CN100475204C - Pilocarpine nitrate dispersible tablet and preparation method thereof - Google Patents
Pilocarpine nitrate dispersible tablet and preparation method thereof Download PDFInfo
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- CN100475204C CN100475204C CNB2006101269913A CN200610126991A CN100475204C CN 100475204 C CN100475204 C CN 100475204C CN B2006101269913 A CNB2006101269913 A CN B2006101269913A CN 200610126991 A CN200610126991 A CN 200610126991A CN 100475204 C CN100475204 C CN 100475204C
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- Prior art keywords
- dispersible tablet
- pilocarpine
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- pilocarpine nitrate
- xerostomia
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- YKFROQCFVXOUPW-UHFFFAOYSA-N 4-(methylthio) aniline Chemical compound CSC1=CC=C(N)C=C1 YKFROQCFVXOUPW-UHFFFAOYSA-N 0.000 title claims abstract description 19
- 229960001963 pilocarpine nitrate Drugs 0.000 title claims abstract description 19
- 239000007919 dispersible tablet Substances 0.000 title claims abstract description 16
- 238000002360 preparation method Methods 0.000 title abstract description 6
- QCHFTSOMWOSFHM-UHFFFAOYSA-N SJ000285536 Natural products C1OC(=O)C(CC)C1CC1=CN=CN1C QCHFTSOMWOSFHM-UHFFFAOYSA-N 0.000 claims description 10
- 229960001416 pilocarpine Drugs 0.000 claims description 10
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims description 8
- GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 claims description 4
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims description 4
- 235000019359 magnesium stearate Nutrition 0.000 claims description 4
- 239000008108 microcrystalline cellulose Substances 0.000 claims description 4
- 229940016286 microcrystalline cellulose Drugs 0.000 claims description 4
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims description 4
- 239000001253 polyvinylpolypyrrolidone Substances 0.000 claims description 4
- 235000013809 polyvinylpolypyrrolidone Nutrition 0.000 claims description 4
- 229920000523 polyvinylpolypyrrolidone Polymers 0.000 claims description 4
- 239000002994 raw material Substances 0.000 claims description 4
- 239000008101 lactose Substances 0.000 claims description 3
- -1 pilocarpine nitrates Chemical class 0.000 claims description 3
- 229920002153 Hydroxypropyl cellulose Polymers 0.000 claims description 2
- 235000010977 hydroxypropyl cellulose Nutrition 0.000 claims description 2
- 239000003795 chemical substances by application Substances 0.000 abstract description 5
- 239000000945 filler Substances 0.000 abstract description 4
- 239000000314 lubricant Substances 0.000 abstract description 4
- 238000000034 method Methods 0.000 abstract description 4
- 239000000470 constituent Substances 0.000 abstract 1
- 208000005946 Xerostomia Diseases 0.000 description 17
- 206010013781 dry mouth Diseases 0.000 description 16
- 239000003814 drug Substances 0.000 description 14
- QCHFTSOMWOSFHM-WPRPVWTQSA-N (+)-Pilocarpine Chemical compound C1OC(=O)[C@@H](CC)[C@H]1CC1=CN=CN1C QCHFTSOMWOSFHM-WPRPVWTQSA-N 0.000 description 8
- 230000000694 effects Effects 0.000 description 6
- 206010039424 Salivary hypersecretion Diseases 0.000 description 5
- 238000001959 radiotherapy Methods 0.000 description 5
- 210000003079 salivary gland Anatomy 0.000 description 5
- 208000026451 salivation Diseases 0.000 description 5
- 229940079593 drug Drugs 0.000 description 4
- 229940068196 placebo Drugs 0.000 description 4
- 239000000902 placebo Substances 0.000 description 4
- 239000011230 binding agent Substances 0.000 description 3
- 230000008859 change Effects 0.000 description 3
- 210000004907 gland Anatomy 0.000 description 3
- 239000000203 mixture Substances 0.000 description 3
- 230000028327 secretion Effects 0.000 description 3
- 239000008107 starch Substances 0.000 description 3
- 235000019698 starch Nutrition 0.000 description 3
- 208000024891 symptom Diseases 0.000 description 3
- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 description 2
- 229920000881 Modified starch Polymers 0.000 description 2
- 229920003081 Povidone K 30 Polymers 0.000 description 2
- 229920002472 Starch Polymers 0.000 description 2
- 238000010521 absorption reaction Methods 0.000 description 2
