CN1919255A - Aim Naoluotong drop pill and its preparation method - Google Patents
Aim Naoluotong drop pill and its preparation method Download PDFInfo
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- CN1919255A CN1919255A CN 200510090989 CN200510090989A CN1919255A CN 1919255 A CN1919255 A CN 1919255A CN 200510090989 CN200510090989 CN 200510090989 CN 200510090989 A CN200510090989 A CN 200510090989A CN 1919255 A CN1919255 A CN 1919255A
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Abstract
The invention discloses a dripping pill preparation and its preparing process, wherein the medicinal composition comprises radix salvia miltiorrhiza extract, tolperisone hydrochloride, Chuanxiong rhizome extract, methyl hesperidine, milk vetch root concrete and vitamin B6. Compared with the existing dosage forms, the drop pill preparation has the advantages of quick-effectiveness, high biological availability, good taste, and fitting for mass production.
Description
Technical field
The invention belongs to medical technical field, being specifically related to a kind of Radix Salviae Miltiorrhizae extractum, tolperisone hydrochloride, Rhizoma Chuanxiong extractum, methylhesperidin, Radix Astragali extractum, vitamin B6 of comprising is oral solid formulation of Main Ingredients and Appearance and preparation method thereof, specifically, relate to aim Naoluotong drop pill preparation of containing Radix Salviae Miltiorrhizae extractum, tolperisone hydrochloride, Rhizoma Chuanxiong extractum, methylhesperidin, Radix Astragali extractum, vitamin B6 and preparation method thereof.
Background technology
Rise the eighties in 20th century, and NAOLUOTONG JIAONANG just is applied to clinical.NAOLUOTONG JIAONANG is the bonded compound preparation of Chinese medicine and western medicine, form by Rhizoma Chuanxiong, Radix Salviae Miltiorrhizae, the Radix Astragali, tolperisone hydrochloride (Tolperisone), methylhesperidin, vitamin B6, function is inrigorating qi and promoting blood circulation, dredge the meridian passage, and can blood vessel dilating, the cerebral blood flow increasing amount, be used for diseases such as headache that apoplexy sequela, cerebral thrombosis, cerebral arteriosclerosis and various cerebrovascular disease cause, dizzy, insomnia, limbs be numb, belong to person due to the resistance of blood stagnancy due to deficiency of QI, the brain network stasis of blood, controlling inrigorating qi and promoting blood circulation to be main.Be suitable for cerebrovascular disease patient life-time service.Tolperisone hydrochloride is a kind of vasodilation and maincenter muscle relaxant, and the effect of direct blood vessel dilating, reduction bone energy muscular tension, cerebral blood flow increasing amount is arranged.Rhizoma Chuanxiong, Radix Salviae Miltiorrhizae are the good medicine of phlegm reduction of blood circulation promoting, and Rhizoma Chuanxiong is again a gas medicine in the blood, reach on the priming, and the Radix Salviae Miltiorrhizae nourshing blood and promoting blood circulation, two medicines mutually 5 have blood vessel dilating, increase the effect of arteria coronaria multiple abscess.In recent years experimentation shows that ligustrazine has anti-radical action, and Radix Salviae Miltiorrhizae has the effect that alleviates ischemical reperfusion injury.The Radix Astragali is the tonifying Qi and lifting yang good merchantable brand, also expansible blood vessel, increases the brain perfusion and improves brain blood and supply.Methylhesperidin can strengthen capillary resistance, in case the sclerosis of stop arteries and veins.Vitamin B6 can prevent atherosclerosis, and participates in aminoacid and lipid metabolism.So the brain ruton has therapeutical effect to cerebrovascular.According to " modern combination of Chinese and Western medicine magazine " 2003,12 (4), 370-371 page or leaf " observation of curative effect of brain ruton treatment cerebral arteriosclerosis and cerebral infarction " report, analyze 110 routine patients' therapeutic effect, the brain ruton has curative effect preferably to cerebrovascular disease as can be seen, effective and the obvious effective rate of treatment cerebral arteriosclerosis reaches 94%, cerebral infarction effectively and obvious effective rate reach 95%, particularly this medicine to improve headache, dizziness, tinnitus, numb limbs and tense tendons, insomnia, symptom such as uncomfortable in chest all has than the curative effect of being satisfied with.
