CN110151835B - Traditional Chinese medicine composition for treating urinary calculus and application and preparation thereof - Google Patents
Traditional Chinese medicine composition for treating urinary calculus and application and preparation thereof Download PDFInfo
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- CN110151835B CN110151835B CN201910463784.4A CN201910463784A CN110151835B CN 110151835 B CN110151835 B CN 110151835B CN 201910463784 A CN201910463784 A CN 201910463784A CN 110151835 B CN110151835 B CN 110151835B
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Abstract
The invention provides a traditional Chinese medicine composition for treating urinary calculus and application and preparation thereof. The traditional Chinese medicine composition is prepared from the following raw material medicines in parts by weight: 300-375 parts of desmodium styracifolium, 200-250 parts of fringed pink, 150-187.5 parts of liquorice, 300-375 parts of plantain seed, 300-375 parts of pyrrosia lingua, 150-187.5 parts of talcum, 70-87.5 parts of ligusticum wallichii and 200-375 parts of achyranthes bidentata. The prescription of the invention has the effects of clearing damp-heat in lower-jiao, promoting urination, promoting ureteral peristalsis and inhibiting calcium absorption, and has obvious curative effect and safety in clinical long-term use. The sugar-free/common granules prepared by the invention have reasonable formula and easy quality control. The granules prepared by the traditional Chinese medicine formula have obvious curative effect and less side effect, improve the taking convenience to the maximum extent, have low cost and save medical resources for the society.
Description
Technical Field
The invention belongs to the field of medical treatment and health, and particularly relates to a traditional Chinese medicine composition for treating urinary calculus, application thereof and a preparation method of traditional Chinese medicine composition granules.
Background
Urinary calculus, abbreviated as urolithiasis, refers to the concentration and precipitation of urine in the urinary system to form particles or lump-like aggregates, which can be classified into the following types according to the location of the calculus: kidney stone, ureteral stone, vesical stone, urethral stone, etc., are common diseases and frequently encountered diseases worldwide. The reported incidence rate of urinary calculus is up to 5-15%, the recurrence rate is almost 50%, and the incidence rate is also rising. Renal colic and hematuria are commonly caused clinically, and the calculi can be embedded, blocked and cause hydronephrosis and secondary urinary infection; renal insufficiency may also occur in the later stage. The research at home and abroad shows that the causes of the urinary calculus are complex, and the formed mechanism is mainly the product formed by abnormal accumulation of crystal substances such as calcium oxalate and the like of the urinary system and organic matters. Clinically, calculus consisting of calcium oxalate, calcium phosphate or a mixture of the calcium oxalate and the calcium phosphate accounts for 95 percent, and the calculus is the most common type of calculus containing calcium. Aiming at the treatment of urinary calculus, a specific method is not available in pure drug treatment, and a treatment means combining a surgical operation and an external shock wave lithotripsy technology is mainly adopted at present. Although the external shock wave lithotripsy technology is widely applied clinically, urinary system calculus is greatly improved in treatment, but the defects of residual calculus, high recurrence rate, physiological pain brought to patients and the like still exist in operative treatment and external shock wave lithotripsy. Therefore, how to remove the residual calculus to the maximum extent and prevent and treat calculus recurrence still remains two major problems for clinical treatment of urinary calculus.
