CN112877400A - Preparation method of microbial limit inspection test solution for cold soft capsules - Google Patents
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Abstract
The invention discloses a preparation method of a microbial limit inspection test solution for a cold soft capsule. Adding 10g of cold soft capsule into a sterilized triangular flask, adding 100mL of sodium chloride-peptone buffer solution with the pH value of 7.0, adding enzyme and surfactant, standing at 45 ℃ for 10 minutes, dissolving, beating with a homogenizer for 1 minute to form uniform suspension, and preparing into a product 1:10 test solution; adding 5g of cold soft capsule shell into a sterilized triangular flask, adding 50mL of sodium chloride-peptone buffer solution with the pH value of 7.0, adding enzyme and surfactant, placing at 45 ℃ for 10 minutes, dissolving, beating with a homogenizer for 1 minute to obtain a soft capsule shell 1:10 test solution; the test solution for the cold soft capsule and the test solution for the cold soft capsule shell form stable suspension, and the microbial limit test is completed. According to the invention, the diluent is added with enzyme and surfactant, so that the problem that the capsule shell of the cold soft capsule can not be dissolved is solved.
Description
Technical Field
The invention relates to a preparation method of a microbial limit inspection test solution for a cold soft capsule, belonging to the technical field of experimental instruments.
Background
9 and 8 enterprises of the current production enterprises of cold soft capsules do not provide a preparation method of a test solution for microbial limit inspection, and a conventional method for preparing the test solution for four parts of the national pharmacopoeia 2015 is adopted in the inspection; 1, a method for providing enterprises: 5g of a sample is taken and added into a beaker containing a sterile mixture of 5g of dissolved span 80, 3g of glycerin monostearate and 10g of polysorbate 80, the mixture is stirred by a sterile glass rod to form a mass, and then sterile sodium chloride-peptone buffer solution with pH of 7.0 at about 45 ℃ is slowly added to 100mL, and the mixture is dissolved by stirring to obtain a 1: 20 sample solution. In the conventional preparation method of the test solution, the capsule shell of the cold soft capsule cannot be broken and cannot form a suspension, and in the other 1 method of adding the surfactant, the glyceryl monostearate is not easy to melt, and the suspension is viscous due to a large amount of the surfactant, so that further test cannot be easily carried out.
The capsule shell of the cold soft capsule consists of gelatin, glycerin, water, opacifier, antioxidant and the like, and the capsule shell cannot be broken and dissolved and cannot form suspension in the microbial limit inspection, so that the test cannot be carried out.
Disclosure of Invention
In view of the above, the invention provides a preparation method of a test solution for microbial limit inspection of cold soft capsules, wherein enzymes and surfactants are added into a diluent, a capsule shell of the cold soft capsules can be dissolved, and the method applicability research is carried out according to a method for microbial limit inspection of four parts of the national pharmacopoeia 2015 edition.
The invention solves the technical problems by the following technical means:
the invention discloses a preparation method of a microbial limit inspection test solution for a cold soft capsule, which comprises the following steps:
1) preparing a cold soft capsule test solution, namely adding 10g of cold soft capsules into a sterilized triangular flask, adding 100mL of sodium chloride-peptone buffer solution with the pH value of 7.0, adding enzyme and surfactant, placing at the temperature of 45 ℃ for 10 minutes, dissolving, beating for 1 minute by using a homogenizer to form a uniform suspension, and preparing into a product 1:10 test solution;
2) preparing a test solution for cold soft capsule shells, namely adding 5g of cold soft capsule shells into a sterilized triangular flask, adding 50mL of sodium chloride-peptone buffer solution with the pH value of 7.0, adding enzyme and surfactant, placing at 45 ℃ for 10 minutes, dissolving, beating for 1 minute by using a homogenizer, and preparing into a product 1:10 test solution;
3) the test solution for the cold soft capsule and the test solution for the cold soft capsule shell form stable suspension, and the microbial limit test is completed.
