CN101028387A - Oral solid preparation for treating chronic prostatic phlogosis and its production - Google Patents
Oral solid preparation for treating chronic prostatic phlogosis and its production Download PDFInfo
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- CN101028387A CN101028387A CN 200610057959 CN200610057959A CN101028387A CN 101028387 A CN101028387 A CN 101028387A CN 200610057959 CN200610057959 CN 200610057959 CN 200610057959 A CN200610057959 A CN 200610057959A CN 101028387 A CN101028387 A CN 101028387A
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Abstract
A medicine Qianlieshule in the form of orally taken solid (tablet or capsule) for treating chronic prostatitis is disclosed, with is the improvement on Qianlieshule particle.
Description
Technical field
The invention belongs to technical field of traditional Chinese medicine pharmacy, be specifically related to a kind of oral solid formulation for the treatment of chronic prostatitis and preparation method thereof.
Technical background
Chronic prostatitis and prostatic hyperplasia are the modal chronic diseases of young and middle-aged male, very high more than 40% of urinary system outpatient that accounts for of sickness rate.Chronic prostatitis belongs to the traditional Chinese medical science " smart turbid ", " stranguria " category.The long card that is deficiency in origin and excess in superficiality of the course of disease more.Clinical manifestation is the time of simulataneous insufficiency and excessive, and damp and hot essence stasis is seen more to suffer from a deficiency of the kidney.Because this disease symptoms complexity, the course of disease are delayed and with General Symptoms, severe patient causes male sterility, sexual dysfunction etc., clinical treatment chronic prostatitis and prostatic hyperplasia adopt Therapeutic Principle's effect of Chinese patent medicine determination of treatment based on pathogenesis obtained through differentiation of symptoms and signs for oral administration remarkable more at present.Prostate disease granule [the 12 (WS of Chinese traditional patent formulation preparation
3-B-2394-97)] be the compound Chinese medicinal preparation that has Herba Epimedii, the Radix Astragali, Pollen Typhae, Herba Plantaginis, Radix Cyathulae Chinese medicine of the five flavours compatibility to form, have tonify Qi of the kidney, effect that blood stasis dispelling is treating stranguria.Herba Epimedii warming and recuperating the kidney-YANG in the side, Radix Astragali QI invigorating diuretic, the Radix Cyathulae invigorating kidney, promoting blood circulation, inducing diuresis for treating stranguria syndrome makes kidney qi full.Clinical many have the obvious treatment effect with diseases such as these compound preparation treatment kidney spleen pair void, qi depression to blood stasis, prostatic hyperplasia, chronic prostatitiss, and said preparation has no side effect, and is one of good Chinese patent medicine preparation.
In view of chronic prostatitis long the course of treatment, the characteristics that refractory is healed, the prostate disease granular preparation is because this dosage form, so adjuvant too much causes the big curative effect of dose to reduce, and the patient need take when taking at every turn and causes shortcomings such as carrying not the aspect, our company is on the basis of prostate disease granule research, be made into capsule preparations and tablet, it is big that this oral solid formulation has overcome the excessive dose that causes of adjuvant, the shortcoming that curative effect reduces, simultaneously easy to carry, reduce cost.
Summary of the invention
For these reasons, research worker of the present invention is through great deal of experimental, traditional compound preparation prostate disease preparation of granules is become capsule preparations and tablet, oral solid formulation of the present invention overcome that the adjuvant of original preparation is too much, dose big, carry shortcoming such as inconvenience, has the characteristics simple, that dose is little, be easy to carry, cost is low, good effect, stable in properties, toxic and side effects reduce of taking.The requirement of aspects such as preparation of the present invention can satisfy the disintegration time of capsule, tablet, and physicochemical property is stable, and be prepared into the capsule preparations good airproof performance, covered the bad smell of Chinese medicine, be easier to be accepted by the patient.The pharmacological results shows that oral solid formulation of the present invention and prostate disease granular preparation relatively have better pharmacological action.
The prostate disease oral solid formulation that the purpose of this invention is to provide a kind of taking convenience, bioavailability height, better efficacy.
Another object of the present invention provides a kind of preparation method of prostate disease oral solid formulation.
