CN100509048C - Jinwu Gutong tablet and preparing method thereof - Google Patents
Jinwu Gutong tablet and preparing method thereof Download PDFInfo
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- CN100509048C CN100509048C CNB2005100031852A CN200510003185A CN100509048C CN 100509048 C CN100509048 C CN 100509048C CN B2005100031852 A CNB2005100031852 A CN B2005100031852A CN 200510003185 A CN200510003185 A CN 200510003185A CN 100509048 C CN100509048 C CN 100509048C
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Abstract
The invention relates to a medicinal tablet composition for treating orthopaedic diseases and process for preparation, wherein the tablet is prepared from Chinese herbal materials including kudzu vine root, curcuma longa, Cibotium barometz, black-tail snake, kudzu vine root, epimeddium, pawpaw, achyranthes and cyathula root, codonopsis lanceolata, Clematis chinensis and other auxiliary materials.
Description
Technical field
The present invention relates to a kind of Chinese medicinal tablet and preparation method thereof, belong to technical field of medicaments.
Background technology
Orthopaedic disease is a frequently-occurring disease, commonly encountered diseases.Its curative is the standing medicine of family, and the 'Jinwugutong ' capsule preparation is arranged in the market, finds in actual use, though their therapeutic effect is good, but also comes with some shortcomings.Show: because capsule 's content has stronger hygroscopicity, and capsule is not complete enclosed system, so in storage process, the easy moisture absorption of the content in the capsule and influence product quality, medicine causes effective ingredient to reduce in storage process, influences the effectiveness of medicine.Content uniformity easily transfinites, and causes taking dose inaccurate; Moisture-sensitive, deliquescing, caking, even go mouldy, light, air, moisture etc. are bigger to its influence.In addition, different patients has different preferences to the dosage form of taking, and only the also inconvenient patient of this a kind of dosage form is to the selection of pharmaceutical dosage form.
Summary of the invention
The objective of the invention is to, a kind of novel formulation for the treatment of orthopaedic disease is provided, solve the problem that prior art exists.
Technical scheme of the present invention.Jinwu Gutong tablet, it is with following materials of weight proportions,
Rhizoma Cibotii 8-24 part, Zaocys 6-18 part,
Radix Puerariae 10-30 part, Herba Epimedii 10-30 part,
Fructus Chaenomelis 6-18 part, Radix Achyranthis 6-18 part,
Radix Campanumoeae 6-18 part, Rhizoma Curcumae Longae 6-18 part,
Radix Clematidis 8-24 part, Fructus Psoraleae 8-24 part;
Add adjuvant again and be prepared into tablet.
The preparation method of above-mentioned 'Jinwugutong ' tablet preparation is characterized in that: be on the waiting list raw material by given components by weight percent, by following step preparation;
A, Radix Puerariae, Rhizoma Curcumae Longae are dried to moisture 3～6%, are ground into 160 orders～200 order fine powders under 60 ℃ of conditions being lower than, the A product;
B, all the other Rhizoma Cibotiis etc. eight flavor decocts with water three times, and each 2 hours, collecting decoction filtered, and it is 1.10 clear paste that filtrate is concentrated into relative density, 80 ℃ of surveys, the B product;
C, get A product and B product, stirred in mixer 10～30 minutes, mix homogeneously is prepared into granule in 14 mesh sieves, the shop dish, grain thickness is controlled at 1～3cm, being dried to moisture in 70～90 ℃ is 4-6%, after 14 mesh sieves shake grain the C product;
D, get the C product, by C product weight, starch 5～20%, stearate 0.2～1.0%, in mixer, mix 10 minutes after, carry out tabletting and get the D product;
E, with the D product with sugar coating material or thin film coating material, carry out coating according to the coating operation, 1000 of finished products.
The preparation method of above-mentioned 'Jinwugutong ' tablet preparation, its step a is; Radix Puerariae, Rhizoma Curcumae Longae are dried to moisture 3～6%, under 20～40 ℃ of conditions, be ground into 160 orders～200 order fine powders, get the A product.