The concentration of sodium chloride in the sodium chloride-peptone buffer solution in the step (1) and the step (2) is 0.1-0.5 mol/L.
In the step (1) and the step (2), the enzyme is lipase, the surfactant is any one of hydrophobic surfactants, the mass of the added enzyme is 0.001-0.01g, and the mass of the added surfactant is 0.5-1 g.
The microbial limit inspection of the medicine is an important index of medicine inspection, and the inspection is meaningful only by reflecting the real microbial pollution state of the medicine through a scientific and reasonable microbial limit inspection method. According to the regulation and requirements of the four parts of the Chinese pharmacopoeia 2015 edition, the research on the applicability of the microbial limit method is a necessary process for establishing a microbial limit detection method of the medicine, and is a feasible and unique way of the method.
The cold soft capsule is a variety recorded in the sixth volume of ministerial standard Chinese medicinal prescription preparation, and is composed of 14 pure Chinese medicaments such as ephedra herb, cassia twig, baical skullcap root, divaricate saposhnikovia root, kudzuvine root and the like. The Chinese medicinal composition has the effects of dispelling wind and relieving fever, and is used for treating headache, fever, nasal obstruction, watery nasal discharge, aversion to cold, no sweat, aching pain of joints and sore throat caused by exogenous wind-cold. The ephedra has the effects of sweating, relieving asthma, promoting diuresis, treating typhoid fever, exterior excess, fever, aversion to cold, no sweat, headache, nasal obstruction and joint pain; cough and asthma; edema due to wind and water, difficult urination; stubborn wind-evil, dull skin, rubella and pruritus. Has wide clinical application.
The capsule shell of the cold soft capsule consists of gelatin, glycerin, water, an opacifier, an antioxidant and the like, and the capsule shell cannot be broken and dissolved and cannot form suspension in the microbial limit inspection, so that the test cannot be carried out.
2019, national appraisal inspection, relating to 9 manufacturers of soft capsules for cold. The preparation method of the test solution is not applicable to the microorganism limit detection method provided by enterprises, some enterprise samples cannot be subjected to microorganism limit detection, and the microorganism limit detection result cannot reflect the microbial contamination condition of the medicine.
The cold soft capsule production enterprises provide a test solution preparation method, and the capsule shells of 1 cold soft capsule cannot be broken and cannot form suspension, so that the test cannot be carried out; in the other 1 method of adding the surfactant, the glyceryl monostearate is not easy to melt, and due to a large amount of the surfactant, the suspension is viscous and is not easy to further test.
According to the invention, the diluent is stored at a proper temperature, the enzyme and the surfactant are added when the diluent is used, the capsule shell of the cold soft capsule can be dissolved, the method applicability research is carried out according to a method for checking the limit of four microorganisms in the 'Chinese pharmacopoeia' 2015 edition, the diluent has no inhibiting effect on indicator bacteria, and the method is feasible.
The invention solves the problem that the sample can not be dissolved out in the preparation process of the cold soft capsule test solution, forms suspension, and can finish the microbial limit inspection test.
The invention solves the preparation of all soft capsule test solutions consisting of gelatin, glycerin, water, opacifier, antioxidant and the like. Including other medicines, health products, foods and cosmetics.
The invention has the beneficial effects that: enzyme and surfactant are added into diluent, the capsule shell of the cold soft capsule can be dissolved, the method applicability research is carried out according to the limit inspection method of four microorganisms in 2015 edition of Chinese pharmacopoeia, the diluent has no inhibition effect on indicator bacteria, and the method is feasible.
