CN113456835B

CN113456835B - Feces excretion contrast agent and preparation method thereof

Info

Publication number: CN113456835B
Application number: CN202110677431.1A
Authority: CN
Inventors: 苑国忠; 袁磊
Original assignee: 'the Medical Technology Changzhou Co ltd
Current assignee: 'the Medical Technology Changzhou Co ltd
Priority date: 2021-06-16
Filing date: 2021-06-16
Publication date: 2023-03-28
Anticipated expiration: 2041-06-16
Also published as: CN113456835A

Abstract

The invention provides a defecation contrast agent and a preparation method thereof, wherein the defecation contrast agent comprises the following components in parts by weight: type II barium sulfate: 25 to 30 percent; sodium hyaluronate: 1.5 to 2.5 percent; carbomer: 1.5 to 2.5 percent; bletilla striata powder: 10 to 15 percent; humectant: 0.1 to 0.2 percent; essence: 0.001 to 0.005 percent; solvent: 55-60%, the formulation of the defecation contrast agent is stable and can be used immediately after being opened, so that the convenience and the comfort in use of medical personnel and patients during defecation contrast examination are improved.

Description

Feces excretion contrast agent and preparation method thereof

Technical Field

The invention relates to the technical field of medical instruments, in particular to a defecation contrast agent and a preparation method thereof.

Background

The defecation radiography examination is a new examination method and is mainly used for treating clinical symptoms of difficult defecation, chronic constipation, mucous and bloody stool, anal pendant expansion, perineum and lumbosacral pain during defecation and the like. The problems of the patients are difficult to find through clinical anus examination, routine barium enema and endoscopy examination, and the abnormality can not be detected when the rectum is empty and can be displayed only when the rectum is full and defecates forcibly. A special pasty contrast agent is injected into the rectum of a person to be examined, and the anus, the rectum and the pelvic floor are statically and dynamically observed under the condition of conforming to the physiological state, so that the special pasty contrast agent is a reliable basis for determining the treatment mode, and is mainly used for diagnosing the functional diseases of the anus, the rectum, such as rectal mucosa prolapse, rectal intussusception, proctoptosis, perineum descent syndrome, pelvic floor muscle spasm syndrome and the like. At present, the hospital generally directly uses II type barium sulfate solution as contrast medium to simulate the feces of normal people, but the shape difference of the feces of the contrast medium and the normal people directly influences the judgment of the detection result.

At present, there is not the defecation contrast medium that can directly use on the market, all be medical personnel and use after configuring II type barium sulfate and water among the prior art, the defecation contrast medium ubiquitous medical personnel field configuration process is loaded down with trivial details, the contrast medium layering is obvious after the configuration, patient experience sense circumstances such as poor, especially the contrast medium after the layering has the viscosity low, the problem that the mobility is high, make the patient have a uncomfortable impression of holding back behind the leading-in patient rectum, the urgent need provide one kind towards medical personnel and patient experience sense high defecation contrast product on the market.

Disclosure of Invention

The invention aims to overcome the defects of the prior art and provides a defecation contrast agent and a preparation method thereof.

In order to achieve the above objects and other objects, the present invention comprises the following technical solutions: the invention firstly provides a defecation contrast agent which comprises the following components in parts by weight: type II barium sulfate: 25 to 30 percent; sodium hyaluronate: 1.5 to 2.5 percent; carbomer: 1.5 to 2.5 percent; bletilla striata powder: 10 to 15 percent; humectant: 0.1 to 0.2 percent; essence: 0.001 to 0.005 percent; solvent: 55 to 60 percent.

In one embodiment, the sodium hyaluronate, carbomer and bletilla striata powder are mixed according to a weight ratio of 1:1: (5-10).

In one embodiment, the sodium hyaluronate has a molecular mass greater than 2000KDa.

In one embodiment, the carbomer is type 941 carbomer.

In one embodiment, the fineness of the bletilla striata powder is 150-200 meshes.

