CN111040256A - Raw material composition for preparing starch matrix hollow capsule and starch matrix hollow capsule - Google Patents

Raw material composition for preparing starch matrix hollow capsule and starch matrix hollow capsule Download PDF

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Publication number
CN111040256A
CN111040256A CN201910818591.6A CN201910818591A CN111040256A CN 111040256 A CN111040256 A CN 111040256A CN 201910818591 A CN201910818591 A CN 201910818591A CN 111040256 A CN111040256 A CN 111040256A
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starch
raw material
material composition
capsule
preparing
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闫丰文
袁国卿
闫芳
丁赤民
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Jiangsu Advocating Science Co ltd
Institute of Chemistry CAS
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Jiangsu Advocating Science Co ltd
Institute of Chemistry CAS
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Abstract

The invention relates to the manufacture of hollow capsules used in the fields of food, medicine and the like, in particular to a raw material composition for preparing starch matrix hollow capsules and a starch matrix hollow capsule which is prepared from the raw material composition and is easy to disintegrate quickly.

Description

Raw material composition for preparing starch matrix hollow capsule and starch matrix hollow capsule
The application is a divisional application of a Chinese invention patent application with the application number of 201410482883.4 and the invention name of raw material composition for preparing starch matrix hollow capsules and starch matrix hollow capsules, which is filed to the national intellectual property office in 2014, 9, 19.
Technical Field
The invention relates to the manufacture of hollow capsules used in the fields of food, medicine and the like, in particular to a raw material composition for preparing starch-based hollow capsules and starch-based hollow capsules which are prepared from the raw material composition and are easy to disintegrate quickly.
Background
The use of gelatin from animal sources for making hollow capsules has been known for at least nearly 200 years. Gelatin capsules are rapidly being used in the manufacture of various solid dosage forms because gelatin can mask the unpleasant taste, odor, or irritation to the stomach of many drugs. Over the past 100 years, various capsules made of gelatin have been marketed for a long time in the international pharmaceutical market. At the end of the last century, the outbreak of mad cow disease eventually dragged the gelatin capsules into an unprecedented crisis. In addition, gelatin capsules present a number of disadvantages in their own right, such as: microorganisms are easy to breed and absorb moisture, the flexibility is poor and the environment humidity is low, the microorganisms are easy to break, the adhesion is easy to occur when the environment humidity is high, and therefore medicines which are easy to absorb moisture or sensitive to water cannot be filled; the molecular chain of the gelatin contains a large number of active groups, and the gelatin is easy to react with the filled medicine.
Compared with gelatin hollow capsules, the hollow capsules prepared by adopting plant-based raw materials can obviously improve the defects. At present, the application of various plant capsules is reported. The capsule division of the company pfugel (Capsugel), U.S. has led to the development of Vcaps, the first non-gelatin capsule to be marketed globally and currently the most influential. The main raw material of the medicine is hydroxypropyl methylcellulose (HPMC) from plants, so that the medicine is suitable for being taken by European and American people, more suitable for being taken by vast crowds such as Muslim, Indian education, Uygur education, Buddhist apprentices and the like, the yield and sales of Vcaps after being on the market rapidly rise, and the annual sales volume is about hundreds of billions. At present, Vcaps are also produced and sold in China, and related patents are applied in China (CN 200780040028.6). Subsequently, the French Capsule company of Capsule introduced a second plant capsule product of NPcaps and rapidly occupied a place in the international capsule market. The product is prepared by using pullulan, a polysaccharide substance from plants, as a raw material. The plant polysaccharide has good water solubility, is colorless and odorless, and can be completely biodegraded in human digestive tract. The capsule prepared by the method has various advantages similar to those of a gelatin capsule, such as low oxygen penetrability, suitability for machine filling, no chemical reaction with the medicine in the capsule shell, suitability for any people to take and the like. Since the time of sale, NPcaps are rapidly popular with preparation factories all over the world, annual sales volume is rapidly increased, and annual yield reaches about billions of grains. Although NPcaps have a plurality of advantages, the raw material of the NPcaps is high in price and difficult to popularize in China.
In recent years, there have been many patent applications for plant-based hollow capsules (for example, CN02827414.8, CN200610093987.1, CN200910186831.1, CN200810016500.9, etc.), but in recent years, hollow capsules made of hydroxypropyl methylcellulose as a main raw material have not been produced in the market by companies, and hollow capsules made of other materials have not been produced. Although the price of the hydroxypropyl methyl cellulose is not very expensive, the glue solution and the water material are large in the production process of preparing the hollow capsule by taking the hydroxypropyl methyl cellulose as the main raw material, the water removal is difficult, the glue solution is long in pasting silk, the forming difficulty is high, and the disintegration time limit of the hollow capsule prepared by taking the hydroxypropyl methyl cellulose as the main raw material is long, so that the market share in China is not high at present. The price of the starch is very low, the hollow capsule prepared by the starch has great attraction, and various domestic manufacturers apply patent of the starch hollow capsule, but because the starch molecules are easy to form strong hydrogen bonds, the starch film is easy to be fragile and fragile, and the hollow capsule with high strength and filling resistance is difficult to prepare. In recent years, some of the U.S. and japanese patents have made hollow capsule shells with higher strength by adding high strength gelatin to a starch matrix, but have also made it difficult to disintegrate the hollow capsule shells, making it difficult to obtain a product that disintegrates rapidly in vivo. Thus, despite numerous patents, there are no products available to the market to date.
