CN115475190B

CN115475190B - Traditional Chinese medicine composition for treating ureteral calculus

Info

Publication number: CN115475190B
Application number: CN202211267919.8A
Authority: CN
Inventors: 陈磊; 高人杰; 曹宏文; 冯懿赓; 白慧明; 王丹; 赵文洋; 孙鹏; 李海滨; 吴效通; 宋子希
Original assignee: Longhua Hospital Affiliated to Shanghai University of TCM
Current assignee: Longhua Hospital Affiliated to Shanghai University of TCM
Priority date: 2022-10-17
Filing date: 2022-10-17
Publication date: 2023-06-06
Anticipated expiration: 2042-10-17
Also published as: CN115475190A

Abstract

The invention discloses a traditional Chinese medicine composition for treating ureteral calculus, and belongs to the technical field of medicines. The traditional Chinese medicine composition comprises the following raw materials in parts by weight: 15-30 parts of lysimachia, 12-15 parts of climbing fern spore, 12-15 parts of pyrrosia lingua, 12-15 parts of white poria, 10-15 parts of radix puerariae, 6-9 parts of radix linderae and 6-9 parts of radix achyranthis bidentatae. The traditional Chinese medicine composition disclosed by the invention is scientific and reasonable in compatibility, can clear heat, promote diuresis, promote qi circulation to remove blood stasis, treat stranguria and remove calculus, and can be used for effectively treating ureteral calculus. Clinical experiments prove that the effective rate of the traditional Chinese medicine composition reasonably combined in the invention for treating ureteral calculus patients is up to 97.37%, the curative effect is obvious, the medicine is safe, and no obvious toxic or side effect is caused.

Description

Traditional Chinese medicine composition for treating ureteral calculus

Technical Field

The invention relates to the technical field of medicines, in particular to a traditional Chinese medicine composition for treating ureteral calculus.

Background

Urinary calculus is one of the most common clinical diseases of urinary surgery, belongs to high morbidity, and accounts for 1/3 or more of the total number of patients in the outpatient and hospitalized urinary surgery. In recent years, the total incidence of urinary calculi is about 1% -5%, and in southern areas, the incidence rate can be as high as 5% -10%, and the situation of increasing the incidence rate is shown.

The 2014 edition of Chinese diagnostic and therapeutic guidelines for urological diseases indicates that 98% of ureteral stones with diameters smaller than 5mm can be discharged by themselves. The lower section calculus of ureteral calculus can reach 71%, the middle section calculus can reach 46%, and the upper section calculus can reach 22%. The doctor and the patient should be allowed to observe the self-discharge of the stones for a certain period of time (1-2 months). EAU guide for urolithiasis states: for ureteral calculus with diameter of 5-10mm, natural calculus removing or medicine calculus removing treatment can be adopted as primary treatment. At present, the calculus removing rate of the medicine calculus removing treatment is up to 65%, and a large amount of data show that the calculus removing treatment of the traditional Chinese medicine can obviously improve the calculus removing effective rate.

The traditional Chinese medicine has long history on the research, and various doctors put forward different treatment ideas according to clinical experience, and methods such as traditional Chinese medicine decoction, acupuncture treatment, acupoint application and the like are widely used in the treatment of the gonorrhea. Along with the clinical experience summary and the progress of modern pharmacological research of traditional Chinese medicine components, traditional Chinese medicine decoction gradually develops to traditional Chinese medicine compound preparations, and scientific compositions are developed. Therefore, the invention aims to provide a traditional Chinese medicine composition for treating ureteral calculus, so as to promote ureteral calculus discharge and shorten the non-operative treatment course.

Disclosure of Invention

The invention aims to provide a traditional Chinese medicine composition for treating ureteral calculus, which solves the problems in the prior art, has scientific and reasonable compatibility, can effectively treat ureteral calculus, is safe to use and has no obvious toxic or side effect, and provides a feasible new medicine for the efficient treatment of ureteral calculus patients.

In order to achieve the above object, the present invention provides the following solutions:

the invention provides a traditional Chinese medicine composition for treating ureteral calculus, which comprises the following raw materials in parts by weight: 15-30 parts of lysimachia, 12-15 parts of climbing fern spore, 12-15 parts of pyrrosia lingua, 12-15 parts of white poria, 10-15 parts of radix puerariae, 6-9 parts of radix linderae and 6-9 parts of radix achyranthis bidentatae.