Drawings
FIG. 1 is a photograph (pH7.0 sodium chloride peptone buffer) of a test solution preparation of Beijing Tongrentang Ganmao capsule;
FIG. 2 is a photograph (pH7.0 sodium chloride peptone buffer solution) of a test solution preparation of the Xueyinghua common cold capsule;
FIG. 3 is a photograph (pH7.0 sodium chloride peptone buffer) of a test solution prepared from TIANJINZHONGXINGANMAO Capsule;
FIG. 4 is a photograph of a test solution for Tianjin Zhongxin Ganmao capsule (pH7.0 sodium chloride peptone buffer solution + Tween + glycerol);
FIG. 5 is a photograph (pH7.0 sodium chloride peptone buffer) of Shanxi yellow river capsule for treating common cold;
FIG. 6 is a photograph (pH7.0 sodium chloride peptone buffer) of a test solution prepared from Shenwei pharmaceutical common cold capsules;
FIG. 7 shows the Guizhou Jinyu cold soft capsule solution (solution A);
FIG. 8 shows a solution (solution A) of XUEYINGHUA Soft Capsule for treating common cold;
FIG. 9 shows Shanxi Huanghe Ganmao Soft Capsule solution (solution A);
FIG. 10 shows the Guizhou shunjian cold soft capsule solution (solution A);
FIG. 11 is a soluble liquid (solution A) of Tianjin Chinese medicinal soft capsule for treating common cold;
FIG. 12 is a Beijing Tongrentang Ganmao Soft Capsule solution (solution A);
FIG. 13 shows capsule shells of different enterprises of the soft capsule for treating common cold;
FIG. 14 is a solution of capsule shell A of soft capsule for treating common cold of different manufacturers;
FIG. 15 dissolving the capsule shell A of the soft capsule of different manufacturers for treating common cold;
FIG. 16 dissolving liquid A of soft capsule shell of common cold capsule of different manufacturers;
FIG. 17 is a suspension prepared from capsule shell of GANMAO Soft Capsule in Beijing Tongrentang;
FIG. 18 shows a suspension formulation made from the capsule shell of a Jilin Tonghua Ganmao Soft Capsule;
FIG. 19 shows a suspension preparation made from the shell of the soft capsule of cherokee rose for treating common cold;
FIG. 20 is a graph of the process applicability recovery of the present invention (1: 10);
FIG. 21 shows the process applicability recovery of the present invention (1: 50).
Detailed Description
The present invention will be described in detail with reference to the following specific examples, wherein the method for preparing the test solution for testing the microbial limitation of the soft capsule for treating cold of the present embodiment comprises the following steps:
1) preparing a cold soft capsule test solution, namely adding 10g of cold soft capsules into a sterilized triangular flask, adding 100mL of sodium chloride-peptone buffer solution with the pH value of 7.0, adding enzyme and surfactant, placing at the temperature of 45 ℃ for 10 minutes, dissolving, beating for 1 minute by using a homogenizer to form a uniform suspension, and preparing into a product 1:10 test solution;
2) preparing a test solution for cold soft capsule shells, namely adding 5g of cold soft capsule shells into a sterilized triangular flask, adding 50mL of sodium chloride-peptone buffer solution with the pH value of 7.0, adding enzyme and surfactant, placing at 45 ℃ for 10 minutes, dissolving, beating for 1 minute by using a homogenizer, and preparing into a product 1:10 test solution;
3) the test solution for the cold soft capsule and the test solution for the cold soft capsule shell form stable suspension, and the microbial limit test is completed.
The concentration of sodium chloride in the sodium chloride-peptone buffer solution in the step (1) and the step (2) is 0.1-0.5 mol/L.
In the step (1) and the step (2), the enzyme is lipase, the surfactant is any one of hydrophobic surfactants, the mass of the added enzyme is 0.001-0.01g, and the mass of the added surfactant is 0.5-1 g.