Disclosure of Invention
It is an object of the present invention to introduce hydroxypropyl- β -cyclodextrin, which is very soluble in water, into a composition for preparing empty capsules to improve the hydrophilicity of the composition, thereby providing a raw material composition for preparing starch-based empty capsules, which is capable of preparing starch-based empty capsules having good flexibility and excellent disintegration properties.
It is a further object of the present invention to provide a starch-based hollow capsule which can be rapidly disintegrated from a raw material composition for preparing the starch-based hollow capsule.
The raw material composition for preparing the starch matrix hollow capsule comprises 80-94.5 wt% of hydroxypropyl starch, 1-10 wt% of hydroxypropyl- β -cyclodextrin and 0.5-19 wt% of a gelling agent.
The substitution degree DS of the hydroxypropyl starch is 0.015-0.21, preferably 0.05-0.2.
The substitution degree DS of the hydroxypropyl- β -cyclodextrin is 3.64-5.33.
The hydroxypropyl starch can be prepared from common starch, and is prepared from the common starch and propylene oxide by a conventional reaction mode in the starch industry.
The common starch can be one or more selected from tapioca starch, wheat starch, potato starch, sweet potato starch, corn starch, bean starch, and rice starch; preferably tapioca starch, bean starch, potato starch, and corn starch.
The gelling agent is one or more selected from pectin, xanthan gum, locust bean gum, carrageenan, gellan gum, agar gum, arabic gum, mannan, guar gum and konjac gum.
The preparation method of the raw material composition for preparing the starch matrix hollow capsule comprises the step of mixing 80-94.5 wt% of hydroxypropyl starch, 1-10 wt% of hydroxypropyl- β -cyclodextrin and 0.5-19 wt% of gelling agent by total weight to obtain the raw material composition for preparing the starch matrix hollow capsule.
After the raw material composition for preparing the starch matrix hollow capsule is mixed with water and heated, gelatinized by gelatinization, the starch matrix hollow capsule with good flexibility and good disintegration property, which is used in the fields of food and medicine, can be prepared by adopting the conventional capsule preparation process.
The raw material composition is mixed with water, and the weight ratio of the raw material composition to the water is 1: 3-1: 6.
When the raw material composition is mixed with water, a coagulant aid (generally 0.5-5 wt% of the content of the gelling agent) can be further added. The coagulant aid can be one or more selected from potassium chloride, potassium carbonate, potassium citrate, potassium acetate, calcium chloride and calcium acetate.
The heating temperature is 80-99 ℃; the heating time is 15-90 minutes.
The invention provides a method for improving the hydrophilicity of materials by introducing hydroxypropyl- β -cyclodextrin into a raw material composition through intensive research on hollow capsules prepared by taking modified starch as a main raw material so as to promote the disintegration of the capsules, wherein the hydroxypropyl- β -cyclodextrin has excellent compatibility with hydroxypropyl starch and smaller molecules, can be uniformly dispersed in a system, does not cause the strength reduction of the prepared hollow capsules, can overcome the hydrogen bond force among starch molecules, plays a role in toughening and enhancing to a certain extent, inhibits the retrogradation of the starch, increases the hydrophilicity of the materials, reduces the viscosity, ensures that the preparation process of the hollow capsules is easy to form, and the prepared starch matrix hollow capsules have excellent disintegration performance.
Detailed Description
Example 1
A raw material composition for preparing a starch-based hollow capsule was prepared by mixing 94.5 wt% of hydroxypropyl corn starch (degree of substitution DS of 0.05, hydroxypropyl corn starch being prepared by reacting corn starch with propylene oxide in a manner conventional in the starch industry), 5 wt% of hydroxypropyl- β -cyclodextrin (degree of substitution DS of 3.64), and 0.5 wt% of konjac gum.
The raw material composition for preparing the starch matrix hollow capsule is mixed with water 6 times the weight of the raw material composition, the mixture is heated at the temperature of 80 ℃ for 90 minutes to be gelatinized and gelatinized, and the starch matrix hollow capsule with good flexibility and good disintegration property is prepared by adopting the conventional capsule preparation process.
According to the prepared starch matrix empty capsule, a ZB-lE intelligent disintegration tester is adopted to carry out disintegration experiments according to the method specified in the 2010 version of the Chinese pharmacopoeia, 50 samples can be completely disintegrated within 7 minutes by testing, and the disintegration time limit reaches the requirements of the pharmacopoeia.
Example 2
