CN100446740C - A kind of tampon, tampon type suppository and preparation process thereof - Google Patents

Abstract

The invention discloses a cotton sliver, a tampon-type suppository and a preparation process thereof. The surface or the surface and the inside of the sliver are saturated with a matrix. The preparation method comprises: rolling absorbent cotton, non-woven fabric or other plant fiber sheets A cylinder of a certain shape is put into the molten hot matrix and soaked until at least the surface of the tampon is saturated with the matrix; the suppository includes the matrix and the drug mixed and then poured into a tether of a certain shape made of PVC and PE A plug body composed of medium, inserted into the surface or the surface and the inside of the tampon saturated with matrix. The tampon and the suppository made of the tampon of the present invention have a matrix adsorbed on the surface or surface of the tampon and its interior and are saturated by the matrix, at least forming a protective layer on the surface of the tampon, improving the utilization rate of the drug, and making all medications The quantity is controlled, and at the same time, it can prevent the phenomenon of being out of shape during the throttling.

Description

A kind of tampon, tampon type suppository and preparation process thereof

technical field

The invention relates to a tampon, a tampon-type suppository and a preparation process thereof, belonging to the field of medicine and hygiene.

Background technique

As an independent dosage form, suppository has a long history. It is a solid preparation made by mixing the main drug with a certain matrix for insertion into different cavities of the human body. The melting point of the suppository is close to the body temperature, and it can melt and soften quickly after being inserted into the cavity, and it can be mixed with the exudate to take effect. The advantages of suppositories avoid the stimulation of oral drugs to the stomach and possible adverse reactions in the gastrointestinal tract, and avoid the damage of drugs by gastric acid and digestive juice; they can prevent or reduce the toxic and side effects of drugs on the liver; they are absorbed faster than oral administration, and the action time is longer It is also long; it is easily accepted by children and patients who have difficulties in taking oral medicine; it is used in gynecology and anorectal diseases, and has a direct effect and remarkable curative effect.

Suppositories are administered locally and distributed on the surface of the mucosa, which can treat local diseases or absorb drugs into the blood through the rectal mucosa to treat systemic diseases.

The preparation method of the suppository is as follows: the base is heated and melted in a water bath, and then the medicine is added into the base in different ways, mixed evenly into a mold, cooled and demolded to obtain the suppository.

Commonly used suppositories are carrier-free, because the dissolving suppositories cannot be fully absorbed in the body in time, and the clothes will be polluted due to the outflow of medicine and matrix during use, which will cause inconvenience to users. Moreover, this outflow will also lead to the inability of the drug to maintain an effective concentration for a long time in the body. Therefore, many technical personnel have improved the structure of the suppository to integrate the cotton suppository and the suppository, which can avoid the outflow of the medicinal liquid, do not pollute the clothes, and can promote the absorption of the medicine, have a long acting time, and are easy to use and carry.

For example, the application number is 89210570.4, a hollow cylindrical cotton base for women's health care products, made of medical absorbent cotton, with a fibrous inner core as a shaft, and a cylindrical cotton layer of a certain shape rolled by absorbent cotton sheets; cotton base column The body is coated with a thin layer of dextrin as an isolation layer; the isolation layer is coated with a four-layer structure of a glycerin gelatin layer containing a mixture of glycerin and gelatin with a certain amount of water. Various vaginal suppositories can be produced using the cotton base as a base. The suppository can fully maintain the concentration of the drug in the body to achieve curative effect, and can prevent the drug and liquid from flowing out, so it is very convenient to use. But this process is more loaded down with trivial details, can increase the processing cost of product, is not convenient for large-scale industrialized production.