In traditional Chinese medicine, urinary calculus belongs to the categories of lumbago, sandlin, urolithiasis and hematuria. The traditional Chinese medicine theory considers that the main pathogenesis of stranguria is that damp-heat accumulates in lower-jiao urine, and the urine accumulates day by day and month, and impurities in the urine are accumulated into sand. Especially, modern people who have no good diet and overeat spicy, fat and sweet substances have failure of transportation and transformation of the spleen and stomach, accumulation of dampness and heat, downward flow of the liver-qi to the bladder, or stagnation of liver qi and obstruction of collaterals by blood stasis due to large living pressure, so that damp-heat in the lower-jiao, unfavorable gasification, deposition of sand stranguria and disfavor of water channels cause repeated and delayed disease conditions. Therefore, the basic principle that 'clearing damp-heat in lower jiao and inducing diuresis for treating stranguria and dissolving stones' are used as Chinese herbal medicines for treating urinary calculus is determined, and the formula is prepared according to the main pathogenesis characteristics of the urinary calculus such as 'damp-heat', 'sand stranguria' and 'stasis' through years of clinical exploration, so that the formula is prepared by combining syndrome differentiation and disease differentiation, emphasizing the efficacy characteristics and pharmacological action of the traditional Chinese medicines and avoiding the toxic and side effects and incompatibility of the traditional Chinese medicines. The Chinese herbal medicine which is widely accepted in clinic by pharmacological action in the treatment of urinary calculus is selected to form a proved formula, namely eight-ingredient desmodium styracifolium urinary calculus removing decoction, the formula is a proved formula which is unique in traditional Chinese medicine and is attached to the first hospital of the medical college of Zhejiang university, the desmodium styracifolium in the formula is a monarch medicine and has the effects of clearing heat, promoting urination and removing urinary calculus, and polysaccharide substances can obviously inhibit the crystal growth of calcium oxalate; the fringed pink has the effects of clearing away heart heat, benefiting damp heat of small intestine and bladder, increasing ureteral peristalsis and dilating ureter; che Qian Zi can induce diuresis and treat stranguria, and tonify kidney, so as to induce diuresis without damaging kidney yin; herba Desmodii Styracifolii, herba Dianthi, and semen plantaginis can also acidify urine, dissolve calculus, inhibit calcium absorption, and prevent calculus from forming; talcum can remove dampness and heat, induce resuscitation and relieve stranguria; the liquorice can directly reach the anterior vagina urethra to play the effects of relieving spasm and pain; rhizoma Ligustici Chuanxiong has effects of promoting blood circulation, activating qi-flowing, dispelling pathogenic wind and relieving pain; achyranthes root, radix Achyranthis bidentatae has the effects of nourishing liver and kidney, and strengthening tendons and bones. The whole formula has the effects of clearing damp-heat in lower-jiao, promoting urination, treating stranguria, removing calculus and preventing calculus recurrence. Based on the theory of traditional Chinese medicine, the Chinese herbal medicine formula of the invention shows special advantages for removing residual urinary calculus and preventing and treating calculus recurrence in clinical use, and clinical summary shows that the formula has remarkable curative effect on treating urinary calculus, low calculus recurrence rate, safety and economy. However, the traditional decoction is inconvenient for patients to take, often fails to take, and is not suitable for the fast-paced life style of modern people. Therefore, the eight-ingredient desmodium styracifolium urinary calculus removing decoction is prepared into a solid preparation, namely eight Chinese herbal medicines such as desmodium styracifolium, dianthus superbus, semen plantaginis, pyrrosia lingua and the like are extracted and processed into granules which are convenient for patients to use, and the granules are respectively prepared into common granules and sugar-free granules for the patients with diabetes and non-diabetes.
Disclosure of Invention
In order to solve the above problems, the present invention aims to provide a Chinese medicine composition for treating urinary calculus. The traditional Chinese medicine composition is prepared from the following eight raw medicinal materials in parts by weight: 300-375 parts of desmodium styracifolium, 200-250 parts of fringed pink, 150-187.5 parts of liquorice, 300-375 parts of plantain seed, 300-375 parts of pyrrosia lingua, 150-187.5 parts of talcum, 70-87.5 parts of ligusticum wallichii and 200-375 parts of achyranthes bidentata.
The weight of the above components is calculated by crude drugs. Each part can be gram or kilogram or ton, if gram is used as unit, the formulation can be prepared into 1000 doses of pharmaceutical preparation. The 1000 dosage is finished medicinal preparation, such as 1000g granule, etc., and the granule can be made into small independent packages, such as 80-500 bags, specifically 80 bags, 100 bags, 125 bags, 200 bags, 250 bags, 400 bags, 500 bags, etc., each bag can be used as a dose for one-time administration.
The above components can be made into preparation with dosage of 50-1000 times, such as granule, and can be made into 100 bags, 1-2 bags per time, and 50-100 times.
The components are proportioned according to weight, and can be increased or reduced according to corresponding proportion during production, for example, the weight can be increased or reduced by taking kilogram or ton as a unit in large-scale production and taking gram as a unit in small-scale production, but the proportion of raw medicinal materials proportioned among the components is unchanged.
The invention also aims to provide application of the traditional Chinese medicine composition in preparing a medicine for treating urinary calculus. The urinary calculus is removed after an external shock wave lithotripsy of a urinary calculus patient, and recurrence and tiny calculus of the urinary calculus are prevented. The medicine is a Chinese medicinal composition granule.