- 125000002057 carboxymethyl group Chemical group [H]OC(=O)C([H])([H])[*] 0.000 description 2
- 239000000064 cholinergic agonist Substances 0.000 description 2
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 2
- 239000002552 dosage form Substances 0.000 description 2
- 230000003203 everyday effect Effects 0.000 description 2
- 210000002216 heart Anatomy 0.000 description 2
- 229940031703 low substituted hydroxypropyl cellulose Drugs 0.000 description 2
- 229920000036 polyvinylpyrrolidone Polymers 0.000 description 2
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 description 2
- 229940001470 psychoactive drug Drugs 0.000 description 2
- 239000004089 psychotropic agent Substances 0.000 description 2
- 239000011734 sodium Substances 0.000 description 2
- 229910052708 sodium Inorganic materials 0.000 description 2
- 210000000106 sweat gland Anatomy 0.000 description 2
- 239000003826 tablet Substances 0.000 description 2
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 description 1
- 208000019505 Deglutition disease Diseases 0.000 description 1
- 206010013786 Dry skin Diseases 0.000 description 1
- 208000008454 Hyperhidrosis Diseases 0.000 description 1
- 229930195725 Mannitol Natural products 0.000 description 1
- 208000003445 Mouth Neoplasms Diseases 0.000 description 1
- 208000002454 Nasopharyngeal Carcinoma Diseases 0.000 description 1
- 206010061306 Nasopharyngeal cancer Diseases 0.000 description 1
- 206010028980 Neoplasm Diseases 0.000 description 1
- 208000025157 Oral disease Diseases 0.000 description 1
- 206010043966 Tongue neoplasm malignant stage unspecified Diseases 0.000 description 1
- 230000000052 comparative effect Effects 0.000 description 1
- FPAFDBFIGPHWGO-UHFFFAOYSA-N dioxosilane;oxomagnesium;hydrate Chemical compound O.[Mg]=O.[Mg]=O.[Mg]=O.O=[Si]=O.O=[Si]=O.O=[Si]=O.O=[Si]=O FPAFDBFIGPHWGO-UHFFFAOYSA-N 0.000 description 1
- 239000006185 dispersion Substances 0.000 description 1
- 208000002173 dizziness Diseases 0.000 description 1
- 238000001035 drying Methods 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- 238000009472 formulation Methods 0.000 description 1
- 210000001035 gastrointestinal tract Anatomy 0.000 description 1
- 239000008187 granular material Substances 0.000 description 1
- 201000010536 head and neck cancer Diseases 0.000 description 1
- 208000014829 head and neck neoplasm Diseases 0.000 description 1
- 230000037315 hyperhidrosis Effects 0.000 description 1
- 230000008676 import Effects 0.000 description 1
- 230000006872 improvement Effects 0.000 description 1
- 210000003734 kidney Anatomy 0.000 description 1
- 208000012987 lip and oral cavity carcinoma Diseases 0.000 description 1
- 210000004185 liver Anatomy 0.000 description 1
- 210000004072 lung Anatomy 0.000 description 1
- 239000000594 mannitol Substances 0.000 description 1
- 235000010355 mannitol Nutrition 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 239000000463 material Substances 0.000 description 1
- 230000027939 micturition Effects 0.000 description 1
- 208000030194 mouth disease Diseases 0.000 description 1
- 201000011216 nasopharynx carcinoma Diseases 0.000 description 1
- 230000008569 process Effects 0.000 description 1
- 238000010298 pulverizing process Methods 0.000 description 1
- 238000003908 quality control method Methods 0.000 description 1
- 230000005855 radiation Effects 0.000 description 1
- 230000036391 respiratory frequency Effects 0.000 description 1
- 210000002345 respiratory system Anatomy 0.000 description 1
- 239000007779 soft material Substances 0.000 description 1
- 238000011287 therapeutic dose Methods 0.000 description 1
- 230000001225 therapeutic effect Effects 0.000 description 1
- 208000025093 tonsil carcinoma Diseases 0.000 description 1
- 231100000331 toxic Toxicity 0.000 description 1
- 230000002588 toxic effect Effects 0.000 description 1
- 238000005303 weighing Methods 0.000 description 1
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- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
The invention relates to a pilocarpine nitrate dispersible tablet and method for preparation, wherein the dispersible tablet comprises the following constituents (by weight ratio): pilocarpine nitrate 0.5-5 parts, filling agent 50-185 parts, crumbling agent 20-140 parts, lubricant 0.2-5 parts.
