CN103638085A - Thorax-comforting pulse controlled-release dropping pill and preparation method thereof - Google Patents
Thorax-comforting pulse controlled-release dropping pill and preparation method thereof Download PDFInfo
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- CN103638085A CN103638085A CN201310540305.7A CN201310540305A CN103638085A CN 103638085 A CN103638085 A CN 103638085A CN 201310540305 A CN201310540305 A CN 201310540305A CN 103638085 A CN103638085 A CN 103638085A
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Abstract
The invention relates to the field of traditional Chinese medicine pulse controlled-release preparations, and discloses a thorax-comforting pulse controlled-release dropping pill. The thorax-comforting pulse controlled-release dropping pill comprises a thorax-comforting dropping pill, a swelling layer and a controlled-release layer. The thorax-comforting pulse controlled-release dropping pill is characterized in that the thorax-comforting dropping pill is covered by the swelling layer and the controlled-release layer sequentially, and the thorax-comforting dropping pill is prepared by extracting ligusticum wallichii, safflower and pseudo-ginseng. The invention further provides a preparation method of the thorax-comforting pulse controlled-release dropping pill. The controlled-release dropping pill is a pulse medicine releasing system, and is capable of releasing the medicine according to a preset time and providing an effective blood medicine concentration when disease attacks, thus achieving an objective of time-selected treatment when angina pectoris attacks early in the morning. The medicine in the system is released when the disease attacks, and therefore medicine adverse reactions and receptor sensibility reduction which are caused by continuous high medicine concentration. According to the disease attack rhythm of a patient, the medicine is taken in advance, thus reducing the number of times of administration and increasing the compliance of the patient.
Description
Technical field
The present invention relates to Chinese medicine pulse-controlled release preparations field, relate in particular to relieving disorders of the chest pulse controlled release drop pill and preparation method thereof.
Background technology
The result of study of chronopharmacology (Chronopharmacology) shows, there is biorhythm in bodily fuctions, disease and symptom occur in 24 hours round the clock also non-uniform Distribution, body presents regular hour dependency to the disposal of medicine and reaction, and the circadian rhythm of disease has caused the variation round the clock of the interior pharmacokinetics of curative object and pharmacodynamics.In view of this, the idea of the pharmacokinetics of conventional relevant drug level " more steadily better " be not suitable for all medicines; Stabilised blood concentration nonideal release, can not meet the needs of clinical rational Drug therapy far away according to the tradition sustained-release preparation that fixedly administering mode gives zero level speed, first-rate release.When clinical application, should to the rhythmicity of drug reaction, decide best administration time and dosage according to body, make it at Best Times, discharge medicine, reach optimum curative effect and minimum untoward reaction, to improve curative effect, reduce toxicity and drug dose.
The outbreak of the diseases such as angina pectoris, asthma, hypertension, rheumatoid has daily rhythmicity, patient when falling asleep in physiology lowstand, do not need drug release, if but take medicine and can not produce rapidly effective blood drug level when night seizure of disease, seizure of disease controlled.So according to the rhythmicity feature of disease incidence, development is taken before falling asleep, when seizure of disease, the Novel Drug Delivery Systems of onset is significant.
Pulsatile drug delivery system is the novel controlled release drug-supplying system according to the principle design of chronopharmacology, according to the rhythm and pace of moving things of patient's morbidity, take medicine in advance, medicine-releasing system discharges medicine in single or multiple ground to schedule, effective blood drug level is provided when seizure of disease, to reach best therapeutic effect, and the receptor sensitivity of having avoided some drugs to cause because of lasting high concentration reduces and the untoward reaction of medicine.Medicine in pulse-controlled release preparations is to discharge when seizure of disease, can avoid body because producing drug resistance in high concentration medicine state for a long time, the medicine that is made generally in pulse preparation arrives small intestinal or colon release after oral administration, therefore, can avoid the first pass effect of liver, the bioavailability of medicine is provided; Reduce administration number of times simultaneously, increased patient's compliance.Pulsatile drug delivery system be particularly suitable for night or wake up after need at once to have the disease of a blood drug level peak value.