The invention also aims to provide a preparation method of the traditional Chinese medicine composition granules, which is realized by the following steps:
(1) weighing the traditional Chinese medicine raw materials of the composition according to the weight ratio;
(2) adding a proper amount of water which is 7-9 times of the amount of the medicinal materials in the formula to completely immerse the medicinal materials;
(3) decocting twice, the first time is 1.5 hours; the second time is 1 hour, and the decoction is merged;
(4) standing the combined decoctions, filtering the supernatant, recovering the filtrate under reduced pressure, concentrating to obtain fluid extract with relative density of about 1.25 (20 deg.C), weighing, and calculating the yield;
(5) according to the yield and the preparation formulation to be prepared, a proper amount of excipient auxiliary materials are weighed and prepared into granules. Including sugar-free/plain type granules.
The preparation process of the granules comprises the following steps: weighing powdered sugar (or stevioside) and dextrin according to the required amount of the prescription, adding into a mixer, mixing for 10 minutes, slowly and uniformly adding the extract diluted by 95% ethanol, uniformly mixing, adding a proper amount of 95% ethanol, and stirring to prepare a proper soft material. Granulating the prepared soft material by using a 16-mesh stainless steel sieve through a swing granulator to ensure that the granules are uniform in size, and drying the granules in a drying room at the temperature of 80-85 ℃ for about 6 hours. And (3) finishing the dried particles by using a screen with the aperture of 10-40 meshes, mixing the particles in a V-shaped mixer for about 10 minutes after finishing the subpackaging of the particles to be subpackaged, and subpackaging the particles to obtain the granules to be subpackaged.
The invention has the advantages that: (1) the prescription of the invention has the effects of clearing damp-heat in lower-jiao, promoting urination, promoting ureteral peristalsis and inhibiting calcium absorption, and has obvious curative effect and safety in clinical long-term use. (2) The invention discloses a prescription of a unique experience Chinese medicinal compound preparation for treating urinary calculus and a preparation process thereof. Based on the requirement of modernization of traditional Chinese medicine, the invention researches the formula on an extraction process, performs trial production according to a test process route, and develops the formula into a preparation according to the preparation requirement of modern traditional Chinese medicine preparations. The sugar-free/common granules prepared by the invention have reasonable formula and easy quality control. (3) The granules prepared by the traditional Chinese medicine formula have the advantages of obvious curative effect, less side effect, low cost and capability of improving the taking convenience to the maximum extent and saving medical resources for the society.
Drawings
FIG. 1 is a 320nm sample chromatogram of a granule.
FIG. 2 is a 250nm sample chromatogram of a granule.
Remarking: peak positions of the control in fig. 1 and 2: 1. geniposide, 2 chlorogenic acid, 3 schaftoside, 4 ferulic acid, 5 liquiritin, 6 verbascoside, 7 beta-ecdysterone and 8 glycyrrhizic acid.
Detailed Description
The invention is further described with reference to the accompanying drawings and specific embodiments.
Example 1A composition of a Chinese medicinal composition for the treatment of urinary calculus
The traditional Chinese medicine composition is prepared from the following eight raw medicinal materials in parts by weight: 300-375 parts of desmodium styracifolium, 200-250 parts of fringed pink, 150-187.5 parts of liquorice, 300-375 parts of plantain seed, 300-375 parts of pyrrosia lingua, 150-187.5 parts of talcum, 70-87.5 parts of ligusticum wallichii and 200-375 parts of achyranthes bidentata.
Example 2 clinical application of the Chinese medicinal composition for treating urinary calculus
(1) The prescription of the traditional Chinese medicine composition comprises: 15g of desmodium styracifolium, 10g of fringed pink, 7.5g of liquorice, 15g of plantain seed, 15g of pyrrosia lingua, 7.5g of talcum, 3.5g of ligusticum wallichii and 10g of achyranthes bidentata;
(2) preparing a decoction: weighing the traditional Chinese medicinal materials of the composition according to the weight ratio, adding an appropriate amount of water which is 7-9 times of the weight ratio, completely immersing the medicinal materials in the composition, and decocting twice for 1.5 hours for the first time; mixing decoctions, mixing, and concentrating to 300ml after 1 hr for the second time;
(3) the taking method comprises the following steps: the decoction is taken with warm boiled water 3 times a day, 100ml each time;
(4) the observation of clinical curative effect is summarized as follows: the traditional Chinese medicine decoction is taken by nearly ten thousand people after being taken for more than ten years in clinic in the hospital, has good effect and is popular with clinical patients. Strict clinical efficacy evaluation is also carried out on the composition in our hospital, and nearly 2000 calculi patients are clinically observed.