Patent No. 96216798.3 is a medicinal compound vaginal suppository, which belongs to medical drug suppositories. It is composed of a drug plug body in the shape of a streamlined aerial bomb, a tampon plug is half-embedded and fixed inside, and a plug lead wire is arranged at the tail of the tampon plug. The medicine embolus also can be molded into bullet shape, duckbill shape. Its processing technology is simple, and it has a lubricating effect, which can prevent the drug liquid from flowing out, does not pollute clothes, can promote drug absorption, has a long action time, and is easy to use and carry. Although the technology of this patent is simple and easy, the suppository material is relatively soft, and it is easy to cause the plug body to be difficult to form during the embolization process, so it cannot be used.

Contents of the invention

The purpose of the present invention is to provide a cotton sliver, the surface of the tampon forms a protective layer to maintain the effective concentration and dosage of the drug, and prevent the phenomenon of being deformed during thrombus tying.

Another object of the present invention is to provide a process for preparing a surface-treated sliver, which is simple and easy to implement and easy for industrial production.

Another object of the present invention is to provide a suppository, which is composed of a tampon and a suppository body, is not easily deformed, does not contaminate clothes when used by patients, and can maintain an effective concentration of drugs in the body for a long time, which is convenient for patients to use.

Another object of the present invention is to provide a suppository preparation process, which is simple and easy for industrial production.

In order to achieve the object of the present invention, the present invention provides a tampon, the surface or the surface and the interior of the tampon are saturated with a matrix.

The tampon is columnar made of medical absorbent cotton, non-woven fabric or other plant fibers or other shapes suitable for preparing suppositories.

The base is a base commonly used in the preparation of suppositories, and can be one of water-soluble, hydrophilic or fat-soluble bases. Including but not limited to one or more of semi-synthetic fatty acid glycerides, hydrogenated vegetable oil, cocoa butter, lanolin, polyethylene glycol, poloxamer, paraffin, glycerin, gelatin, polyoxyethylene stearate A combination of the above; wherein the preferred base is one of semi-synthetic fatty acid glycerides, lanolin, paraffin, polyethylene glycol, gelatin or poloxamer.

A method for preparing a surface-treated sliver of the present invention is as follows: roll absorbent cotton, non-woven fabric or other plant fiber sheets into a cylinder of a certain shape, put it into a molten heat matrix and soak until at least the sliver The surface is saturated with the matrix.

The thermal matrix is a matrix that maintains the matrix in a molten state, and the melting temperature of the matrix depends on the matrix used, usually the melting temperature is 20-80°C, preferably 30-50°C.

Saturation of the matrix requires the formation of a protective film on the surface or sufficient wetting.

For the absorbent cotton sliver, it is generally soaked for 1-360 seconds, preferably 10-30 seconds to reach saturation.

In order to achieve another object of the present invention, the present invention provides a suppository, which includes a suppository formed by mixing a matrix and a drug, and is characterized in that it also includes a tampon whose surface or surface and its interior are saturated with the matrix.

The suppository formed by mixing the matrix and the drug may contain various components and their contents disclosed in the prior art. The medicine can be different components according to the needs of treatment, such as traditional Chinese medicine powder, western medicine powder or a combination of the two, including but not limited to metronidazole, clotrimazole, chlorhexidine acetate or other traditional Chinese medicine compositions. The base is a mixture of one or two or more of semi-synthetic fatty acid glycerides, lanolin, polyethylene glycol, poloxamer, paraffin, glycerin, gelatin, etc., wherein the mixing of bases can be carried out by those skilled in the art. The preferred mixing ratio is 1:1 to 1:10.

The suppository of the present invention also includes a tether for packaging, made of PVC and PE, and the tether is a sealed packaging sheet corresponding to the shape of the suppository itself and wrapping several suppositories therein.

Preferably, each tether of the present invention includes 3-20 individually packaged suppositories.

Usually, the matrix used in the suppository is the same as the matrix used to treat the tampon, but it can also be different. When the two matrixes are different, generally the two matrixes are of the same type, such as water-soluble, hydrophilic or fat-soluble matrix. .

