose, one or more of cross-linked carboxymethyl cellulose sodium etc.;
Described fluidizer is: micropowder silica gel, or one or more of magnesium stearate etc.;
Described correctives is: A Basi is sweet, stevioside, sucrose, maltose alcohol, citric acid etc. are edible or one or more of medicinal correctives; Preferably use A Basi sweet with citric acid 1: 1.
16, according to the described a kind of gynecological of claim 13 hemostatic port cavity disintegrating tablet, it is characterized in that: the required adjuvant part by weight of preparation oral cavity disintegration tablet consists of:
100g Herba Clinopodii extract or Herba Clinopodii general glycoside cooperate filler 5～200g, disintegrating agent 3～50g, fluidizer 0.3～15g, correctives an amount of, and the best is preferably:
The 100g Herba Clinopodii extract cooperates filler 80g, disintegrating agent 35g, fluidizer 5g agent, correctives an amount of.
17, can coatedly make coated dispersing tablet, coated drop pill, coating effervescent tablet, coating oral cavity disintegration tablet, coated micropill according to claim 2,6,9,12,14, described a kind of gynecological hemostasis drop pill, dispersible tablet, effervescent tablet, oral cavity disintegration tablet, micropill etc.; The coating solution prescription can for:
Polyvinylpyrrolidone 20g
Hydroxypropyl methylcellulose 5～7g
95% alcoholic solution 198ml
Pulvis Talci 4～6g
Magnesium stearate 2g
Titanium dioxide 4～6g
Polyethylene glycol 6000 2g
Pigment 1～3g
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2005100335843A CN100434065C (en) | 2005-03-09 | 2005-03-09 | Hemostatic preparation for gynecology department |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2005100335843A CN100434065C (en) | 2005-03-09 | 2005-03-09 | Hemostatic preparation for gynecology department |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1682885A true CN1682885A (en) | 2005-10-19 |
| CN100434065C CN100434065C (en) | 2008-11-19 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CNB2005100335843A Expired - Fee Related CN100434065C (en) | 2005-03-09 | 2005-03-09 | Hemostatic preparation for gynecology department |
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1321630C (en) * | 2005-05-23 | 2007-06-20 | 上海玉森新药开发有限公司 | Method for preparing blood flow cutting off dispersing tablet |
| CN100438858C (en) * | 2005-05-23 | 2008-12-03 | 上海玉森新药开发有限公司 | Preparation method of Chinese clinopodium herb effervescence tablet |
| CN101940616A (en) * | 2010-08-31 | 2011-01-12 | 中国药科大学 | Preparation method of effective part of Clinopodium chinense (Benth.) O. Kuntze for preventing and treating diabetes and medicine application thereof |
| CN102228509A (en) * | 2011-06-30 | 2011-11-02 | 安庆乘风制药有限公司 | Film coating method of Chinese patent drug herba clinopodii tablets |
| CN111714686A (en) * | 2019-03-19 | 2020-09-29 | 广东博与再生医学有限公司 | Bone hemostatic material and preparation method thereof |
Family Cites Families (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1569121A (en) * | 2004-04-29 | 2005-01-26 | 周亚球 | Medicinal capsule of Chinese clinopodium herb for and its preparing process |
-
2005
- 2005-03-09 CN CNB2005100335843A patent/CN100434065C/en not_active Expired - Fee Related
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1321630C (en) * | 2005-05-23 | 2007-06-20 | 上海玉森新药开发有限公司 | Method for preparing blood flow cutting off dispersing tablet |
| CN100438858C (en) * | 2005-05-23 | 2008-12-03 | 上海玉森新药开发有限公司 | Preparation method of Chinese clinopodium herb effervescence tablet |
| CN101940616A (en) * | 2010-08-31 | 2011-01-12 | 中国药科大学 | Preparation method of effective part of Clinopodium chinense (Benth.) O. Kuntze for preventing and treating diabetes and medicine application thereof |
| CN102228509A (en) * | 2011-06-30 | 2011-11-02 | 安庆乘风制药有限公司 | Film coating method of Chinese patent drug herba clinopodii tablets |
| CN111714686A (en) * | 2019-03-19 | 2020-09-29 | 广东博与再生医学有限公司 | Bone hemostatic material and preparation method thereof |
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| Publication number | Publication date |
|---|---|
| CN100434065C (en) | 2008-11-19 |
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