CN114099565A - Pharmaceutical composition for treating frequent nocturia and preparation method thereof - Google Patents
Pharmaceutical composition for treating frequent nocturia and preparation method thereof Download PDFInfo
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- CN114099565A CN114099565A CN202111624489.6A CN202111624489A CN114099565A CN 114099565 A CN114099565 A CN 114099565A CN 202111624489 A CN202111624489 A CN 202111624489A CN 114099565 A CN114099565 A CN 114099565A
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- parts
- spina gleditsiae
- fenugreek
- extract
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
- A61K35/56—Materials from animals other than mammals
- A61K35/63—Arthropods
- A61K35/64—Insects, e.g. bees, wasps or fleas
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
- A61K36/483—Gleditsia (locust)
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P13/00—Drugs for disorders of the urinary system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P13/00—Drugs for disorders of the urinary system
- A61P13/10—Drugs for disorders of the urinary system of the bladder
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
- A61K2236/333—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using mixed solvents, e.g. 70% EtOH
Abstract
The invention discloses a pharmaceutical composition for treating frequent nocturia, which is a preparation consisting of three medicaments of fenugreek, spina gleditsiae and dung beetle. The invention has simple and unique prescription and obvious curative effect. Clinical researches prove that the medicament can obviously reduce frequent nocturia, improve the life quality of patients and reduce residual urine, has the effective rate of 83.33 percent, and has high safety and no obvious side effect. The invention also discloses a preparation method of the pharmaceutical composition, which is prepared by crushing or solvent extraction and other pretreatments according to different characteristics of each traditional Chinese medicine and then proportioning.
Description
Technical Field
The invention relates to a pharmaceutical composition for treating frequent nocturia, in particular to a Chinese patent medicine prepared by using fenugreek, spina gleditsiae and dung beetle as main raw materials, and also relates to a preparation method of the pharmaceutical composition.
Background
Normal persons urinate 0-2 times in the night, the urine volume is 300-400 ml, and the total amount is 1/4-1/3 in 24 hours. The ratio of daytime urine volume to nocturnal urine volume gradually decreases with age, with a ratio of 1: 1 by age 60.
The reason why the night urine is too much is mainly that:
1. the bladder of the elderly women is degenerated, so that the muscular layer of the bladder is thinned and atrophied, the urine storage is reduced, or the nerve dysfunction for regulating the bladder contraction is regulated, and the frequent micturition and the nocturia are increased.
2. Prostatic hyperplasia: since the age of 50, men have different degrees of hyperplasia of the prostate. Frequent urination is often the first symptom of a patient with enlarged prostate. Early stage is caused by the stimulation of prostate hyperemia, which is more remarkable at night, and if the condition is worsened, the enlarged prostate presses the neck of the bladder, so that the frequency of urine is gradually increased when the residual urine volume of the bladder is increased, which is caused by the reduction of effective volume due to the partial filling state of the bladder.
3. The kidney concentration function of the old people is declined, so that a large amount of raw urine can not be fully reabsorbed, the nocturia is increased, and various kidney diseases can cause renal insufficiency and the nocturia is increased.
At present, no medicine with definite curative effect for treating frequent nocturia exists, the clinical requirement is not met, and the development prospect is good.
Disclosure of Invention
The invention aims to provide a traditional Chinese medicine for treating frequent nocturia and a corresponding preparation thereof. It is characterized in that: can quickly relieve the clinical symptoms of frequent nocturia of patients, obviously improve the life quality of the patients, and has high safety and no obvious side effect.
The traditional Chinese medicine considers that frequent nocturia is mainly caused by insufficiency of kidney yang and failure of bladder, the disease position is between kidney and bladder, deficiency of kidney yang, abnormal bladder gasification and downward flow of water into bladder, the frequent nocturia is caused.
The invention relates to a pharmaceutical composition for treating frequent nocturia, which is characterized by being prepared from the following raw material medicines in parts by weight: 5-90% of fenugreek, 5-90% of spina gleditsiae and 5-80% of dung beetle.
The medicine of the invention can be any one of the medicines of the dosage forms in pharmacy.
The preparation of the medicine can be prepared according to various conventional methods in pharmaceutics, such as:
directly pulverizing Catharsii Molossi into fine powder, or extracting Catharsii Molossi with ethanol by conventional method, recovering solvent, and removing oil to obtain Catharsii Molossi extract; extracting semen Trigonellae and spina Gleditsiae with ethanol or water by conventional method, mixing Catharsii Molossi, semen Trigonellae and spina Gleditsiae extract, and making into desired dosage form.
In the above preparation process, if necessary, appropriate amount of pharmaceutically-acceptable adjuvants such as starch, dextrin, microcrystalline cellulose, compressible starch, magnesium stearate, silica gel micropowder, sucrose, and sodium carboxymethyl starch can be added.
The clinical use results of the medicine of the invention show that the medicine has the following advantages:
(1) obviously reducing frequent nocturia;
(2) the life quality of the patient is obviously improved;
(3) the residual urine volume is obviously reduced;
(3) high safety and no obvious side effect.