The preparation method of aforesaid 'Jinwugutong ' tablet preparation, its steps d is; Get the C product,, add starch 10%, stearate 0.5% by C product weight, in mixer, mix 10 minutes after, carry out tabletting and get the D product.
Compared with the prior art, the present invention is on the prescription basis of former 'Jinwugutong ' capsule, through testing, contrast, conclude, screen, sum up a kind of preparation method of acquisition repeatedly.In the present invention: Radix Puerariae, Rhizoma Curcumae Longae are ground into 160 orders～200 purpose fine powders under rated condition; Part medical material decocting; Be condensed into after the decoction extractum to the regulation relative density and under suitable temperature, carry out drying; According to the substance characteristics of extraction extractum, select the use amount of proper supplementary material and adjuvant, under rated condition, be pressed into tablet, and carry out film coating; All be the result that the inventor obtains on a large amount of experiment basis.Preparation medicine composition dissolution height of the present invention, bioavailability height, the compliance that medicine stability is good, the patient takes this product all are better than existing preparation.The present invention still to existing dosage form do not carried out replenishing, perfect, and enriched the kind of dosage form, can make things convenient for different patients according to preference to the dosage form of taking, pharmaceutical dosage form is selected to take.
The applicant carries out a series of experiments, and can confirm that method provided by the invention is effectively controlled, the preparation good effect.
The present invention to the influence of grinding particle size and pulverize temperature the influence of puerarin, curcumin content is studied, the results are shown in Table 1 and table 2 to the water content of Radix Puerariae and Rhizoma Curcumae Longae.
Table 1. Radix Puerariae and Rhizoma Curcumae Longae water content are to the influence (crossing 200 mesh sieves) of grinding particle size
| Water content (%) | 0.3 | 1 | 3 | 6 | 9 | 12 | 15 |
| Powder of Radix Puerariae sieving rate (%) | 100 | 100 | 100 | 100 | 95 | 93 | 83 |
| Curcuma powder sieving rate (%) | 100 | 100 | 100 | 100 | 99 | 96 | 86 |
According to result of the test, moisture is lower than 6%, and medicated powder is crossed 200 mesh sieves and reached 100% percent of pass, and moisture is 9-12%, and medicated powder is crossed 200 mesh sieves and reached 90% percent of pass.Consider production cost, in conjunction with crushing effect, it is best that the medical material water content is controlled at 3%-6%.
The pulverizing temperature of table 2. Radix Puerariae and Rhizoma Curcumae Longae is to the influence of puerarin and curcumin content
| The pulverizing temperature (℃) | -20 | 0 | 20 | 40 | 60 | 80 | 100 |
| Radix Puerariae (puerarin mg/g) | 26.88 | 26.66 | 26.68 | 26.80 | 26.65 | 26.63 | 25.06 |
| Rhizoma Curcumae Longae (curcumin mg/g) | 1.56 | 1.60 | 1.56 | 1.53 | 1.51 | 1.50 | 1.30 |
Result of the test shows that temperature is controlled at-20 ℃ to the 80 ℃ basic no changes of puerarin, considers composite factors such as production cost and constant product quality, and temperature preferably is controlled at 20 ℃ to 40 ℃.
The present invention tests the influence of tabletting the granule water content, according to the viscosity characteristics of this kind extraction extractum, need investigate the influence of tabletting effect the water content of mixed material, get the A product of different moisture content respectively, carry out the tabletting test, the results are shown in Table 3:
Table 3, the granule water content is to the influence of tabletting
| Moisture (%) | 10 | 8 | 6 | 3 | 2 |
| The tabletting effect | Mobility of particle is poor; The tabletting sticking; Tablet is rough, out-of-flatness, and the method for double differences is defective. | Mobility of particle is poor; A small amount of tabletting sticking; Tablet is rough, out-of-flatness, and the method for double differences is defective. | Mobility of particle is good; Tabletting is sticking not; The tablet flat appearance is smooth, and the method for double differences is qualified. | Mobility of particle is good; Tabletting is sticking not; The tablet flat appearance is smooth, and the method for double differences is qualified. | Mobility of particle is good; The easy part of tabletting, take off lid, the friability disqualification rate is greater than 20%. |
The result shows that the water content of this material is controlled at 3%-6%, can obtain qualified tablet.