Further, the material comprises the following raw materials in parts by weight: 30 parts of desmodium, 15 parts of climbing fern spore, 14 parts of pyrrosia lingua, 15 parts of white poria, 12 parts of radix puerariae, 9 parts of radix linderae and 6 parts of radix achyranthis bidentatae.

The invention also provides a preparation method of the traditional Chinese medicine composition, which comprises the following steps:

soaking the raw materials in water according to a proportion, decocting and collecting filtrate A, decocting filter residues in water, collecting filtrate B, and combining the filtrate A and the filtrate B to obtain the traditional Chinese medicine composition.

Further, the water content ratio of the raw materials to the water soaked by adding water is (5-21) g: (80-100 mL) and soaking in water for 30-60min.

Further, the time of the decoction and the water decoction is 20-30min.

The invention also provides application of the traditional Chinese medicine composition in preparing a medicine for treating ureteral calculus.

Further, the medicament also comprises pharmaceutically acceptable auxiliary materials.

Further, the pharmaceutically acceptable auxiliary materials comprise any one or more of a filler, a disintegrating agent, an adhesive, a lubricant and a flavoring agent.

Further, the dosage form of the medicament comprises an oral preparation.

The formula of the traditional Chinese medicine composition of the invention is as follows:

herba Lysimachiae Christinae: sweet and salty in flavor, slightly cold in nature, can promote diuresis to alleviate jaundice, induce diuresis to treat stranguria. Spora Lygodii: sweet and salty in flavor, cold in nature, can clear damp-heat, treat stranguria and relieve pain. Small pyrrosia lingua: bitter and sweet in flavor, slightly cold in nature, can induce diuresis to treat stranguria, cool blood and stop bleeding. Poria cocos: sweet and bland in taste, mild in nature, can excrete dampness and invigorate spleen. Radix puerariae powder: sweet and pungent in flavor, cool in nature, can promote qi circulation to alleviate pain, warm kidney and dispel cold. Radix Linderae: pungent in nature and warm in nature, it can activate blood and promote qi circulation, dispel wind and alleviate pain. Achyranthes bidentata: bitter, sweet and sour in flavor, mild in nature, can activate blood and unblock meridians, induce diuresis and treat stranguria, and induce fire to descend.

Herba lysimachiae has the effects of clearing heat and promoting diuresis, treating stranguria and removing urinary calculus, and is an essential drug for treating Dan Linbing, and is a group Fang Jun drug; the climbing fern spore has the effects of clearing heat and promoting diuresis, treating stranguria and relieving pain, the pyrrosia lingua has the effects of promoting diuresis and treating stranguria, relieving spasm and stopping bleeding, and the desmodium is assisted to clear heat and promote diuresis and treat stranguria, so that the pathogenic factors have the effect of complement each other and are taken as ministerial drugs; with the assistance of the white poria, the spleen is strengthened, the qi is moved and the water is removed, the radix puerariae powder lifts the yang qi, and the radix aconiti kusnezoffii powder warms the kidney, moves qi and relieves pain; achyranthes root, radix Achyranthis bidentatae has the effects of inducing diuresis and treating stranguria, and guiding the lower-grade medicines to act as a guiding medicine. The medicines are used together to promote qi and blood circulation, and help the accumulation of heat and the downward flow of water dampness, so that the symptoms are self-healed.

The invention discloses the following technical effects:

the traditional Chinese medicine composition disclosed by the invention is scientific and reasonable in compatibility, can clear heat, promote diuresis, promote qi circulation to remove blood stasis, treat stranguria and remove calculus, and can be used for effectively treating ureteral calculus. Meanwhile, clinical experiments prove that the effective rate of the reasonably compatible traditional Chinese medicine composition for treating ureteral calculus patients is up to 97.37%, the curative effect is obvious, the medicine is safe, and no obvious toxic or side effect is caused.

Detailed Description

Various exemplary embodiments of the invention will now be described in detail, which should not be considered as limiting the invention, but rather as more detailed descriptions of certain aspects, features and embodiments of the invention.