At present clinically NAOLUOTONG JIAONANG use many, but preparation type tradition relatively, conventional formulation is long because of disintegration time, absorb slow, the performance of problems affect curative effect such as bioavailability is low.How to overcome these shortcomings, make the medicine quick acting become the problem of people's active research, drop pill is a kind of spheric pill that utilizes the solid dispersion technology system of dripping to form, it utilizes water-solubility carrier to improve the dissolubility and the dissolution rate of medicine, improve the infiltration rate and the absorbtivity of medicine, thereby improves bioavailability of medicament and improve the curative effect of medicine, but the composition between medicine active ingredient and the adjuvant then is the factor that influences drop pill that the present invention forms just on this basis.
Summary of the invention
The objective of the invention is to overcome the deficiencies in the prior art, a kind of rapid-action, oral aim Naoluotong drop pill preparation that bioavailability is high and preparation method thereof is provided.
The Vinpocetine drop pills of making by dropping pill formulation Technology of the present invention not only have disintegrate molten loose fast, dissolution and dissolution rate improve, steady quality, the pill volume is little, and both can swallow also can buccal, easy to carry and use, onset is rapid, and compliance is good, is particularly suitable for the characteristics that child, old people, bed patient and dysphagia patients are taken, but also have working condition and production equipment is simple, compare the less advantage of supplementary product consumption with capsule with tablet.
The weight ratio of main active described in the present invention is: Radix Salviae Miltiorrhizae extractum: tolperisone hydrochloride: Rhizoma Chuanxiong extractum: Radix Astragali extractum: methylhesperidin: vitamin B6=50: 50: 50: 50: 10: 2.
The preparation of Radix Salviae Miltiorrhizae extractum:
Get Radix Salviae Miltiorrhizae and decoct with water three times, each 2 hours, collecting decoction filtered, and filtrate is concentrated into thick paste, is being dried to dry extract below 100 ℃, measures moisture and must not cross 5%, promptly.
The preparation of Rhizoma Chuanxiong extractum:
Get Rhizoma Chuanxiong and decoct with water three times, each 2 hours, collecting decoction filtered, and filtrate is concentrated into thick paste, is being dried to dry extract below 100 ℃, measures moisture and must not cross 5%, promptly.
The preparation of Radix Astragali extractum
Get the Radix Astragali and decoct with water three times, each 2 hours, collecting decoction filtered, and filtrate is concentrated into thick paste, is being dried to dry extract below 100 ℃, measures moisture and must not cross 5%, promptly.
The inventor finds: after conventional employing raw material adding appropriate solvent (ethanol equal solvent) adds water-soluble base (for example polyethylene glycol 6000) again, find in the process of the aim Naoluotong drop pill of preparation: the two mixing is inhomogeneous, cause drop pill surface piebaldism, the drop pill roundness is poor, in dissolution test, dissolution time is elongated, and this shows that the preparation of aim Naoluotong drop pill and physicochemical property thereof are difficult to expect.
The inventor determine to adopt following adjuvant (substrate) to prepare aim Naoluotong drop pill but is not limited to following adjuvant: poloxamer, PEG400, cetomacrogol 1000, polyethylene glycol 1500, Macrogol 4000, polyethylene glycol 6000, cetomacrogol 1000 0, sodium stearate, glycerin gelatine, stearic acid, glyceryl monostearate, worm are cured, xylitol, starch or its mixed system.
When adopting single adjuvant to carry out the preparation of drop pill, be preferably Macrogol 4000, polyethylene glycol 6000, adopt two kinds of adjuvants to carry out drop pill when preparing, be preferably Macrogol 4000 and polyethylene glycol 6000, polyethylene glycol 1500 and polyethylene glycol 6000, xylitol and starch, the ratio of two kinds of adjuvants can be various ways; When adopting the adjuvant of two or more form of mixtures, its ratio can adopt various ways.
During the preparation aim Naoluotong drop pill, principal agent composition (six kinds) is 1 with the weight ratio of adjuvant: 1-10 is preferably 1: 2-8 most preferably is 1: 2-5.
After drop pill is finished, can adopt plain ball directly to use; Or adopted film-coated technique that plain ball is carried out coating, can effectively cover the bitterness of medicine and prevent the moist and drop pill moisture absorption that cause of drawing of principal agent, the dissolve accretions phenomenon, guarantee drop pill in preservation not dried ball, split ball, also guarantee the stability of drop pill in the middle of storing.Described coating material comprises for example conventional coating material or Opadry coating material.