The present invention carries out screening test to different adjuvants, and has determined the consumption of adjuvant, and experimental result sees Table 4:
Table 4. disintegrating agent is to slice, thin piece EFFECT OF CORK STOPPER (plain sheet disintegration=30min)
According to table 4 result of the test, starch addition 5-20%, slice, thin piece disintegration time all in acceptability limit (＜30min), all the other disintegrate effects are all not as starch, so select the disintegrating agent of starch as this product for use.
Table 5. lubricant is to the influence of tabletting effect
| The lubricant kind | Magnesium stearate (1%) | Micropowder silica gel (1%) | Pulvis Talci (1%) | Sodium laurylsulfate (1%) |
| The tabletting effect | Mobility of particle is good; Slice, thin piece is sticking not; The tablet flat appearance is smooth, no piebaldism, and the method for double differences is qualified. | Mobility of particle is strong excessively, and tabletting is sticking not, the easy part of slice, thin piece, slice, thin piece is overweight rate 8 %, and the method for double differences is defective. | Adhesive force is relatively poor, the easy sticking of upper punch during tabletting, and piebaldism appears in slice, thin piece. | Mobility of particle is relatively poor; The slice, thin piece sticking; Tablet is rough, smooth, and the method for double differences is defective. |
According to table 5 result of the test, select for use magnesium stearate as lubricant, the resultant effect of tabletting is best, so this preparation selects for use magnesium stearate as the lubricant in the tablet forming technique.
Table 6. magnesium stearate addition is to the influence of tabletting effect
| Magnesium stearate | 0.1% | 0.2% | 0.6% | 1.0% | 1.5% |
| The tabletting effect | Mobility of particle is poor, and tablet is rough, out-of-flatness, slice, thin piece piebaldism rate 5%. | Mobility of particle is good; Slice, thin piece is sticking not; The tablet flat appearance is smooth, and the method for double differences is qualified. | Mobility of particle is good; Slice, thin piece is sticking not; The tablet flat appearance is smooth, and the method for double differences is qualified. | Mobility of particle is good; Tabletting is sticking not; The tablet flat appearance is smooth, and the method for double differences is qualified. | Mobility of particle is good, tabletting not sticking but the easy part of slice, thin piece, take off lid, slice, thin piece is long partially disintegration. |
According to table 6 result of the test, the magnesium stearate consumption is between 0.2-1.0%, and the resultant effect of tabletting is best, so the consumption of this preparation magnesium stearate is 0.2-1%.
The Jinwu Gutong tablet of the present invention to being prepared according to above-mentioned technological parameter, carried out accelerated test, to investigate its stability, experimental condition is: 40 ℃ ± 2 ℃ of temperature, placed 6 months under the condition of relative humidity 75% ± 5%, duration of test respectively at 0 month, 1 month, 2 months, 3 months, 6 samplings at the end of month once, detects according to the national Specification project.(seeing Jinwu Gutong tablet stability test log 7 to 9)
Table 7. Jinwu Gutong tablet stability test record (lot number: 20040601)
Table 8. Jinwu Gutong tablet stability test record (lot number: 20040602)
Table 9. Jinwu Gutong tablet stability test record (lot number: 20040603)
Experiment shows, by the experiment to the Jinwu Gutong tablet of three different lot numbers, three lot numbers all meet the requirement of national Specification as a result, and every index is qualified.
The specific embodiment
Embodiment.Jinwu Gutong tablet.By following materials of weight proportions,
Rhizoma Cibotii 160g, Zaocys 120g,
Radix Puerariae 200g, Herba Epimedii 200g,
Fructus Chaenomelis 120g, Radix Achyranthis 120g,
Radix Campanumoeae 120g, Rhizoma Curcumae Longae 120g,
Radix Clematidis 160g, Fructus Psoraleae 160g;
The adjuvant that adds above raw material percentage ratio again:
Starch 10%, stearate 0.5%;
Be prepared into 1000 of Jinwu Gutong tablets.