It is to be understood that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. In addition, for numerical ranges in this disclosure, it is understood that each intermediate value between the upper and lower limits of the ranges is also specifically disclosed. Every smaller range between any stated value or stated range, and any other stated value or intermediate value within the stated range, is also encompassed within the invention. The upper and lower limits of these smaller ranges may independently be included or excluded in the range.

Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Although only preferred methods and materials are described herein, any methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention. All documents mentioned in this specification are incorporated by reference for the purpose of disclosing and describing the methods and/or materials associated with the documents. In case of conflict with any incorporated document, the present specification will control.

It will be apparent to those skilled in the art that various modifications and variations can be made in the specific embodiments of the invention described herein without departing from the scope or spirit of the invention. Other embodiments will be apparent to those skilled in the art from consideration of the specification of the present invention. The specification and examples of the present invention are exemplary only.

As used herein, the terms "comprising," "including," "having," "containing," and the like are intended to be inclusive and mean an inclusion, but not limited to.

Materials, instruments and reagents used in the present invention are commercially available unless otherwise specified; the experimental methods used, unless otherwise specified, are all routine in the art.

Example 1A Chinese medicinal composition for treating ureteral calculus

Mixing herba Lysimachiae Christinae 15g, spora Lygodii 14g, folium Pyrrosiae 12g, poria 12g, radix Puerariae 10g, radix Linderae 6g and Achyranthis radix 8g uniformly, placing into a medicinal tank, adding 400mL water, soaking for 40min, decocting with strong fire to boil, decocting with slow fire for 25min, and filtering to obtain filtrate A and residue; adding 250mL of water into the filter residue, immersing, decocting with strong fire until boiling, decocting with slow fire for 25min, filtering to obtain filtrate B, mixing filtrate A and filtrate B, and mixing to obtain the traditional Chinese medicine composition for treating ureteral calculus.

Example 2A Chinese medicinal composition for treating ureteral calculus

Mixing herba Lysimachiae Christinae 30g, spora Lygodii 15g, folium Pyrrosiae 14g, poria 15g, radix Puerariae 12g, radix Linderae 9g, and Achyranthis radix 6g, placing into a medicinal tank, adding 500mL water, soaking for 30min, decocting with strong fire to boil, decocting with slow fire for 30min, and filtering to obtain filtrate A and residue; adding 300mL of water into the filter residue, immersing, decocting with strong fire until boiling, decocting with slow fire for 30min, filtering to obtain filtrate B, mixing filtrate A and filtrate B, and mixing to obtain the traditional Chinese medicine composition for treating ureteral calculus.

Example 3A Chinese medicinal composition for the treatment of ureteral calculus

Mixing herba Lysimachiae Christinae 21g, spora Lygodii 12g, folium Pyrrosiae 15g, poria 14g, radix Puerariae 15g, radix Linderae 7g, and Achyranthis radix 9g, placing into a medicinal tank, adding 450mL water, soaking for 60min, decocting with strong fire to boil, decocting with slow fire for 20min, and filtering to obtain filtrate A and residue; adding 200mL of water into the filter residue, immersing, decocting with strong fire until boiling, decocting with slow fire for 20min, filtering to obtain filtrate B, mixing filtrate A and filtrate B, and mixing to obtain the traditional Chinese medicine composition for treating ureteral calculus.

Comparative example 1

The same as in example 1, except that desmodium was replaced with herba Polygoni Avicularis.

Comparative example 2

The same as in example 1, except that spora Lygodii was replaced with fringed pink.

Comparative example 3

The same as in example 1, except that the raw materials of the traditional Chinese medicine composition are: 15g of climbing fern spore, 14g of radix puerariae powder, 12g of radix linderae, 12g of white poria, 10g of lysimachia christinae, 6g of pyrrosia lingua and 8g of radix achyranthis bidentatae.

