CN1202866C - Gastrointestinal contrast agent containing biomass - Google Patents

Abstract

A gastrointestinal contrast agent containing biomass belongs to the technical field of medical X-ray gastrointestinal contrast agents. It is characterized by adding ultra-fine powder low-absorption X-Ray material from biomass to traditional non-toxic metal salts (such as barium sulfate, etc.) high-absorption X-Ray material [A] as the main material [A] B] (or) and auxiliary agents such as bonding, blending and seasoning [C], silicone oil and other defoamers [D] and water [E], [A]+[B]+[C]+[D]+ [E] = 0.5-99.5% + 0.5-99.5% + 0-5% + 0-1% + 0-99% = 100% (w/w). It can not only perform good imaging, but also enhance the contrast effect and promote gastrointestinal motility. It is a new type of gastrointestinal contrast agent with the concept of "green".

Description

Biomass-Contained Gastrointestinal Contrast Media

(1) Technical field:

The invention relates to a gastrointestinal contrast agent containing biomass, which is mainly used for medical oral X-Ray gastrointestinal contrast agent and belongs to the field of medical drug manufacturing.

(two) background technology:

In the past, X-Ray gastrointestinal contrast agent mainly used non-toxic metal salts such as barium sulfate in the gastrointestinal tract and high-absorption X-Ray material fine powder as the material, supplemented by flavoring powders such as flavoring agents to adjust Slurry to drink or use as an enema. A typical barium meal: "100-120g of medical barium sulfate, 200ml of water and appropriate amount of gum arabic can also be replaced by peach mucilage, medical soluble carboxymethyl cellulose, tragacanth gum, bletilla striata gum, etc." ("Medical Nursing Technical Operation Specification" , Lou Fangcen, etc., Chinese People's Liberation Army Soldiers Publishing House, Beijing, 1982.P.1568).

The traditional barium meal is effective, but there are some problems that the fine powder of barium sulfate (such as non-toxic metal salts with high absorption X-Ray materials) has a high concentration and a large specific gravity, which is easy to form precipitates, poor suspension or sticky colloids. It is inconvenient to eat or the taste is not good; after entering the digestive tract, it cannot effectively promote gastrointestinal peristalsis, so the descending is not smooth, especially when it is far from the gastrointestinal function and conditions when the actual food exists, and the contradiction is more prominent when the whole digestive tract is contrasted ; and "sometimes constipation may be caused after gastrointestinal contrast" ("Clinical Drug Handbook" Long Xie et al., Jindun Publishing House, Beijing, 1993.P.957); because the "concentration" is relatively high, the suspension stability must be poor, It is easy to precipitate, although the relevant area can be observed by squeezing, but sometimes it will affect the imaging; because the water in the previous barium meal is gradually absorbed during the downward process, when it reaches the lower intestinal tract, only the barium sulfate powder of the barium meal is left. Mainly, it is easy to become hardened powder agglomerates, the volume, distribution, and spreadability are poor, and the contrast effect on the intestinal tract is not ideal. This is one of the biggest problems. In order to observe the intestinal tract carefully, it is necessary to We have to rely on a barium enema from the lower part to confirm that it is not possible, and the result is twice the result with half the effort; in addition, the higher content of barium sulfate powder has a high X-Ray blocking rate and a large imaging contrast. The negative effect also increases at the same time. On the other hand, such a high concentration is not necessary and necessary during the operation and imaging process. The increase in concentration and the reduction in volume in the lower intestinal segment will further reduce the ductility and spreadability, which has affected the contrast. Efficiency, nor can we expect to form a sense of hierarchy. The imaging and contrast effects are not very good.

(3) Contents of the invention:

Aiming at the deficiencies of the prior art, the present invention provides a novel medical oral X-Ray gastrointestinal contrast agent, specifically a biomass-containing gastrointestinal contrast agent. It is characterized in that it is suitable for the use of gastrointestinal contrast agents, and the metal salt high-absorption X-Ray material [A] with a fineness of 0.5-1.0 microns and a biomass-sourced ultrafine powder whose fineness is ≤100 microns in the largest dimension Low-absorption X-Ray material [B] or as well as bonding, blending, flavoring aids [C], defoamer silicone oil [D] and water [E], wherein the weight percentage of each component is as follows:

[A]: 0.5 to 99.5%

[B]: 0.5 to 99.5%

[C]: 0 to 5%

[D]: 0~1%

[E]: 0 to 99%.

The traditional metal salt high-absorption X-Ray material [A] that is suitable for gastrointestinal contrast agents used in the present invention refers to medical barium sulfate, osmium citrate (bismuth) potassium, others, and their composites and complexes. compound.