In one embodiment, the humectant is any one or more of polyhydric alcohol, collagen, chitin and seaweed extract.

In one embodiment, the solvent is normal saline or purified water.

The invention also provides a preparation method of the defecation contrast agent, which comprises the following steps: the method comprises the following steps: mixing sodium hyaluronate, carbomer, bletilla striata powder, a humectant, a solvent, essence and II-type barium sulfate to obtain the defecation contrast agent.

In one embodiment, the mixing comprises ultrasonic mixing or stirring mixing, and the mixing time is 15-30 min.

In one embodiment, the mixing is ambient temperature mixing.

As mentioned above, the formula of the invention can well simulate the feces of normal people, the prepared contrast agent can be directly packaged in a sealing way, the viscosity of the contrast agent still meets the requirement of normal feces after being placed for two months, and the use comfort of patients and medical staff is improved.

Detailed Description

The embodiments of the present invention are described below with specific examples, and other advantages and effects of the present invention will be readily apparent to those skilled in the art from the description provided herein. The invention is capable of other and different embodiments and of being practiced or of being carried out in various ways, and its several details are capable of modification in various respects, all without departing from the spirit and scope of the present invention.

The invention firstly provides a defecation contrast agent, which comprises the following raw materials in parts by weight: type II barium sulfate: 25 to 30 percent; sodium hyaluronate: 1.5 to 2.5 percent; carbomer: 1.5 to 2.5 percent; bletilla striata powder: 10 to 15 percent; humectant: 0.1 to 0.2 percent; essence: 0.001 to 0.005 percent; solvent: 55 to 60 percent.

Further, the defecation contrast agent can comprise the following raw materials in parts by weight: type II barium sulfate: 28 to 30 percent; sodium hyaluronate: 1.8 to 2.5 percent; carbomer: 1.8 to 2.5 percent; bletilla striata powder: 11 to 12 percent; humectant: 0.18 to 0.19 percent; essence: 0.001 to 0.002 percent; solvent: 55 to 60 percent.

The type II barium sulfate can be type II barium sulfate, for example, a type II barium sulfate dry suspension, and the type II barium sulfate dry suspension is suitable for single and double contrast radiography examination of esophagus, stomach, duodenum, small intestine and colon. The barium salt can absorb a large amount of X-rays, and after entering cavities such as gastrointestinal tracts or respiratory tracts and the like in vivo, the barium salt and surrounding tissue structures form density contrast on an X-ray image, so that the positions, contours, forms, surface structures and functional activities of the cavities are displayed. The thickness unevenness type shows good to the mucous membrane phase microstructure such as the gastric subdistrict, and the II type barium sulfate meets the standard requirement of Chinese pharmacopoeia.

The sodium hyaluronate, carbomer and bletilla striata powder are all additives with certain viscosity and expansibility and low X-ray absorption, and in some embodiments, the weight ratio of the sodium hyaluronate, carbomer and bletilla striata powder can be 1:1: (5 to 10), for example, 1:1: 6. 1:1: 7. 1:1:8, and the like. The viscosity of the finally obtained contrast agent can be better regulated by adopting three different high-viscosity high-swelling additives, the sodium hyaluronate can be high molecular weight sodium hyaluronate, further, the molecular weight of the sodium hyaluronate can be more than 2000KDa, and further, the molecular weight of the sodium hyaluronate can be 1.0MDa, 1.4MDa, 1.5MDa and the like. Considering that the medical detection tool can not be absorbed by human body and can influence the accuracy of detection by participating in human body metabolism, the invention can adopt high molecular weight sodium hyaluronate. In one embodiment, the sodium hyaluronate may be available from Huaxi Biotechnology, inc. The carbomer can be a carbomer of type 941, the carbomer can be selected from luoborun management (Shanghai) Co., ltd, and the fineness of the bletilla striata powder can be 100-200 meshes, and further can be 150-200 meshes. The bletilla striata powder is adopted to replace common viscosity adjusting powder such as konjac powder, wheat bran and the like commonly used in the market at present, so that bacteria breeding can be avoided, and long-term storage is facilitated.