Example 1
The preparation method of the microbial limit inspection test solution for the cold soft capsules comprises the following steps:
1) preparing a cold soft capsule test solution, namely adding 10g of cold soft capsules into a sterilized triangular flask, adding 100mL of sodium chloride-peptone buffer solution with the pH value of 7.0, adding enzyme and surfactant, placing at the temperature of 45 ℃ for 10 minutes, dissolving, beating for 1 minute by using a homogenizer to form a uniform suspension, and preparing into a product 1:10 test solution;
2) preparing a test solution for cold soft capsule shells, namely adding 5g of cold soft capsule shells into a sterilized triangular flask, adding 50mL of sodium chloride-peptone buffer solution with the pH value of 7.0, adding enzyme and surfactant, placing at 45 ℃ for 10 minutes, dissolving, beating for 1 minute by using a homogenizer, and preparing into a product 1:10 test solution;
3) the test solution for the cold soft capsule and the test solution for the cold soft capsule shell form stable suspension, and the microbial limit test is completed.
The concentration of sodium chloride in the sodium chloride-peptone buffer solution in the step (1) and the step (2) is 0.2 mol/L.
In the step (1) and the step (2), the enzyme is amylase, the surfactant is polyethylene glycol, the mass of the added amylase is 0.004g, and the mass of the added surfactant is 0.6 g.
Example 2
The preparation method of the microbial limit inspection test solution for the cold soft capsules comprises the following steps:
1) preparing a cold soft capsule test solution, namely adding 10g of cold soft capsules into a sterilized triangular flask, adding 100mL of sodium chloride-peptone buffer solution with the pH value of 7.0, adding enzyme and surfactant, placing at the temperature of 45 ℃ for 10 minutes, dissolving, beating for 1 minute by using a homogenizer to form a uniform suspension, and preparing into a product 1:10 test solution;
2) preparing a test solution for cold soft capsule shells, namely adding 5g of cold soft capsule shells into a sterilized triangular flask, adding 50mL of sodium chloride-peptone buffer solution with the pH value of 7.0, adding enzyme and surfactant, placing at 45 ℃ for 10 minutes, dissolving, beating for 1 minute by using a homogenizer, and preparing into a product 1:10 test solution;
3) the test solution for the cold soft capsule and the test solution for the cold soft capsule shell form stable suspension, and the microbial limit test is completed.
The concentration of sodium chloride in the sodium chloride-peptone buffer solution in the step (1) and the step (2) is 0.5 mol/L.
In the step (1) and the step (2), the enzyme is lipase, the surfactant is any one of hydrophobic surfactants, the mass of the added enzyme is 0.001-0.01g, and the mass of the added surfactant is 0.5-1 g.
Example 3
1. Preparing a cold soft capsule test solution, namely adding 10g of cold soft capsules into a sterilized triangular flask, adding 100ml of pH7.0 sodium chloride-peptone buffer solution, adding enzyme and surfactant, placing at 45 ℃ for 10 minutes, dissolving, beating with a homogenizer for 1 minute, and preparing into a product 1:10 a test solution to be tested is added,
according to the invention, the enzyme and the surfactant are added into the diluent, so that the cold soft capsule can be dissolved to form uniform suspension. The cold soft capsules of 6 different manufacturers can realize dispersion and form suspension. Respectively, Guizhou Jinyu, Xueya Yinghua, Shanxi Huanghe, Guizhou Shunjian, Tianjin Chinese medicine and Beijing Tongrentang Ganmao capsule for treating common cold.
2. Preparation of test solution for capsule shell of soft capsule for treating common cold
Adding 5g of cold soft capsule shell into a sterilized triangular flask, adding 50ml of pH7.0 sodium chloride-peptone buffer solution, adding enzyme and surfactant, standing at 45 deg.C for 10 min, dissolving, beating with a homogenizer for 1 min to obtain 1:10 test solutions.
According to the invention, the enzyme and the surfactant are added into the diluent, so that the capsule shell of the cold soft capsule can be dissolved. The cold soft capsules of 6 different manufacturers can realize dispersion and form suspension. Respectively, Guizhou Jinyu, Xueya Yinghua, Shanxi Huanghe, Guizhou Shunjian, Tianjin Chinese medicine and Beijing Tongrentang Ganmao capsule for treating common cold.
