CN115845001A - Solid preparation composition for treating hemorrhoid inflammation and preparation method and application thereof - Google Patents
Solid preparation composition for treating hemorrhoid inflammation and preparation method and application thereof Download PDFInfo
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- Medicines Containing Plant Substances (AREA)
Abstract
The invention relates to the technical field of medicinal preparations, in particular to a hemorrhoid diminishing solid preparation composition and a preparation method and application thereof. The solid preparation is prepared by extracting fructus Cannabis, folium Callicarpae Formosanae, flos Sophorae Immaturus, flos Lonicerae, radix Sangusorbae, radix Paeoniae alba, notoginseng radix, lalang grass rhizome, herba Artemisiae Scopariae and fructus Aurantii to obtain fluid extract, mixing with maltodextrin, drying, and pulverizing. The solid preparation is dried in a specific drying mode by using maltodextrin with a specific DE value as a preparation auxiliary material, so that the solid preparation can obtain better preparation stability compared with the prior art.
Description
Technical Field
The invention relates to the technical field of medicinal preparations, in particular to a hemorrhoid diminishing solid preparation composition and a preparation method and application thereof.
Background
The hemorrhoid inflammation diminishing granule is prepared from ten medicines of fructus cannabis, folium callicarpae pedunculatae, flos sophorae, honeysuckle, garden burnet, white paeony root, pseudo-ginseng, couchgrass root, oriental wormwood and fructus aurantii, is collected in volume twelfth of the drug standard Chinese medicinal prescription preparation of Ministry of health of the people's republic of China, and has the effects of clearing heat and removing toxicity, relaxing bowel, stopping bleeding, relieving pain, diminishing swelling and the like. Can be used for treating hemorrhoid inflammation swelling and pain, anal fissure pain, constipation after hemorrhoid operation, hematochezia, and senile constipation.
According to the record of the twelfth book of Chinese herbal medicine prescription preparations, the prescription of the hemorrhoid inflammation eliminating granules comprises 150g of fructus cannabis, 150g of folium callicarpae pedunculatae, 75g of flos sophorae, 75g of lonicerae flos, 75g of sanguisorba officinalis, 60g of radix paeoniae alba, 5g of pseudo-ginseng, 150g of lalang grass rhizome, 75g of oriental wormwood and 50g of fructus aurantii. The preparation method described at the same time is as follows: the ten raw materials except the pseudo-ginseng, the rest of fructus cannabis and other nine raw materials are crushed, water is added for decoction twice, each time lasts for 2 hours, the decoction is filtered while the decoction is hot, the filtrate is concentrated to about 1 percent, three times of ethanol is added, the mixture is stirred evenly and is kept stand overnight, supernatant fluid is filtered, the filtrate is combined, the ethanol is recovered, and the mixture is continuously concentrated to paste. Pulverizing Notoginseng radix into coarse powder, extracting with 70% ethanol under heating for three times, each for 2 hr, heat filtering the extractive solution, recovering ethanol from the filtrate, concentrating to paste, mixing with the above soft extract, adding appropriate amount of sucrose powder into the extract, mixing, supporting, drying at 70 deg.C, and making into 1000 g. In addition, the Chinese pharmacopoeia records the preparation process of Zhiyanxiao granule, and the auxiliary materials for pelletizing may be mannitol, aspartame and steviosin to prepare the saccharose-free Zhiyanxiao granule.
CN1596962A describes a hemorrhoid diminishing capsule, which is prepared by mixing one or more of hydroxypropyl methylcellulose, povidone K30, silica gel, aspartame, starch, dextrin, magnesium stearate, essence, talc, microcrystalline cellulose, and sodium carboxymethyl starch, granulating to obtain sugar-free capsule preparation, and extracting the above raw materials to obtain fluid extract.
However, the hemorrhoid inflammation eliminating granules or capsules in the prior art have the problem of poor stability, and need to be stored under special conditions.
Disclosure of Invention
The invention aims to provide a hemorrhoid inflammation eliminating solid preparation with better stability.
The purpose of the invention is realized by the following technical scheme.
A solid preparation for treating hemorrhoid inflammation is prepared from fructus Cannabis, folium Callicarpae Formosanae, flos Sophorae Immaturus, flos Lonicerae, radix Sangusorbae, radix Paeoniae alba, notoginseng radix, lalang grass rhizome, herba Artemisiae Scopariae and fructus Aurantii by extracting to obtain fluid extract, mixing with maltodextrin, drying, and pulverizing.