In order to show the clinical effect of the invention, 72 patients with frequent nocturia and dialectical deficiency of kidney yang in traditional Chinese medicine are selected, all the patients are randomly divided into a treatment group and a control group, wherein 36 patients in the treatment group and 36 patients in the control group are treated by the invention, and the control group is treated by the Jinkui kidney qi pills. Age minimum 42 years, maximum 71 years, mean 52.18 ± 3.33 years; 42 men and 30 women; the shortest disease course is 5 months, the longest disease course is 200 months, the average disease course is 41.30 +/-10.71 months, and the age, the disease condition and the sex of the two groups have no obvious difference before treatment. The treatment course is 4 weeks. The effective rate and symptom improvement condition of two groups of patients after treatment are observed before and after taking the medicine respectively, and the observation indexes are as follows:
(1) the safety index is as follows: blood pressure, pulse, blood, urine and excrement routine and electrocardiogram, liver and kidney function test
(2) The curative effect index is as follows:
(a) the frequency of nocturia: a nocturia diary.
(b) Measuring the residual urine volume: the transabdominal B-ultrasonic method is adopted.
(c) Quality of life scoring:
(3) observation of adverse reactions
The change of each index before and after treatment is shown in tables 1-4:
TABLE 1 comparison of quality of life index (QOL) before and after two groups of treatments
Note:*p < 0.05 compared to pre-treatment,**p < 0.01 compared to pre-treatment;ΔΔindicates that p is less than 0.01 in comparison with the Jinkui Shenqi pill group, the same applies below.
TABLE 2 comparison of nocturia before and after treatment
Note: the p-values are as above.
TABLE 3 comparison of residual urine volume (PVR) before and after two groups of treatments
Note: the p-values are as above.
TABLE 4 comparison of the clinical effects of the two groups
The results show that: after treatment, the effective rate of patients in a treatment group is far higher than that of patients in a control group, the improvement of the nocturia times, the life quality score and the residual urine volume is obviously better than that of the control group, and the difference between the two groups has statistical significance (P is less than 0.01). No obvious adverse reaction is seen in the process of taking the medicine, and no obvious changes are caused in the conventional processes of electrocardiogram, liver and kidney functions, blood and urine before and after taking the medicine.
Detailed Description
The present invention will be further described with reference to the following examples.
The medicine of the invention can have various different component compositions and different proportioning relations, such as (the dosage is weight percentage):
(1) 5-90 parts of fenugreek, 5-80 parts of dung beetle and 5-90 parts of spina gleditsiae
(2) 10-20 parts of fenugreek, 60-70 parts of dung beetle and 10-30 parts of spina gleditsiae
(3) 20-30 parts of fenugreek, 50-60 parts of dung beetle and 20-30 parts of spina gleditsiae
(4) 30-40 parts of fenugreek, 30-40 parts of dung beetle and 30-40 parts of spina gleditsiae
(5) 20-30 parts of fenugreek, 20-30 parts of dung beetle and 30-40 parts of spina gleditsiae
(6) 30-40 parts of fenugreek, 20-30 parts of dung beetle and 30-40 parts of spina gleditsiae
(7) Fenugreek 40, dung beetle 20, and spina Gleditsiae 40
(8) 70-80 parts of fenugreek, 10-20 parts of dung beetle and 10-20 parts of spina gleditsiae
1. The preparation method of the medicine takes 5-90 parts of fenugreek, 5-80 parts of dung beetle and 5-90 parts of spina gleditsiae (weight percentage) as an example, and can refer to the following method:
(1) directly pulverizing Catharsii Molossi into fine powder; reflux-extracting semen Trigonellae with ethanol, and recovering solvent to obtain semen Trigonellae extract; extracting spina Gleditsiae with water, concentrating to obtain spina Gleditsiae extract, mixing Catharsii Molossi powder with semen Trigonellae and spina Gleditsiae extract, adding appropriate amount of starch, drying, granulating, and making into granule.
(2) Extracting Catharsii Molossi and semen Trigonellae with ethanol under reflux, recovering solvent, concentrating, and removing oil to obtain ethanol extract; extracting spina Gleditsiae with water, concentrating to obtain spina Gleditsiae extract, mixing spina Gleditsiae extract with ethanol extract, adding appropriate amount of starch, drying, granulating, and making into capsule.
(3) Extracting Catharsii Molossi with ethanol under reflux, recovering solvent, concentrating, and removing oil to obtain Catharsii Molossi extract; reflux-extracting semen Trigonellae with ethanol, recovering solvent, and concentrating to obtain semen Trigonellae extract; extracting spina Gleditsiae with water, concentrating to obtain spina Gleditsiae extract, mixing spina Gleditsiae, Catharsii Molossi, and semen Trigonellae extract, adding appropriate amount of starch, drying, granulating, and making into tablet.