The sodium hyaluronate of the invention has the chemical formula of (C) ₁₄ H ₂ ONO ₁₁ Na) n, which is an inherent component in a human body, is a glucuronic acid, has no species specificity, and is widely present in tissues such as placenta, amniotic fluid, crystalline lens, articular cartilage, skin dermis and the like; it is distributed in cytoplasm and intercellular substance, and has lubricating and nourishing effects on cells and cell organs contained therein. The moisturizing effect is the most important effect of sodium hyaluronate in cosmetics, and the relative humidity of the surrounding environment has less influence on the moisturizing effect compared with other moisturizing agents. The sodium hyaluronate contrast agent has lubricating effect on intestinal tract, and the lubricating effect of the sodium hyaluronate contrast agent enables the product to be easily injected into anus. The bletilla striata powder can astringe to stop bleeding, relieve swelling and promote tissue regeneration, is prepared from pure traditional Chinese medicines, is convenient to obtain, contains a large amount of colloid, and is sticky and greasy (especially obvious when being prepared by boiled water). The carbomer is a hydrophilic thickening agent, a stable emulsifying agent, a suspending agent and a gelling agent, has good transparency, is also called carbomer, is acrylic acid cross-linked resin obtained by cross-linking pentaerythritol and the like with acrylic acid, is a very important rheological regulating agent, is an excellent gel matrix, has important purposes of thickening, suspending and the like, has simple process and good stability, and is widely applied to emulsion, cream and gel.

The moisturizer of the present invention may be any one or more of polyhydric alcohol, collagen, chitin, seaweed extract, and further may be polyhydric alcohol-based moisturizer such as glycerin (glycerol), propylene glycol, 1, 3-butylene glycol, sorbitol, polyethylene glycol, hexylene glycol, 2-methyl-2, 4-pentanediol, polypropylene glycol, and the like, which may have a moisturizing effect in order to protect the skin of the intestinal tract. The essence can be various plant essential oils, such as rose essential oil and the like, and the essential oil can eliminate psychological obstacles of patients and improve the examination comfort of patients. Furthermore, carbomer is added into the defecation contrast agent, so that the defecation contrast agent has certain odor, and the use comfort of the contrast agent can be further improved by adopting a proper amount of essential oil. The solvent can be various nontoxic and low toxic solvents, including normal saline, purified water and the like, and further purified water can be used, and water is preferably used for preparing the contrast agent for examination because of convenience, economy and good compatibility with human bodies.

In another aspect, the present invention also provides a method for preparing a defecation contrast agent, the method comprising the following steps: mixing sodium hyaluronate, carbomer, bletilla striata powder, a humectant, a solvent, essence and II-type barium sulfate to obtain the defecation contrast agent.

In some embodiments, the mixing is room temperature mixing, and the mixing may be performed in multiple steps, for example, a first mixing and a second mixing may be included, the first mixing may include first mixing the moisturizer, the bletilla striata powder, the sodium hyaluronate, the carbomer and the solvent sufficiently to obtain a first mixture, the first mixing may be performed under the condition of ultrasound, and the ultrasound time may be 5-10 min, such as 5min, 6min, and the like. The second mixing can be carried out under the condition of stirring, and the stirring time can be 10-20 min. In one embodiment, the preparation of the defecation contrast agent can further comprise the steps of subsequent packaging, sealing and the like to form a finished product.

The invention is further illustrated below by performance evaluation of different contrast agent formulations.

Evaluation of

A specific contrast agent formulation table is shown in table 1. In table 1, glycerin was purchased from the national medicine group chemical reagent limited, bletilla striata powder was purchased from beijing synanthotan (bozhou) decoction pieces limited, sodium hyaluronate was purchased from huaxi biotechnology limited, type II barium sulfate was purchased from Qingdao hong butterfly new material limited, carbomer was purchased from luobo run management (shanghai) limited, purified water was provided inside the bomai company, and rose essence was purchased from the daohai bio-engineering limited. Table 2 shows performance test data and patient experience data of different samples in table 1, wherein an austenite viscometer is used for testing the viscosity, a comparison method is used for testing the viscosity, and the reference value of the viscosity of normal human feces is 229-253 g (clinical application of simulated defecation radiography, china journal of traditional Chinese medicine, volume 25 of 5.2007).