In some preferred embodiments, the maltodextrin has a DE value of 10 to 15.
In some preferred embodiments, the amount of maltodextrin is more than 30% of the total amount of the fluid extract.
In some preferred embodiments, the ratio of the amount of maltodextrin to the solids content of the fluid extract is 6-7. .
In some preferred embodiments, the fluid extract is prepared by the following steps:
step 1) decocting fructus cannabis, folium callicarpae peduncularis, flos sophorae, flos lonicerae, garden burnet root, white paeony root, lalang grass rhizome, oriental wormwood and fructus aurantii with water, filtering, concentrating, adding ethanol, standing, filtering again to obtain supernatant, and concentrating to obtain clear paste A;
step 2) extracting pseudo-ginseng with ethanol, filtering, and concentrating the filtrate to obtain clear paste B;
and 3) combining the clear paste A and the clear paste B to obtain the clear paste.
In some preferred embodiments, the fluid extract is prepared by the following steps:
step 1) decocting 9 medicinal materials of fructus cannabis, folium callicarpae pedunculatae, flos sophorae, lonicerae flos, garden burnet root, white paeony root, lalang grass rhizome, oriental wormwood and fructus aurantii for 1-3 times by using 10-20 times of water, wherein each time lasts for 1-3 hours, the decoction is filtered and mixed, the mixture is concentrated to 1-1.5;
step 2) extracting the pseudo-ginseng for 1-3 times by using 70% ethanol with the weight of 4-6 times, filtering, concentrating the filtrate to obtain clear paste B with the relative density of 1.1-1.3 ((30 ℃);
and 3) combining the clear paste A and the clear paste B to obtain the clear paste.
In some preferred embodiments, in step 1) or step 2), the herbs are subjected to a pulverization step before extraction.
In some preferred embodiments, the components are used in amounts of parts by weight
100-150 parts of fructus cannabis, 100-150 parts of folium callicarpae pedunculatae, 50-100 parts of flos sophorae, 50-100 parts of lonicera confusa, 50-100 parts of sanguisorba officinalis, 50-100 parts of radix paeoniae alba, 5-10 parts of pseudo-ginseng, 100-150 parts of lalang grass rhizome, 50-100 parts of oriental wormwood and 50-100 parts of fructus aurantii.
In some preferred embodiments, the components are used in amounts of parts by weight
150 parts of fructus cannabis, 150 parts of folium callicarpae formosanae, 75 parts of flos sophorae, 75 parts of lonicera confusa, 75 parts of radix sanguisorbae, 60 parts of radix paeoniae alba, 5 parts of pseudo-ginseng, 150 parts of lalang grass rhizome, 75 parts of oriental wormwood and 50 parts of fructus aurantii.
In some preferred embodiments, in step 1), the relative density of clear paste a is 1.20 to 1.26, and the relative density of clear paste B in step 2) is 1.20 to 1.26.
In some preferred embodiments, the drying is performed using vacuum belt drying.
In some preferred embodiments, the drying conditions of the belt vacuum drying are: the temperature range of the first zone is 100-110 ℃, the temperature range of the second zone is 80-100 ℃, the temperature range of the third zone is 70-90 ℃, the temperature range of the fourth zone is 30-40 ℃, and the vacuum degree is 80-100 kPa.
In some preferred embodiments, the pulverizing is to 30-50 mesh.
In some preferred embodiments, the solid formulation is filled into capsules after pulverization.
The maltodextrin used in the invention is a derivative which is prepared by hydrolyzing starch or starchiness as a raw material by an enzyme method or an acid method and refining and does not contain free starch, wherein the DE value is the percentage of dry substances in the calculation of all reducing sugars as glucose.
The invention has the advantages that:
1. the invention adopts maltodextrin with proper parameters as an auxiliary material of the hemorrhoid inflammation eliminating solid preparation, and combines a proper drying method and drying parameters to obtain the solid preparation which has higher glass transition temperature (Tg) and higher stability, and does not agglomerate or form columns after being stored for a long time.