Angina pectoris is cardiovascular disease more common in coronary heart disease, the coronary insufficiency causing due to a variety of causes, cardiac muscle temporary transient ischemia, anoxia sharply, or due to coronary spasm, along with the raising of people's living standard and the variation of life style, its sickness rate is continuous ascendant trend.And angina pectoris has obvious daily rhythmicity, its morning odds high, be therefore necessary that design prevents and treats angina pectoris at the preparation of release in morning and occurs.
Radix Notoginseng in chest relaxing drop pills, Flos Carthami, Rhizoma Chuanxiong three taste medical material compatibilities are used, and take ferulic acid, ginsenoside, arasaponin etc. is main component, has expansion coronary vasodilator, increases coronary blood flow and antiplatelet effect; To all kinds angina pectoris, myocardial infarction, heart failure, silent ischemias etc. all have remarkable result.Therefore, this research selects the chest relaxing drop pills of determined curative effect as model drug, adopts multiple coatings technology to prepare pulse-controlled release preparations, effectively control impuls drug release time, make medicine start to discharge and onset rapidly in predetermined time, be conducive to giving full play to of drug effect; Reduce toxic and side effects, administration number of times reduces simultaneously, also can greatly increase patient's compliance; There is the good prospect of marketing, can have a tremendous social and economic benefits.
Summary of the invention
The object of the invention is to overcome the deficiency that the preparations such as existing SHUXIONG PIAN, chest relaxing drop pills exist, a kind of effectively control impuls drug release time is provided, make medicine start to discharge and onset rapidly in predetermined time, be conducive to giving full play to of drug effect, reduce toxic and side effects, administration number of times reduces simultaneously, also can greatly increase the relieving disorders of the chest pulse controlled release drop pill of patient's compliance.
First the invention provides a kind of relieving disorders of the chest pulse controlled release drop pill, comprise chest relaxing drop pills, swell layer and controlled release layer, at described chest relaxing drop pills, wrap up successively swell layer and controlled release layer outward, described chest relaxing drop pills is for to extract made drop pill by Rhizoma Chuanxiong, Flos Carthami and Radix Notoginseng.
Described swell layer makes chest relaxing drop pills weightening finish 10% ~ 30%.
Described controlled release layer makes chest relaxing drop pills weightening finish 5% ~ 15%.
Described swell layer comprises swollen material and binding agent, described swollen material is one or more the mixture in cross-linking sodium carboxymethyl cellulose, crosslinked carboxymethyl fecula sodium, low-substituted hydroxypropyl cellulose, polyvinylpolypyrrolidone, sodium lauryl sulphate, and binding agent is hydroxypropyl emthylcellulose.
Described controlled release layer comprises film control material, and described film control material is crylic acid resin aqueous dispersion, cellulose acetate aqueous dispersion or Aquacoat.
Further, provide a kind of preparation method of above-mentioned relieving disorders of the chest pulse controlled release drop pill, comprise the following steps:
S1. Rhizoma Chuanxiong, Flos Carthami and Radix Notoginseng are extracted and refining rear mixing be condensed into extractum, with substrate mixed melting, prepare drop pill;
S2. by binding agent dissolving soluble in water, add swollen material, mix homogeneously, is mixed with swell layer coating solution;
S3. by film control material dilute with water, be mixed with controlled release layer coating solution;
S4. drop pill is placed in to fluid bed, from swell layer to controlled release layer, carries out coating, make relieving disorders of the chest pulse controlled release drop pill.
In swell layer coating solution described in step S2, the concentration of binding agent is 16 ~ 24g/L, and the concentration of swollen material is 21 ~ 42g/L.
In controlled release layer coating solution described in step S3, the concentration of film control material is 70 ~ 90g/L.
Chest relaxing drop pills is made to pulse-controlled release preparations, can discharge to schedule medicine, effective blood drug level is provided when seizure of disease, the object for the treatment of when morning, outbreak was selected to reach angina pectoris.Compare with preparations such as existing SHUXIONG PIAN, chest relaxing drop pills, said preparation has following beneficial effect:
1, medicine is to discharge when seizure of disease, has avoided medicine to reduce and the untoward reaction of medicine because of the receptor sensitivity that continues high concentration and cause.
2, according to the rhythm and pace of moving things of patient's morbidity, take medicine in advance, reduced administration number of times, increased patient's compliance.