Mixing 94.5 wt% of hydroxypropyl tapioca starch (the degree of substitution DS is 0.2, the hydroxypropyl tapioca starch is prepared by reacting tapioca starch and propylene oxide in a conventional reaction mode in the starch industry), 1 wt% of hydroxypropyl- β -cyclodextrin (the degree of substitution DS is 4) and 4.5 wt% of carrageenan to prepare the raw material composition for preparing the starch matrix hollow capsule.
The raw material composition for preparing the starch matrix hollow capsule is mixed with water which is 3 times of the weight of the raw material composition, the mixture is heated for 15 minutes at the temperature of 99 ℃ to be gelatinized and gelatinized, and the starch matrix hollow capsule with good flexibility and good disintegration property is prepared by adopting the conventional capsule preparation process.
According to the prepared starch matrix empty capsule, a ZB-lE intelligent disintegration tester is adopted to carry out disintegration experiments according to the method specified in the 2010 version of the Chinese pharmacopoeia, 50 samples can be completely disintegrated within 7 minutes by testing, and the disintegration time limit reaches the requirements of the pharmacopoeia.
Example 3
A starting composition for the preparation of starch-based hollow capsules was prepared by mixing 80 wt% of hydroxypropyl potato starch (degree of substitution DS of 0.21, which is prepared from potato starch and propylene oxide by the reaction method customary in the starch industry), 1 wt% of hydroxypropyl- β -cyclodextrin (degree of substitution DS of 5.33) and 19 wt% of guar gum.
The raw material composition for preparing the starch matrix hollow capsule is mixed with water 6 times the weight of the raw material composition, heated at 85 ℃ for 40 minutes to be gelatinized and gelatinized, and the starch matrix hollow capsule with good flexibility and good disintegration property is prepared by adopting the conventional capsule preparation process.
According to the prepared starch matrix empty capsule, a ZB-lE intelligent disintegration tester is adopted to carry out disintegration experiments according to the method specified in the 2010 version of the Chinese pharmacopoeia, 50 samples can be completely disintegrated within 7 minutes by testing, and the disintegration time limit reaches the requirements of the pharmacopoeia.
Example 4
Mixing 90.5 wt% of hydroxypropyl tapioca starch (the degree of substitution DS is 0.13, the hydroxypropyl tapioca starch is prepared by reacting tapioca starch with propylene oxide in a conventional reaction mode in the starch industry), 7 wt% of hydroxypropyl- β -cyclodextrin (the degree of substitution DS is 4.7) and 2.5 wt% of carrageenan to prepare the raw material composition for preparing the starch matrix hollow capsule.
The raw material composition for preparing the starch matrix hollow capsule is mixed with water which is 5 times of the weight of the raw material composition, the mixture is heated at the temperature of 90 ℃ for 30 minutes to be gelatinized and gelatinized, and the starch matrix hollow capsule with good flexibility and good disintegration property is prepared by adopting the conventional capsule preparation process.
According to the prepared starch matrix empty capsule, a ZB-lE intelligent disintegration tester is adopted to carry out disintegration experiments according to the method specified in the 2010 version of the Chinese pharmacopoeia, 50 samples can be completely disintegrated within 7 minutes by testing, and the disintegration time limit reaches the requirements of the pharmacopoeia.
Example 5
93 wt% of hydroxypropyl tapioca starch (the degree of substitution DS is 0.2, the hydroxypropyl tapioca starch is prepared by reacting tapioca starch and propylene oxide in a conventional reaction mode in the starch industry), 2.5 wt% of hydroxypropyl- β -cyclodextrin (the degree of substitution DS is 4) and 4.5 wt% of carrageenan are mixed, then 0.5 wt% of potassium chloride of the content of the carrageenan is added and mixed uniformly, and the raw material composition for preparing the starch matrix hollow capsule is prepared.
The raw material composition for preparing the starch matrix hollow capsule is mixed with water 4 times the weight of the raw material composition, the mixture is heated at the temperature of 92 ℃ for 40 minutes to be gelatinized and gelatinized, and the starch matrix hollow capsule with good flexibility and good disintegration property is prepared by adopting the conventional capsule preparation process.
According to the prepared starch matrix empty capsule, a ZB-lE intelligent disintegration tester is adopted to carry out disintegration experiments according to the method specified in the 2010 version of the Chinese pharmacopoeia, 50 samples can be completely disintegrated within 7 minutes by testing, and the disintegration time limit reaches the requirements of the pharmacopoeia.
Example 6
Mixing 95 wt% of hydroxypropyl tapioca starch (the degree of substitution DS is 0.2, the hydroxypropyl tapioca starch is prepared by reacting tapioca starch and propylene oxide in a conventional reaction mode in the starch industry), 2.5 wt% of hydroxypropyl- β -cyclodextrin (the degree of substitution DS is 4.2) and 2.5 wt% of carrageenan, then adding calcium chloride with the content of the carrageenan of 5 wt% and uniformly mixing to prepare the raw material composition for preparing the starch matrix hollow capsule.
The raw material composition for preparing the starch matrix hollow capsule is mixed with water 4 times the weight of the raw material composition, the mixture is heated at 91 ℃ for 50 minutes to be gelatinized and gelatinized, and the starch matrix hollow capsule with good flexibility and good disintegration property is prepared by adopting the conventional capsule preparation process.
According to the prepared starch matrix empty capsule, a ZB-lE intelligent disintegration tester is adopted to carry out disintegration experiments according to the method specified in the 2010 version of the Chinese pharmacopoeia, 50 samples can be completely disintegrated within 7 minutes by testing, and the disintegration time limit reaches the requirements of the pharmacopoeia.