Detailed Description
Example 1
A solid preparation for treating hemorrhoid inflammation is prepared from the following components
150g of fructus cannabis, 150g of folium callicarpae formosanae, 75g of flos sophorae, 75g of lonicera confusa, 75g of radix sanguisorbae, 60g of radix paeoniae alba, 5g of pseudo-ginseng, 150g of rhizoma imperatae, 75g of herba artemisiae scopariae and 50g of fructus aurantii.
The preparation is carried out by the following steps:
step 1) crushing 9 medicinal materials of fructus cannabis, folium callicarpae pedunculatae, flos sophorae, lonicerae flos, garden burnet root, white paeony root, lalang grass rhizome, oriental wormwood and fructus aurantii, decocting for 2 times by using 10 times of water, 2 hours each time, filtering and combining decoction, concentrating to 1;
step 2) crushing the pseudo-ginseng, extracting for 3 times at 80-85 ℃ by using 70% ethanol with the weight 5 times that of the crushed pseudo-ginseng, filtering, and concentrating the filtrate to obtain clear paste B with the relative density of 1.20-1.26 (30 ℃);
and 3) combining the clear paste A and the clear paste B to obtain the clear paste for eliminating hemorrhoid inflammation.
Step 4) taking the clear paste for treating hemorrhoid inflammation obtained in the step 3), measuring the solid content, and mixing the clear paste solid: maltodextrin (DE = 10) =7:3, weighing maltodextrin and the hemorrhoid inflammation eliminating clear paste, uniformly mixing, and drying the mixture by belt type vacuum drying under the specific drying conditions:
the temperature range of the first zone is 110 ℃, the temperature range of the second zone is 80 ℃, the temperature range of the third zone is 90 ℃, the temperature range of the fourth zone is 40 ℃ and the vacuum degree is 100kPa.
And 5) crushing the dried mixture to 30-60 meshes to obtain the hemorrhoid diminishing solid preparation.
Example 2
The only difference from example 1 is that in step 4), maltodextrin (DE = 15).
Example 3
The only difference from example 1 is that in step 4) the clear paste solids: maltodextrin = 6.
Example 4
The only difference from example 1 is that in step 4), the specific drying conditions are:
the temperature range of the first zone is 100 ℃, the temperature range of the second zone is 100 ℃, the temperature range of the third zone is 70 ℃, the temperature range of the fourth zone is 30 ℃ and the vacuum degree is 80kPa.
Comparative example 1
The only difference from example 1 is that in step 4) maltodextrin (DE = 5).
Comparative example 2
The only difference from example 1 is that in step 4) maltodextrin (DE = 20).
Comparative example 3
The only difference from example 1 is that in step 4) the maltodextrin was replaced by mannitol.
Comparative example 4
The only difference from example 1 is that in step 4) the maltodextrin is replaced by sucrose.
Comparative example 5
The only difference from example 1 is that, in step 4), no maltodextrin was added.
Comparative example 6
Only differs from example 1 in that in step 4) the hemorrhoid inflammation relief fluid extract solids: maltodextrin = 4.
Comparative example 7
The only difference from example 1 is that in step 4) the maltodextrin is replaced by microcrystalline cellulose (MCC).
Comparative example 8
The only difference from example 1 is that in step 4), the drying process is changed into spray drying and then wet granulation, and the specific spray drying conditions are as follows: the air inlet temperature is 160-170 ℃, the rotational speed of the atomizer is 18000r/min, the power of the material receiving fan is 85%, the feeding speed is 11-14, the power of the exhaust fan is 85%, and the hot air heating temperature is 40 ℃; the wet granulation conditions are that the bottom materials are spray drying powder and maltodextrin, the adhesive is 80-90% ethanol, and the mixture is stirred and granulated and dried at 60 ℃.
Comparative example 9
The difference from the example 1 is only that in the step 4), the drying process is changed into the pulsating vacuum drying, and the specific pulsating vacuum drying conditions are as follows:
1-stage pulsing 6-12 seconds waiting 0.5 seconds
2-stage pulse 25-30 seconds waiting for 0.5-1 second
3-phase pulsing 35-45 seconds wait 1 second.
Comparative example 10
The only difference from example 1 is that in step 4), the maltodextrin was replaced by microcrystalline cellulose (MCC) and the drying process was changed to pulsating vacuum drying, the specific pulsating vacuum drying conditions being:
1-stage pulsing 6-12 seconds waiting 0.5 seconds
2-stage pulsing 25-30 seconds waiting 0.5-1 second
3-phase pulsing 35-45 seconds wait 1 second.