Description
Technical field
The present invention relates to a kind of preparation of M cholinergic agonist, specifically, is a kind of Pilocarpine nitrate dispersible tablet agent that relates to.
Background technology
Pilocarpine is the M cholinergic agonist, thereby cause secretion increasing alleviation xerostomia by direct exciting sweat gland, salivary gland, lachrymal gland, digestive tract and respiratory tract gland cell M-cholinoceptor after the oral absorption, wherein the most obvious to the effect of sweat gland, salivary gland.Be mainly used in due to the treatment psychotropic drugs xerostomia after xerostomia, senile xerostomia and head, the tumor colli radiotherapy clinically.In the therapeutic dose scope, heart rate, respiratory frequency all there are not obvious influence, Electrocardioscopy does not have change, except that causing that salivary gland secretion increases, can increase the secretion of broncheal gland and enteraden yet.
Greenspan first report in 1987, the xerostomia disease that oral pilocarpine nitrate treatment tumor of head and neck causes because of radiotherapy.12 routine patient ages between 16～79 years old, wherein carcinoma of tonsil 4 examples, nasopharyngeal carcinoma 3 examples, carcinoma of tongue 2 examples, oral cancer 2 examples, oberkieferkrebs 1 example.All patients accept radiation treatment, and (accumulated dose is xerostomia disease to occur after 5500～800rad).Adopt the double blind random cross matching, be divided into two groups, every group 6 example.One group begins to use the pilocarpine sheet, every day 3 times, each 2～3 (every contains 2.5mg); Another group is used placebo earlier.Two groups of each successive administration 90d, luxuriant dose and pilocarpine sheet 90d are pacified in two groups of exchange administrations then, measure the improvement of salivation and subjective symptom.The result: accept to have in 12 examples of pilocarpine treatment 9 examples to improve, and when using placebo only 2 examples improve both comparative statistics significances.
Usefulness pilocarpine such as Rieke JW and placebo have carried out the double blind control research in 12 weeks to 369 routine radiotherapy xerostomia patients, the each 5mg of oral pilocarpine 3 times on the one, took medicine 28 days continuously, the result shows that pilocarpine can obviously increase patient's salivation amount, and medication is safer.Side effect is 29% except that the perspiration incidence rate, and other side effect symptoms (feel sick, feel cold, frequent micturition, dizziness etc.) incidence rate is 3-9%.
Find in the clinical research of xerostomia due to the pilocarpine nitrate treatment psychotropic drugs, relatively there were significant differences before patient took the salivation amount that recorded in 45 minutes behind the pilocarpine and takes medicine (P≤0.05, taking medicine relatively had highly significant difference (P≤0.01 with the salivation amount that recorded in 180 minutes and before taking medicine in back 90 minutes; Value slightly descended than 90 minutes values in 180 minutes, pointed out to reach the peak in 90 minutes, was maintained until 180 minutes front and back peak values and began to descend.Patient's total effective rate for the treatment of xerostomia in 28 days of taking medicine continuously reaches 77.8%, with 74% basically identical of external report, illustrates that this medicine treatment xerostomia is effective.