3. Method for preparing test solution for microbial limit detection of soft capsule for treating common cold
Adding cold soft capsule 10g into sterilized triangular flask, adding pH7.0 sodium chloride-peptone buffer solution 100ml, adding enzyme and surfactant into the other 1 group, standing at 45 deg.C for 10 min, dissolving, beating with homogenizer for 1 min to obtain 1:10 test solutions.
Adding 1 group of pH7.0 sodium chloride-peptone buffer solution, the capsule shell of the cold soft capsule obviously exists, adding 1 group of enzyme, and melting the capsule shell of the cold soft capsule to obtain suspension preparation.
4. Establishment of microbial limit inspection method for cold soft capsules
According to the invention, the enzyme and the surfactant are added into the diluent, so that the capsule shell of the cold soft capsule can be dissolved. According to the limit inspection method of microorganisms in four parts of the year 2015 edition of Chinese pharmacopoeia, the method applicability research is carried out, the diluent has no inhibition effect on the indicator bacteria, and the method is feasible.
Example 4
The cold soft capsule production enterprises provide a test solution preparation method, and the capsule shells of 1 cold soft capsule cannot be broken and cannot form suspension, so that the test cannot be carried out; in the other 1 method of adding the surfactant, the glyceryl monostearate is not easy to melt, and due to a large amount of the surfactant, the suspension is viscous and is not easy to further test. As shown in fig. 1-6, respectively: beijing Tongrentang (pH7.0 sodium chloride peptone buffer); snow cherry (pH7.0 sodium chloride peptone buffer); tianjin Chinese medicine industry, pH7.0 sodium chloride peptone buffer solution; tianjin Chinese medicine, pH7.0 sodium chloride peptone buffer solution + Tween + glycerol; shanxi yellow river (pH7.0 sodium chloride peptone buffer); shenwei pharmaceutical industry (pH7.0 sodium chloride peptone buffer).
Adding cold soft capsule 10g into sterilized triangular flask, adding pH7.0 sodium chloride-peptone buffer solution 100ml, adding enzyme and surfactant, standing at 45 deg.C for 10 min, dissolving, beating with homogenizer for 1 min to obtain 1:10 a test solution to be tested is added,
according to the invention, the enzyme and the surfactant are added into the diluent, so that the cold soft capsule can be dissolved to form uniform suspension. Referring to FIGS. 7-12, Guizhou Jinyu (solution A); snow cherry blossom (liquid a); shanxi yellow river (liquid a); guizhou shunjian (liquid A); tianjin Chinese medicine (liquid A); beijing Tongrentang (liquid A).
Adding 5g of cold soft capsule shell into a sterilized triangular flask, adding 50ml of pH7.0 sodium chloride-peptone buffer solution, adding enzyme and surfactant, standing at 45 deg.C for 10 min, dissolving, beating with a homogenizer for 1 min to obtain 1:10 test solutions.
According to the invention, the enzyme and the surfactant are added into the diluent, so that the capsule shell of the cold soft capsule can be dissolved. See fig. 13-16. The method comprises the following steps: capsule shells of different enterprises of the cold soft capsule; dissolving the capsule shell A of the cold soft capsule; dissolving the capsule shell A of the cold soft capsule; dissolving the capsule shell A solution of the cold soft capsule.
Compared with the preparation method of the microbial limit inspection test solution of the soft capsule for treating the cold,
adding cold soft capsule 10g into sterilized triangular flask, adding pH7.0 sodium chloride-peptone buffer solution 100ml, adding enzyme and surfactant into the other 1 group, standing at 45 deg.C for 10 min, dissolving, beating with homogenizer for 1 min, and making into 1:10 test solutions. Adding 1 group of pH7.0 sodium chloride-peptone buffer solution, the capsule shell of the cold soft capsule obviously exists, adding 1 group of enzyme, and melting the capsule shell of the cold soft capsule to obtain suspension preparation. See fig. 17-19. Respectively Beijing Tongrentang; carrying out general digestion on Jilin; snow cherry blossom.
The microbial limit inspection method of the cold soft capsule is established.