Apparently, the present invention is to add " diluent " in the traditional contrast agent that is main material with nontoxic metal salts (as barium sulfate etc.) high absorption X-Ray material [A], so-called " diluent " is mainly made of Ultrafine powder bio-sourced low-absorption X-Ray material [B] refers to bio-sourced, non-digestible and absorbable cellulose, hemicellulose, pectin, chitin, or other biomass-based normal temperature water Insoluble or poorly soluble fine-quality crude products or analogs (such as grains and other epidermis), non-digestible ultra-fine powders, etc., or their composites and compound compositions; the fineness of which is ≤ 100 microns in the largest dimension, that is, the largest dimension The size is roughly below the resolution of the human eye. This kind of "diluent" and the main material of traditional radiography, with non-toxic metal salts (such as barium sulfate, etc., the specifications can be regulated according to the general traditional medical requirements; when necessary, the particle size is used, and some people propose that the particle size is 0.5 ~ 1.0 Micron is better. "Complete Book of Diagnosis and Treatment for Clinicians", Wang Yucai, etc., China Science and Technology Press, Beijing, 1992.P.1002) When the high-absorbing X-Ray material [A] is compounded, the moisture [E] and adhesion Under the joint action of auxiliary agents such as [C], blending, and seasoning, the non-toxic metal salts with small particle size (such as barium sulfate, etc.) and high-absorption X-Ray materials [A] are evenly and fully "wrapped" in the particle size, The surroundings of low-absorption X-Ray materials [B] derived from biomass with similar fineness and larger particle size can not only provide good imaging, but also fully "dilute" and "disperse" the contrast agent without Affects the contrast effect and the imaging performance of the fine structure of the inner surface of the digestive tract, because the inner surface structure of the general digestive tract is smaller than ordinary cells (7-70 microns), and the resolution of the human eye is 70-100 microns, so it will not affect the subtleties Imaging and contrast, and due to adhesion, the contrast effect will be enhanced.

Biomass-derived low-absorption X-Ray material [B] of the present invention refers to biomass-derived medical and food-grade non-digestible cellulose, hemicellulose, pectin, chitin, Or other biomass insoluble or difficult to dissolve in water at room temperature, high-quality products, crude products, ultrafine powders with a fineness of ≤100 microns in the largest dimension or their composites and complexes.

Some preparation methods of low-absorption X-Ray materials [B] derived from biomass that cannot be completely digested and absorbed:

(1), powder

1. Whole bran: There are two kinds of cleaning or not, and the grinding is up to the standard.

2. Decompose phytic acid whole bran, ferment with yeast, decompose phytic acid, wash or not, grind finely.

3. Refined bran, heat preservation and enzymatic hydrolysis, remove part or all of protein, starch and phytic acid, grind finely

4. Bean curd

5. Sweet potato powder: sweet potato is peeled, steamed, sliced, dried, crushed, and sieved to obtain a powder of less than 80 mesh.

(2) For sauce and slurry, the water content should be appropriate.

1. Sweet potatoes are peeled, steamed, beaten, colloid milled, and sieved with a maximum particle diameter of less than 100 microns.

2. Hawthorn is peeled, pitted, steamed, beaten, colloid milled, and sieved with a maximum particle diameter of less than 100 microns.

The low-absorption X-Ray material [B] that cannot be fully digested and absorbed by the biomass source described in the present invention is insoluble in normal temperature water or insoluble matter is cellulose, hemicellulose, pectin, or almost pure cellulose. Butin, etc. But for cost reduction consideration, its rough product or similar (such as epidermis such as grain) also can adopt. Generally, it can be finely processed powder derived from grain skins such as grains, such as bran, pea, and soybean skins, or it can be completely or partially replaced by some finely processed fruit skins or dry powders such as fruits, roots, tubers, etc. . All processing, the key is that its particle size must meet the requirement of the present invention. In many cases, in order to fully achieve and pursue the relative content of normal temperature water-insoluble or insoluble and non-digestible substances of the low-absorption X-Ray material [B] of biomass origin described in the present invention, some processes are required to remove general grains Soluble and digestible substances in grain skins, such as bran, pea and soybean skins. For example, ordinary ones still contain a large amount of protein, starch, etc. that can be digested and absorbed by the human body, and the fiber content is generally only about 25-35%. Remove protein, starch and other substances on millet bran; and general enzymatic treatment to remove protein, starch and other substances to increase dietary fiber substances. This technology is a conventional technology, and you can also refer to US patents US4765994A and US4774096A A similar preparation method to the dietary fiber mentioned in .

The bonding, blending and flavoring auxiliary agent [C] of the present invention refers to medical and food grade flavoring agents, sweeteners, sour agents, preservatives, and medical and food grade seaweed gum, xanthan gum, arabic Glue, peach glue and other natural resin glue, soluble carboxymethyl cellulose, tragacanth gum, bletilla striata gum natural biomass-derived polymer material mucilage, or other non-biological sources of medical and food-grade polymer material dispersion Binder auxiliary component.