3, the present invention adopts most suitable component, and original slow release is regulated and controled.
Accompanying drawing explanation
Fig. 1 is the cumulative release curve chart of first group of embodiment.
Fig. 2 is the cumulative release curve chart of second group of embodiment.
Fig. 3 is the cumulative release curve chart of the 3rd group of embodiment.
The specific embodiment
Below in conjunction with the drawings and specific embodiments, further describe the present invention.Unless stated otherwise, reagent, equipment and the method that the present invention adopts is the conventional commercial reagent of the art, equipment and the conventional method of using.
Below in conjunction with accompanying drawing and several groups of specific embodiments, relieving disorders of the chest pulse controlled release drop pill of the present invention and preparation method thereof is described in further detail, release adopts the device of 2010 editions two the little agar diffusion methods of appendix X C dissolution method the 3rd method of < < Chinese Pharmacopoeia > >, the operation of appendix X D drug release determination method the second method, dissolution medium (0.1 mol/L hydrochloric acid solution, pH6.8 phosphate buffer) be 250mL, bath temperature is (37 ± 0.5) ℃, and rotating speed is 100 r/min.Front 2h measures in 0.1 mol/L hydrochloric acid solution, continues to measure after 2h in pH6.8 phosphate buffer, and interval sampling 5mL, measures on schedule.
Every group of embodiment below all provided prescription and the preparation technology of relieving disorders of the chest pulse controlled release drop pill, and vitro release result of the test.
The test of embodiment 1 different swollen materials
Prescription:
| Principal agent | Chest relaxing drop pills |
| Swollen material | CCMC-Na、CCMS-Na、L-HPC、PVPP |
| Binding agent | HPMC |
| Film control material | Aquacoat |
Preparation technology:
(1) preparation of swell layer coating solution: binding agent HPMC is dissolved in suitable quantity of water, magnetic agitation is to dissolving completely, be mixed with the solution that concentration is 20 gL-1, adding CCMC-Na or other swollen materials (CCMS-Na, L-HPC, PVPP) to make its mass concentration is 35 gL-1, be stirred to evenly, standing over night, makes its abundant swelling.
(2) preparation of controlled release layer coating solution: get Aquacoat and be diluted with water to the solution that concentration is 80 gL-1, be stirred to evenly and get final product.
(3) spray art for coating at the bottom of fluid bed: the chest relaxing drop pills of suitable size (10 ~ 15 mg) is placed in to fluid bed, coating successively from swell layer to controlled release layer, air intake pressure is 0.3 ~ 0.4 MPa, leaving air temp is (37.0 ± 2.0) ℃, hydrojet speed is 1.5 ~ 2.0 mLmin-1, atomisation pressure is 0.16 ~ 0.20 MPa, in end spray mode, carries out coating.Swell layer coating weightening finish is 15%, and the weightening finish of controlled release layer coating is 7%, fluidized drying 10 min after each coating, and coating completes and is placed in baking oven 40 ℃ and solidifies 2 h and get final product, and carries out vitro release test.
Vitro release result of the test:
The impact of the different swollen materials of table 1 on drug release
The test of the different swell layer coating weightening finishes of embodiment 2
Prescription:
| Principal agent | Chest relaxing drop pills |
| Swollen material | CCMC-Na |
| Binding agent | HPMC |
| Film control material | Aquacoat |
Preparation technology:
(1) preparation of swell layer coating solution: binding agent HPMC is dissolved in suitable quantity of water, and magnetic agitation, to dissolving completely, is mixed with the solution that concentration is 20 gL-1, adding CCMC-Na to make its mass concentration is 35 gL-1, be stirred to evenly, standing over night, makes its abundant swelling.
(2) preparation of controlled release layer coating solution: get Aquacoat and be diluted with water to the solution that concentration is 80 gL-1, be stirred to evenly and get final product.
(3) spray art for coating at the bottom of fluid bed: with embodiment 1, wherein, the weightening finish of swell layer coating is respectively 10%, 15%, 20%, 25%, 30%.
Vitro release result of the test:
The impact of the different swell layer coating weightening finishes of table 2 on drug release
The test of the different controlled release layer coating weightening finishes of embodiment 3
Prescription: with embodiment 2.