The present invention is achieved through the following technical solutions:
One, process recipes
(1) prescription crude drug weight proportion is:
Herba Epimedii 80-240 weight portion, Radix Astragali 40-120 weight portion, Pollen Typhae 30-90 weight portion, Herba Plantaginis 40-120 weight portion, Radix Cyathulae 10-30 weight portion;
(2) preparation of principal agent
According to prostate disease granule (WS in [the 12 in Chinese traditional patent formulation preparation]
3-B-2394-97) item descends the effective site that the method in the method for making is extracted:
Herba Epimedii, the Radix Astragali, Pollen Typhae, Herba Plantaginis, Radix Cyathulae Chinese medicine of the five flavours add the water boil secondary, and 2 hours for the first time, 1.5 hours for the second time, merge first and second decocting liquid, filtering, be concentrated into relative density is 1.4 (80 ℃), obtains effective site, i.e. principal agent;
(3) oral solid formulation prescription:
Tablet formulation consists of: principal agent 50-100 weight portion, pharmaceutic adjuvant are the 25-300 weight portion;
The capsule prescription consists of: principal agent 50-80 weight portion, pharmaceutic adjuvant are the 25-240 weight portion;
(4) preparation of oral solid formulation:
Get principal agent, add acceptable pharmaceutic adjuvant on the pharmaceutics, be prepared into tablet, capsule with conventional pharmaceutical technology.
Two, detection method
The check and analysis of icariin [measure according to high performance liquid chromatography (appendix VID of pharmacopeia version in 2005))]:
Chromatographic condition and system suitability test: with octadecylsilane chemically bonded silica is filler; With acetonitrile-water (30: 70) is mobile phase; The detection wavelength is 270nm.Number of theoretical plate is pressed the icariin peak and is calculated, and should be not less than 1500.
The preparation of reference substance solution: it is an amount of that precision takes by weighing the icariin reference substance, adds methanol and make the solution that every 1ml contains 0.1mg, promptly.
Algoscopy: precision is measured this product 500mg, puts in the 100ml measuring bottle, adds mobile phase to scale, shakes up.Precision is measured 10 μ l and is injected chromatograph of liquid, the record chromatogram; Other gets reference substance solution, measures with method, presses external standard method with calculated by peak area, promptly; Measurement result sees Table 1.
Icariin assay in the table 1 prostate disease oral solid formulation
| Group | Icariin (mgg -1) |
| The prostate disease granule | 0.649 |
| The prostate disease tablet | 0.731 |
| The prostate disease capsule preparation | 0.726 |
Result: show that by above check and analysis experiment technology of the present invention has practical significance.
Three, pharmacology embodiment
In order to confirm the therapeutic effect of prostate disease oral solid formulation of the present invention, research worker of the present invention has been carried out following pharmacodynamics test to said preparation.
Reagent and animal: prostate disease granule (commercially available product); Prostate disease oral solid formulation of the present invention (, providing) by the good space medical sci-tech Chinese medicine laboratory of Beijing star sky by preparation technology's preparation of the present invention; Healthy Kunming mouse, body weight 18-30g;
1. to the influence of Oleum Tiglii induced mice ear swelling
40 of healthy Male Kunming strain mice, body weight 25-30g is divided into the blank group at random, prostate disease groups of grains, oral solid formulation group of the present invention.Irritate stomach 20ml/kg medicine or equal-volume normal saline every day 1 time, continuous 3 days, the 45min auris dextra was coated with Oleum Tiglii 30 μ l/ and only causes inflammation behind the last medicine, causing scorching back 15min puts to death mice, the ears punching is weighed, and as the swelling level index, the results are shown in Table 2 with two auricle weight differences.
Table 2 prostate disease oral solid formulation is to the influence of Oleum Tiglii induced mice ear swelling (x ± s)
| Group | Mus number (only) | Dosage (g/kg) | Swelling degree (mg) |
| The blank group | 10 | - | 37.45±2.63 |
| The prostate disease granule | 10 | 1.0 | 26.17±5.12 ** |
| The prostate disease tablet | 10 | 1.0 | 21.64±4.85 **# |
| The prostate disease capsule preparation | 10 | 1.0 | 19.78±6.42 **# |
(annotate: compare with matched group
*#P＜0.01 is compared with the prostate disease groups of grains in P＜0.05)
Result of the test shows: the prostate disease oral solid formulation has significant inhibitory effect to Oleum Tiglii induced mice ear swelling.