The defoamer [D] such as silicone oil in the present invention refers to the composition of medical and food grade silicone oil and other medical and food grade surfactants.

The water [E] used in the present invention refers to medical sterile water or drinking water of medical and food grades that meet the hygienic index.

The gastrointestinal contrast agent containing biomass provided by the present invention can also be used in conjunction with traditional barium meal and barium glue. That is, first use an appropriate amount of traditional barium sulfate high-concentration, low-consistency, and good-spreading barium mucilage, after observing the upper gastrointestinal tract (mainly the mucous membrane, etc.), and then use the characteristics of traditional barium, However, the biomass-containing gastrointestinal contrast agent provided by the present invention contains more solids (ultrafine powder of biomass substances, etc.) and has a lower concentration and a larger volume. Generally speaking, the gastrointestinal contrast agent containing biomass provided by the present invention can achieve all the effects of the traditional barium agent and meet all requirements by adjusting the formula components.

Other gas-generating agents, metoclopramide, morphine, senna, phenolphthalein, etc. can be added according to the general routine and specific conditions. And pay attention to adjusting (with saline and other substances) osmotic pressure.

The product state of the present invention has one of three basic forms, and the three basic forms are: ① a powder product mixed with water for use; ② a sauce paste product for direct use or eating or diluted with water; ③It is a pasty product that can be eaten directly when it is ready for use.

The final products of all formula substances should be sterilized, sterilized and harmless. The sterilization method uses heating, radiation such as cobalt 60, etc., which can be flexibly selected according to the production situation.

(4) Specific implementation methods:

The following several embodiments all meet the basic formula, and the formula optimization within its scope.

Embodiment 1. Powder product: when in use, the medical staff will mix it with water according to the situation and requirements.

20-70% barium sulfate, 20-70% fine powder of bran (or rice bran, treated or not after removing protein and starch), 0.5-1.5% gum arabic powder, 8-9% sugar powder, sour agent and Just the right amount of fragrance.

Within the above range, the powdery product embodiment is: 60% of barium sulfate, 30% of bran powder, 1% of gum arabic powder, 8.2% of powdered sugar, 0.8% citric acid, and an appropriate amount of essence. When in use, adjust the concentration by 50-80% (w/w or w/v) according to personal taste and other water, and take 100-250 g of it orally once. In the case of barium enema, condiments such as sugar powder and citric acid can be canceled or reduced, and the former two can be added at discretion. According to the situation at that time, the dosage is 150-300g according to the doctor's advice.

Embodiment 2. Powdered product: when in use, the medical staff will mix it with water according to the situation and requirements.

Barium sulfate 20-70%, bran (or rice bran, etc., treated to remove protein and starch or not) fine powder 20-70%, gum arabic powder 0.5-1%, hawthorn fruit powder 5-9%, sweetener , sour agent and flavor amount.

Within the above range, the embodiment of this powder product is: 60% of barium sulfate, 30% of fine bran powder, 1% of gum arabic powder, 9% of hawthorn fruit powder, appropriate amount of cyclamate and essence. When in use, adjust the concentration of water to 50-80% (w/w or w/v) according to personal taste, and take 100-250g of it once orally as directed by the doctor. In the case of barium enema, add the first two at discretion (the rest can be canceled), and the dosage is 150-300g according to the situation.

Embodiment 3. Powdered product: when in use, the medical staff will mix it with water according to the situation and requirements.

20-70% of barium sulfate, 20-70% of sweet potato powder, appropriate amount of sweetener, sour agent and essence.

Within the above range, the embodiment of this powder product is: barium sulfate 64%, sweet potato powder 36%, appropriate amount of cyclamate and essence. When in use, adjust the concentration of water to 50-80% (w/w or w/v) according to personal taste, and take 100-250g of it once orally as directed by the doctor. If it is barium enema, add the first two at discretion (the rest can be canceled), and the dosage is 150-300g.

Embodiment 4. Sauce paste product: directly use (or eat), or suitably add water to dilute and use.

Barium sulfate 20-60%, bran (or rice bran, etc., after removing protein and starch or not) fine powder 20-50%, Arabic gum powder 0.5-1.5%, fruit pulp 10-15%, water 10- 15%, powdered sugar 8-9%, sour agent, preservative and essence in right amount.

Within the above range, the paste-like product embodiment is: barium sulfate 50%, fine bran powder 25%, gum arabic powder 1%, fruit pulp 10%, water 5%, powdered sugar 8%, 0.8% citric acid, Potassium sorbate 0.1%, appropriate amount of essence (w/w or w/v). When in use, add appropriate amount of water until it is suitable for oral administration. According to the doctor's advice, the general oral dose is 120-300g at a time.