Preparation technology:
(1) preparation of swell layer coating solution: with embodiment 2.
(2) preparation of controlled release layer coating solution: with embodiment 2.
(3) spray art for coating at the bottom of fluid bed: with embodiment 1, wherein, the weightening finish of controlled release layer coating is respectively 5%, 7%, 10%, 15%.
Vitro release result of the test:
The impact of the different controlled release layer coating weightening finishes of table 3 on drug release
From the dissolution test result of table 1 ~ 3 and the release curve chart of Fig. 1 ~ 3, can find out, by adjusting the coating of swell layer and controlled release layer, write out a prescription, can reach desirable lag time and the pulsed release time.
Claims (8)
1. a relieving disorders of the chest pulse controlled release drop pill, comprises chest relaxing drop pills, swell layer and controlled release layer, it is characterized in that, at described chest relaxing drop pills, wraps up successively swell layer and controlled release layer outward, and described chest relaxing drop pills is for to extract made drop pill by Rhizoma Chuanxiong, Flos Carthami and Radix Notoginseng.
2. relieving disorders of the chest pulse controlled release drop pill according to claim 1, is characterized in that, described swell layer makes chest relaxing drop pills weightening finish 10% ~ 30%.
3. relieving disorders of the chest pulse controlled release drop pill according to claim 1, is characterized in that, described controlled release layer makes chest relaxing drop pills weightening finish 5% ~ 15%.
4. relieving disorders of the chest pulse controlled release drop pill according to claim 1, it is characterized in that, described swell layer comprises swollen material and binding agent, described swollen material is one or more the mixture in cross-linking sodium carboxymethyl cellulose, crosslinked carboxymethyl fecula sodium, low-substituted hydroxypropyl cellulose, polyvinylpolypyrrolidone, sodium lauryl sulphate, and binding agent is hydroxypropyl emthylcellulose.
5. relieving disorders of the chest pulse controlled release drop pill according to claim 4, is characterized in that, controlled release layer comprises film control material, and described film control material is crylic acid resin aqueous dispersion, cellulose acetate aqueous dispersion or Aquacoat.
6. a preparation method for relieving disorders of the chest pulse controlled release drop pill according to claim 1, is characterized in that, comprises the following steps:
S1. Rhizoma Chuanxiong, Flos Carthami and Radix Notoginseng are extracted and refining rear mixing be condensed into extractum, with substrate mixed melting, prepare drop pill;
S2. by binding agent dissolving soluble in water, add swollen material, mix homogeneously, is mixed with swell layer coating solution;
S3. by film control material dilute with water, be mixed with controlled release layer coating solution;
S4. drop pill is placed in to fluid bed, from swell layer to controlled release layer, carries out coating, make relieving disorders of the chest pulse controlled release drop pill.
7. preparation method according to claim 6, is characterized in that, in the swell layer coating solution described in step S2, the concentration of binding agent is 16 ~ 24g/L, and the concentration of swollen material is 21 ~ 42g/L.
8. preparation method according to claim 6, is characterized in that, in the controlled release layer coating solution described in step S3, the concentration of film control material is 70 ~ 90g/L.
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| CN201310540305.7A CN103638085A (en) | 2013-11-05 | 2013-11-05 | Thorax-comforting pulse controlled-release dropping pill and preparation method thereof |
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| CN201310540305.7A CN103638085A (en) | 2013-11-05 | 2013-11-05 | Thorax-comforting pulse controlled-release dropping pill and preparation method thereof |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107669727A (en) * | 2017-11-17 | 2018-02-09 | 广东药科大学 | A kind of easypro chest pulse controlled release dripping pill for strengthening the effect of chest relaxing drop pills coronary vasodilation and preparation method thereof |
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2013
- 2013-11-05 CN CN201310540305.7A patent/CN103638085A/en active Pending
Non-Patent Citations (1)
| Title |
|---|
| 陈卉等: "舒胸脉冲控释滴丸的研制", 《中药材》 * |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107669727A (en) * | 2017-11-17 | 2018-02-09 | 广东药科大学 | A kind of easypro chest pulse controlled release dripping pill for strengthening the effect of chest relaxing drop pills coronary vasodilation and preparation method thereof |
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Application publication date: 20140319 |