The clinical efficacy of riel glad (determination of pilocarpine nitrate tablets) treatment 181 routine radiotherapy xerostomias, medicine source property xerostomia and the salivary gland illness xerostomia of China's development is observed by 5 tame hospitals such as tumour hospital of Chinese medicine institute.Usage is glad 4mg/ time of oral riel, 3 times/day, and be respectively for 2 week and 4 weeks the course of treatment, and select comparable illness patient of the same race 65 examples, contrast with placebo.The clinical observation on the therapeutic effect result: oral riel is glad can obviously to change radiotherapy xerostomia, medicine source property xerostomia and salivary gland illness xerostomia patient xerostomia symptom, and the obvious amount of ptyalizing.Curative effect comprehensive assessment result is total effective rate 95% (wherein obvious effective rate is more than 40%, and effective percentage is more than 50%).After clinical observation was taken medicine 90 minutes to the patient in addition, the salivation amount can peak, and began after 3 hours to descend, and showed that the glad absorption of riel is fast, and produce effects is rapid.When taking the dosage of 12mg every day, except 17 examples (10.1%) have many tears, 8 examples (4.8%) have outside the hyperhidrosis, and the heart, lung, liver, kidney, vision be there is no obvious toxic and side effects.
Summary of the invention
First purpose of the present invention provides a kind of Pilocarpine nitrate dispersible tablet.
Another object of the present invention provides the preparation method of this Pilocarpine nitrate dispersible tablet.
In order to achieve the above object, the present invention is by the following technical solutions:
This kind Pilocarpine nitrate dispersible tablet, contain the raw material of following weight portion:
Pilocarpine nitrate 0.5-5 part
Filler 50-185 part
Disintegrating agent 20-140 part
Lubricant 0.2-5 part.
Described filler is selected from lactose, microcrystalline Cellulose, mannitol, pregelatinized Starch and/or starch.
Described disintegrating agent is selected from a kind of or its combination in polyvinylpolypyrrolidone, low-substituted hydroxypropyl cellulose, carboxymethyl starch sodium, the crosslinked carboxymethyl fecula sodium.
Described lubricant is selected from magnesium stearate or/and Pulvis Talci.
Preferably, described raw material and weight portion thereof are: 2 parts of pilocarpine nitrates, 47.5 parts of lactose, 120 parts of microcrystalline Cellulose, 20 parts of low-substituted hydroxypropyl celluloses, 10 parts of polyvinylpolypyrrolidone, 0.5 part of magnesium stearate.
Binding agent optional from polyvidone, hydroxypropyl emthylcellulose or/and starch, use amount is the use amount of binding agent in the common dispersible tablet.
This Pilocarpine nitrate dispersible tablet makes by the following technical solutions:
A, each raw material pulverizing is crossed 100 mesh sieves;
B, take by weighing pilocarpine nitrate, filler and disintegrating agent, by equivalent incremental method mix homogeneously;
C, adding 5% 30 POVIDONE K 30 BP/USP
30Alcoholic solution system soft material is with 20 mesh sieve system wet granulars;
D, wet granular are in 60～70 ℃ of dryings, and dry back is with 20 mesh sieve granulate, and even with mix lubricant again, tabletting is packed promptly.
The invention has the advantages that, compare with former dosage form behind the Pilocarpine nitrate dispersible tablet dosage changing form, have following characteristics: 1, the development Pilocarpine nitrate dispersible tablet makes its oral formulations dosage form variation, provides more choices for clinicist and patient's medication simultaneously; 2, both kept characteristics such as tablet manufacturing is simple for process, quality control is reliable, easy to carry, and improved its inherent quality again, drug release is fast, and the interior bioavailability of body is effectively ensured; 3, taking convenience can be swallowed, chew to contain and suck or with taking after the aqueous dispersion, especially is fit to some other oral disease patients such as old man, dysphagia person and takes, and has improved patient's compliance.
The specific embodiment
Be embodiments of the invention below, described embodiment just is used for illustrating the present invention, and should not be considered to be limitation of the present invention.