2. the Dichlorodiphenyl Acetate induced mice abdominal cavity capillary permeability influence of increasing
40 of healthy Male Kunming strain mice, body weight 25-30g is divided into the blank group at random, prostate disease groups of grains, oral solid formulation group of the present invention.Irritate stomach 20ml/kg medicine or equal-volume normal saline every day 1 time, continuous 3 days, the blue physiological salt liquid 10ml/kg of 45min tail vein injection 0.5% ivens after the last administration, lumbar injection 0.7% glacial acetic acid normal saline solution 0.2ml/ only immediately, put to death behind the 15min, cut off skin of abdomen muscle, divide the washing abdominal cavity three times with the 6ml normal saline, draw cleaning mixture, merge back adding normal saline and be settled to 10ml, the centrifugal 10min of 3000rpm gets supernatant and measures absorbance in the 590nm place, the results are shown in Table 3;
The influence that table 3 prostate disease oral solid formulation Dichlorodiphenyl Acetate induced mice abdominal cavity capillary permeability increases (x ± s)
| Group | Mus number (only) | Dosage (g/kg) | The OD value |
| The blank group | 10 | - | 0.41±0.21 |
| The prostate disease granule | 10 | 1.0 | 0.34±0.13 * |
| The prostate disease tablet | 10 | 1.0 | 0.26±0.18 ** |
| The prostate disease capsule preparation | 10 | 1.0 | 0.24±0.15 ** |
(annotate: compare with matched group
*Compare with the prostate disease groups of grains P＜0.05
*P＜0.01)
Result of the test shows: prostate disease Dichlorodiphenyl Acetate induced mice abdominal cavity capillary permeability increases significant inhibitory effect.
3. acute toxicity testing
Get 40 of healthy mices, body weight 18-22g,, male and female half and half.Be divided into the blank group at random, prostate disease groups of grains, oral solid formulation group of the present invention.The tail intravenously administrable, dosage is converted into the mice dosage according to 50 times of people's dosage according to body surface area, administration every day 1 time, continuous 7 days, observe the dead mouse situation, record data, experimental result sees Table 4.
Table 4 chmice acute toxicity test
| Group | Number of animals (only) | Death toll (only) | Mortality rate (%) |
| The prostate disease tablet | 20 | 3 | 15 |
| The prostate disease capsule preparation | 20 | 2 | 10 |
Above-mentioned experimental result shows: prostate disease oral solid formulation of the present invention has good safety.
Five, preparation embodiment
Embodiment 1
(1) preparation of principal agent
According to prostate disease granule (WS in [the 12 in Chinese traditional patent formulation preparation]
3-B-2394-97) item descends the effective site that the method in the method for making is extracted:
Get Chinese medicine Herba Epimedii 240g, Radix Astragali 120g, Pollen Typhae 90g, Herba Plantaginis 120g, Radix Cyathulae 30g, add the water boil secondary, 2 hours for the first time, 1.5 hours for the second time, merge first and second decocting liquid, filtering, be concentrated into relative density is 1.4 (80 ℃), obtain effective site, i.e. principal agent.
(2) oral solid formulation prescription:
Tablet formulation consists of: principal agent 50g, pharmaceutic adjuvant are 25g;
The capsule prescription consists of: principal agent 80g, pharmaceutic adjuvant are 40g;
(3) preparation of oral solid formulation:
Form according to preparation prescription, be prepared into 1000 in tablet, 1000 of capsules with conventional pharmaceutical technology.
Embodiment 2
(1) preparation of principal agent
According to prostate disease granule (WS in [the 12 in Chinese traditional patent formulation preparation]
3-B-2394-97) item descends the effective site that the method in the method for making is extracted:
Get Chinese medicine Herba Epimedii 480g, Radix Astragali 240g, Pollen Typhae 180g, Herba Plantaginis 240g, Radix Cyathulae 60g, add the water boil secondary, 2 hours for the first time, 1.5 hours for the second time, merge first and second decocting liquid, filtering, be concentrated into relative density is 1.4 (80 ℃), obtain effective site, i.e. principal agent.
(2) oral solid formulation prescription:
Tablet formulation consists of: principal agent 240g, pharmaceutic adjuvant are 180g;
The capsule prescription consists of: principal agent 240g, pharmaceutic adjuvant are 150g;
(3) preparation of oral solid formulation:
Form according to preparation prescription, be prepared into 1000 in tablet, 1000 of capsules with conventional pharmaceutical technology.
Embodiment 3
(1) preparation of principal agent
According to prostate disease granule (WS in [the 12 in Chinese traditional patent formulation preparation]
3-B-2394-97) item descends the effective site that the method in the method for making is extracted:
Get Chinese medicine Herba Epimedii 300g, Radix Astragali 160g, Pollen Typhae 110g, Herba Plantaginis 150g, Radix Cyathulae 50g, add the water boil secondary, 2 hours for the first time, 1.5 hours for the second time, merge first and second decocting liquid, filtering, be concentrated into relative density is 1.4 (80 ℃), obtain effective site, i.e. principal agent.
(2) oral solid formulation prescription:
Tablet formulation consists of: principal agent 90g, pharmaceutic adjuvant are 140g;
The capsule prescription consists of: principal agent 110g, pharmaceutic adjuvant are 110g;
(3) preparation of oral solid formulation:
Form according to preparation prescription, be prepared into 1000 in tablet, 1000 of capsules with conventional pharmaceutical technology.