The mixing ratio of matrix and drug can generally be controlled at 1:1-1:80, preferably 1:5-1:50.

The suppositories can be made into circular, oval, triangular, star, prismatic, rectangular, conical or duckbill-shaped, etc., but not limited thereto, so that the patient is comfortable and convenient to use, and the suppository is mostly used for storage. Depends on the body structure of the part.

For the convenience of taking out, a lead wire can also be arranged at the end of the suppository. The material of the lead wire is cotton thread.

The suppository can be prepared by methods disclosed in the prior art. For example, the preparation of the suppository comprises the following steps:

1) Print PVE and PE sheets, blow mold them into a sheet with several protruding grooves corresponding to the shape of the suppository, and then weld it into a sheet containing several hollow holes corresponding to the shape of the suppository for containing And the tethering, cooling, molding, and final trimming of the formed suppository for use;

2) Pretreating the cotton plug to obtain a cotton plug whose surface or surface and its interior are saturated by the matrix;

3) After melting the suppository base, add the medicine according to the proportion, stir evenly to form a medicine liquid, and set aside;

4) Pour the prepared medicinal solution into the tether, then insert the treated cotton plug, and cool and form it;

5) post-processing.

The post-processing includes sealing and cutting the tether.

The preparation process of the tether is as follows: preheating the plate at 50-150°C, blow molding at 70-150°C, welding at 90-180°C, cooling at 0-30°C, and finally aligning the edges for later use.

For the process of pretreating the tampon, refer to the aforementioned sliver preparation process.

Take the prepared suppository base and put it into a water bath to heat and melt at 20-100°C, preferably at 80°C; take the sieved powder at 20-100°C and put it into the melted base in equal increments to prepare Medicinal solution, or add a small amount of substrate in advance and stir to make a paste, then add a large amount of substrate to make a medicinal solution, and stir for 5 to 60 minutes for later use.

Preheat the equipment first, control the interlayer temperature of the feeding tank within 20-80°C, control the temperature of the feeding valve at 20-80°C, and control the temperature of the filling head at 20-80°C.

Put the prepared liquid medicine into the feeding tank, start the stirring paddle and stir for 5-60 minutes. Put the tether, and after the tether is delivered in place, open the liquid medicine shut-off valve to pour the medicine into the tether with a filling volume of 0.1-5g, then insert the saturated cotton plug, and cool and solidify at -15-35°C Make it into shape, then seal, trim, and cut to get the finished product.

The fineness of the medicated powder is about 100 mesh.

The tampon and the suppository made of the tampon of the present invention have a matrix adsorbed on the surface or surface of the tampon and its interior and are saturated by the matrix, at least forming a protective layer on the surface of the tampon, improving the utilization rate of the drug, and making all medications The quantity is controlled, and at the same time, it can prevent the phenomenon of being out of shape during the throttling.

Detailed ways

The present invention will be described in detail below in conjunction with the drawings and specific embodiments, but the embodiments are only used to illustrate the present invention rather than limit the present invention.

Description of drawings

Fig. 1 is the schematic diagram that the present invention is used to prepare the tether sheet of suppository and tether;

Fig. 2 is a sectional view of Fig. 1A-A;

Fig. 3 is the schematic diagram of the suppository with tether and tampon of the present invention;

Fig. 4 is a cross-sectional view of Fig. 3B-B;

Fig. 5 is a schematic diagram of the suppository with a tether and a tampon in Fig. 3 of the present invention.

The following are specific embodiments of the present invention.

Example 1

This embodiment is a surface-treated sliver, and the surface of the sliver is adsorbed with a semi-synthetic fatty acid glyceride matrix. The preparation method is as follows: after melting the semi-synthetic fatty acid at 80 DEG C, put the cotton sliver at 45 DEG C for 30 seconds, the adsorption is saturated, and the cotton sliver forms a protective layer.