2. The preparation method of the medicine takes fenugreek 40, dung beetle 20 and spina gleditsiae 40 (weight percentage) as an example, and can refer to the following method:
(1) directly pulverizing Catharsii Molossi into fine powder; reflux-extracting semen Trigonellae with ethanol, and recovering solvent to obtain semen Trigonellae extract; extracting spina Gleditsiae with water, concentrating to obtain spina Gleditsiae extract, mixing Catharsii Molossi powder with semen Trigonellae and spina Gleditsiae extract, adding appropriate amount of starch, drying, granulating, and making into granule.
(2) Extracting Catharsii Molossi and semen Trigonellae with ethanol under reflux, recovering solvent, concentrating, and removing oil to obtain ethanol extract; extracting spina Gleditsiae with water, concentrating to obtain spina Gleditsiae extract, mixing spina Gleditsiae extract with ethanol extract, adding appropriate amount of starch, drying, granulating, and making into capsule.
(3) Extracting Catharsii Molossi with ethanol under reflux, recovering solvent, concentrating, and removing oil to obtain Catharsii Molossi extract; reflux-extracting semen Trigonellae with ethanol, recovering solvent, and concentrating to obtain semen Trigonellae extract; extracting spina Gleditsiae with water, concentrating to obtain spina Gleditsiae extract, mixing spina Gleditsiae, Catharsii Molossi, and semen Trigonellae extract, adding appropriate amount of starch, drying, granulating, and making into tablet.
Claims (7)
1. A pharmaceutical composition for treating frequent nocturia is characterized in that the range of the mixture ratio (dosage is weight percentage) of the raw materials is as follows: 5-90 parts of fenugreek, 5-90 parts of spina gleditsiae and 5-80 parts of dung beetle.
2. The medicine according to claim 1, wherein the range of the mixture ratio (dosage is weight percent) of the raw materials is as follows: 10-20 parts of fenugreek, 60-70 parts of dung beetle and 10-30 parts of spina gleditsiae.
3. The medicine according to claim 1, wherein the range of the mixture ratio (dosage is weight percent) of the raw materials is as follows: 20-30 parts of fenugreek, 50-60 parts of dung beetle and 20-30 parts of spina gleditsiae.
4. The medicine according to claim 1, wherein the range of the mixture ratio (dosage is weight percent) of the raw materials is as follows: 70-80 parts of fenugreek, 10-20 parts of dung beetle and 10-20 parts of spina gleditsiae.
5. The medicine according to claim 1, wherein the range of the mixture ratio (dosage is weight percent) of the raw materials is as follows: fenugreek 40, dung beetle 20 and spina gleditsiae 40.
6. Pharmaceutical according to any one of claims 1 to 5, characterized in that the pharmaceutical is in a dosage form selected from granules or tablets or capsules.
7. A process for the preparation of a medicament according to any one of claims 1 to 5, characterized in that: extracting semen Trigonellae and spina Gleditsiae with water or ethanol solution of different concentrations by conventional method to obtain extract; pulverizing Catharsii Molossi into fine powder, or extracting Catharsii Molossi with ethanol solution of different concentrations, recovering solvent, concentrating, and removing oil to obtain Catharsii Molossi extract; mixing semen Trigonellae, spina Gleditsiae and Catharsii Molossi extract, adding adjuvants, drying, granulating, and making into desired dosage form.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202111624489.6A CN114099565A (en) | 2021-12-29 | 2021-12-29 | Pharmaceutical composition for treating frequent nocturia and preparation method thereof |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202111624489.6A CN114099565A (en) | 2021-12-29 | 2021-12-29 | Pharmaceutical composition for treating frequent nocturia and preparation method thereof |
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| CN114099565A true CN114099565A (en) | 2022-03-01 |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN116549505A (en) * | 2023-06-14 | 2023-08-08 | 成都前路通生物科技有限公司 | Novel traditional Chinese medicine for treating kidney deficiency and blood stasis syndrome and preparation method thereof |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101480424A (en) * | 2009-01-08 | 2009-07-15 | 郭凯 | Medicine for treating prostatosis and method for preparing same |
| CN105641029A (en) * | 2016-02-19 | 2016-06-08 | 郭凯 | Pharmaceutical composition for treating BOO (bladder outlet obstruction) and preparation method of pharmaceutical composition |
-
2021
- 2021-12-29 CN CN202111624489.6A patent/CN114099565A/en active Pending
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101480424A (en) * | 2009-01-08 | 2009-07-15 | 郭凯 | Medicine for treating prostatosis and method for preparing same |
| CN105641029A (en) * | 2016-02-19 | 2016-06-08 | 郭凯 | Pharmaceutical composition for treating BOO (bladder outlet obstruction) and preparation method of pharmaceutical composition |
Non-Patent Citations (2)
| Title |
|---|
| 杨欣等: "益气活血化瘀中药对大鼠前列腺增生组织血管新生及bFGF表达的影响", 《中华中医药杂志》 * |
| 王正国等: "以前列舒乐胶囊为对照评价前列通闭方治疗前列腺增生症的临床研究", 《中药药理与临床》 * |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN116549505A (en) * | 2023-06-14 | 2023-08-08 | 成都前路通生物科技有限公司 | Novel traditional Chinese medicine for treating kidney deficiency and blood stasis syndrome and preparation method thereof |
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Application publication date: 20220301 |
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