Examples of effects
Tg test: the sample was tested for a gaseous atmosphere of high purity nitrogen (> 99.999%) with a gas flow of 20mL/min. The sample loading is about 9-10 mg. The scanning procedure comprises heating from-50 deg.C to 120 deg.C at 100 deg.C min-1, keeping the temperature for 5min, cooling from 120 deg.C to-50 deg.C at 100 deg.C min-1, keeping the temperature for 5min, and continuously scanning from-50 deg.C at a heating rate of 20 deg.C min-1, and heating to 120 deg.C. The half-width temperature of the curve was taken as the characteristic value of Tg.
And (3) stability testing: the materials of each example and comparative example were encapsulated, and placed in a high temperature (50 ℃) stability box using aluminum-plastic-aluminum as an outer package, and the dispersibility of the materials was observed every 10 days.
Table 1 results of the effect test
| Sample name | Tg/℃ | Stability (high temperature condition 50 ℃ C.) |
| Example 1 | 58.17 | Good dispersion in 4 months |
| Example 2 | 56.51 | Good dispersion in 4 months |
| Example 3 | 53.23 | Good dispersion in 4 months |
| Example 4 | 50.52 | Good dispersion in 4 months |
| Comparative example 1 | 49.52 | Slightly caking in 2 months and pillaring in 3 months |
| Comparative example 2 | 45.42 | Slightly caking in 2 months and pillaring in 3 months |
| Comparative example 3 | 44.39 | Slightly caking in 2 months and pillaring in 70 days |
| Comparative example 4 | 42.22 | Slightly caking in 2 months and pillaring in 70 days |
| Comparative example 5 | 51.59 | After 10 days, the extract is self-adhered to form a column |
| Comparative example 6 | 52.11 | Good dispersion in 3 months and slightly caking in 4 months |
| Comparative example 7 | 23.06 | 5 days into column |
| Comparative example 8 | 44.75 | Pillar formation for 10 days |
| Comparative example 9 | 23.56 | 5 days into column |
| Comparative example 10 | 26.54 | 5 days into column |
It can be seen that in the examples of the present invention, the formulation pillaring and glass transition temperature are related, when the Tg is higher, the long-term storage stability of the formulation is better, when the moisture content is dried to be less than 4%, the prepared solid formulation has better long-term stability, the dispersion can be maintained well for 4 months at 50 ℃, and when the moisture content is more than 4%, the stability is greatly reduced, and the agglomeration phenomenon occurs in two months under the 50 ℃ stability test. In addition, it can be seen from comparative examples 5, 6 and 7 that maltodextrin is essential for the stability of the solid preparation of the present invention, and when maltodextrin is not added or added little (20%), the prepared solid preparation cannot be stored for a long period of time, and when maltodextrin is replaced with MCC (microcrystalline cellulose), the preparation stability of the prepared solid preparation at 50 ℃ cannot be ensured. As can be seen from comparative examples 8 and 9, different drying processes also have a large influence on the stability of the solid preparation of the present invention, and the stability of the solid preparation cannot meet the requirement of long-term storage even though the moisture content is controlled to be 4% or less by using the spray drying process or the pulsating vacuum drying process.
Finally, it should be noted that the above-mentioned contents are only used for illustrating the technical solutions of the present invention, and not for limiting the protection scope of the present invention, and that the simple modifications or equivalent substitutions of the technical solutions of the present invention by those of ordinary skill in the art can be made without departing from the spirit and scope of the technical solutions of the present invention.
Claims (10)
1. A solid preparation for treating hemorrhoid inflammation is prepared from fructus Cannabis, folium Callicarpae Formosanae, flos Sophorae Immaturus, flos Lonicerae, radix Sangusorbae, radix Paeoniae alba, notoginseng radix, lalang grass rhizome, herba Artemisiae Scopariae and fructus Aurantii by extracting to obtain fluid extract, mixing with maltodextrin, drying, and pulverizing.
2. The solid formulation according to claim 1, wherein the maltodextrin has a DE value of 10 to 15.
3. The solid preparation according to claim 1, wherein the ratio of the amount of maltodextrin to the solid content of the fluid extract is 6-7.