In addition, part exemplary compositions and preparation process parameter thereof are selected listed as following table in the drop pill of the present invention:
| Project | Scope | Preferable range |
| Polyethylene glycol 1500 accounts for weight ratio Macrogol 4000 in the matrix and accounts for weight ratio Macrogol 6000 in the matrix and account for weight ratio poloxamer in the matrix and account for weight ratio main ingredient in the matrix-matrix ratio material temperature dripping temperature cooling medium condensate temperature water dropper to condensate liquid and increase weight apart from coating solution concentration dressing | 0%-100% 0%-100% 0%-100% 0%-50% 1: 1.0-10 70-100 ℃ 70-100 ℃ atoleine, dimethicone, soybean oil 0-20 ℃ 0-60cm 8-20% 1-8% | 0%-30% 0%-100% 0%-100% 0%-30% 1: 2-5 85-95 ℃ 80-95 ℃-atoleine 5-12 ℃, silicone oil 6-18 ℃ of soybean oil 5-15 ℃ of 25-45cm 12-15% 2-6% |
The preparation method of drop pill of the present invention comprises the steps:
(1) by the weight proportion of each component,, makes its fusion, stir, add the micronized principal agent (six kinds) of recipe quantity, stir heating in selected putting of the adjuvant batch can;
(2) with the preheating of drop pill machine, fluid storage compartment temperature constant temperature is fluid temperature, and selecting cooling medium is liquid paraffin or silicone oil or soybean oil, and being chilled to temperature in advance is 0-20 ℃.
(3) pour medicinal liquid into fluid storage compartment, start valve, medicinal liquid is splashed into to condensed fluid,, absorb surface condensation liquid, promptly get plain ball in collecting a mouthful collection drop pill.
(4) plain ball is adopted conventional coating material or Opadry coating material carry out coating, get coated drop pill.
Aim Naoluotong drop pill smooth surface of the present invention, hardness is suitable and roundness good, and particle diameter can be 2-5mm, is suitable for easily, without any the administration of uncomfortable ground.
Following table is the comparing data of aim Naoluotong drop pill and commercially available capsule.
| Project | Drop pill | Capsule |
| The molten diffusing time (minute) 10 minutes dissolutions | 5.0 more than 60% | 20-40 5-30％ |
Measuring the dissolution method is: change the basket method, dissolution medium is a 900ml water, 37 ℃ of temperature, and rotating speed is 100 rev/mins, calculates with tolperisone hydrochloride.
Following examples are intended to further specify, and the scope of the invention are not limited.
Embodiment 1
Drop pill (coated pill is not plain ball 1)
| Prescription is formed | Consumption |
| The principal agent of recipe quantity (six kinds) Macrogol 4000 | 10.6g 25g |
Preparation process: in putting of 25g Macrogol 4000 batch can, changing the batch can temperature is 80 ℃, makes its fusion, stirs, and adds the micronized principal agent of 10.6g recipe quantity (six kinds), stirs; With the preheating of drop pill machine, it is 90 ℃ that the fluid storage compartment temperature is promptly dripped system temperature constant temperature, and cooling medium adopts soybean oil, and being chilled to temperature in advance is 6-10 ℃, regulate water dropper to condensed fluid apart from 30cm.Pour medicinal liquid into fluid storage compartment, start valve, medicinal liquid is splashed into to condensed fluid,, absorb surface condensation liquid, promptly in collecting a mouthful collection drop pill.
Embodiment 2
Drop pill (coated pill is not plain ball 2)
| Prescription is formed | Consumption |
| The principal agent of recipe quantity (six kinds) | 10.6g |
| The poloxamer polyethylene glycol 6000 | 5 25g |
Preparation process: in 25g polyethylene glycol 6000, putting of 5g poloxamer batch can, changing the batch can temperature is 90 ℃, makes its fusion, stirs, and adds 10.6g recipe quantity micronization principal agent (six kinds), stirs; With the preheating of drop pill machine, it is 95 ℃ that the fluid storage compartment temperature is promptly dripped system temperature constant temperature, and cooling medium adopts liquid paraffin, and being chilled to temperature in advance is 8-12 ℃, regulate water dropper to condensed fluid apart from 25cm.Pour medicinal liquid into fluid storage compartment, start valve, medicinal liquid is splashed into to condensed fluid,, absorb surface condensation liquid, promptly in collecting a mouthful collection drop pill.
Embodiment 3
Drop pill (plain ball 3)
| Prescription is formed | Consumption |
| Recipe quantity principal agent (six kinds) | 10.6g |
| The polyethylene glycol 1500 Macrogol 4000 | 10 30g |
Preparation process: in 30g Macrogol 4000, putting of 10g polyethylene glycol 1500 batch can, changing the batch can temperature is 80 ℃, makes its fusion, stirs, and adds 10.6g recipe quantity micronization principal agent (six kinds), stirs; With the preheating of drop pill machine, it is 85 ℃ that the fluid storage compartment temperature is promptly dripped system temperature constant temperature, and cooling medium adopts liquid paraffin, and being chilled to temperature in advance is 8-12 ℃, regulate water dropper to condensed fluid apart from 30cm.Pour medicinal liquid into fluid storage compartment, start valve, medicinal liquid is splashed into to condensed fluid,, absorb surface condensation liquid, promptly in collecting a mouthful collection drop pill.