Embodiment 5. Sauce paste product: directly use (or eat), or use after being diluted with water appropriately.

Barium sulfate 20-60%, sweet potato powder 20-50%, Arabic gum powder 0.5-1.5%, fruit pulp 10-15%, water 10-15%, sugar powder 8-9%, sour agent, preservative and essence Appropriate amount.

Within the above range, the embodiment of this kind of paste product is: barium sulfate 50%, sweet potato fine powder 25%, gum arabic powder 1%, fruit pulp 10%, water 5%, sugar powder 8%, 0.8% citric acid , potassium sorbate 0.1%, appropriate amount of flavor (w/w or w/v). When in use, add appropriate amount of water until it is suitable for oral administration. According to the doctor's advice, the general oral dose is 120-300g at a time.

Embodiment 6. Paste-like product: its water content is the highest, and it can be eaten directly when it is basically available for use. Since sedimentation may occur when placed, it can be shaken as much as possible when used.

Barium sulfate 20-60%, bran (or rice bran, etc., treated to remove protein and starch or not) fine powder 20-30%, gum arabic powder 0.5-1.5%, fruit pulp 10-15%, water 20- 35%, powdered sugar 8-9%, sour agent, preservative and essence in right amount.

Within the above range, the embodiment of the paste product is: barium sulfate 40%, bran fine powder 20%, gum arabic powder 1%, fruit pulp 10%, sugar powder 8%, 0.8% citric acid, potassium sorbate 0.05 %, 20% water, appropriate amount of essence (w/w or w/v). According to the doctor's advice, generally take 120-500g orally once.

Embodiment 7. paste product:

Barium sulfate 20-60%, sweet potato powder 20-30%, Arabic gum powder 0.5-1.5%, fruit pulp 10-15%, water 20-35%, sugar powder 8-9%, sour agent, preservative and essence Appropriate amount.

Within the above range, the embodiment of paste product is: 40% barium sulfate, 20% sweet potato powder, 1% gum arabic powder, 10% pulp, 8% sugar powder, 0.8% citric acid, 0.05% potassium sorbate , 20% water, appropriate amount of essence (w/w or w/v). According to the doctor's advice, generally take 120-500g orally once.

Claims (6)

1, a kind of gastrointestinal contrast agent that contains biomass, it is characterized in that low absorption X-Ray material [B] and/or bonding, mediation, seasoning adjuvant [C], defoamer silicone oil [D] and water [E] that the high biomass that absorb X-Ray material [A] and the fineness superfines in maximum dimension≤100 micron of the metallic salt of 0.5～1.0 micron of, fineness that gastrointestinal contrast agent uses by being applicable to are originated forms, wherein the percentage by weight of each component is as follows:

[A]：0.5～99.5％

[B]：0.5～99.5％

[C]：0～5％

[D]：0～1％

[E]：0～99％。

2, the gastrointestinal contrast agent that contains biomass according to claim 1 is characterized in that the high X-Ray material [A] that absorbs of described metallic salt is meant barium sulfate, citric acid osmium potassium, and compound, compound.

3, the gastrointestinal contrast agent that contains biomass according to claim 1, the low absorption X-Ray material [B] that it is characterized in that described biomass source is meant medical, the cellulose that can not be digested and assimilated of food grade, hemicellulose, pectic substance, the chitin class in biomass source, or other biomass class normal-temperature water is insoluble or indissoluble material elaboration crude product.

4, the gastrointestinal contrast agent that contains biomass according to claim 1, it is characterized in that bonding, mediation, seasoning adjuvant [C] are meant medical, the flavouring agent of food grade, sweeting agent, acidic flavoring agent, antiseptic, and the rubber cement in the alginate jelly of medical, food grade, xanthan gum, arabic gum, Resina persicae slurry, solubility carboxymethyl cellulose, tragacanth, Pseudobulbus Bletillae (Rhizoma Bletillae) glue natural biomass source, or the macromolecular material medical, food grade in other abiotic sources disperses the binding agent auxiliary element.

5, the gastrointestinal contrast agent that contains biomass according to claim 1 is characterized in that water [E] is meant the medical aseptic water or the drinking water that meet sanitary index medical, food grade.

6, according to claim 1 or 2 or 3 or the 4 or 5 described gastrointestinal contrast agents that contain biomass, it is characterized in that Product Status has one of three kinds of primitive forms, described three kinds of primitive forms are respectively: the powdery product that use after 1. water is in harmonious proportion, 2. directly use the beans paste product of edible or suitable thin up use, the paste shape product that directly eat when 3. available.