Preparation process is as follows;
A, Radix Puerariae, Rhizoma Curcumae Longae are dried to moisture 6%, under 40 ℃ of conditions, are ground into 200 order fine powders, the A product;
B, all the other Rhizoma Cibotiis etc. eight flavor decocts with water three times, and each 2 hours, collecting decoction filtered, and it is 1.10 clear paste that filtrate is concentrated into relative density, 80 ℃ of surveys, the B product;
C, get A product and B product, stirred 20 minutes in mixer, mix homogeneously is prepared into granule in 14 mesh sieves, the shop dish, grain thickness is controlled at 2cm, being dried to moisture in 80 ℃ is 6%, after 14 mesh sieves shake grain the C product;
D, get the C product, add starch, stearate, in mixer, mix 10 minutes after, carry out tabletting and get the D product;
E, with the D product with sugar coating material or thin film coating material, carry out coating according to existing coating operation, 1000 of finished product Jinwu Gutong tablets, every 0.35 ± 0.02g.Oral, each 3, every day 3 times; Or follow the doctor's advice.
Claims (3)
1, the preparation method of Jinwu Gutong tablet is characterized in that: with following materials of weight proportions,
Rhizoma Cibotii 8-24 part, Zaocys 6-18 part,
Radix Puerariae 10-30 part, Herba Epimedii 10-30 part,
Fructus Chaenomelis 6-18 part, Radix Achyranthis 6-18 part,
Radix Campanumoeae 6-18 part, Rhizoma Curcumae Longae 6-18 part,
Radix Clematidis 8-24 part, Fructus Psoraleae 8-24 part;
Add adjuvant again and be prepared into tablet; Be on the waiting list raw material by given components by weight percent, by following step preparation;
A, Radix Puerariae, Rhizoma Curcumae Longae are dried to moisture 3～6%, are ground into 160 orders～200 order fine powders under 60 ℃ of conditions being lower than, the A product;
B, all the other Rhizoma Cibotiis etc. eight flavor decocts with water three times, and each 2 hours, collecting decoction filtered, and it is 1.10 clear paste that filtrate is concentrated into relative density, 80 ℃ of surveys, the B product;
C, get A product and B product, stirred in mixer 10～30 minutes, mix homogeneously is prepared into granule in 14 mesh sieves, the shop dish, grain thickness is controlled at 1～3cm, being dried to moisture in 70～90 ℃ is 4-6%, after 14 mesh sieves shake grain the C product;
D, get the C product,, add starch 5～20%, stearate 0.2～1% by C product weight, in mixer, mix 10 minutes after, carry out tabletting and get the D product;
E, with the D product with sugar coating material or thin film coating material, carry out coating according to the coating operation, 1000 of finished products.
2, the preparation method of Jinwu Gutong tablet according to claim 1 is characterized in that: described step a is; Radix Puerariae, Rhizoma Curcumae Longae leader are dried to moisture 3～6%, are ground into 160 orders～200 order fine powders under 20～40 ℃ of conditions being lower than, the A product.
3, the preparation method of Jinwu Gutong tablet according to claim 2 is characterized in that: described steps d is; Get the C product, by C product weight, starch 10%,, stearate 0.5%, in mixer, mix 10 minutes after, carry out tabletting and get the D product.
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| CNB2005100031852A CN100509048C (en) | 2005-08-25 | 2005-08-25 | Jinwu Gutong tablet and preparing method thereof |
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| CN104840972A (en) * | 2015-05-14 | 2015-08-19 | 宁波御坊堂生物科技有限公司 | Tablet preparation method capable of overcoming hang punching of tablet press |
| CN108669488A (en) * | 2018-04-25 | 2018-10-19 | 古蔺县盛源农业开发有限公司 | A kind of health-care chewable tablet and preparation method having wrinkled papaya and pueraria lobata effect concurrently |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN1413702A (en) * | 2002-11-19 | 2003-04-30 | 贵州神奇制药有限公司 | 'Jinwugutong' capsule and its preparation technology |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN1413702A (en) * | 2002-11-19 | 2003-04-30 | 贵州神奇制药有限公司 | 'Jinwugutong' capsule and its preparation technology |
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