The results are as follows:
(ii) clinical data
2004-2009 patients after extracorporeal shock wave lithotripsy in urology surgery were randomly assigned to a traditional Chinese medicine treatment group and a western medicine control group. The administration method comprises the following steps: the traditional Chinese medicine treatment group comprises: the decoction is administered with warm boiled water 3 times per day, 100ml each time; and the western medicine control group comprises: the self-made preparation of the hospital, namely 10 percent potassium citrate oral solution, is taken as a control treatment drug, 10ml of the drug is taken each time, 3 times a day, and the drug is taken orally after a meal. Final patient case data in cohort: the traditional Chinese medicine treatment groups comprise 476 female cases and 524 male cases, wherein the age is 18-70 years, and the average age is 45.5 +/-11.3 years; the western medicine treatment groups comprise 422 female patients and 578 male patients, wherein the age is 18-70 years, and the average age is 44.9 +/-13.1 years.
Calculus position and clinical efficacy: 1) in the traditional Chinese medicine treatment group, 660 cases of calculus in the ureter have the largest calculus discharge amount of 1.2cm and the smallest calculus discharge amount of 0.2 cm. The ureter calculus removing rate is 86.4%. In 340 cases of the stones located in the renal pelvis and the renal calyx, the stone discharge rate is 34.5 percent, and the maximum discharged stone is 0.8cm and the minimum discharged stone is 0.3 cm. No special pathological changes and adverse reactions are found in all cases of taking the medicine. 2) The contrast group of western medicines, 637 cases of calculus in ureter, has maximum calculus discharge of 0.8cm and minimum calculus discharge of 0.2 cm. The ureter calculus removing rate is 56.2%. In 363 cases of stones located in the renal pelvis and renal calyx, the stone discharge rate is 22.1%, and the maximum discharged stone is 0.6cm and the minimum discharged stone is 0.2 cm. No special pathological changes and adverse reactions were observed in all cases (Table 1).
TABLE 1 clinical observation of case data and statistics of therapeutic effects
② clinical summary
The eight-ingredient desmodium styracifolium urinary calculus removing decoction is a Chinese herbal medicine preparation, is safe and reliable, and has no harm to human bodies and adverse reactions. Through 1000 clinical cases of observation of a treatment group, the total discharge rate of the calculus is 64.7%, and the total effective rate of the medicine is 85.5%. The formula is prepared from desmodium styracifolium, fringed pink, liquorice, plantain seed, pyrrosia lingua, talc, ligusticum wallichii, achyranthes bidentata and the like, and has the functions of clearing damp-heat in lower-jiao, promoting urination, promoting ureteral peristalsis and inhibiting calcium absorption. Clinical verification shows that the medicine has the special effects of removing calculus, dissolving calculus and inhibiting calculus formation. Especially, the recipe can inhibit the absorption of calcium by the intestinal tract and is also of great significance in preventing the formation of calculi. At present, with the common application of extracorporeal shock wave lithotripsy, the proved formula of the traditional Chinese medicine of the invention, namely the eight-ingredient desmodium styracifolium lithospermi decoction, has unique curative effect on lithotripsy of patients after lithotripsy. Is popular with patients with calculus through years of clinical application. Especially has obvious curative effect on eliminating tiny calculus after the extracorporeal shock wave lithotripsy, reduces the recurrence rate of calculus of a patient, reduces the physiological pain of the patient, reduces the incidence rate of other complications caused by the calculus, and is economical and cheap.
EXAMPLE 3 preparation of the Chinese medicinal composition granule (Normal type) of the present invention
(1) The traditional Chinese medicine composition comprises the following components: 375g of desmodium styracifolium, 250g of fringed pink, 187.5g of liquorice, 375g of plantain seed, 375g of pyrrosia lingua, 187.5g of talcum, 87.5g of szechuan lovage rhizome and 375g of achyranthes root.