Embodiment 4
Drop pill (plain ball 4)
| Prescription is formed | Consumption |
| Recipe quantity principal agent (six kinds) polyethylene glycol 1500 polyethylene glycol 6000 | 21.2g 21.2g 21.2g |
Preparation process: in 21.2g polyethylene glycol 1500, putting of 21.2g polyethylene glycol 6000 batch can, changing the batch can temperature is 85 ℃, makes its fusion, stirs, and adds 21.2g recipe quantity micronization principal agent (six kinds), stirs; With the preheating of drop pill machine, it is 85 ℃ that the fluid storage compartment temperature is promptly dripped system temperature constant temperature, and cooling medium adopts dimethicone, and being chilled to temperature in advance is 8-12 ℃, regulate water dropper to condensed fluid apart from 30cm.Pour medicinal liquid into fluid storage compartment, start valve, medicinal liquid is splashed into to condensed fluid,, absorb surface condensation liquid, promptly in collecting a mouthful collection drop pill.
Embodiment 5
Drop pill (plain ball 5)
| Prescription is formed | Consumption |
| Recipe quantity principal agent (six kinds) polyethylene glycol 1500 Macrogol 4000 polyethylene glycol 6000 | 10.6g 2g 20g 15g |
Preparation process: in 2g polyethylene glycol 1500,20g Macrogol 4000, putting of 15g polyethylene glycol 6000 batch can, changing the batch can temperature is 95 ℃, makes its fusion, stirs, and adds 10.6g recipe quantity micronization principal agent (six kinds), stirs; With the preheating of drop pill machine, it is 95 ℃ that the fluid storage compartment temperature is promptly dripped system temperature constant temperature, and cooling medium adopts dimethicone, and being chilled to temperature in advance is 8-10 ℃, regulate water dropper to condensed fluid apart from 25cm.Pour medicinal liquid into fluid storage compartment, start valve, medicinal liquid is splashed into to condensed fluid,, absorb surface condensation liquid, promptly in collecting a mouthful collection drop pill.
Embodiment 6
Drop pill (plain ball 6)
| Prescription is formed | Consumption |
| Recipe quantity principal agent (six kinds) starch xylitol | 10.6g 10g 20g |
Preparation process: in 20g xylitol, putting of 10g starch batch can, changing the batch can temperature is 95 ℃, makes its fusion, stirs, and adds 10.6g recipe quantity micronization principal agent (six kinds), stirs; With the preheating of drop pill machine, it is 95 ℃ that the fluid storage compartment temperature is promptly dripped system temperature constant temperature, and cooling medium adopts liquid paraffin, and being chilled to temperature in advance is 10-12 ℃, regulate water dropper to condensed fluid apart from 35cm.Pour medicinal liquid into fluid storage compartment, start valve, medicinal liquid is splashed into to condensed fluid,, absorb surface condensation liquid, promptly in collecting a mouthful collection drop pill.
Embodiment 7
Drop pill (plain ball 7)
| Prescription is formed | Consumption |
| Recipe quantity principal agent (six kinds) polyethylene glycol 6000 | 10.6g 25g |
Preparation process: in putting of 25g polyethylene glycol 6000 batch can, changing the batch can temperature is 90 ℃, makes its fusion, stirs, and adds 10.6g recipe quantity micronization principal agent (six kinds), stirs; With the preheating of drop pill machine, it is 90 ℃ that the fluid storage compartment temperature is promptly dripped system temperature constant temperature, and cooling medium adopts soybean oil, and being chilled to temperature in advance is 10-12 ℃, regulate water dropper to condensed fluid apart from 25cm.Pour medicinal liquid into fluid storage compartment, start valve, medicinal liquid is splashed into to condensed fluid,, absorb surface condensation liquid, promptly in collecting a mouthful collection drop pill.
Embodiment 8
Coated drop pill
Preparation process:
1). get any one of the plain ball of embodiment 1-7 gained, carry out following operation.
2). drop pill adopts Opardry II coating materials, presses the conventional preparation of Opardry II coating materials coating solution, carries out coating.Full water is solvent, coating solution solid content 15%.Inlet temperature is 85 ℃, and the sheet bed tempertaure is 35-38 ℃, and atomizing pressure is 1.5bar, and the coating pan rotating speed is 15-23 rev/min, charging flow velocity 3-4g/min.Product clothing film-strength is good, and adhesive force is better, uniform coloring.