Table 1 contrast medium formulation table for different samples

TABLE 2 sample Properties comparison Table

As can be seen from table 2, in order to make the viscosity of samples 2 to 3 and sample 5 meet the requirement of normal human feces viscosity, more sodium hyaluronate needs to be added, but sodium hyaluronate is not easily dissolved in water and is not easily directly prepared for use, hot water needs to be used for on-site preparation during clinical use, so that the use is inconvenient, the problem that the viscosity of a contrast agent formula without adding bletilla striata powder is reduced continuously exists, samples 1 to 3 can show that the viscosity of the contrast agent is increased to different degrees along with the lapse of time, and the result that the inside of the contrast agent is gradually agglomerated along with the lapse of the placing time shows that sample 1 can still meet the requirement of normal feces after being placed for two months, and the properties are not greatly changed, while samples 4 to 8 show the problems of layering, solidification agglomeration and the like to different degrees.

The discharge time refers to the time when a doctor instructs a patient to discharge the contrast agent out of the body after the contrast agent is injected into the body, the defecation radiography is carried out in the time and then the development detection is carried out, the discharge time is controlled within 2-3 seconds and can best simulate the normal defecation condition, the sample 1 shows that the patient can normally hold the contrast agent in the rectum, and the formula (sample 8) prepared by barium sulfate and water commonly used in the prior art is too thin, so that the patient can have the feeling of being unable to hold, and the contrast agent is rapidly discharged out of the body after the discharge instruction is heard, and the detection accuracy is affected.

Therefore, the invention effectively overcomes various defects in the prior art and has high industrial utilization value. The foregoing embodiments are merely illustrative of the principles and utilities of the present invention and are not intended to limit the invention. Any person skilled in the art can modify or change the above-mentioned embodiments without departing from the spirit and scope of the present invention. Accordingly, it is intended that all equivalent modifications or changes which may be made by those skilled in the art without departing from the spirit and scope of the present invention as defined in the appended claims.

Claims

1. A defecation contrast agent is characterized by comprising the following components in parts by weight:

type II barium sulfate: 25 to 30 percent;

sodium hyaluronate: 1.5 to 2.5 percent;

carbomer: 1.5 to 2.5 percent;

bletilla striata powder: 10 to 15 percent;

humectant: 0.1 to 0.2 percent;

essence: 0.001 to 0.005 percent;

solvent: 55 to 60 percent;

the sodium hyaluronate, carbomer and bletilla striata powder are mixed according to the weight ratio of 1:1: (5-10).

2. A defecation contrast agent as claimed in claim 1, characterised in that: the molecular mass of the sodium hyaluronate is greater than 2000KDa.

3. A defecation contrast agent as claimed in claim 1, characterised in that: the carbomer is type 941 carbomer.

4. A defecation contrast agent as claimed in claim 1, characterised in that: the fineness of the bletilla striata powder is 150-200 meshes.

5. A stool image contrast agent according to claim 1, characterized in that: the humectant is one or more of polyalcohol, collagen, chitin, and Sargassum extract.

6. A defecation contrast agent as claimed in claim 1, characterised in that: the solvent is normal saline or purified water.

7. A process for the preparation of a faecal contrast agent according to any of claims 1 to 6: the method is characterized in that: mixing sodium hyaluronate, carbomer, bletilla striata powder, a humectant, a solvent, essence and II-type barium sulfate to obtain the defecation contrast agent.

8. The method of claim 7, wherein: the mixing comprises ultrasonic mixing or stirring mixing, and the mixing time is 15-30 min.

9. The method of claim 7, wherein: the mixing is normal temperature mixing.