(2) Preparation method of granule (common type):
adding 7-9 times of water into the eight medicinal materials to completely immerse the medicinal materials; decocting twice, the first time is 1.5 hours; the second time is 1 hour, and the decoction is merged;
② standing the combined decoction, filtering the supernatant, decompressing and recovering the filtrate, concentrating to obtain clear paste with the relative density of about 1.25 (20 ℃), weighing, calculating the yield, and reserving for later use;
thirdly, according to the yield of the clear paste, weighing the powdered sugar and the dextrin according to the required amount of the prescription according to the proportion of the dextrin to the powdered sugar being 10:8:10, adding the powdered sugar and the dextrin into a mixer for mixing for 10 minutes, then slowly and uniformly adding the extract diluted by 95 percent ethanol, uniformly mixing, adding a proper amount of 95 percent ethanol, stirring to prepare a proper soft material, granulating the prepared soft material by a 16-mesh stainless steel sieve through a swing type granulator to ensure that the size of the particles is uniform, sending the particles to a drying room, controlling the temperature to be between 80 and 85 ℃, drying for about 6 hours, granulating the dried particles by a sieve with the aperture of between 10 and 40 meshes, and mixing the particles in a V-shaped mixer for about 10 minutes after finishing granulation to prepare 1000g of particles;
fourthly, the particles are packed into 100 bags according to 10g per bag, thus obtaining the product.
EXAMPLE 4 preparation of Chinese medicinal composition granules (sugar-free type) of the present invention
(1) The traditional Chinese medicine composition comprises the following components: 375g of desmodium styracifolium, 250g of fringed pink, 187.5g of liquorice, 375g of plantain seed, 375g of pyrrosia lingua, 187.5g of talcum, 87.5g of szechuan lovage rhizome and 375g of achyranthes bidentata;
(2) the preparation method of the granules (sugar-free type) comprises the following steps:
adding 7-9 times of water into the eight medicinal materials to completely immerse the medicinal materials; decocting twice, the first time is 1.5 hours; the second time is 1 hour, and the decoction is merged;
② standing the combined decoction, filtering the supernatant, decompressing and recovering the filtrate, concentrating to obtain clear paste with the relative density of about 1.25 (20 ℃), weighing, calculating the yield, and reserving for later use;
thirdly, according to the yield of the clear paste, according to the proportion of dextrin to steviosin of 7:12:1, weighing dextrin and steviosin which are required by the prescription, adding the dextrin and the steviosin into a mixer, mixing for 10 minutes, slowly and uniformly adding the extract diluted by 95% ethanol, uniformly mixing, adding a proper amount of 90% ethanol containing 3% povidone K30, stirring to prepare a proper soft material, granulating the prepared soft material by a 16-mesh stainless steel sieve through a swing type granulator to ensure that the size of the particles is uniform, drying the particles in a drying room at the temperature of 80-85 ℃ for about 6 hours, granulating the dried particles by a screen with the aperture of 10-40 meshes, and mixing the particles in a V-shaped mixer for about 10 minutes after finishing granulation to prepare 1000g of particles;
fourthly, the particles are packed into 100 bags according to 10g per bag, thus obtaining the product.
Example 5 quality inspection of granules of the Chinese medicinal composition of the present invention
The granules of the invention meet the regulations of the granules (appendix IC of the first part of the Chinese pharmacopoeia 2010).
The sum of the inability to pass through sieve one and the ability to pass through sieve five, as determined by granulometry (appendix XI B second method, double sieve method), was 12.4%, not more than 15%.
[ WATER ] about 1g of the sample was taken, dried at 75 ℃ under reduced pressure for 5 hours, cooled for 30 minutes, precisely weighed, dried at the above temperature for 1 hour, cooled, and weighed until the difference between two successive weighing steps does not exceed 5mg, as measured by the method of moisture determination (appendix IX H). The water content of granule (common type) and granule (sugar-free type) is 2.9% and 3.8%, respectively, and is not more than 6%.
[ SOLUBILITY ] A1-pack sample was placed in 200ml of hot water, stirred for 5 minutes, and immediately observed to be completely dissolved, resulting in slight turbidity in the form of granules (normal type) or granules (sugar-free type).