Example 2

The same as in Example 1, the difference is that the matrix used is polyethylene glycol, the heating temperature is 90°C, and the tampon is placed at 50°C for 50 seconds.

Example 3

Same as Example 1, the difference is that the matrix used is paraffin, the heating temperature is 120°C, and the tampon is placed at 80°C for 10 seconds.

Example 4

Same as Example 1, the difference is that the matrix used is poloxamer, the heating temperature is 60° C., and the tampon is placed at 30° C. for 60 seconds.

Example 5

Same as Example 1, the difference is that the matrix used is gelatin, the heating temperature is 150°C, and the tampon is placed at 75°C for 5 seconds.

Example 6

Same as Example 1, the difference is that the matrix used is 1 kg of lanolin, 3 kg of paraffin, 50 kg of semi-synthetic fatty acid glycerides (there must be a specific amount), the heating temperature is 90 ° C, and the absorbent cotton plug is put into it at 50 ° C. 50 seconds.

Example 7

With embodiment 1, difference is that used substrate is 5 kilograms of lanolin, 5 kilograms of paraffins, 100 kilograms of semi-synthetic fatty acid glycerides (concrete consumption must be arranged), heating temperature is 120 ℃, puts into cotton plug 10 at 80 ℃ Second.

Example 8

With embodiment 1, difference is that used substrate is 15 kilograms of lanolin, 5 kilograms of paraffins, 300 kilograms of semi-synthetic fatty acid glycerides, heating temperature is 60 ℃, puts into cotton plug 360 seconds at 30 ℃.

Example 9

Referring to accompanying drawings 1-3, take PVC or PE sheet material and print, blow mold into the sheet material 1 corresponding to suppository shape, with several protruding suppository-shaped grooves 2 outwards. The specific process is as follows: first preheat at 50-150°C, blow molding at 100°C, and then weld two oppositely placed sheets 1 at 120°C, so that the three sides 3 of the suppository groove are welded to form a semi-closed structure, only an opening 4 is left on the outward edge for dosing, and then cooled and formed at room temperature, the obtained tether 10 (omitted in the figure) is ready for use.

Add purified water into the water bath to reach the water level mark, take any one of the prepared suppository bases of Examples 1 to 8, put it into a container and heat it to melt at 20-100°C.

At 45°C, take the sieved (100 mesh) powder at a ratio of 1:5 to 1:50 and put it into the melted matrix in equal increments to make a medicinal liquid, or add a small amount of matrix in advance and stir to make a paste. A large amount of matrix is formulated into a liquid medicine, stirred for 30 minutes, and set aside.

Before pouring, the equipment is preheated so that the temperature of the interlayer of the feeding tank is 55°C, the temperature of the feeding valve is 45°C, and the temperature of the pouring head is 40°C. Put the prepared liquid medicine into the feeding tank, start the stirring paddle and stir for about 30 minutes. Put the tether 10 (made of PVC, PE), and after the tether is delivered in place, open the liquid medicine shut-off valve so that 2.2g of medicine is poured into the tether through an opening 4, and then insert the saturated The cotton plug 7 is cooled and solidified at 0-25°C to form a packaging sheet 6 with a suppository 5; then seal, edge trim, and shear, and then package to obtain a finished product.

Example 10

Referring to accompanying drawings 1-3, take PVC or PE sheet material and print, blow mold into the sheet material 1 corresponding to suppository shape, with several protruding suppository-shaped grooves 2 outwards. The specific process is as follows: first preheat at 50-150°C, blow molding at 70-150°C, and then weld at a temperature of 90-180°C to form a semi-closed structure by welding the three sides 3 of the suppository groove. An opening 4 is left on the side of the tube for dosing, and then cooled and shaped at 0-30° C., and the finally obtained tether is ready for use.

Referring to Example 9, take the prepared suppository base and put it into a water bath to heat and melt at 20-100°C, preferably at a temperature of 80°C; at 20-100°C, take the sieved powder and put it into the melted powder in equal increments. Add a small amount of base and stir it into a paste, then add a large amount of base to make a liquid, and stir for 5 to 60 minutes for later use.