According to the invention, the enzyme and the surfactant are added into the diluent, so that the capsule shell of the cold soft capsule can be dissolved. According to the limit inspection method of microorganisms in four parts of the year 2015 edition of Chinese pharmacopoeia, the method applicability research is carried out, the diluent has no inhibition effect on the indicator bacteria, and the method is feasible. See fig. 20 and 21. The process applicability recovery (1:10) and the process applicability recovery (1:50), respectively.
Finally, the above embodiments are only for illustrating the technical solutions of the present invention and not for limiting, although the present invention has been described in detail with reference to the preferred embodiments, it should be understood by those skilled in the art that modifications or equivalent substitutions may be made to the technical solutions of the present invention without departing from the spirit and scope of the technical solutions of the present invention, and all of them should be covered in the claims of the present invention.
Claims (3)
1. The preparation method of the microbial limit inspection test solution of the cold soft capsule is characterized in that,
1) preparing a cold soft capsule test solution, namely adding 10g of cold soft capsules into a sterilized triangular flask, adding 100mL of sodium chloride-peptone buffer solution with the pH value of 7.0, adding enzyme and surfactant, placing at the temperature of 45 ℃ for 10 minutes, dissolving, beating for 1 minute by using a homogenizer to form a uniform suspension, and preparing into a product 1:10 test solution;
2) preparing a test solution for cold soft capsule shells, namely adding 5g of cold soft capsule shells into a sterilized triangular flask, adding 50mL of sodium chloride-peptone buffer solution with the pH value of 7.0, adding enzyme and surfactant, placing at 45 ℃ for 10 minutes, dissolving, beating for 1 minute by using a homogenizer, and preparing into a product 1:10 test solution;
3) the test solution for the cold soft capsule and the test solution for the cold soft capsule shell form stable suspension, and the microbial limit test is completed.
2. The method for preparing a microbial limit test solution for a cold soft capsule according to claim 1, wherein the method comprises the following steps: the concentration of sodium chloride in the sodium chloride-peptone buffer solution in the step (1) and the step (2) is 0.1-0.5 mol/L.
3. The method for preparing a microbial limit test solution for a cold soft capsule according to claim 1, wherein the method comprises the following steps: in the step (1) and the step (2), the enzyme is lipase, the surfactant is any one of hydrophobic surfactants, the mass of the added enzyme is 0.001-0.01g, and the mass of the added surfactant is 0.5-1 g.
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Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| KR20040040882A (en) * | 2002-11-08 | 2004-05-13 | 한미약품 주식회사 | A composition for oral administration of water-insoluble anti-cold drug and a preparation method thereof |
| CN102539588A (en) * | 2011-11-11 | 2012-07-04 | 云南良方制药有限公司 | Method for preparing test solution for quality detection of safe stagnation removing preparation |
| CN111235213A (en) * | 2018-11-29 | 2020-06-05 | 广州迈达康医药科技有限公司 | Method for checking total aerobic bacteria number of ranitidine hydrochloride capsule |
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2020
- 2020-12-21 CN CN202011533020.7A patent/CN112877400A/en active Pending
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| KR20040040882A (en) * | 2002-11-08 | 2004-05-13 | 한미약품 주식회사 | A composition for oral administration of water-insoluble anti-cold drug and a preparation method thereof |
| CN102539588A (en) * | 2011-11-11 | 2012-07-04 | 云南良方制药有限公司 | Method for preparing test solution for quality detection of safe stagnation removing preparation |
| CN111235213A (en) * | 2018-11-29 | 2020-06-05 | 广州迈达康医药科技有限公司 | Method for checking total aerobic bacteria number of ranitidine hydrochloride capsule |
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| Title |
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| MITSUKO TABA OHARA ET AL.: ""Application of Triphenyltetrazolium Chloride in Microbial Limit Test of Pharmaceuticals and Cosmetics"", 《JOURNAL OF AOAC INTERNATIONAL》, vol. 78, no. 6, pages 1525 - 1529 * |
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