[ MEANS FOR SOLVING PROBLEMS ] 10 bags of test articles were taken, the weight of the contents in each bag was determined, and the contents in each bag were compared with the labeled contents, and the contents of the granules (ordinary type) and the granules (sugar-free type) did not exceed the 5% limit of the difference in the contents (Table 2).
TABLE 2 examination of the difference in the granule contents
[ microbial Limit ] according to the microbial Limit test method (appendix XII C), both granules (normal type) and granules (sugar-free type) meet the specifications.
[ IDENTIFICATION ] identification of Glycyrrhrizae radix adopts thin layer chromatography with Glycyrrhrizae radix control as control. Extracting the sample with ethanol, removing impurities with chloroform, extracting with water saturated n-butanol, evaporating the extractive solution to dryness, passing through neutral alumina chromatographic column, and developing with chloroform-methanol-water (40: 10: 1) as developing agent to obtain sample chromatogram with main spot identical to that of the control material.
The identification of granule (common type) and granule (sugar-free type) "radix Glycyrrhizae" meets the requirements.
[ CONTENT DETERMINATION ] Glycyrrhrizae radix is determined by high performance liquid chromatography (appendix VI D). The relative contents of glycyrrhizin at 320nm and glycyrrhizic acid at 250nm were measured by Agilent 1200 high performance liquid chromatography (Agilent, USA) under the following chromatographic conditions. Chromatographic conditions, chromatographic column: SB-C18Column (250 mm. times.4.6 mm,5 μm), mobile phase: methanol-formic acid water (PH 3.0); column temperature: 35 ℃; flow rate: 0.8 ml/min; sample introduction amount: 10 uL; detection wavelength: 0-35 min, 320 nm; 35-75 min at 250 nm; the elution gradient was performed as specified in the table below (table 3). The number of theoretical plates is not less than 5000 calculated according to liquiritin peak.
TABLE 3 mobile phase elution gradient
| t/ |
0 | 20 | 35 | 65 | 75 |
| |
10 | 35 | 50 | 90 | 100 |
The reference solution is prepared by precisely weighing appropriate amount of liquiritin reference substance and glycyrrhizic acid reference substance, and adding 50% methanol to obtain solutions containing liquiritin 20 μ g and ammonium glycyrrhizinate 0.2mg per 1 ml.
Preparation of test solution 1g of the prepared granules are precisely weighed, the granules are placed in a conical flask with a plug, 100ml of 50% methanol is precisely added, the plug is sealed, the weight is weighed, ultrasonic treatment is carried out for 30 minutes, cooling is carried out, the weight is weighed again, the granules are uniformly shaken by using the weight of 50% methanol, and filtering is carried out to obtain the subsequent filtrate.
The determination method comprises precisely sucking 10 μ l of each of the reference solution and the sample solution, injecting into liquid chromatograph, and determining.
The product contains glycyrrhizin not less than 0.5% and glycyrrhizic acid not less than 2.0% calculated on dried product.
The content determination of the granular formulation (common type) and the granular formulation (sugar-free type) "liquorice" meets the regulations.
Example 6 study results of stability of the Chinese medicinal composition granule of the present invention
(1) Accelerated test
A sample of a commercially available package, granule (general type) lot number: 100501, 100502, 100503, granules (sugar-free type) 100601, 100602, 100603, and accelerated test at 40 ℃ ± 2 ℃ and RH 75% ± 5% for 3 months, respectively, samples were taken at the end of 0, 1, 2, and 3 months, and relevant indexes were examined, and the results are shown in table 4 and table 5. The product was tested for solubility at 3 months in accelerated tests, and the results were in compliance with the regulations. The sample was still left under this condition for further examination.
(2) Long term room temperature sample retention test
Samples of commercially available packages (granules (general type) lot numbers 100501, 100502, 100503, granules (sugar-free type) 100601, 100602, 100603) were taken and subjected to long-term sample retention test at room temperature. Samples were taken at the end of 0, 1, 2, 3, 6 and 12 months, respectively, to examine the index. The results are shown in tables 6 and 7. At 3, 6 and 12 months of long-term test, samples are taken to carry out the dissolubility inspection on the product, and the results all accord with the regulations. The sample was still left under this condition for further examination.
(3) Conclusion
The commercial package is simulated, the samples are respectively placed under the conditions of accelerated test and long-term room temperature observation, sampling is carried out periodically, and the investigation indexes are detected, the result shows that the investigation indexes have no obvious change after the accelerated test is carried out for 3 months and the long-term room temperature investigation is carried out for 12 months (table 4, table 5, table 6 and table 7), so that the effective period of the product is temporarily determined to be 24 months.