Preheat the equipment first, control the interlayer temperature of the feeding tank within 20-80°C, control the temperature of the feeding valve at 20-80°C, and control the temperature of the filling head at 20-80°C.

Put the prepared liquid medicine into the feeding tank, start the stirring paddle and stir for 5-60 minutes. Put the tether, and after the tether is delivered in place, open the liquid medicine shut-off valve to pour the medicine into the tether with a filling volume of 0.1-5g, and then insert any of the saturated cotton in Examples 2-6. The plug 7 is cooled and solidified at -15 to 35°C to form it, then sealed, trimmed, and cut into 1 to 20 pieces/piece to obtain the finished product 6.

Claims (12)

1. A tampon, characterized in that the surface or surface and the inside of the tampon are saturated with the commonly used matrix for preparing suppositories, and the matrix is one of water-soluble, hydrophilic or fat-soluble matrix; comprising One or a combination of semi-synthetic fatty acid glycerides, hydrogenated vegetable oil, cocoa butter, lanolin, polyethylene glycol, poloxamer, paraffin, glycerin, gelatin, polyoxyethylene stearate. 2. The tampon according to claim 1, characterized in that the matrix is one of semi-synthetic fatty acid glycerides, lanolin, polyethylene glycol or poloxamer. 3. A sliver according to claim 1, characterized in that, the sliver is a columnar shape made of medical absorbent cotton, non-woven fabric or other fibers. 4. The method for preparing a sliver according to any one of claims 1-3, characterized in that the column of a definite shape rolled into absorbent cotton, non-woven fabric or other fibers is put into a molten thermal matrix and soaked until at least the cotton The surface of the strip is saturated with the matrix. 5. The method according to claim 4, characterized in that the thermal matrix is a matrix that maintains the matrix in a molten state, the melting temperature of the matrix is 20-80°C, and the immersion time is 1-360 seconds. 6. The method according to claim 5, characterized in that the melting temperature of the matrix is 30-50°C, and the immersion time is 10-60 seconds. 7. A suppository, said suppository comprising a suppository composed of a matrix and a drug mixture, characterized in that a tampon as claimed in any one of claims 1-3 is also embedded inside said suppository. 8. The suppository according to claim 7, characterized in that the suppository also includes a strap for packaging, the strap is corresponding to the shape of the suppository itself, and several suppositories are respectively coated therein A packaging sheet, the matrix used in the suppository is the same as or different from the matrix used to treat the tampon; the matrix used in the suppository is semi-synthetic fatty acid glycerides, lanolin, polyethylene glycol, poloxamer , paraffin, glycerin, gelatin or a mixture of two or more. 9. The suppository according to claim 8, characterized in that the medicine is traditional Chinese medicine powder or western medicine powder, wherein the mixing ratio of the matrix used in the suppository body and the medicine is 1:1-1:80. 10. The suppository according to claim 8, characterized in that the mixing ratio of the base and the drug used in the suppository is 1:5-1:50. 11. The suppository according to claim 8, characterized in that the mixing ratio of the base and the drug used in the suppository is 1:1-1:10. 12. the preparation method of suppository described in claim 8, comprises the steps: 1) The plate is printed and blow-molded into a sheet with several protruding grooves corresponding to the shape of the suppository, and then welded into a sheet containing several hollow holes corresponding to the shape of the suppository for holding and forming the suppository Tethering, cooling, forming, and final trimming for use; 2) Pretreating the sliver to obtain a sliver whose surface or surface and its interior are saturated by the matrix; 3) After melting the suppository base, add the medicine according to the proportion, stir evenly to form a medicine liquid, and set aside; 4) Pour the prepared medicinal solution into the tether, then insert the treated sliver, cool and form, 5) post-processing.

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