Effect example

I case data

(1) The western diagnosis accords with ureteral calculus;

(2) The differentiation of the traditional Chinese medicine accords with the syndrome of damp-heat accumulation (the main syndrome, the secondary syndrome and the tongue pulse meet the conditions);

(4) Age 18-65 years;

(5) The stones are located below the first physiological stenosis of the ureter (where the renal pelvis and ureter travel). The transverse diameter of the stone is 5mm-10mm;

(6) Ureteral stones or renal colic episodes were diagnosed within 1 month prior to group entry;

(7) The kidney function of the affected side is good, if the patient has hydronephrosis, the hydronephrosis degree is at or below moderate (9-14 mm of renal pelvis separation);

(8) The whole body has good condition, no serious internal medical diseases and self-care of life;

(9) The patient voluntarily attends.

266 cases of treatment cases of the invention are outpatient cases, and the traditional Chinese medicine preparations prepared in examples 1-3 and comparative examples 1-3 and the existing compound desmodium granules are used for treatment, and 38 cases of treatment are randomly allocated to each group.

II diagnostic criteria

(1) Traditional Chinese medicine syndrome waiting diagnosis standard: the standard preparation of the medical preparation is formulated by referring to the Chinese medical science of the department of urology of the traditional Chinese medicine Dan Linbing: according to the specific requirements of the clinical test, the tongue pulse is combined to diagnose the damp-heat accumulation.

Typical clinical symptoms are:

main symptoms are as follows: pain in the waist and abdomen, frequent urination, urgent urination, burning urethra and turbid urine;

secondary symptoms: dry mouth, hematuria, and pain in urination;

tongue texture: the tongue is red, and the tongue coating is yellow or yellow and greasy; pulse condition: chords or chord numbers;

(2) Western diagnostic criteria (ureteral calculus): diagnostic criteria are formulated with reference to 2014 chinese diagnostic guidelines for urological disease, based primarily on the primary manifestations of the patient (clinical symptoms and physical examination) and imaging examinations.

(1) The main performances are as follows: primary diagnosis is mainly carried out according to medical history and physical signs: there may be a history of typical sudden onset of renal or ureteral colic with pain radiating to the ipsilateral lower abdomen, testes or labia with or without symptoms of nausea and vomiting, cold sweat, pale complexion, abdominal distension, shortness of breath, etc.; with or without macroscopic or microscopic hematuria; or the patient only has waist soreness and discomfort and lower abdomen ureter walking area pain; or the patient has a history of calculus removal in the past. The physical sign is as follows: in the event of an acute episode, the renal or ureteral area of the patient is positive for a tap or pressure pain.

(2) Imaging examination: mainly adopts full urinary tract flat scanning CT. CT examination indicates the existence of ureteral calculus, and also specifies the size, position, number, renal and ureteral water accumulation conditions, etc.

III treatment regimen

Examples 1-3 and comparative examples 1-3 groups: the Chinese medicinal compositions prepared in examples 1-3 and comparative examples 1-3 of the present invention were taken at a temperature of 2 hours after breakfast and supper of 250mL each time, with a administration period of 28 days.

Control group: the compound herba Lysimachiae granule is taken 3 times a day, 1 bag each time, 30min after meals, 250mL warm water. Each group had a dosing period of 28 days.

During treatment: health education is performed on the cases which are brought into the test, and patients are ordered:

1. light diet, limiting intake of strong tea, coffee, cocoa, reducing intake of high calcium, high oxalic acid and animal proteins;

2. the daily water intake is more than 2000mL, and the water intake is sanitary;

3. maintaining a proper amount of movement but not excessive resulting in excessive sweating;

4. acute originators of renal colic can be treated with spasmolytic and analgesic treatments.

IV diagnostic criteria for efficacy

(1) Efficacy observation index

(1) Full urinary tract flat scan CT: the position, size, number and hydronephrosis of ureteral calculus are clear. Full urinary tract flat scan CT examination must be performed during screening period and visit 2. If the condition changes in visit 1, full urinary tract flat scan CT or urinary system ultrasound is needed;

(2) integral of Chinese medicine symptoms: screening period, visit 2 were recorded 1 time each.

(2) Therapeutic effect criterion

And (3) curing: the stones are lowered to the bladder, urethra or discharged outside;

the effect is shown: the stones move downwards by more than 6cm;

invalidation: stone changes do not correspond to both;

effective rate= (cure+significant effect)/total case number x 100%.