Claims (8)
1. aim Naoluotong drop pill, comprise that the mixture with Radix Salviae Miltiorrhizae extractum, tolperisone hydrochloride, Rhizoma Chuanxiong extractum, methylhesperidin, Radix Astragali extractum, vitamin B6 is an active ingredient,, xylitol cured with poloxamer, PEG400, cetomacrogol 1000, polyethylene glycol 1500, Macrogol 4000, polyethylene glycol 6000, cetomacrogol 1000 0, sodium stearate, glycerin gelatine, stearic acid, glyceryl monostearate, worm, starch or its mixed system are pharmaceutic adjuvant, and principal agent (six kinds) is 1 with the weight ratio of adjuvant: 1-10.
2. pharmaceutical composition according to claim 1, main component wherein are the micronization form of Radix Salviae Miltiorrhizae extractum, tolperisone hydrochloride, Rhizoma Chuanxiong extractum, methylhesperidin, Radix Astragali extractum, vitamin B6.
3. drop pill according to claim 1, pharmaceutic adjuvant are selected from and are polyethylene glycol 6000, Macrogol 4000 or their mixture.
4. drop pill according to claim 1, pharmaceutic adjuvant are Macrogol 4000.
5. drop pill according to claim 1, the wherein said Main Ingredients and Appearance of being made up of Radix Salviae Miltiorrhizae extractum, tolperisone hydrochloride, Rhizoma Chuanxiong extractum, methylhesperidin, Radix Astragali extractum, vitamin B6 and the weight ratio of adjuvant are 1: 2-8.
6. drop pill according to claim 1, the wherein said Main Ingredients and Appearance of being made up of Radix Salviae Miltiorrhizae extractum, tolperisone hydrochloride, Rhizoma Chuanxiong extractum, methylhesperidin, Radix Astragali extractum, vitamin B6 and the weight ratio of adjuvant are 1: 2-5.
7. drop pill according to claim 1, the weight ratio of wherein said active component is: Radix Salviae Miltiorrhizae extractum: tolperisone hydrochloride: Rhizoma Chuanxiong extractum: Radix Astragali extractum: methylhesperidin: vitamin B6=50: 50: 50: 50: 10: 2.
8. the preparation method of each described drop pill among the claim 1-7 is followed successively by the following step:
(1) by the weight proportion of each component,, makes its fusion, stir, add recipe quantity micronization principal agent (six kinds), stir heating in selected putting of the adjuvant batch can;
(2) with the preheating of drop pill machine, fluid storage compartment temperature constant temperature is fluid temperature, and selecting cooling medium is liquid paraffin or silicone oil or soybean oil, and being chilled to temperature in advance is 0-20 ℃.
(3) pour medicinal liquid into fluid storage compartment, start valve, medicinal liquid is splashed into to condensed fluid,, absorb surface condensation liquid, promptly get plain ball in collecting a mouthful collection drop pill.
(4) plain ball is adopted conventional coating material or Opadry coating material carry out coating, get coated drop pill.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200510090989 CN1919255A (en) | 2005-08-24 | 2005-08-24 | Aim Naoluotong drop pill and its preparation method |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200510090989 CN1919255A (en) | 2005-08-24 | 2005-08-24 | Aim Naoluotong drop pill and its preparation method |
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| Publication Number | Publication Date |
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| CN1919255A true CN1919255A (en) | 2007-02-28 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 200510090989 Pending CN1919255A (en) | 2005-08-24 | 2005-08-24 | Aim Naoluotong drop pill and its preparation method |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103862912A (en) * | 2014-03-19 | 2014-06-18 | 嘉兴职业技术学院 | Preparing method of protection film for protecting books |
| CN104906119A (en) * | 2015-05-15 | 2015-09-16 | 海南葫芦娃制药有限公司 | Naoluotong capsule and preparation method therefor |
-
2005
- 2005-08-24 CN CN 200510090989 patent/CN1919255A/en active Pending
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103862912A (en) * | 2014-03-19 | 2014-06-18 | 嘉兴职业技术学院 | Preparing method of protection film for protecting books |
| CN103862912B (en) * | 2014-03-19 | 2015-09-16 | 嘉兴职业技术学院 | For the protection of the preparation method of the diaphragm of books |
| CN104906119A (en) * | 2015-05-15 | 2015-09-16 | 海南葫芦娃制药有限公司 | Naoluotong capsule and preparation method therefor |
| CN104906119B (en) * | 2015-05-15 | 2017-10-27 | 海南葫芦娃药业集团股份有限公司 | NAOLUOTONG JIAONANG and preparation method thereof |
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