4. The solid preparation according to claim 1, wherein the fluid extract is prepared by the following steps:
step 1) decocting fructus cannabis, folium callicarpae formosanae, flos sophorae, flos lonicerae, garden burnet root, white paeony root, lalang grass rhizome, oriental wormwood and fructus aurantii with water, filtering, concentrating, adding ethanol, standing, filtering again to obtain supernatant, and concentrating to obtain clear paste A;
step 2) extracting pseudo-ginseng with ethanol, filtering, and concentrating the filtrate to obtain clear paste B;
and 3) combining the clear paste A and the clear paste B to obtain the clear paste.
5. The solid preparation according to claim 4, wherein the fluid extract is prepared by the following steps:
step 1) decocting 9 medicinal materials of fructus cannabis, folium callicarpae pedunculatae, flos sophorae, lonicerae flos, garden burnet root, white paeony root, lalang grass rhizome, oriental wormwood and fructus aurantii for 1-3 times by using 10-20 times of water, wherein each time lasts for 1-3 hours, filtering and merging the decoction, adding 2-4 times of ethanol for standing after concentrating to 1-1.5;
step 2) extracting the pseudo-ginseng for 1-3 times by using 60-70% ethanol with the weight of 4-6 times, filtering, concentrating the filtrate to obtain clear paste B with the relative density of 1.1-1.3;
and 3) combining the clear paste A and the clear paste B to obtain the clear paste.
6. The solid preparation according to claim 1, wherein the solid preparation comprises, in parts by weight,
100-150 parts of fructus cannabis, 100-150 parts of folium callicarpae pedunculatae, 50-100 parts of flos sophorae, 50-100 parts of lonicera confusa, 50-100 parts of sanguisorba officinalis, 50-100 parts of radix paeoniae alba, 5-10 parts of pseudo-ginseng, 100-150 parts of lalang grass rhizome, 50-100 parts of oriental wormwood and 50-100 parts of fructus aurantii.
7. The solid preparation according to claim 6,
150 parts of fructus cannabis, 150 parts of folium callicarpae formosanae, 75 parts of flos sophorae, 75 parts of lonicera confusa, 75 parts of radix sanguisorbae, 60 parts of radix paeoniae alba, 5 parts of pseudo-ginseng, 150 parts of lalang grass rhizome, 75 parts of oriental wormwood and 50 parts of fructus aurantii.
8. The solid preparation as claimed in claim 5, wherein in step 1), the relative density of the fluid extract A is 1.20-1.26, and the relative density of the fluid extract B in step 2) is 1.20-1.26.
9. The solid formulation according to claim 1, wherein the drying is carried out by vacuum belt drying.
10. The solid formulation according to claim 9, wherein the drying conditions of the belt vacuum drying are: the temperature range of the first zone is 100-110 ℃, the temperature range of the second zone is 80-100 ℃, the temperature range of the third zone is 70-90 ℃, the temperature range of the fourth zone is 30-40 ℃, and the vacuum degree is 80-100 kPa.
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Citations (3)
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| CN1596962A (en) * | 2004-07-27 | 2005-03-23 | 谢子龙 | Capsule for treating hemorrhoid inflammation and its preparation method |
| CN109287926A (en) * | 2018-12-10 | 2019-02-01 | 湖南康尔佳生物医药科技有限公司 | One kind, which is relieved inflammation or internal heat, treats hemorrhoid solid beverage and preparation method thereof |
| CN113413434A (en) * | 2020-12-03 | 2021-09-21 | 江中药业股份有限公司 | Moisture-proof Shenbao capsule and preparation method thereof |
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| CN1596962A (en) * | 2004-07-27 | 2005-03-23 | 谢子龙 | Capsule for treating hemorrhoid inflammation and its preparation method |
| CN109287926A (en) * | 2018-12-10 | 2019-02-01 | 湖南康尔佳生物医药科技有限公司 | One kind, which is relieved inflammation or internal heat, treats hemorrhoid solid beverage and preparation method thereof |
| CN113413434A (en) * | 2020-12-03 | 2021-09-21 | 江中药业股份有限公司 | Moisture-proof Shenbao capsule and preparation method thereof |
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| 刘巧丽;罗晓健;梁红波;何雁;熊磊;饶小勇;: "中药浸膏粉与辅料共混物的玻璃化转变温度对巨安神制剂干法制粒的影响", 中国实验方剂学杂志, vol. 23, no. 13, pages 13 - 17 * |
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