(2) Chinese medicine symptom score

The standard preparation of the medical preparation is formulated by referring to the Chinese medical science of the department of urology of the traditional Chinese medicine Dan Linbing: the curative effect of the traditional Chinese medicine symptoms is judged according to an integral method (nimodipine method is adopted): (pre-treatment integral-post-treatment integral/pre-treatment integral) ×100%.

Clinical recovery: the integral of the symptoms of the traditional Chinese medicine is more than or equal to 95 percent;

the effect is shown: the integral of the symptoms of the traditional Chinese medicine is more than or equal to 60 percent;

the method is effective: the integral of the symptoms of the traditional Chinese medicine is more than or equal to 30 percent;

invalidation: the integral of the traditional Chinese medicine syndrome is less than 30%;

the effective rate of the traditional Chinese medicine syndrome is = (clinical cure + significant effect + effective)/total case number is multiplied by 100%.

V treatment outcome

According to the treatment scheme, 38 patients suffering from ureteral calculus are treated by orally taking the traditional Chinese medicine combination decoction and the compound desmodium granules prepared in the examples 1-3 and the comparative examples 1-3 respectively, and the treatment effect is counted after 1 treatment course. The results were as follows:

table 1 statistics of the efficacy of each group

Group of	Number of examples	Cure (example)	Display effect (example)	Invalidation (example))	Effective rate (%)
						Example 1	38	17	20	1	97.37
Example 2	38	20	17	1	97.37
						Example 3	38	18	19	1	97.37
Comparative example 1	38	14	16	8	78.95
						Comparative example 2	38	12	16	10	73.68
Comparative example 3	38	10	17	11	71.05
						Control group	38	6	17	15	60.53

The results in Table 1 show that the Chinese medicinal preparation prepared by the invention has remarkable treatment effect on ureteral calculus, the effective rate is as high as 97.37%, the Chinese medicinal preparation is obviously superior to a control group, the purpose of clinical treatment is achieved, and no obvious adverse reaction is caused in the treatment process. Whereas the traditional Chinese medicine preparations of comparative examples 1-2 have reduced efficacy due to the change of the monarch drug components; in comparative example 3, the drug effect is affected by changing the principle of monarch, minister, assistant and guide compatibility.

The invention has reasonable dosage, reliable curative effect, economy and safety, no obvious toxic or side effect, is effectively used for treating ureteral calculus, and has practical clinical significance and popularization value.

The above embodiments are only illustrative of the preferred embodiments of the present invention and are not intended to limit the scope of the present invention, and various modifications and improvements made by those skilled in the art to the technical solutions of the present invention should fall within the protection scope defined by the claims of the present invention without departing from the design spirit of the present invention.

Claims

1. The traditional Chinese medicine composition for treating ureteral calculus is characterized by being prepared from the following raw materials in parts by weight: 15-30 parts of lysimachia, 12-15 parts of climbing fern spore, 12-15 parts of pyrrosia lingua, 12-15 parts of white poria, 10-15 parts of radix puerariae, 6-9 parts of radix linderae and 6-9 parts of radix achyranthis bidentatae.

2. The traditional Chinese medicine composition according to claim 1, which is characterized by being prepared from the following raw materials in parts by weight: 30 parts of desmodium, 15 parts of climbing fern spore, 14 parts of pyrrosia lingua, 15 parts of white poria, 12 parts of radix puerariae, 9 parts of radix linderae and 6 parts of radix achyranthis bidentatae.

3. A method for preparing the traditional Chinese medicine composition according to claim 1 or 2, comprising the following steps:

4. The method according to claim 3, wherein the ratio of the raw materials to the water soaked in water is (5-21) g: (80-100 mL) and soaking in water for 30-60min.

5. A method according to claim 3, wherein the time of the decocting and the decocting with water is 20-30min.

6. Use of a Chinese medicinal composition according to any one of claims 1-2 for the preparation of a medicament for the treatment of ureteral calculus.

7. The use according to claim 6, wherein the medicament further comprises pharmaceutically acceptable excipients.

8. The use according to claim 7, wherein the pharmaceutically acceptable excipients comprise any one or more of fillers, disintegrants, binders, lubricants and flavouring agents.

9. The use according to claim 6, wherein the pharmaceutical dosage form is an oral formulation.