Embodiment 4
(1) preparation of principal agent
According to prostate disease granule (WS in [the 12 in Chinese traditional patent formulation preparation]
3-B-2394-97) item descends the effective site that the method in the method for making is extracted:
Get Chinese medicine Herba Epimedii 1000g, Radix Astragali 600g, Pollen Typhae 450g, Herba Plantaginis 500g, Radix Cyathulae 150g, add the water boil secondary, 2 hours for the first time, 1.5 hours for the second time, merge first and second decocting liquid, filtering, be concentrated into relative density is 1.4 (80 ℃), obtain effective site, i.e. principal agent.
(2) oral solid formulation prescription:
Tablet formulation consists of: principal agent 200g, pharmaceutic adjuvant are 240g;
The capsule prescription consists of: principal agent 250g, pharmaceutic adjuvant are 140g;
(3) preparation of oral solid formulation:
Form according to preparation prescription, be prepared into 1000 in tablet, 1000 of capsules with conventional pharmaceutical technology.
Claims (2)
1. prostate disease oral solid formulation, it is characterized in that it is effective site after being extracted by Herba Epimedii, the Radix Astragali, Pollen Typhae, Herba Plantaginis, the Radix Cyathulae Chinese medicine of the five flavours preparation that to be principal agent form fully with suitable adjuvant, wherein the ratio of principal agent and adjuvant is 1: 0.5-3.
2. the preparation method of a kind of prostate disease oral solid formulation as claimed in claim 1, its feature may further comprise the steps:
(1) prescription crude drug weight proportion is:
Herba Epimedii 80-240 weight portion, Radix Astragali 40-120 weight portion, Pollen Typhae 30-90 weight portion, Herba Plantaginis 40-120 weight portion, Radix Cyathulae 10-30 weight portion;
(2) preparation of principal agent
Herba Epimedii, the Radix Astragali, Pollen Typhae, Herba Plantaginis, Radix Cyathulae Chinese medicine of the five flavours add the water boil secondary, and 2 hours for the first time, 1.5 hours for the second time, merge first and second decocting liquid, filtering, being concentrated into relative density under 80 ℃ of conditions is 1.4, obtains effective site, i.e. principal agent.
(3) oral solid formulation prescription:
Tablet formulation consists of: principal agent 50-100 weight portion, pharmaceutic adjuvant are the 25-300 weight portion;
The capsule prescription consists of: principal agent 50-80 weight portion, pharmaceutic adjuvant are the 25-240 weight portion;
(4) preparation of oral solid formulation:
Get principal agent, add acceptable pharmaceutic adjuvant on the pharmaceutics, be prepared into tablet, capsule with conventional pharmaceutical technology.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200610057959 CN101028387A (en) | 2006-03-02 | 2006-03-02 | Oral solid preparation for treating chronic prostatic phlogosis and its production |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200610057959 CN101028387A (en) | 2006-03-02 | 2006-03-02 | Oral solid preparation for treating chronic prostatic phlogosis and its production |
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| Publication Number | Publication Date |
|---|---|
| CN101028387A true CN101028387A (en) | 2007-09-05 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 200610057959 Pending CN101028387A (en) | 2006-03-02 | 2006-03-02 | Oral solid preparation for treating chronic prostatic phlogosis and its production |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104297353A (en) * | 2013-07-17 | 2015-01-21 | 江西普正制药有限公司 | HPLC finger-print establishing method of blood stasis-dispersing stranguria-treating capsule |
| CN105497330A (en) * | 2015-12-24 | 2016-04-20 | 贵州华安堂药业有限公司 | Preparation method of Qianlieshule preparation |
| CN105535291A (en) * | 2015-12-24 | 2016-05-04 | 贵州华安堂药业有限公司 | Preparation process of Qianlieshule preparation |
| CN105616753A (en) * | 2015-12-25 | 2016-06-01 | 贵州华安堂药业有限公司 | Application of Qianlieshule preparation in preparation of drug for treating chronic atrophic gastritis and complications thereof |
-
2006
- 2006-03-02 CN CN 200610057959 patent/CN101028387A/en active Pending
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104297353A (en) * | 2013-07-17 | 2015-01-21 | 江西普正制药有限公司 | HPLC finger-print establishing method of blood stasis-dispersing stranguria-treating capsule |
| CN105497330A (en) * | 2015-12-24 | 2016-04-20 | 贵州华安堂药业有限公司 | Preparation method of Qianlieshule preparation |
| CN105535291A (en) * | 2015-12-24 | 2016-05-04 | 贵州华安堂药业有限公司 | Preparation process of Qianlieshule preparation |
| CN105616753A (en) * | 2015-12-25 | 2016-06-01 | 贵州华安堂药业有限公司 | Application of Qianlieshule preparation in preparation of drug for treating chronic atrophic gastritis and complications thereof |
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