TABLE 4 accelerated test examination of granules (Normal type) (40 ℃. + -. 2 ℃ RH 75%. + -. 5%)
TABLE 5 accelerated test examination of granules (sugar-free type) (40 ℃. + -. 2 ℃ RH 75%. + -. 5%)
TABLE 6 Long-term room temperature sample test results (RH 30% -80% at 10 ℃ -30 ℃) for granules (Normal type)
TABLE 7 Long-term room temperature sample test results (10 ℃ -30 ℃ RH 30% -80%) of granules (sugar-free type)
Claims (1)
1. The application of a traditional Chinese medicine composition in preparing a medicine for treating urinary calculus is characterized in that the treatment of urinary calculus refers to the stone removal after external shock wave lithotripsy of a urinary calculus patient, and the prevention of recurrence of calculus and fine calculus, and the medicine is granules; the traditional Chinese medicine composition is prepared from the following eight raw medicinal materials in parts by weight: 300-375 parts of desmodium styracifolium, 200-250 parts of fringed pink, 150-187.5 parts of liquorice, 300-375 parts of plantain seed, 300-375 parts of pyrrosia lingua, 150-187.5 parts of talcum, 70-87.5 parts of ligusticum wallichii and 200-375 parts of achyranthes bidentata; the granules are realized by the following steps:
(1) weighing the traditional Chinese medicine raw materials according to the weight ratio of the composition;
(2) adding a proper amount of water which is 7-9 times of the amount of the medicinal materials in the formula to completely immerse the medicinal materials;
(3) decocting twice, the first time is 1.5 hours; the second time is 1 hour, and the decoction is merged;
(4) standing the combined decoctions, filtering the supernatant, recovering the filtrate under reduced pressure, concentrating to obtain fluid extract with relative density of 1.25, weighing, and calculating the yield;
(5) the preparation method of the sugar-free granules comprises the following steps: according to the yield of the clear paste, according to the proportion of dextrin to steviosin =7:12:1, weighing dextrin and steviosin in required amount according to a prescription, adding the dextrin and the steviosin into a mixer for mixing for 10 minutes, slowly and uniformly adding the extract diluted by 95% ethanol, uniformly mixing, adding a proper amount of 90% ethanol containing 3% povidone K30, stirring to prepare a proper soft material, granulating the prepared soft material by a 16-mesh stainless steel sieve through a swing type granulator to ensure that the size of the particles is uniform, sending the particles to a drying room, drying at the temperature of 80-85 ℃ for about 6 hours, granulating the dried particles by a sieve with the aperture of 10-40 meshes, and mixing the particles in a V-type mixer for about 10 minutes after finishing the granulation to prepare the granules;
(6) the preparation method of the common granules comprises the following steps: according to the yield of the clear paste, the powdered sugar and the dextrin with required amount according to the prescription are weighed and added into a mixer to be mixed for 10 minutes according to the proportion of the clear paste to the dextrin and the powdered sugar =10:8:10, then the extract diluted by 95% ethanol is slowly and uniformly added to be uniformly mixed, a proper amount of 95% ethanol is added to be stirred to prepare a proper soft material, the prepared soft material is granulated by a 16-mesh stainless steel sieve through a swing type granulator to ensure that the size of the granules is uniform, the granules are sent to a drying room to be dried for about 6 hours at the temperature of 80-85 ℃, the dried granules are granulated by a sieve with the aperture of 10-40 meshes, and the granules are mixed for about 10 minutes in a V-shaped mixer after finishing the granulation, thus preparing the granules.
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| 几种中成药老药新用综述;任军民等;《中国医药导报》;20070831;第4卷(第22期);第95-96页，尤其是第96页右栏倒数第5段 * |
| 广金钱草排石汤对输尿管结石ESWL术后的止痛及排石作用;张德珍等;《中国实验方剂学杂志》;20120930;第18卷(第17期);第289-291页 * |
| 石韦散加味辅助体外冲击波碎石术术后排石及肾损伤保护作用的临床研究;张永刚等;《中国民间疗法》;20110430;第19卷(第4期);第45-46页，尤其是第45页右栏第2段 * |
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