Claims (8)

1. A raw material composition for preparing a starch matrix hollow capsule is characterized by comprising 80-94.5 wt% of hydroxypropyl starch, 1-10 wt% of hydroxypropyl- β -cyclodextrin and 0.5-19 wt% of a gelling agent;
the substitution degree DS of the hydroxypropyl starch is 0.05-0.21;
the substitution degree DS of the hydroxypropyl- β -cyclodextrin is 3.64-5.33.
2. The raw material composition for preparing the starch-based empty capsule as claimed in claim 1, which is characterized in that: the hydroxypropyl starch is prepared from common starch and propylene oxide.
3. The raw material composition for preparing the starch-based empty capsule as claimed in claim 2, which is characterized in that: the common starch is selected from one or more of tapioca starch, wheat starch, potato starch, sweet potato starch, corn starch, bean starch, and rice starch.
4. The raw material composition for preparing the starch-based empty capsule as claimed in claim 1, which is characterized in that: the gelling agent is one or more selected from pectin, xanthan gum, locust bean gum, carrageenan, gellan gum, agar gum, arabic gum, mannan, guar gum and konjac gum.
5. A starch substrate hollow capsule is characterized in that: the powder-based hollow capsule is prepared by mixing the raw material composition for preparing the starch-based hollow capsule as claimed in any one of claims 1 to 4 with water, heating, gelatinizing and gelatinizing.
6. The starch-based empty capsule according to claim 5, wherein: the raw material composition is mixed with water, and the weight ratio of the raw material composition to the water is 1: 3-1: 6.
7. The starch-based empty capsule according to claim 5, wherein: the raw material composition is further added with a coagulant aid when being mixed with water;
the coagulant aid is selected from one or more of potassium chloride, potassium carbonate, potassium citrate, potassium acetate, calcium chloride and calcium acetate.
8. The starch-based empty capsule according to claim 5 or 7, wherein: the heating temperature is 80-99 ℃; the heating time is 15-90 minutes.
CN201910818591.6A 2014-09-19 2014-09-19 Raw material composition for preparing starch matrix hollow capsule and starch matrix hollow capsule Pending CN111040256A (en)

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Application publication date: 20200421