The part material source:
Microcrystalline Cellulose: Zhejiang eyot prospect Pharmaceutical chemistry company limited meets two quality standards of Chinese Pharmacopoeia version in 2000.
Low-substituted hydroxypropyl cellulose: Zhejiang eyot prospect Pharmaceutical chemistry company limited meets two quality standards of Chinese Pharmacopoeia version in 2000.
Polyvinylpolypyrrolidone: international special product company limited meets import drugs registered standard JX20020242.
30 POVIDONE K 30 BP/USP 30: Zhejiang eyot prospect Pharmaceutical chemistry company limited meets two quality standards of Chinese Pharmacopoeia version in 2000.
Magnesium stearate: Zhejiang eyot prospect Pharmaceutical chemistry company limited meets two quality standards of Chinese Pharmacopoeia version in 2000.
Embodiment 1-35
Please refer to the 6th page of table 1 and table 2 to last page.Wherein, binding agent adopts polyvidone.
Carry out factors influencing by embodiment 25, the results are shown in Table 2.
The result shows that Pilocarpine nitrate dispersible tablet provided by the invention meets the regulation of Chinese Pharmacopoeia (version in 2000) about dispersible tablet.
More than Pilocarpine nitrate dispersible tablet provided by the present invention and preparation method thereof is described in detail, used specific case herein principle of the present invention and embodiment are set forth, the explanation of above embodiment just is used for helping to understand method of the present invention and core concept thereof; Simultaneously, for one of ordinary skill in the art, according to thought of the present invention, the part that all can change in specific embodiments and applications, in sum, this description should not be construed as limitation of the present invention.
Claims (1)
1. a Pilocarpine nitrate dispersible tablet is characterized in that, contains the raw material of following weight portion: 2 parts of pilocarpine nitrates, 47.5 parts of lactose, 120 parts of microcrystalline Cellulose, 20 parts of low-substituted hydroxypropyl celluloses, 10 parts of polyvinylpolypyrrolidone, 0.5 part of magnesium stearate.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2006101269913A CN100475204C (en) | 2006-09-18 | 2006-09-18 | Pilocarpine nitrate dispersible tablet and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2006101269913A CN100475204C (en) | 2006-09-18 | 2006-09-18 | Pilocarpine nitrate dispersible tablet and preparation method thereof |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1919183A CN1919183A (en) | 2007-02-28 |
| CN100475204C true CN100475204C (en) | 2009-04-08 |
Family
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CNB2006101269913A Expired - Fee Related CN100475204C (en) | 2006-09-18 | 2006-09-18 | Pilocarpine nitrate dispersible tablet and preparation method thereof |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN100475204C (en) |
-
2006
- 2006-09-18 CN CNB2006101269913A patent/CN100475204C/en not_active Expired - Fee Related
Non-Patent Citations (3)
| Title |
|---|
| WPI/DERWENT:FR2737661A 1997.02.14 |
| 分散片的研究进展. 张素中.CNKI：全国中药标准研究学术研讨会论文集. 2005 |
| 分散片的研究进展. 张素中.CNKI：全国中药标准研究学术研讨会论文集. 2005 * |
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| Publication number | Publication date |
|---|---|
| CN1919183A (en) | 2007-02-28 |
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Owner name: HUNAN WARRANT PHARMACEUTICAL CO., LTD. Free format text: FORMER OWNER: HUANG BENDONG Effective date: 20140820 |
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Effective date of registration: 20140820 Address after: 410331 Liuyang biological medicine Park, Changsha, Hunan Patentee after: Hunan Warrant Pharmaceutical Co., Ltd. Address before: Baiyun District of Guangzhou City, Guangdong province 510000 and 97 with Yun Xiang Road, building No. 28 room 605 Patentee before: Huang Bendong |
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Address after: 410331 Liuyang biological medicine Park, Hunan Province Patentee after: HUNAN WARRANT PHARMACEUTICAL CO., LTD. Address before: 410331 Liuyang biological medicine Park, Changsha, Hunan Patentee before: Hunan Warrant Pharmaceutical Co., Ltd. |
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